Traditional Chinese medicine composition for treating constipation after invasive mechanical ventilation, preparation and application

Abstract

The invention relates to the field of traditional Chinese medicine, and discloses a traditional Chinese medicine composition for treating constipation after invasive mechanical ventilation, a preparation and application. The active ingredient raw materials of the traditional Chinese medicine composition comprise the following raw materials in parts by weight: 10-20 parts of raw rhubarb, 15-25 parts of fried immature bitter orange, 10-20 parts of mirabilite, 5-15 parts of coptis chinensis, 15-25 parts of radix scrophulariae, 25-35 parts of honey-fried astragalus membranaceus, 5-15 parts of ginseng and 25-35 parts of roasted radix asteris. The primordial qi tonifying, toxic material counteracting and qi supporting decoction has a good effect on improving the constipation symptom of a patient after the invasive mechanical ventilation operation, has a good effect on improving the constipation symptom of the patient after the invasive mechanical ventilation operation, promoting gastrointestinal emptying, inducing defecation, improving pulmonary ventilation and the like, and is rapid and direct in curative effect and free of toxic and side effects. Particularly, the medicine has the advantages which western medicines do not have in the aspect of quickly inducing defecation, and is safe and reliable.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition, preparation and application for treating constipation after invasive mechanical ventilation. Background Art

[0002] Constipation after invasive ventilation is a gastrointestinal complication of postoperative respiratory support in critically ill patients. Due to the effects of anesthetic drugs, the respiratory muscles of patients are paralyzed for a period of time after surgery, and the active respiratory rhythm disappears, resulting in the need for postoperative patients to rely on ventilator support for respiratory maintenance. Under mechanical respiratory conditions, part of the airflow enters the gastrointestinal tract through the upper digestive tract, causing excessive inflation of the gastrointestinal tract, leading to abdominal distension in patients under invasive ventilation; at the same time, due to gastrointestinal paralysis caused by the use of anesthetic drugs, the transient decrease of motilin and gastrin after surgery is not conducive to gastrointestinal activity and emptying, and together induces the occurrence of postoperative constipation. In response to the symptoms of constipation after invasive ventilation, some researchers have systematically elaborated on its mechanism, risk factors, diagnosis and treatment status, etc., formed a general understanding of constipation after invasive ventilation, and put forward practical treatment suggestions for the postoperative rehabilitation of such patients. In terms of clinical treatment, although cathartics, active biological preparations, Chinese medicine / Chinese patent medicine preparations with cathartic effects, acupuncture, moxibustion, and massage have certain effects on relieving postoperative constipation and abdominal distension, they also show some shortcomings in specific studies, which are prominently reflected in the unclear time nodes of intervention, the lack of systematic evaluation standards, and the lack of integration between traditional Chinese medicine diagnosis and modern medicine quantitative evaluation. Therefore, further strengthening targeted diagnosis and treatment based on reasonable diagnosis is the primary task of future clinical treatment of postoperative constipation after invasive mechanical ventilation.

[0003] Defecation, also known as "excretion", refers to the biological process of the body excreting undigested food residues through the digestive tract. It is also an important way to maintain normal metabolism. In this process, gastrointestinal function, defecation reflex, and anal contraction and expansion will all affect normal defecation. The biological significance of defecation is mainly reflected in maintaining normal eating, reducing gastrointestinal pressure, reducing intra-abdominal pressure, and avoiding endogenous poisoning caused by accumulation of metabolites. It is extremely important for maintaining normal digestive stability.

[0004] There are many factors that induce defecation disorders after invasive ventilation. First, since the reflex center that controls defecation is located in the spinal cord, its reflex pathway is easily affected by many factors and defecation disorders occur. The more common ones are neurogenic rectal and spinal anesthesia caused by spinal cord injury. Defecation disorders in patients after invasive mechanical ventilation are of this type. Second, gastrointestinal nerves belong to autonomic nerves, and their functions are relatively autonomous and not regulated by subjective consciousness. Under the dual induction of internal and external factors, the possibility of autonomic dysfunction is high. Defecation disorders induced by this are more common, and traumatic stress gastrointestinal dysfunction is of this type. Third, another important auxiliary factor of gastrointestinal emptying is intra-abdominal pressure. Under normal conditions, intra-abdominal pressure can promote the release of gastrointestinal emptying function and quickly transfer and decompose food. However, under pathological conditions, due to the damage of lung function, the patient's active respiratory function is lost or weakened, the intra-abdominal pressure is relatively reduced, the emptying speed of gastrointestinal contents is slowed down, the intestinal retention time is prolonged, and the excessive reabsorption of water in metabolites causes dryness, which hinders the discharge of normal digestive products. This is an important cause of constipation in the state of impaired lung function. Fourth, another reason that is easily overlooked by researchers is the impact of nasogastric feeding after invasive ventilation. In this state, the function of the patient's upper digestive tract in participating in food digestion is greatly weakened. The mushy food is quickly decomposed after entering the stomach, and the indigestible part cannot be further decomposed and absorbed by the intestines. It is easy to deposit in the stomach and intestines, forming the original source of dry stool. At the same time, the lack of access to fibrous food prevents the undigested residue from being effectively aggregated to form shaped feces and excreted, accumulating in the intestines to form stool, inducing abdominal distension and constipation. Furthermore, the patient's intestinal vitamins and trace elements are deficient, and the stable reproduction and property preservation of intestinal probiotics cannot be effectively maintained, making it difficult to further digest food residues, and eventually forming stool accumulation. In addition, the patient drinks less water and lacks water in the intestine, which further aggravates the symptoms of constipation. Studies have shown that the proportion of patients who eat through a nasogastric tube after invasive surgery and those who eat independently are 82% and 23% respectively, with a significant difference between the two, indicating that eating through a nasogastric tube may be an important factor inducing postoperative constipation in patients. Therefore, it is of significant clinical significance to reasonably regulate the postoperative status of patients and remove the nasogastric tube as soon as possible to improve postoperative nutrition and promote the normal functioning of digestive function.

[0005] The persistence of constipation after invasive mechanical ventilation is very detrimental to the patient's postoperative recovery, and to a considerable extent increases the severity of the disease, with a high clinical risk. Based on current clinical observations, the risk of constipation after invasive mechanical ventilation is manifested in the following aspects.

[0006] First, it induces or aggravates deep lung infection. Microbiological studies have confirmed that there is a wide and profound microbial connection between the lung and the intestine, especially in terms of the interaction between the two, that is, biphasic infection. The distribution of pulmonary flora is affected by the lung structure and presents completely different characteristics of the upper and lower respiratory tracts. The main flora in the upper respiratory tract (especially the mouth and nose) is aerobic flora, which also includes a large number of anaerobic bacteria; while the main flora in the lower respiratory tract (bronchial and alveolar) is Bacteroidetes, Firmicutes and Proteobacteria. Under normal conditions, there is a certain regularity in the transfer of flora between the upper and lower respiratory tracts in the lung flora, and the clearance of specific flora by lung epithelial cells makes the number of biological flora in the upper and lower respiratory tracts decrease, which effectively ensures the cleanliness of the lungs and prevents the occurrence of inflammatory infections. Clinical studies have confirmed that bacterial plants that are invisible under normal conditions can be found in the deep lungs under respiratory distress conditions, and they are similar to the intestinal flora under the same condition at the same time. It is speculated that the infectious flora in the deep lungs may come from intestinal transfer. Under invasive ventilation, the patient's spontaneous breathing weakens, mechanical ventilation cannot stimulate the activity of deep lung tissue at any time, and the lung epithelial cells are damaged. The bacteria that cannot attach to the lung epithelial cells at this time reproduce with the help of the damaged lung epithelial cells, further weakening the patient's lung function and increasing the probability of lung infection in the patient. At the same time, due to the homology of tissue cell differentiation between the lung and intestine, the same structural source is bound to determine the close relationship between function and pathology. The homology of respiratory and intestinal tissue sources provides a pathological structural basis for the connection between lung and intestinal microecological imbalance. Further analysis pointed out that gastrointestinal dysfunction in patients under invasive ventilation, especially constipation, indicates that the patient's intestinal flora is in an unbalanced state, and the constipation symptoms of the patient are positively correlated with the severity of the imbalance. The excessive proliferation of harmful bacteria in the intestine shows obvious characteristics of transmission to the periphery. Studies have shown that harmful intestinal flora can significantly stimulate the immunogenicity of lung epithelial cells and induce a type II immune response; or further stimulate the NF-κB inflammatory pathway to induce the occurrence of deep lung infection. Dissection of mice with induced enteritis revealed that the intestinal flora of the mice was in a state of obvious imbalance, and the composition of the lung flora was highly similar to that of the intestinal flora. Other studies have pointed out that intestinal metabolites, especially short-chain fatty acids, are important substances that effectively inhibit airway hyperresponsiveness, and their mechanism may be related to their induction of T cell differentiation. Under high-fiber dietary conditions, the number and function of Treg cells in the lungs can be effectively enhanced to avoid the occurrence of airway allergic reactions. Other studies have confirmed that the destruction of the stable state of gastrointestinal flora will accelerate the body's inflammatory response. The relevant mechanism may be that the intestinal microbiota interacts with pattern recognition receptors (PRS) to activate downstream regulatory inflammatory responses and innate immune responses.In this process, innate lymphoid cells (ILCs) play a very important role; ILCS are a type of immune effector cells, which play an important role in host defense, metabolic homeostasis, etc., and participate in tissue repair and inflammatory response processes; ILCS are less abundant in the blood circulation and abundant in mucosal barriers such as the intestines and airways. Some researchers believe that IL-25 and IL-33 can activate ILC2, induce ILC2 to migrate to the lungs, participate in rapid "type 2 immunity", and produce a large amount of IL-5 and IL-13 to participate in inflammatory responses. It can be seen that there is a significant biological correlation between the lungs and the intestines, regardless of physiological or pathological conditions, especially in terms of the functional interaction of the microbial flora of the two.

[0007] Second, it induces intestinal infection and spread of inflammation. Literature research confirms that in the postoperative state of critically ill patients with invasive ventilation, the weakening of respiratory function will lead to the weakening of the function of the beneficial flora in the upper respiratory tract, and the respiratory discharge of infected bacteria or harmful flora will be affected. They will reach the gastrointestinal tract in various ways, such as descending or through fluid exchange. These harmful flora will induce the occurrence of infectious inflammation in the body on the one hand, and weaken the activity, quantity and distribution of beneficial flora in the gastrointestinal tract on the other hand, thus leading to gastrointestinal dysfunction in postoperative patients, and severe cases will lead to gastrointestinal infection in patients. Specifically, the toxic secretions produced by the proliferation of anaerobic flora erode the intestinal mucosa and induce the occurrence of intestinal infection; the metabolites produced by the apoptosis of proliferating pathogens combine with intestinal feces, and the obstruction blocks formed by the two may induce new obstructions. In severe cases, it may also cause gastrointestinal perforation, induce abdominal infection, and increase the risk of septicemia in patients. In addition, the weakening of respiratory function and the physical weakness of patients cannot actively increase the peristalsis and emptying of the gastrointestinal tract, which together strengthen the infection symptoms of patients. The neurotoxicity produced by harmful bacteria may also cause gastrointestinal nerve poisoning and paralysis, blocking the defecation reflex, leading to aggravated infection in patients. Microbiological studies have further confirmed this inference. The neurotoxicity of harmful bacteria is currently a relatively blank research topic, but a large number of clinical studies have confirmed the existence of this effect, especially in the case of combined respiratory and digestive system diseases. This effect is diffused and locally aggregated through microcirculation patterns, especially in tissue structures such as alveoli, gastrointestinal diverticula, and intestinal mucosa. It can be seen that continued constipation after invasive mechanical ventilation is not only prone to induce gastrointestinal infection and increase the risk of infection in patients, but can also cause the spread of intestinal infection, trigger a systemic inflammatory storm, aggravate the severity of the patient's condition, and increase the risk of severe illness.

