A traditional Chinese medicine composition for preventing and treating postoperative complications of hemorrhoids

Abstract

The present invention discloses a traditional Chinese medicine composition for preventing and treating postoperative complications of hemorrhoids, which is prepared from the following raw materials in parts by weight: 6-11 parts of rhubarb, 7-13 parts of frankincense, 25-35 parts of dandelion, 7-13 parts of gardenia, 25-35 parts of phellodendron bark, 25-35 parts of millettia reticulata, 10-20 parts of honeysuckle, and 10-20 parts of chrysanthemum. The pharmaceutical composition of the present invention can effectively relieve the pain after hemorrhoid surgery, which is superior to simple TDP irradiation. At the same time, it can reduce postoperative bleeding and defecation difficulties, and reduce the incidence of anal distension and perianal edema, with remarkable effects. In terms of the average hospitalization time and the incision healing time, after the traditional Chinese medicine wet compress therapy intervention with the traditional Chinese medicine composition of the present invention, the occurrence of postoperative complications is effectively reduced, the local inflammation is improved, the wound healing is promoted, and the hospitalization time is significantly shortened, having practical popularization and application value.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine composition for preventing and treating postoperative complications of hemorrhoids. Background Art

[0002] Hemorrhoids are one of the most common anorectal diseases clinically. The results of epidemiological investigations in the United States show that the prevalence of hemorrhoids ranges from 4% to 55%, the number of annual consultations is nearly 4 million, and the risk of hemorrhoids is the highest in the population aged 45 - 65. The results of disease censuses organized by the Chinese Society of Anorectal Diseases of Traditional Chinese Medicine in China show that the total incidence of anorectal diseases in the country is 59.1%, among which the incidence of hemorrhoids is the highest at 51.56%, accounting for 87.25% of all anorectal diseases. The incidence of internal hemorrhoids is the highest at 52.23%, followed by mixed hemorrhoids at 21.05% and external hemorrhoids at 14.04%.

[0003] Currently, the treatment of hemorrhoids mainly includes conservative treatment and surgical treatment. Among them, patients with grade I - III hemorrhoids who are ineffective in conservative treatment and / or instrument treatment or patients with grade IV hemorrhoids who are willing to accept surgical treatment can consider surgical treatment. However, due to the special location of hemorrhoids, with rich perianal nerve endings, lymph, and veins, the postoperative pain, edema, and long healing time bring great pain to patients. Traditional Chinese medicine has obvious advantages in perioperative management. Oral administration of traditional Chinese medicine, hip bath, etc. all have certain effects. However, some patients have severe gastrointestinal reactions when taking oral traditional Chinese medicine and cannot tolerate the taste of traditional Chinese medicine. Some patients cannot tolerate hip bath due to body position reasons. At the same time, there are still some patients with obvious postoperative pain and a high incidence of postoperative complications. Therefore, there is an urgent need for a new therapy for preventing and treating postoperative complications of hemorrhoids.

[0004] As a classic traditional therapy, the traditional Chinese medicine wet compress therapy applies the prepared medicine to the local area and cooperates with heating, enabling the drug components to directly enter the local meridian qi and blood. The local drug concentration is high and the systemic side effects are small, and it is widely used in rheumatic arthritis and skin diseases. However, there is currently no