[0008] Third, it increases the risk of respiratory failure in patients. Respiratory failure that exists in patients after invasive ventilation may be aggravated by the persistence of constipation. The clinical criteria for determining respiratory failure are changes in arterial oxygen partial pressure (PaO2) and arterial carbon dioxide partial pressure (PaCO2). Under normal circumstances, the normal value of arterial oxygen partial pressure (PaO2) is 80-100 mmHg, and the normal value of arterial carbon dioxide partial pressure (PaCO2) is 35-45 mmHg. PaO2 is critical at 60 mmHg. When PaO2 is less than 60 mmHg, it can be judged as type I respiratory failure; when PaO2 is less than 60 mmHg and PaCO2 is greater than 50 mmHg, it can be judged as type II respiratory failure. When PaCO2 is greater than 45 mmHg, respiratory compensation for acidosis or alkali metabolism should be considered; when PaCO2 is less than 35 mmHg, respiratory compensation for alkaliosis or acidosis should be considered. The direct consequence of the persistence of constipation in patients after invasive ventilation is electrolyte disorder and abnormal acid-base metabolism. The reason is that, on the one hand, due to the persistence of constipation, the normal metabolism of intestinal microorganisms and beneficial flora is disturbed and in a disordered state. Under this condition, the original acid-base balance of metabolites released by various microorganisms is broken. On the other hand, due to the biological connection between the gastrointestinal tract and the lungs, the internal environment of the lungs is inevitably unbalanced. The data of this study showed that the PaCO2 of the two groups of patients before treatment was greater than 45 mmHg, indicating that the respiratory compensation pattern of acid exhalation or alkali metabolism in patients after invasive ventilation was more significant. Physiological studies have shown that the gas in the human intestine is mainly nitrogen and carbon dioxide. After being absorbed by the intestinal wall, it circulates to the lungs through the blood and is finally discharged by the respiratory system. The total amount of gas discharged is more than 20 times the amount of gas discharged directly through the anus. Therefore, when respiratory failure is complicated by constipation, its carbon dioxide retention is more obvious, which further confirms the conclusion of the experiment. Persistent respiratory failure will have an irreversible effect on the patient's lung function and may become an important factor leading to the patient's postoperative death.

[0009] The above analysis shows that the occurrence and persistence of constipation after invasive ventilation will have a profound impact on the patient's disease status and postoperative outcome. In addition, since there are relatively few studies on the symptoms of constipation after invasive ventilation in emergency critically ill patients and the relevant research has not received enough attention, it is necessary to conduct a more in-depth and systematic discussion on constipation after invasive ventilation, in order to improve diagnosis and treatment on the basis of clarifying its mechanism of occurrence and reduce the burden on patients.

[0010] Traditional Chinese medicine believes that "the lung and the large intestine are the exterior and interior of each other", and there are extensive and profound physiological and pathological connections between the two. In terms of the function of the internal organs, the lung governs qi, has the function of ascending and descending, and together with the qi of water and grain, it constitutes the "Zongqi", forming and promoting the circulation of heart blood, which is the root of the lung's qi in the whole body; at the same time, the lung governs water, has the function of regulating the waterway, and is the "upper source of water". The so-called "water essence is distributed in four directions and five meridians run in parallel" means that the body's water metabolism is sponsored by the lung qi, ascending upward and descending downward, and the water and grain essence produced by the "acquired foundation" is systematically metabolized through multiple organs, and the waste produced is discharged from the body through the intestines and bladder through the descending function. Therefore, whether the lung qi is full or not, whether the lung qi operates normally or not, and whether the ascending and descending functions of the lung are normally exerted or not all have very important functional support for the normal metabolism of related internal organs. Correspondingly, the large intestine is the "conduction organ" and governs the body's fluid. The so-called fluid refers to the relatively light and clear part of the internal organs' fluids, and the main function of fluid is "moistening". The large intestine classifies and absorbs the essence transmitted downward and then integrates it into the body's water metabolism again. The complete performance of this process depends on the ascending and descending of the lung qi. The intestines finally conduct the discarded dregs out of the body, which still depends on the descending of the lung qi. The so-called "unblocking and descending" means this. The large intestine relies on the promotion of lung qi to perform its normal defecation function, and forms the traction force of the lung qi descending downward. The two complement each other. Therefore, the so-called "lung and large intestine are exterior and interior" not only discusses the close functional connection between the lung and the large intestine, but also emphasizes the mutual influence between the two in the development of the disease. If the lung qi fails to be released, the large intestine cannot carry and release the absorbed fluid, and the body fluid is retained in the intestines, which rots the inner wall of the intestines and produces diarrhea; if the lung qi is blocked, the unblocking and descending are abnormal, the intestines are weak in pushing, and the dry feces cannot be discharged from the body, inducing constipation. Heat in the intestines and viscera boils the yin fluid, and the heat attacks the lungs, burning the lung lobes, causing them to wither and char, seriously injuring the lungs; the body fluid in the intestines dries up, and the virtual fire rises, which also burns the lung lobes, aggravates the deficiency of lung qi, and damages the lung's "passing and descending" function. Under invasive ventilation, the patient's lung respiratory function is significantly limited, the lung qi is not full, the source of ascending is insufficient, and the passing and descending are weak. The intestines lose the power to absorb body fluids and push feces out, resulting in intestinal dryness and body fluid deficiency, heat and toxicity, and dry feces, forming the fundamental crux of constipation. Therefore, according to the theory of traditional Chinese medicine that "the lungs and the large intestine are the exterior and interior of each other", the premise of clearing the bowels and purging, strengthening the body and detoxifying, and producing body fluids and removing dryness is that it is necessary to reasonably supplement the lung qi, shorten the patient's invasive ventilation time, and appropriately supplement the "lung deficiency" in the intestines to achieve the purpose of correcting constipation, which is the so-called lung and intestine treatment.

[0011] Heat and toxicity are another important feature of lung and intestinal diseases under invasive mechanical ventilation. The so-called heat and toxicity do not refer to poisoning, but to the fact that the patient's lung qi is stagnant and inflammation is diffused in the lungs under invasive ventilation. Metabolites (mainly phlegm) cannot be discharged from the airway in time through the function of dispersing and releasing, and then they are trapped in the lung network, phlegm and blood stasis turn into fire, and burn the lung yin; this heat syndrome cannot be emitted from the mouth and nose, but instead moves down to the intestines, causing heat and toxicity to be trapped, aggravating the evaporation of body fluid in the intestines, and making the patient appear to have "body fluid deficiency and heat accumulation". In view of this, in view of the constipation, fever and other symptoms caused by body fluid deficiency and heat accumulation under invasive mechanical ventilation, combined with the patient's disease characteristics of "excessive superficial and deficient underlying", the method of Dachengqi Decoction to clear the bowels, release heat, and preserve yin can be used.

[0012] The formula of Chengqi Decoction was first seen in Zhang Zhongjing's Treatise on Febrile Diseases in the Eastern Han Dynasty. It is a representative prescription for treating heat accumulation. Zhang Zhongjing first clarified the formula and dosage of Dachengqi Decoction in Treatise on Febrile Diseases, and used it to treat relatively serious gastrointestinal diseases. Dachengqi Decoction is composed of four medicines: rhubarb, mirabilite, immature bitter orange, and magnolia bark. This formula is designed based on the theory of traditional Chinese medicine for internal invasion of heat evil and dryness and accumulation of intestines and viscera. Among them, rhubarb and mirabilite clear away heat and relieve constipation, attack the key points and disperse the accumulation; immature bitter orange and magnolia bark promote qi and disperse the accumulation, eliminate lumps and relieve fullness. The combination of the four medicines is like a thunderbolt, directly hitting the intestines and viscera, clearing away heat evil, thereby harmonizing the internal organs and restoring the balance of yin and yang in the body. In modern research, Dachengqi Decoction is often used to treat acute abdominal diseases such as acute simple intestinal obstruction, acute cholecystitis, and acute appendicitis. In addition, Dachengqi Decoction also has a good effect on some symptoms such as dry intestinal constipation caused by fever, and abdominal pain and bloating caused by internal blood stasis. Studies have also confirmed that Dachengqi Decoction can be used to treat respiratory distress syndrome and relieve symptoms such as shortness of breath and cyanosis.

[0013] In the early stage, Wang Zhiqiang and others took into account the strengthening of the body on the basis of the laxative effect of Dachengqi Decoction, and created Fuzheng Tongfu Decoction (raw rhubarb, stir-fried immature bitter orange, roasted magnolia bark, mirabilite, apricot kernel, Scrophularia, raw angelica, raw rehmannia, raw ophiopogon, honey astragalus, codonopsis, honey roasted aster), and small sample clinical observations also confirmed that it can effectively improve the constipation of patients after invasive mechanical ventilation, and has good improvements in indicators such as the first defecation time, Bristol score and quantitative gastric residue, but the improvement of respiratory recovery in such patients is not satisfactory. According to clinical observations, most patients who used Fuzheng Tongfu Decoction did not have significant improvement in indicators such as mechanical ventilation index and blood gas analysis. The reason for this is related to the pathological characteristics of "heat and toxic accumulation and deficiency of vital energy" in critically ill patients after invasive ventilation surgery. Therefore, the applicant of the present invention, under the guidance of the theory of "lung and large intestine are exterior and interior of each other" in traditional Chinese medicine and the modern "lung-intestine axis", optimized the prescription on this basis, strengthened the effects of replenishing vital energy and clearing away heat and toxicity, and created the Buyuan Gongdu Chengqi Decoction. Summary of the invention

[0014] In view of the deficiencies in the prior art, the present invention provides a Chinese medicine composition, preparation and application for treating constipation after invasive mechanical ventilation. The Chinese medicine composition is Buyuan Gongdu Chengqi Decoction, which can perform comprehensive lung and intestinal regulation without increasing the burden on the patient's body, and can take into account both lung and qi tonification, yin nourishing and foundation strengthening, and purgative and digestive effects.

[0015] In order to achieve the above-mentioned purpose, the present invention adopts the following technical solutions:

[0016] A traditional Chinese medicine composition for treating constipation after invasive mechanical ventilation. The active ingredients of the traditional Chinese medicine composition include the following raw materials in parts by weight: 10-20 parts of raw rhubarb, 15-25 parts of stir-fried immature bitter orange, 10-20 parts of sodium sulfate, 5-15 parts of coptis root, 15-25 parts of Scrophularia ningpoensis, 25-35 parts of honey astragalus, 5-15 parts of ginseng, and 25-35 parts of roasted aster.

[0017] Preferably, the active ingredient raw materials of the traditional Chinese medicine composition include the following raw materials in parts by weight: 13-17 parts of raw rhubarb, 18-22 parts of stir-fried immature bitter orange, 13-17 parts of sodium sulfate, 8-12 parts of coptis chinensis, 18-22 parts of Scrophularia ningpoensis, 28-32 parts of honey astragalus, 7-11 parts of ginseng, and 28-32 parts of roasted aster.

[0018] Preferably, the Chinese medicine composition further comprises other Chinese medicine extracts and / or other raw materials.

[0019] Furthermore, the present invention also provides a Chinese medicine composition preparation for treating constipation after invasive mechanical ventilation, wherein the Chinese medicine composition preparation comprises the Chinese medicine composition and / or added pharmaceutical excipients, and / or added food additives.

[0020] Preferably, the Chinese medicine composition preparation is a tablet, chewable tablet, powder, granule, granule, capsule, paste, pill or liquid preparation.

[0021] Preferably, the preparation is taken orally, by nasogastric feeding or for external use.

[0022] Furthermore, the present invention also provides the use of the Chinese medicine composition or the Chinese medicine composition preparation in the preparation of a method for treating constipation after invasive mechanical ventilation.

[0023] Preferably, the Chinese medicine composition or Chinese medicine composition preparation can perform comprehensive lung and intestinal conditioning without increasing the burden on the patient's body, tonifying the lungs and replenishing qi, nourishing yin and consolidating the foundation, and promoting digestion, thereby effectively improving constipation symptoms after invasive mechanical ventilation surgery.

[0024] Furthermore, the present invention also provides a method for preparing a Chinese medicine composition for treating constipation after invasive mechanical ventilation, which adopts the following steps: according to the Chinese medicine composition of claim 1 or 2, all medicinal materials are weighed in proportion, decocted and concentrated, and prepared into a preparation in an appropriate dosage form.

[0025] Preferably, the temperature during decoction of the medicinal materials is 40° C. to 60° C., the time is 30 to 60 minutes, and the dosage form is prepared after being concentrated to the desired concentration.

[0026] The formula analysis of the Chinese medicine composition of the present invention (hereinafter referred to as: Buyuan Gongdu Chengqi Decoction) is as follows:

[0027] Li Yongcui of the Qing Dynasty believed in Zhengzhi Huibu that "if Shaoyin cannot defecate, moisten it with pungent herbs; if Taiyin cannot defecate, purge it with bitter herbs; clear yang knots; warm yin knots; dredge qi stagnation; moisten it with insufficient body fluid". Under the guidance of this medication idea and combined with Zhang Zhongjing's method of treating "heat knot constipation", "strong purgation" and "preserving yin", rhubarb and mirabilite, which have the functions of attacking toxins and dissolving knots, are selected as the main drugs. The lung is Taiyin, and its constipation should be "purge with bitter herbs".

[0028] Raw rhubarb is bitter and cold, and belongs to the spleen, stomach, large intestine and pericardium meridians. It has the functions of purging and attacking accumulation, clearing away heat and purging fire, cooling blood and detoxifying, removing blood stasis and dredges the meridians. For constipation caused by lung heat and gastrointestinal stagnation, this medicine can cleanse the stomach and intestines, and it is an important medicine for treating constipation. Because it is bitter and cold, it can settle and purge heat, so it is particularly suitable for constipation caused by heat. Modern research has also confirmed that the main medicinal ingredients of rhubarb include rhubarb, rhein, chrysophanol and aloe-emodin, and its active ingredients can significantly inhibit gastrointestinal bacteria, reduce the permeability of the gastrointestinal mucosa, effectively improve gastrointestinal function, and effectively prevent the occurrence of gastrointestinal functional failure.

[0029] Glauber's salt is salty, bitter and cold in nature. It enters the stomach and large intestine meridians. It has the function of purging and attacking accumulation, moistening dryness and softening hard masses. It is often used as a medicine with rhubarb to treat constipation caused by excess heat in the stomach and intestines. The difference is that rhubarb has a strong effect and is especially good at cleansing, while Glauber's salt tastes salty and can also nourish the kidneys to soften hard masses.

[0030] The combination of the above two ingredients has a very strong purgative effect on constipation caused by heat accumulation in Taiyin and Yangming meridians, which conforms to the treatment principle of "clearing the Yang". At the same time, considering the pathological essence of Qi and Yin deficiency in patients after invasive ventilation, the purgative effect of bitter and cold herbs is too strong, which may damage the Yin of the lungs and stomach and aggravate the symptoms of Qi and Yin deficiency. Therefore, on the basis of comprehensive syndrome differentiation, it is also necessary to combine the method of "nourishing Yin and replenishing Qi" to consolidate the foundation and nourish the essence, so Astragalus and ginseng are used as ministerial drugs.

[0031] Astragalus is sweet and slightly warm in nature. It enters the lung and spleen meridians. It has the functions of replenishing qi and strengthening the spleen, raising yang and lifting sunken, strengthening the body's defense and strengthening the exterior, promoting diuresis and reducing swelling, and removing toxins and promoting muscle regeneration. After being roasted with honey, Astragalus is specifically used in the middle jiao. In addition to replenishing lung qi, it can also strengthen the spleen and stomach. It is an important medicine for treating lung and spleen deficiency. Honey Astragalus combined with ginseng can replenish the spleen and lungs, strengthen the foundation and nourish the essence, and improve the patient's qi deficiency caused by qi and yin deficiency.

[0032] Coptis chinensis and Scrophularia ningpoensis are bitter and cold and can dispel heat. Coptis chinensis is particularly good at treating damp-heat toxicity in the middle burner, and has the effect of thickening the stomach and intestines, so it can treat the symptoms of excessive heat damaging yin. In addition to being bitter and cold, Scrophularia ningpoensis has a salty taste and enters the kidney meridian, nourishing the kidney and yin. Coptis chinensis is used in small amounts but is specifically used to dispel heat, while Scrophularia ningpoensis is used in large amounts but is mainly used to nourish yin, effectively avoiding the disadvantages of Coptis chinensis's bitter and cold nature that damages yin. The two medicines are used together to achieve the effect of nourishing yin and promoting body fluid, as adjuvants.

[0033] Zhishi breaks up qi, disperses blood stasis, and resolves nodules, and is the driving force of all medicines; Ziyuan descends qi, relieves cough, resolves phlegm, warms and unblocks the lung qi, and takes the meaning of "lifting the pot and opening the lid", unblocking the lung qi to induce purgation. The two medicines together are the guiding medicine.

[0034] The combination of these medicines can have a strong laxative effect without damaging the body, attack the toxins without damaging the yin, and break up the knots without damaging the qi. At the same time, it takes into account the functions of the lungs, spleen, and kidneys. It attacks the toxins while also replenishing the body. It can nourish yin, replenish qi, and strengthen the foundation. It is beneficial to take care of the reality of critically ill patients with weak constitutions and intolerance to strong laxatives, and is more conducive to the rapid digestion of acute constipation, eliminating the disease without damaging the body.

[0035] Compared with Fuzheng Tongfu Decoction, Buyuan Gongdu Chengqi Decoction is modified on the original basis, and Coptis chinensis is added. Coptis chinensis is good at attacking and resolving the damp-heat poison in the middle jiao, and it also strengthens the stomach and intestines. This can strengthen the power of clearing heat and poison, and it can also strengthen the stomach and intestines to strengthen the middle jiao. The middle jiao is healthy and smooth, and the power of clearing the bowels is better than before. Because the tonic power of Codonopsis pilosula is insufficient, the vitality of this type of patients is greatly damaged after surgery, and the overall qi is weak. Ginseng is replaced to greatly replenish the vitality. It also replenishes the lung qi, and strengthens the power of strengthening and attacking poison on the original basis. By observing indicators such as mechanical ventilation index and blood gas analysis, it is found that it can effectively improve the patient's respiratory function and make up for the deficiency of Fuzheng Tongfu Decoction in improving lung ventilation function.

[0036] Therefore, compared with Fuzheng Tongfu Decoction, Buyuan Gongdu Chengqi Decoction not only has advantages in attacking heat and toxicity, but also takes into account the stomach and intestines, and even more so takes into account the replenishment of vital energy. It is more powerful in expelling evil and strengthening the body. It not only grasps the current main symptoms, but also grasps other important concomitant symptoms. While attacking toxins and clearing the bowels, it also improves the patient's respiratory function, which is something that Fuzheng Tongfu Decoction cannot achieve.

[0037] The Buyuan Gongdu Chengqi Decoction provided by the present invention has a good effect on improving constipation symptoms in patients undergoing invasive mechanical ventilation surgery, and has good effects in improving constipation symptoms in patients undergoing invasive mechanical ventilation surgery, promoting gastrointestinal emptying, inducing defecation, improving lung ventilation, etc., and the therapeutic effect is more rapid and direct, especially in terms of rapid induction of defecation, which is an advantage that Western medicine does not have, and the safety is reliable. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 This is a diagram showing the difference in the distribution of primary diseases between the two groups of patients.

[0039] Figure 2 This is a comparison chart of the duration of constipation and the duration of the first bowel movement after surgery between the two groups of patients.

[0040] Figure 3 This is a comparison chart of the defecation characteristics scores between the two groups of patients after surgery.

[0041] Figure 4 This is a comparison chart of the quantitative GRV (mL) of gastric residues between the two groups of patients.

[0042] Figure 5 This is a comparison chart of invasive mechanical ventilation related parameters of patients in the treatment group before and after treatment.

[0043] Figure 6 This is a comparison chart of invasive mechanical ventilation related parameters of patients in the control group before and after treatment.

[0044] Figure 7 This is a comparison chart of ventilator-related parameters between the two groups of patients after treatment.

[0045] Figure 8 This is a comparison chart of arterial blood gas analysis indexes before and after treatment in the treatment group.

[0046] Fig. 9 This is a comparison chart of arterial blood gas analysis indexes in the control group before and after treatment.

[0047] Fig.10 This is a comparison chart of arterial blood gas analysis indexes between the two groups of patients after treatment.

[0048] Fig.11 This is a comparison chart of the adverse reactions in the two groups of patients.

[0049] Fig.12 This is a comparison chart of the follow-up status of the two groups of patients.

[0050] Fig.13 This is a comparison of the overall efficacy between the two groups of patients. DETAILED DESCRIPTION

[0051] The following is a clear and complete description of the technical solutions in the embodiments of the present invention in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0052] Example 1

[0053] The formula of the Chinese medicine composition is: 15 parts of raw rhubarb, 20 parts of stir-fried immature bitter orange, 15 parts of sodium sulfate, 10 parts of coptis root, 20 parts of Scrophularia ningpoensis, 30 parts of honey astragalus, 9 parts of ginseng, and 30 parts of roasted aster.

[0054] Usage and dosage: Decoction and seal in bags, 100mL / bag, soak and heat in warm water, preferably around 40℃, draw out with a 50mL sterile syringe, nasogastric feeding, 1 bag at a time, 2 times a day, give the medicine half an hour after normal nasogastric feeding. 5-day course of treatment.

[0055] Research on the beneficial effects of the present invention:

[0056] 1. Clinical Data and Methods

[0057] (I) General Information

[0058] 1. Patient sources and ethical requirements

[0059] This study selected 70 critically ill patients with invasive ventilation admitted to the emergency department of Xianju County Hospital of Traditional Chinese Medicine from December 2021 to December 2023. All patients received invasive ventilation within 24 hours of admission, and the postoperative status was ≥72 hours. Ethical review: This study was approved by the Ethics Committee of Xianju County Hospital of Traditional Chinese Medicine (Ethics No.: 2021 Lunshen No. 23).

[0060] 2. Sample size estimation

[0061] Since this study is a clinical trial, the scheme adopted is a randomized, parallel, controlled trial, and the required sample size calculation formula is as follows:

[0062]

[0063] According to the comparative diagnosis and treatment scheme of Chinese and Western medicine for constipation in previous literature references, p1 is the treatment group with an effective rate of 96%, and p2 is the Western medicine control group with an effective rate of about 70%. According to the statistical sample size principle, α = 0.05, β = 80%, then Z α =1.96, Z β =0.84, p is the mean of p1 and p2, q refers to the mean of 1-p1 and 1-p2. According to the sample size estimation formula, the requirements of the Guiding Principles for Clinical Research of New Chinese Medicines, and the previous patient visits to our hospital, plus the expected maximum dropout rate of 10%, the final calculation shows n1=n2=35 cases, so at least 70 patients need to be included.

[0064] 2. Diagnostic criteria

[0065] 1. Western medicine diagnostic criteria

[0066] According to the "Research Progress on Anesthesia and Postoperative Gastrointestinal Function Recovery" (2023), "Several Issues in Emergency Tracheal Intubation" (2005) and "International Functional Gastrointestinal Disorders (FGIDS)-Rome IV" (2016), the diagnostic criteria for constipation after invasive mechanical ventilation were formulated: ① Patients with invasive mechanical ventilation after anesthesia have clear records of the use of anesthetic and analgesic drugs; ② Invasive mechanical ventilation status, ventilation time ≥ 72 hours; ③ Under invasive mechanical ventilation status, bowel movements are no more than 3 times a week, no laxatives, and almost no smooth bowel movements; ④ The diagnostic conditions for irritable bowel syndrome are insufficient.

[0067] 2. TCM Syndrome Differentiation Standards

[0068] According to the "Diagnosis and Therapeutic Effect Evaluation of TCM Diseases" (2010) issued by the State Administration of Traditional Chinese Medicine and the textbook "Chinese Medicine Internal Medicine·Constipation" (2020 1st edition), the syndrome differentiation criteria of "heat and toxicity stagnation, qi and yin damage" are formulated:

[0069] Main symptoms: ① Red face, fever and irritability; ② Dry stool or involuntary bowel movements; ③ Weakened bowel sounds.

[0070] Secondary symptoms: ① sputum that sounds like roaring; ② abdominal distension; ③ reduced flatulence; ④ abdominal pain that is resistant to pressure; ⑤ shallow and rapid breathing; ⑥ sweating all over the body.

[0071] Tongue and pulse: The tongue is red, pale and tender, with thick or greasy coating; the pulse is deep and tight or slippery and rapid.

[0072] Main symptom ① is required and at least 2 of any other main symptom + secondary symptoms are required. If the tongue and pulse match, the diagnosis can be made.

[0073] (III) Inclusion criteria

[0074] 1. Meet the diagnostic criteria;

[0075] 2. Applicants aged 40 to 99, regardless of gender;

[0076] 3. Constipation during invasive ventilation, confirmed by TCM diagnosis;

[0077] 4. ≥72 hours after invasive ventilation, with stable vital signs and feeding through nasogastric tube;

[0078] 5. Patients who sign the informed consent and are willing to accept the treatment plan of this study (family members sign on behalf of the patient).

[0079] (IV) Exclusion criteria

[0080] 1. Patients with gastrointestinal failure (AGI grade Ⅲ or Ⅳ) and enteral nutrition intolerance;

[0081] 2. Organic constipation caused by intestinal stenosis and obstruction, and drug-induced constipation caused by oral medications;

[0082] 3. Patients with primary cardiovascular, cerebrovascular and endocrine diseases with poor clinical control, vascular dementia and mental illness;

[0083] 4. Patients with severe pancreatitis, liver and kidney dysfunction;

[0084] 5. Patients who have been dependent on drugs due to long-term use of gastrointestinal motility agents and laxatives for constipation before surgery;

[0085] 6. Patients who refuse Chinese medicine treatment and refuse to sign the Informed Consent Form.

[0086] (V) Termination and withdrawal standards

[0087] 1. The patient should not continue the trial due to adverse events or lack of efficacy:

[0088] 2. The subject voluntarily withdraws the Informed Consent Form, or withdraws from the study due to poor efficacy, or is lost to follow-up:

[0089] 3. The compliance of the test takers is poor, which affects the evaluation of efficacy;

[0090] 4. Intention-to-treat analysis was performed for subjects who did not complete the clinical trial but had at least one follow-up data.

[0091] (VI) Experimental Grouping

[0092] The 70 patients were randomly divided into two groups, 35 cases in each group, and were treated with Buyuan Gongdu Chengqi Decoction via nasogastric feeding (treatment group, n=35) and conventional treatment (control group, n=35), respectively.

[0093] 7. Treatment plan

[0094] 1. Basic treatment: mechanical ventilation to maintain normal breathing, maintain stable blood pressure, and take a series of measures such as anti-infection, fluid replacement, correction of electrolyte disorders, and control of blood sugar to ensure the stability of vital signs. At the same time, routine care is given, the diet structure is adjusted, and dietary fiber and appropriate amounts of high-quality protein are supplemented reasonably. Reasonable water replenishment, 800-1200mL / day, small amounts and multiple times. Assist gastrointestinal motility (abdominal massage) and adjust intestinal motility function. Carry out reasonable emotional counseling and psychological intervention to prevent patients from depression and emotional disorders.

[0095] 2. Conventional drug treatment plan: Bifidobacterium quadruple live bacteria tablets + lactulose nasogastric feeding.

[0096] Medicines: Bifidobacterium quadruple live bacteria tablets, lactulose.

[0097] Usage and dosage: Bifidobacterium tetravalent live bacteria tablets, 3 tablets at a time, grind into powder and dissolve in 40℃ warm water, 3 times a day, nasogastric tube; lactulose, 30mL each time for adults, once a day, nasogastric tube.

[0098] Treatment course: 5 days.

[0099] 3. Chinese medicine nasogastric feeding treatment plan:

[0100] Prescription composition and dosage: raw rhubarb (added later) 15g, stir-fried immature bitter orange 20g, sodium sulfate (taken with water) 15g, coptis 10g, Scrophularia 20g, honeyed astragalus 30g, ginseng 9g, roasted aster 30g.

[0101] Drug source: The above-mentioned drugs are decoction preparations, all of which come from our hospital's Chinese medicine pharmacy.

[0102] Usage and Dosage: The above drugs are decocted uniformly by our hospital's Chinese medicine pharmacy, packed and sealed, 100mL / bag, soaked and heated in warm water when used, the temperature is preferably around 40℃, drawn with a 50mL sterile syringe, and administered by nasogastric feeding, 1 bag at a time, twice a day, and the drug should be administered half an hour after normal nasogastric feeding.

[0103] Treatment course: 5 days.

[0104] The control group received basic treatment combined with conventional drug treatment, and the treatment group received basic treatment combined with Chinese medicine nasogastric feeding treatment.

[0105] (VIII) Evaluation indicators and cycles

[0106] 1. General observation indicators

[0107] It includes the frequency of gastrointestinal motility, number of bowel sounds, number of flatulence, time of first bowel movement within 7 days, and amount of first bowel movement within 24 hours before and after treatment; the time of first bowel movement within 7 days after treatment is used as the test indicator.

[0108] 2. Feature indicators

[0109] ①Gastric Residual Volume (GRV): Gastric residual volume is measured 2 hours after the patient eats through a nasogastric tube. The specific method is to extract the patient's gastric residual volume through the nasogastric tube with a 50mL sterile syringe, and evaluate whether the patient has gastric retention or weakened digestive function according to the amount extracted. Generally speaking, when the amount of gastric residual volume is less than 200mL, it indicates that the patient's gastric function is still good and nasogastric tube nutrition support can continue; when the residual volume is more than 500mL, it can be regarded as a patient with gastric retention symptoms. However, it should be noted that if only a single measurement indicates that the amount of gastric residual volume is between 200 and 500mL, it cannot effectively confirm that the patient has gastric retention symptoms. At this time, enteral nutrition should not be stopped without authorization. Clinically, a total gastric residual volume of more than 1000mL in 24 hours is regarded as an important indicator of abnormal gastric emptying. ②Stool character evaluation (Bristol): The Bristol stool character scale is divided into 7 types according to the stool character from hard to watery, and the score corresponds to the classification level (1 to 7 points). Fecal score evaluation method: add the fecal characteristics scores during spontaneous defecation in the previous week, and then divide it by the total number of spontaneous defecation in a week to get the average score. ③ Mechanical ventilation index: observe whether the patient's Vt, oxygen concentration, PEEPi, and PSV4 parameters have changed before and after medication. Among them, an increase in Vt, a decrease in oxygen concentration, a decrease in PEEPi, and a decrease in PSV are effective indicators. ④ Laboratory examination indicators: blood gas analysis: observe whether the patient's PaO2 and PaCO2 indicators have changed before and after medication. An increase in PaO2 and a decrease in PaCO2 are effective indicators.

[0110] 3. Observation Node

[0111] General indicators and observation indicators ① to ④ were recorded once before the start of treatment, 24 hours after treatment, and 5 days after treatment. After the end of treatment, the observation was continued for 2 weeks, and patients who met the exclusion and dropout criteria were screened out, and valid case data were recorded; the overall efficacy was evaluated after 6 months of follow-up.

[0112] 4. Efficacy evaluation criteria

[0113] According to the evaluation standards stipulated in the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes" (2012 edition of the State Administration of Traditional Chinese Medicine), the efficacy evaluation is divided into cure, marked effect, effectiveness and ineffectiveness, as follows: ① Cure: constipation disappears within 24 hours (1 day) of medication, and bowel movements are normal. ② Marked effect: clinical symptoms and signs are significantly alleviated within 48 hours (2 days) of medication. ③ Effective: symptoms and signs are alleviated within 72 hours (3 days) of medication. ④ Ineffective: clinical symptoms and signs are not improved after 72 hours (3 days) of medication, and there is no bowel movement. Total effective rate (%) = (cure + marked effect + effectiveness) / total number of people.

[0114] (IX) Adverse reactions and responses

[0115] 1. Pyloric obstruction

[0116] The main symptoms are abdominal distension after medication, which is manifested as distension under the xiphoid process, loss of appetite, hyperactive bowel sounds, local tympanic sounds on percussion, water sounds in the stomach, tenderness (+), rebound pain (+), reduced flatus, belching with stool odor, and vomiting of gastric contents. Response: Stop medication, improve pyloric obstruction under the microscope, and give symptomatic gastric protection treatment, such as pantoprazole, omeprazole, etc.

[0117] 2. Intestinal obstruction

[0118] The main symptoms are severe abdominal pain with severe constipation after medication, shallow and rapid breathing, hard or strip-like dry stool that can be felt locally on abdominal palpation, hyperactive or weakened bowel sounds, or accompanied by obvious metallic sounds, reduced or no flatus, cold sweats, panic, and increased blood pressure. Response: Stop medication, control blood pressure, and perform surgical intervention in a timely manner after a clear diagnosis.

[0119] 3. Acute enteritis

[0120] The main symptoms are diarrhea after medication, several times a day, thin or watery stools, fatigue, dizziness, palpitations, high blood pressure, hyperactive bowel sounds, abdominal pain or emptiness, sponge-like palpation, obvious burning pain or falling sensation in the anus, and stool leakage while passing gas. In severe cases, it may manifest as fecal incontinence. Response: Stop medication, control blood pressure, give fluids, correct electrolyte disorders, and give symptomatic antidiarrheal drugs such as montmorillonite powder and berberine for mild symptoms; give intravenous volume expansion or appropriate antibiotics (gentamicin) for severe symptoms to prevent shock and intestinal infection.

[0121] 4. Gastrointestinal bleeding

[0122] The main symptoms are abdominal pain after taking the drug, diffuse tenderness and rebound pain in the whole abdomen, blood in the stool, diffuse abdominal distension in case of constipation, eyelid congestion, white lips, weak breathing, and deep and thin pulse. Response: Stop the drug, quickly identify the cause and bleeding point, give intravenous hemostatic drugs or stop bleeding under gastrointestinal endoscopy, and blood transfusion is required in severe cases.

[0123] 5. Others

[0124] The main observation is the hepato-renal toxicity during the use of Chinese medicine prescriptions, as well as poisoning or other major adverse reactions caused by the use of drugs. Response: If hepato-renal toxicity and poisoning reactions are found, the drug should be stopped immediately, and symptomatic examinations should be conducted to determine the degree of poisoning, and appropriate detoxification drugs should be given for detoxification.

[0125] 10. Statistical methods

[0126] SPSS 19.0 statistical software was used for statistical methods, and the measurement data were expressed as mean ± standard deviation. All data were subjected to one-way analysis of variance, rank sum test was used for data with unequal variance, paired t test was used for intra-group and inter-group comparisons for data with equal variance, and chi-square test was used for comparisons of count data. 2 The results of this study were analyzed with P < 0.05, indicating that the difference was statistically significant.

[0127] 2. Results

[0128] (I) Comparison of general information between the two groups of patients

[0129] 1. Case details and cycle description

[0130] Since the focus of this study is on emergency critically ill patients, a comprehensive assessment of the patient's general condition, underlying condition, invasive ventilation maintenance time and parameter settings is required before enrollment. In addition, the defect of the patient's underlying condition that makes it impossible to use Chinese patent medicine / Chinese medicine preparations must also be considered, as well as comprehensive indicators such as the patient's average clinical life expectancy. Therefore, the initial enrollment of this study was 35 patients in each group (70 patients in total), including 48 males and 22 females.

[0131] The treatment course was set at 5 days, the clinical observation period was set at 2 weeks (14 days, starting from the day after the end of clinical treatment), and the follow-up observation was 6 months after the end of treatment (180 days, starting from the day after the end of the clinical observation period). The clinical study period of this study was terminated when the patient's condition stabilized and was transferred to a regular ward, recovered and left the hospital, or died clinically. Therefore, the clinical observation time was set at 2 weeks (14 days). Death during this period or interruption of the study due to other reasons was considered as loss. Statistics were collected for patients who died within 90 days (including 90 days) (mortality rate), patients who were hospitalized for treatment due to recurrent digestive dysfunction within 180 days were collected, and patients who received combined medication for constipation during clinical observation and follow-up were collected.

[0132] During the clinical observation period, 2 patients in the control group died (1 male and 1 female), and the post-treatment data were not obtained, so the study was terminated. In addition, no other patients in the two groups terminated or withdrew from the study. 68 patients completed data collection and analysis before treatment, after treatment, and during the follow-up period. By the end of the follow-up period, a total of 50 patients in the two groups died, including 24 in the treatment group (16 males and 8 females) and 26 in the control group (16 males and 10 females).

[0133] Finally, this study obtained 68 effective cases, including 35 cases in the treatment group (26 males and 9 females) and 33 cases in the control group (21 males and 11 females).

[0134] 2. General data analysis

[0135] In terms of gender, the majority of patients in both groups were male. The specific relationship between gender and the disease cannot be determined at present, but the gender composition is similar to previous studies, and there is no statistical difference in the gender composition of the two groups of patients (P>0.05). In terms of age, the age of the treatment group was 77.83±10.87 years old, and the age of the control group was 76.57±12.63 years old. There was no statistically significant difference in age between the two groups (P>0.05). In terms of course of disease, both groups of patients calculated the time (unit: day) from the last bowel movement before enrollment. In terms of the length of unresolved stool, the treatment group was 4.97±1.29 days, and the control group was 4.71±1.30 days. There was no statistically significant difference in the length of unresolved stool between the two groups of patients (P>0.05). Therefore, in terms of gender composition, age and course of disease, there was no significant difference between the two groups of patients, and they were comparable. See Table 1 for details:

[0136] Table 1 Comparison of general information of patients in the two groups

[0137]

[0138] Note: 2 The results showed that the gender structure, average age and average duration of the disease between the two groups were not statistically significant and comparable.

[0139] Table 2 Comparison of primary diseases between the two groups of patients [(n) %]

[0140]

[0141] Note: 2 The distribution of primary diseases between the two groups was compared by test, P = 0.9666 > 0.05, indicating that there was no significant difference in the distribution of primary diseases between the two groups. Figure 1 .

[0142] Table 1, 2 and Figure 1The results of relevant data analysis showed that there was no statistically significant difference in gender distribution, age, course of disease and distribution of primary diseases between the two groups of patients in this study (P>0.05). The data of the two groups of patients were consistent and could be further clinically studied and analyzed. Secondly, in terms of gender distribution, the proportion of male patients (about 70%) was significantly higher than that of female patients (about 30%). The reason may be related to the living habits of male patients (smoking, drinking and high-fat diet) and basic medical history, which is similar to the conclusions of previous studies. In terms of primary diseases, respiratory diseases, digestive diseases, nervous system diseases and circulatory system diseases occupy the top four incidences, which is consistent with the actual incidence in clinical studies. The musculoskeletal system and immune system do not have a significant proportion in the incidence of severe diseases; the incidence of severe diseases in traumatic diseases is relatively low.

[0143] Combined with previous literature research, it was found that the postoperative ventilator use rate of patients with respiratory and digestive system diseases was high, accounting for about 40% of the total patients; the circulatory system and nervous system occupied the last two places, with a postoperative ventilator support rate of about 30%. Patients with the above four types of diseases constituted the main group of postoperative ventilator support. The study also found that the mortality rate of patients with the above four types of diseases within 6 months after surgery was 11.7% (respiratory system), 10.25% (circulatory system), 10.08% (digestive system), and 9.27% ​​(nervous system), and the mortality rate was significantly positively correlated with the degree of primary disease and postoperative respiratory support time. In terms of the incidence of constipation, relevant research results show that the incidence of constipation symptoms is not significantly correlated with the patient's severity and mortality rate, but is related to the primary disease and the duration of ventilator use. The digestive tract symptoms of critically ill patients with the above four types of primary diseases after invasive mechanical ventilation are digestive system (65.2%), respiratory system (41.5%), nervous system (31.5%), and circulatory system (30.7%). The results of the study also confirmed that postoperative patients with gastrointestinal tumors, hepatobiliary and pancreatic diseases, severe lung infections, multiple organ failure and other disease states are more likely to experience digestive tract dysfunction, and the incidence of constipation is more significant than that of other systemic diseases under postoperative respiratory support, and the overall incidence of constipation can rise to more than 75%. Among the fatal factors of the above four types of diseases, respiratory failure and circulatory failure are the main causes, but the occurrence of constipation symptoms undoubtedly aggravates the degree of deterioration of the condition of critically ill patients. Therefore, whether it is constipation symptoms after invasive mechanical ventilation in non-critically ill patients or constipation symptoms in invasive mechanical ventilation in critically ill patients, they have become factors that aggravate the patient's condition. How to reasonably and effectively improve the constipation symptoms of patients under invasive mechanical ventilation is an issue that should be paid attention to in current Chinese medicine for critical and severe diseases.

[0144] (II) Comparison of the average first defecation time between the two groups of patients after treatment

[0145] Table 3 Comparison of the time of first defecation between the two groups of patients after treatment ( days, n = 68)

[0146]

[0147] Note: After paired t-test within the group, # compared with the control group, P>0.05; ▲ compared with the control group, P<0.05.

[0148] According to the data analysis in Table 3, there was no statistically significant difference in the duration of postoperative constipation between the two groups of patients (P>0.05). This shows that the incidence and severity of postoperative constipation in the two groups of patients after invasive ventilation are basically the same and comparable. The observation period of the patient's first defecation time starts from the time of drug treatment until the patient's first defecation. In this study, combined with clinical practice, the number of days was recorded. The part exceeding 24 hours was counted as 1 day, and the part less than 24 hours was counted as 0 day. After treatment, all 35 patients in the treatment group had defecation reactions during the treatment period. Data analysis showed that the first defecation time of the treatment group was 1.54 days after treatment. Among the 33 patients in the control group, 5 patients did not defecate until the end of clinical treatment (5 days), indicating that drug treatment was ineffective and enema treatment was required to improve the constipation symptoms of patients; the first defecation time of the control group was 3.03 days. The comparison of the first defecation time between the two groups of patients after surgery was statistically significant (P<0.05). The recorded data showed that 17 patients had bowel movements within 24 hours after nasogastric feeding of Buyuan Gongdu Chengqi Decoction (accounting for about 48.57% of the patients in the treatment group), and the stool was relatively dry and hard, accompanied by intestinal secretions, without obvious diarrhea. Two patients had bowel movements on the 4th day after treatment, and most patients had bowel movements within 48 hours after treatment. Among the 33 patients in the control group, 5 patients still had no bowel movements after the end of the drug treatment cycle, accounting for 15.15% of the total number of cases, and the drug treatment was considered ineffective. One patient had bowel movements on the 7th day after treatment, 2 patients had bowel movements on the 6th day after treatment, and 2 patients had bowel movements on the 5th day after treatment. The number of patients who had bowel movements for 5 days or more accounted for 15.15% of the total number of patients in the control group. The results suggest that Buyuan Gongdu Chengqi Decoction is more effective than Western medicine in improving constipation symptoms in patients under invasive mechanical ventilation, especially in shortening the time to the first bowel movement. On the one hand, Buyuan Gongdu Chengqi Decoction selects "strong purgative" according to the patient's condition. The drug composition contains some drugs for attacking poison and purging, which can quickly eliminate accumulation, relax the intestines and regulate qi, and cleanse heat and toxicity; secondly, the drugs for Buyuanqi Yiyinye in the prescription can effectively change the level of body fluid in the patient's intestines, improve the state of body fluid deficiency and dryness in the patient's intestines, increase fluid to soften dry stool, and replenish vital energy to make the intestines move vigorously. The two effects work together to quickly expel the accumulation in the intestines.

[0149] (III) Comparison of the difference in defecation characteristics score (Bristol) between the two groups after treatment

[0150] Table 4 Comparison of defecation characteristics scores between the two groups of patients after treatment ( n=68)

[0151]

[0152] Note: Paired t-test within the group, compared with the control group after treatment, ▲P<0.05.

[0153] Combined with the data analysis in Table 4, the stool characteristics of the patients in the treatment group showed significant improvement after treatment, and there was a significant difference between their stool characteristics scores and those of the control group, which was statistically significant (P < 0.05). The difference was specifically manifested in that the stool of the patients in the treatment group changed from hard, loose, and granular to strip-shaped, moist, and formed, and the discharge process was relatively smooth. Among the 35 patients in the treatment group, 5 patients had pasty stools, accounting for 14.29% of the total number of patients in the treatment group, without obvious watery stools, and the stool characteristics of 2 patients were relatively poor. Combined with the analysis of the condition, considering that the patient's age (1 case was 90 years old) was relatively old, the basic physical condition was low, the constipation time was relatively long, the symptoms were stubborn, and accompanied by obvious preoperative intestinal function symptoms; another case was considered to be due to the condition (after gastrointestinal anastomosis), the gastric motility was insufficient, and the effect was poor due to the patient's disease, which could not be attributed to the efficacy of drug treatment. The majority of patients in the treatment group scored 3 points or above (29 cases), accounting for 82.86% of the total. Among the 33 patients in the control group, except for 5 patients who did not defecate, 7 patients had a stool quality score of 1 point, 8 patients had a score of 2 points, and patients with less than 3 points (15 cases) accounted for 53.57% of the total number of patients with defecation (28 cases). This result indicates that the patients in the control group did not show significant improvement in stool quality. The overall stool quality showed scattered hard lumps or strip-shaped hard lumps, which were difficult to pass, and there was no significant difference compared with before treatment. Further analysis of the above data showed that the proportion of patients with 3 points or above in the two groups was significantly higher in the treatment group (82.86%) than in the control group (39.39%), and the difference between the two groups was statistically significant (P < 0.05). The above results fully show that as the most intuitive evidence of constipation symptom improvement, the Bristol stool quality score can explain the difference in the results of different treatment strategies between the two groups of patients to a certain extent. It also proves that Buyuan Gongdu Chengqi Decoction has a good improvement effect on constipation symptoms in patients with invasive mechanical ventilation, and the effect takes a relatively short time (within 5 days), and the overall efficacy is more significant than the use of Western medicine.

[0154] (IV) Comparison of gastric residual volume (GRV) between the two groups after treatment

[0155] Table 5 Comparison of quantitative differences in gastric residues between the two groups of patients after treatment ( mL, n = 68)

[0156]

[0157] Note: Paired t-test within the group, compared with the control group after treatment, ▲P<0.05.

[0158] Quantitative analysis of gastric residue is an important indicator for evaluating whether the patient has gastric retention or weakened digestive function. Generally speaking, when the amount of gastric residue is less than 200 mL, it indicates that the patient's gastric function is still good and nasogastric tube nutrition support can be continued; when the residue is more than 500 mL, it can be regarded as a patient with gastric retention symptoms. However, it should be noted that if only a single measurement indicates that the amount of gastric residue is between 200 and 500 mL, it cannot effectively confirm that the patient has gastric retention symptoms. At this time, enteral nutrition should not be stopped without authorization. Clinically, a total gastric residue of more than 1000 mL in 24 hours is regarded as an important indicator of abnormal gastric emptying. According to the data analysis in Table 5, the purpose of quantitative analysis of gastric residue in the 24th hour after treatment in both groups of patients is to observe the onset time of drug treatment. Generally speaking, the onset time of laxatives or cathartics is within 24 hours after treatment. According to previous experience, constipated patients taking lactulose or bioactive preparations generally have gastric emptying reactions within 24 hours, and the gastric residue is relatively reduced, which is conducive to continuous diet. In this study, gastric emptying occurred within 24 hours of nasogastric administration in the control group, and the gastric residue decreased. Combined with the data analysis results in Tables 3 and 4, it can be found that even if the patient had a gastric emptying reaction, there was no obvious defecation reaction within 24 hours. The gastric contents may only be decomposed or moved down to the intestines by drug factors, and the gastrointestinal active peristalsis and the power to promote emptying were insufficient, resulting in most patients having no obvious defecation within 72 hours after medication. Compared with the weakened response of patients in the control group, 17 patients in the treatment group had defecation within 24 hours after treatment, and 28 patients (including the first 17) had defecation within 48 hours. All patients had their first bowel movement within the fifth day of medication. Combined with the results of gastrointestinal motility frequency and bowel sound monitoring, it was suggested that about 4 hours after nasogastric administration of Buyuan Gongdu Chengqi Decoction, patients showed increased gastrointestinal motility and gradually enhanced bowel sounds. After 12 hours (second administration), gastrointestinal motility and bowel sounds increased to a relatively hyperactive state, flatus increased, and some patients showed wet anus, indicating precursory defecation. The extraction and analysis of gastric residues after treatment showed that the gastric residues in the treatment group were significantly reduced, and the patients had at least one bowel movement per day. The gastric residues in the control group were relatively more, and some patients had abdominal distension and reduced nasogastric diet intake. The comparison of gastric residues in the 24th hour after drug treatment and the gastric residues after the end of treatment between the two groups of patients was statistically significant (P < 0.05). It suggests that Buyuan Gongdu Chengqi Decoction has a significant effect in effectively improving gastric emptying disorders in patients, and has the characteristics of short onset time and rapid efficacy.

[0159] (V) Comparison of mechanical ventilation index between the two groups of patients before and after treatment

[0160] Table 6 Comparison of mechanical ventilation index between the two groups of patients before and after treatment ( n=68)

[0161]

[0162] Note: Paired t-test within the same group showed that the difference between the two groups before treatment was #P<0.05; the difference between the two groups after treatment was ▲P<0.05.

[0163] According to the comparison of the differences in invasive mechanical ventilation-related indexes between the two groups of patients in Table 6, the oxygen supply concentration (%), PSV (pressure support, cmH2O), Vt (tidal volume, mL), PEEPi (positive end-expiratory pressure, cmH2O) and other indexes of the treatment group before and after treatment were significantly improved, while the indexes of the control group before and after treatment were not statistically significant (P>0.05), indicating that the lung function of the patients in the treatment group was relatively improved after treatment, and the degree of ventilator dependence was reduced. The lung function of the patients in the control group before and after treatment was not improved well, and the degree of ventilator dependence was not significantly improved. The overall improvement of the condition was not as good as that of the patients in the treatment group, and the difference was statistically significant (P<0.05). During positive pressure ventilation, a positive airway pressure (unit: cmH2O) in the expiratory phase is given to make the airway pressure ≥ 0. This positive airway pressure is called positive end-expiratory pressure (PEEPi). This pressure can mechanically expand the small airways and alveoli, reopen the collapsed alveoli, increase the release of pulmonary surfactant, and reduce pulmonary edema, so that the lung compliance can be increased and the airway resistance can be reduced. In addition, the antagonistic effect on the endogenous positive end-expiratory pressure is conducive to improving ventilation. Pressure support (PSV) refers to the high-speed airflow provided by the ventilator after the patient's spontaneous inspiratory effort reaches the trigger standard, so that the airway pressure quickly reaches the preset auxiliary pressure level to overcome the inspiratory resistance and expand the lungs, and maintain this pressure until the inspiratory flow rate decreases to a certain percentage of the peak inspiratory flow rate, and then the respiratory phase is switched (inhalation to exhalation). Tidal volume (Vt) refers to the amount of air inhaled or exhaled each time during quiet breathing. It is the most basic component of respiratory volume and one of the easiest parameters to measure. The amount of gas inhaled and exhaled each time by a normal adult at rest is about 500mL, which is called the physiological tidal volume. The tidal output of the ventilator can reach 10-15mL / Kg, which is often 1-2 times the physiological tidal volume.

[0164] According to the data analysis in Table 6, in terms of oxygen supply concentration, the average oxygen supply concentration of the patients in the treatment group was about 51% before treatment, and the average oxygen supply level dropped to 36% after treatment; in terms of pressure support (PSV), the patients in the treatment group were 21.34cmH2O before treatment, and dropped to 15.66cmH2O after treatment; in terms of tidal volume, the physiological tidal volume of the patients in the treatment group was 418.66mL before treatment, and rose to 483.43mL after treatment, close to the level of conventional tidal volume; in terms of positive end-expiratory pressure (PEEPi), the patients in the treatment group were 5.57cmH2O before treatment, and dropped to 3.54cmH2O after treatment. Analyzing the connotation and significance of the above four ventilation indexes, it can be clearly seen that the spontaneous breathing function of the patients in the treatment group is in a gradual recovery stage, especially the numerical changes of tidal volume and positive end-expiratory pressure, which can better explain that the dependence of the patients in the treatment group on ventilator support is significantly lower than before treatment. The numerical changes of some patients indicate that the ventilator support can be gradually withdrawn and switched to ordinary respiratory support. The above values ​​were statistically significant when compared with those in the treatment group before treatment (P < 0.05), and were statistically significant when compared with those in the control group after treatment (P < 0.05); correspondingly, there were no significant differences between the values ​​of the control group patients before and after treatment, and the differences were not statistically significant (P > 0.05). The above results fully demonstrate that Buyuan Gongdu Chengqi Decoction can quickly improve the patient's constipation symptoms while further relieving the respiratory pressure of the lungs. The use of Coptis chinensis in Buyuan Gongdu Chengqi Decoction is good at removing the damp-heat toxins in the middle burner and thickening the intestines and stomach. The heat toxins blocked in the lungs are resolved by strengthening the middle burner. When the heat toxins in the lungs are blocked and the large intestine conducts differently, the heat toxins cannot be discharged upwards or discharged downwards, and are trapped in the body, causing the lung qi to fail to be discharged and the lung yin to be damaged. Therefore, Coptis chinensis is used to strengthen the middle burner, clear damp-heat and transform heat toxins, thicken the intestines and stomach, promote intestinal peristalsis, strengthen the conduction of the large intestine, and further improve the patient's weak constitution. At the same time, through the role of Buyuanqi Yiyinye drugs, the lung qi is balanced, the lung yin is nourished, and the acquired biochemical qi and blood can be transported to the lungs, providing power support for the gradual recovery of lung function.

[0165] (VI) Comparison of arterial blood gas analysis between the two groups of patients before and after treatment

[0166] Table 7 Comparison of arterial blood gas analysis between the two groups of patients before and after treatment ( n=68)

[0167]

[0168] Note: Paired t-test within the same group showed that the difference between the two groups before treatment was #P<0.05; the difference between the two groups after treatment was ▲P<0.05.

[0169] Arterial blood gas analysis is an important indicator for judging the patient's respiratory function. It has significant value in evaluating whether acid-base metabolic imbalance occurs during invasive mechanical ventilation in critically ill patients. Under normal circumstances, the normal value of arterial oxygen partial pressure (PaO2) is 80-100 mmHg, and the normal value of arterial carbon dioxide partial pressure (PaCO2) is 35-45 mmHg. PaO2 is critical at 60 mmHg. When PaO2 is less than 60 mmHg, it can be judged as type I respiratory failure; when PaO2 is less than 60 mmHg and PaCO2 is greater than 50 mmHg, it can be judged as type II respiratory failure. The difference between the two lies in the concentration of arterial carbon dioxide partial pressure, which is also an important criterion for judging patients' acid-base metabolism / base-acid metabolism. Combined with the data analysis of this study, the PaO2 values ​​of the patients in the treatment group changed before and after treatment, and the difference was not statistically significant (P>0.05); the PaCO2 value decreased after treatment and was lower than before treatment, and the difference was statistically significant (P<0.05). The overall PaCO2 value of the treatment group after treatment was lower than 45mmHg. Combined with the clinical significance of PaCO2 data, it was found that when PaCO2 was greater than 45mmHg, respiratory compensation for acidosis or alkali metabolism was considered. In this state, the possibility of type II respiratory failure in patients increased, which was not conducive to the further recovery of lung function. The PaO2 and PaCO2 values ​​of the patients in the control group did not change significantly before and after treatment, and there was no statistically significant difference in the intra-group comparison (P>0.05). There was no statistically significant difference in PaO2 and PaCO2 between the two groups of patients after treatment (P>0.05). The above results show that there is no significant difference in the efficacy of the two treatment schemes in effectively improving the patient's pulmonary ventilation status and respiratory failure. The possible advantage of the treatment group is that the PaCO2 value of the patient is slightly reduced, which can alleviate the probability of type II respiratory failure in the patient to a certain extent. Combined with the data analysis in Table 6, the results may be related to the increase in lung tidal volume and the relative enhancement of active respiratory function in the treatment group, which may also be related to the fact that Buyuan Gongdu Chengqi Decoction improves lung heat and relieves the obstruction of the middle-jiao qi. In summary, Buyuan Gongdu Chengqi Decoction, on the one hand, attacks the heat and toxic stasis of the lung and stomach, removes stasis to generate new qi, and on the other hand, it guides the stool accumulation in the intestines, disinfects to strengthen the body, treats the upper and middle jiao at the same time, and replenishes the original qi and attacks the toxic qi, which together achieves the purpose of improving the patient's lung ventilation.

[0170] (VII) Adverse reaction evaluation

[0171] Table 8 Comparison of adverse reactions

[0172]

[0173] Note: Comparison of adverse reaction rates between the two groups, χ 2 =0.6980, P=0.4034>0.05, indicating that there was no statistically significant difference in the incidence of adverse reactions between the two groups of patients.

[0174] According to the data analysis in Table 8, the total number of adverse reactions in the treatment group was 3 (2 cases of acute enteritis and 1 case of upper gastrointestinal bleeding), accounting for 8.57% of the patients in the treatment group, and the number of adverse reactions in the control group was 5 (1 case of intestinal obstruction, 3 cases of acute enteritis, and 1 case of upper gastrointestinal bleeding), accounting for 15.15% of the patients in the control group. The difference in adverse reaction rates between the two groups was not statistically significant (P>0.05). The adverse reactions observed in this study were mainly concentrated in the digestive system. On the one hand, constipation symptoms are closely related to the digestive system, and the digestive tract is the main organ and place of action for Chinese medicine nasogastric feeding treatment; on the other hand, in the two groups of patients observed, except for patients with respiratory diseases (37 cases), digestive system diseases accounted for the second place of primary diseases of patients (11 cases), which was relatively large. Therefore, this study mainly took the adverse reactions of the digestive system as the main observation object and recorded them, and used them to analyze clinical drug safety. As shown in the data analysis results in the above table, it is currently impossible to effectively determine the clear connection between drug use and adverse reactions. The reason is that on the one hand, there are few subjects to observe, and the adverse reactions are atypical, which is not valuable as the main evidence analysis; on the other hand, the reaction analysis of a single system cannot be used as a representative of the adverse reactions during drug use, and it cannot be generalized. Therefore, for this study, the observation of adverse reactions is only used as general evidence to show the relative safety of the current use of traditional Chinese medicine.

[0175] 8. Comparison of the two groups of patients during the follow-up period

[0176] Table 9 Comparison of follow-up of patients in the two groups

[0177]

[0178] Note: Paired t-test, compared with the control group, ▲P<0.05.

[0179] During the clinical observation period, 2 patients in the control group died (1 male and 1 female), and the post-treatment data were not obtained, so the study was terminated. In addition, no other patients in the two groups terminated or withdrew from the study. 68 patients completed the data collection and analysis before treatment, after treatment and during the follow-up period. At the end of the follow-up period, a total of 50 patients died in the two groups, including 24 patients in the treatment group (16 males and 8 females) and 26 patients in the control group (16 males and 10 females). In terms of the average survival time, the treatment group was 129.82±88.91 days, and the control group was 83.57±77.41 days. The difference between the two groups was statistically significant (P<0.05). In terms of the mortality rate within 90 days, the treatment group was 34.29% (12 cases), which was significantly lower than the control group 60.61% (20 cases). The difference between the two groups was statistically significant (P<0.05). After follow-up, the survival rates of the two groups of patients were 31.43% in the treatment group (11 cases) and 21.21% in the control group (7 cases). There was no significant difference between the two groups (P>0.05). According to the epidemiological survey of emergency critical care diagnosis and treatment and related consensus, the survival time of critically ill patients after invasive ventilation is generally 6 to 10 months, and about 70% of patients are expected to survive for about 6 months. The results of this study are consistent with this. In terms of combined medication, there was no combined medication in the treatment group. Thirteen patients in the control group continued to use combined medication due to constipation symptoms. The top three combined medications were lactulose, Ma Ren Wan, and Mosapride. In addition, pantoprazole, omeprazole and other stomach-protecting drugs also had a certain proportion of use. The difference in combined medication between the two groups was statistically significant (P<0.05). In terms of re-hospitalization, there was no re-hospitalization due to digestive dysfunction in the two groups of patients, and the difference was not statistically significant (P>0.05). There was a statistically significant difference in the number of bowel movements per week between the treatment group and the control group during the follow-up period (P<0.05).

[0180] The follow-up situation was summarized. Combined with the statistical analysis of different data of the two groups of patients during the follow-up period, it was found that the constipation symptoms of the patients in the treatment group were improved compared with those in the control group, which was mainly reflected in the increase in the number of bowel movements per week and the reduction in combined medication. This indicated that the gastrointestinal function of the patients in the treatment group continued to improve after treatment with Buyuan Gongdu Chengqi Decoction, which showed that the sustained efficacy of Chinese medicine treatment was more obvious than that of Western medicine, and the comprehensive improvement ability showed a good effect on further prevention and treatment of digestive systemic diseases. The comprehensive survival time and mortality rate within 90 days of the two groups of patients were compared. The treatment group was significantly better than the control group, and the difference was statistically significant (P < 0.05), indicating that Buyuan Gongdu Chengqi Decoction was effective in prolonging the survival time of patients and reducing the mortality rate within the period. There was no statistically significant difference in the survival rate of the two groups of patients after 180 days (P > 0.05). The main reason may be the influence of the primary disease and the reduction of the patient's comprehensive constitution, which was not significantly correlated with the use of drugs.

[0181] (IX) Comparison of overall efficacy between the two groups of patients before and after treatment

[0182] Table 10 Overall efficacy evaluation

[0183]

[0184] Note: Total effective rate (%) = (cured + markedly effective + effective) / total number of cases. Ridit analysis, compared with the control group, ▲P < 0.01.

[0185] According to the clinical evaluation criteria, the improvement of constipation symptoms within 24 hours of medication is considered cured, the improvement of symptoms within 48 hours is considered effective, the improvement of symptoms within 72 hours is considered effective, and the improvement of symptoms after 72 hours or no significant improvement is considered ineffective. Combined with the data analysis in Table 9, the total effective rate was 94.28% in the treatment group and only 72.73% in the control group. The difference between the two groups was statistically significant (P < 0.01). The above results show that Buyuan Gongdu Chengqi Decoction has the characteristics of fast onset, good effect, and high safety in rapidly improving the constipation symptoms of patients with invasive mechanical ventilation, which is faster than conventional treatment.

[0186] Discussion

[0187] (I) Distinguishing between “deficiency” and “excess” of constipation after invasive mechanical ventilation

[0188] The diagnosis and treatment of constipation begins with distinguishing deficiency from excess. Dryness and heat accumulated in the stomach and intestines are heat constipation; stagnation of qi is excess constipation; deficiency of qi, blood, yin and yang is deficiency constipation; stagnation of yin and cold is cold constipation. Among the four, deficiency and excess are the main criteria. Heat constipation, qi constipation, and cold constipation are excess; constipation caused by insufficient yin, yang, qi, and blood is deficiency. Cold, heat, deficiency, and excess often coexist or transform into each other. If heat constipation is prolonged and not cured, the body fluids are gradually depleted, which can lead to deficiency of yin and fluid, loss of intestinal moisture, and the condition turns from excess to deficiency; or if qi stagnation is seen, which turns into fire over time, then qi stagnation and heat accumulation coexist; if qi and blood are deficient, and they are injured by diet or stimulated by emotions, deficiency and excess are more common. The symptoms of constipation in patients under invasive mechanical ventilation are different from those of simple constipation, but they do not deviate from the barriers of "symptoms and causes" and "deficiency and excess".

[0189] In terms of comprehensive syndrome differentiation, constipation caused by the postoperative state of invasive mechanical ventilation should be classified as "excessive symptoms and deficiency in the root". The so-called "excessive symptoms" indicates that this type of constipation is mainly caused by heat accumulation in the intestines and viscera, accompanied by endogenous excess symptoms such as fever, irritability, sweating, and deep, tight and strong pulse; secondary complications such as abdominal distension, abdominal pain, and limb spasms may also occur; some patients may also see excess symptoms such as abdominal distension and refusal to press, shallow and rapid breathing, and flushed face and hot body. The so-called "fullness, fullness, dryness and excess" are all present, and the syndrome should be differentiated as excess symptoms of heat accumulation in the intestines and viscera, internal heat and toxicity, and obstruction of visceral qi. The treatment should be to clear the viscera and release heat, attack the toxicity and eliminate the accumulation. The so-called "deficiency in the root" refers to the state of the patient after a serious illness and invasive ventilation, with lung qi deficiency, relatively low visceral function, and damage to the vital energy; in addition, the body cannot recover after the trauma, the spleen and stomach are weak, and the source of qi and blood is insufficient. Although there is excess in the intestines and viscera, the functions of the five internal organs are damaged. Although the local excess evil is heavy, it is not enough to reverse the essence of the body's deficiency. At the same time, the use of antibiotics and the excessive use of cathartic drugs will lead to severe water consumption, aggravating the body's yin deficiency, virtual fire inflammation, and combined with dry stool in the intestines, which will aggravate the patient's lung qi damage; the two are linked to each other, making the patient in a state of continuous consumption, and the exhaustion is getting worse. When the syndrome is diagnosed as deficiency of vital energy and deficiency of qi and yin, the treatment should be to strengthen the body and strengthen the foundation, replenish qi and nourish yin.

[0190] (II) Diagnostic and therapeutic ideas of Buyuan Gongdu Chengqi Decoction

[0191] In this study, the diagnosis and treatment ideas of Buyuan Gongdu Chengqi Decoction for constipation after invasive mechanical ventilation are as follows: First, based on the pathological characteristics of patients after invasive mechanical ventilation, namely, heat accumulation in the intestines and viscera, internal heat and toxicity in the lungs and intestines, and deficiency of both qi and yin in the body. Through comprehensive syndrome differentiation of patients after invasive mechanical ventilation, it was found that within a period of time (3 to 7 days) after invasive mechanical ventilation, the symptoms of heat accumulation in the intestines and viscera of patients were relatively prominent. Most patients had a series of symptoms such as abdominal distension, abdominal fullness and refusal to press, irritability, fever, and sweating, accompanied by weakened bowel sounds, slowed gastrointestinal motility, and reduced gas discharge, etc. Gastrointestinal dysfunction manifestations. At the same time, patients cannot eat independently due to invasive ventilation, resulting in insufficient intake of body water and nutrients. Their oxygen supply level and ventilator pressurization level were at high values ​​within one week after surgery. The use of cathartics aggravated the rate of water loss in patients to a certain extent, and some critically ill patients had typical symptoms of deficiency of both qi and yin, such as oliguria, night sweats, and periodic fever (mainly hot at night). For most patients, the time of first bowel movement after surgery is extended to 3-4 days. The stool is hard, dry, and resembles sheep dung, and is accompanied by a strong odor, indicating that the heat and toxins in the lungs sink into the gastrointestinal tract, causing dry stool in the intestines and a lack of body fluids.

[0192] Secondly, the staged disease symptoms of "fundamental deficiency" and "excessive symptoms" of the patients suggest that "drastic purgation to eliminate heat and purgation to preserve yin" is a well-targeted diagnosis and treatment method. The patients showed staged symptom changes under invasive mechanical ventilation. Within 1 to 3 days after surgery, the patients had severe qi deficiency and mild yin deficiency, and dry stool in the intestines had not yet formed. The symptoms were abdominal distension, weakened bowel sounds, and slowed gastrointestinal motility. At this stage, the patients were not thirsty, and the intake of water and related nutrients could still support consumption. The overall function was in a period of mild damage. 4 to 7 days after surgery, the patients were in the extreme stage of qi and yin deficiency. At the same time, dry stool gathered in the intestines, blocking the intestinal qi. The patients had abdominal distension and refused to press, fever and irritability, profuse sweating or sweating, further weakened bowel sounds, weak gastrointestinal motility, no flatus, thirst for water, vomiting after drinking, little or no urine, unconsciousness, weakened active breathing, and a significantly increased oxygen demand. The machine pressure index is high, with a fishy smell in the mouth, foul tongue coating, and occasional loss of air that is unbearable. Overall, the intestines are "dry and full" and the body is deficient in both qi and yin. 7 days after the operation, the patient's condition may improve, the dryness in the intestines is discharged through catharsis, the patient's gastrointestinal motility is slow and rhythmic, the symptoms of lung qi deficiency are relatively improved, the oxygen supply and time are gradually reduced, and some patients can choose to remove the tube or be transferred out with a tube; while some patients may experience worsening of their condition, extreme lung qi deficiency, repeated inability to discharge dryness in the intestines, gastrointestinal dysfunction to failure, and complications of respiratory system fatigue and lung function failure. At this stage, the patient has deficiency of both yin and yang, or is in a state of complete separation of yin and yang, and is incurable. Therefore, this study selected patients who underwent invasive mechanical ventilation 72 hours (3 days) after surgery as the research subjects. First, at this stage, the constipation symptoms of patients are just beginning, the symptoms are not yet strong, and the condition is not severe, so both Chinese and Western medicine interventions are relatively desirable; second, at this stage, the symptoms of "fullness, dryness and solidity" in the intestines of patients are relatively prominent, and although the deficiency of both qi and yin is at its extreme stage, the degree of damage is still mild, and the patient's body can still tolerate the short-term use of strong drugs to attack the knot; third, at this stage, rapid digestion and removal of heat in the patient's intestines can preserve the yin of the patient's internal organs to the greatest extent, so that yin and yang are not separated, which is conducive to the overall outcome of the disease, the so-called "urgent purgation to preserve yin".

[0193] Finally, under the guidance of the TCM theory of "lung and large intestine are exterior and interior", lung and intestine treatment is an inevitable choice. Constipation symptoms are an important complication of patients after invasive mechanical ventilation, and its mechanism of occurrence is relatively complex. Especially for patients with severe physical weakness, postoperative constipation symptoms often aggravate the complexity of the patient's condition, and even affect the length of time the patient uses the ventilator, which has an adverse effect on the effective recovery of the patient's lung function. Secondly, through clinical observation of the symptoms of a large number of postoperative patients, it was found that the possibility of patients with pulmonary infection symptoms after invasive mechanical ventilation increased. The reason may be that the risk of bacterial infection caused by the opening of the respiratory tract increases, and at the same time, the patient's immune function decreases, the active exhaust function of the lung decreases, and there is a wide range of bacterial proliferation between the upper and lower respiratory tracts, inducing lung infection. In this process, the patient's constipation symptoms will aggravate the degree of lung infection. On the one hand, harmful respiratory flora penetrate the intestinal mucosa through the lung-intestinal axis to cause intestinal infection. Secondly, harmful gastrointestinal flora diffuse to the lower respiratory tract through reverse diffusion, damage the alveolar system, and induce further aggravation of lung infection symptoms. The whole process can be described as "lung and large intestine are exterior and interior" according to traditional medical theory. Therefore, when choosing a specific treatment plan, the degree of retention of the patient's lung and intestinal environment and related functions should be comprehensively considered, and comprehensive lung and intestinal treatment should be performed without increasing the burden on the patient's body, taking into account both tonifying the lungs and replenishing qi, nourishing yin and strengthening the foundation, and promoting digestion.

[0194] (III) Analysis of the efficacy and safety of Buyuan Gongdu Chengqi Decoction in the treatment of constipation after invasive mechanical ventilation

[0195] Combined with the relevant results and data analysis of this study, the two treatment regimens have a certain improvement effect on the constipation symptoms of patients under invasive mechanical ventilation. The treatment group's treatment regimen is more significant than the control group's in terms of comprehensive efficacy and medication safety. The results of the two in improving constipation symptoms, stool characteristics, promoting gastrointestinal emptying, and assisting in improving lung function are statistically significant (P < 0.05). The analysis of adverse reaction monitoring data confirmed that the treatment group's treatment regimen is safer and more clinically effective, and the difference is statistically significant compared with the control group (P < 0.05).

[0196] Combined with the above data analysis results, it is clear that Buyuan Gongdu Chengqi Decoction has a practical and reliable effect on improving constipation in patients under invasive mechanical ventilation. Its therapeutic effect can be reflected in the degree of symptoms, stool characteristics evaluation, gastrointestinal emptying rate and improvement of pulmonary ventilation function. Correspondingly, the efficacy of conventional cathartics and bioactive preparations in this study was not as good as expected, and it was even difficult to achieve the corresponding therapeutic effect. In terms of adverse reaction monitoring and drug safety evaluation, the combination of cathartics and bioactive preparations is more likely to cause patients to experience acute gastrointestinal symptoms (diarrhea, enteritis, gastrointestinal bleeding, etc.), aggravating the patient's condition and increasing the difficulty of diagnosis and treatment.

[0197] Further analysis of the causes of its occurrence shows that, on the one hand, the constipation symptoms of patients under invasive mechanical ventilation are essentially different from the common chronic or functional constipation in clinical practice, and the symptoms of intestinal heat are more significant; on the other hand, the disease factors of patients under invasive mechanical ventilation are relatively more complicated. Constipation, as a common complication in this state, cannot affect the fact that the patient is seriously ill. In addition, the symptoms of constipation occur early, the condition is acute, and the functional disorder is significant. Simple cathartics and bioactive preparations cannot achieve intervention and relief of the overall condition and are only used as symptomatic treatment. Related studies have also confirmed that cathartics combined with bioactive preparations can be used as a reference or auxiliary therapy to improve acute severe constipation, but more comprehensive diagnosis and treatment methods are also needed to improve the constipation symptoms of patients; especially for critically ill patients, the use of cathartics needs to be more cautious to prevent the risk of dehydration and electrolyte imbalance. Combined with clinical studies, it can be made clear that cathartics combined with bioactive preparations have a good effect on the over-prevention of constipation, especially in improving the disorder of intestinal flora, adjusting intestinal function, and stabilizing the intestinal environment. It has irreplaceable clinical therapeutic significance for other drugs. Therefore, the study selected a cathartic combined with a biologically active preparation as a control on the one hand, and Buyuan Gongdu Chengqi Decoction was used for tonifying deficiency and inducing purgation on the basis of comprehensive syndrome differentiation on the other hand as an observation. Combined with long-term clinical observation and follow-up, the long-term efficacy of the two study regimens was clarified, and a credible conclusion was drawn.

[0198] The above is a description of the embodiments of the present invention. Through the above description of the disclosed embodiments, professionals and technicians in the field can implement or use the present invention. Various modifications to these embodiments will be apparent to professionals and technicians in the field. The general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to these embodiments shown in this article, but will conform to the widest range consistent with the principles and novelties disclosed herein.

Claims

1. A Chinese medicine composition for treating constipation after invasive mechanical ventilation, characterized in that: The active ingredients of the Chinese medicine composition include the following raw materials by weight: 10-20 parts of raw rhubarb, 15-25 parts of stir-fried immature bitter orange, 10-20 parts of sodium sulfate, 5-15 parts of coptis root, 15-25 parts of Scrophularia ningpoensis, 25-35 parts of honey astragalus, 5-15 parts of ginseng, and 25-35 parts of roasted aster.

2. A Chinese medicine composition for treating constipation after invasive mechanical ventilation according to claim 1, characterized in that: The active ingredient raw materials of the traditional Chinese medicine composition include the following raw materials by weight: 13-17 parts of raw rhubarb, 18-22 parts of stir-fried immature bitter orange, 13-17 parts of sodium sulfate, 8-12 parts of coptis root, 18-22 parts of Scrophularia ningpoensis, 28-32 parts of honey astragalus, 7-11 parts of ginseng, and 28-32 parts of roasted aster.

3. A Chinese medicine composition for treating constipation after invasive mechanical ventilation according to claim 1 or 2, characterized in that: The Chinese medicine composition also includes adding other Chinese medicine extracts and / or adding other raw materials.

4. A Chinese medicine composition preparation for treating constipation after invasive mechanical ventilation, characterized in that: The Chinese medicine composition preparation comprises the Chinese medicine composition according to any one of claims 1 to 3 and / or added pharmaceutical excipients and / or added food additives.

5. A Chinese medicine composition preparation for treating constipation after invasive mechanical ventilation according to claim 4, characterized in that: The Chinese medicine composition preparation is in the form of tablets, chewable tablets, powders, granules, granules, capsules, ointments, pills or liquid preparations.

6. The Chinese medicine composition preparation according to claim 4 or 5, characterized in that: The preparation can be taken orally, by nasal feeding or externally.

7. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine composition preparation according to any one of claims 4 to 5 in the preparation of a treatment for constipation after invasive mechanical ventilation.

8. The use according to claim 1, characterized in that: The Chinese medicine composition or Chinese medicine composition preparation can perform comprehensive lung and intestinal conditioning without increasing the burden on the patient's body, and can simultaneously invigorate the lungs and replenish qi, nourish yin and consolidate the foundation, and promote digestion, thereby effectively improving constipation symptoms after invasive mechanical ventilation surgery.

9. A method for preparing a Chinese medicine composition for treating postoperative constipation after invasive mechanical ventilation, characterized in that: The following steps are adopted: according to the Chinese medicine composition of claim 1 or 2, all medicinal materials are weighed in proportion, decocted and concentrated, and prepared into a preparation in an appropriate dosage form.

10. The preparation method according to claim 9, characterized in that: The temperature during decoction of the medicinal materials is 40° C. to 60° C., the time is 30 to 60 minutes, and the dosage form is prepared after being concentrated to the required concentration.

Images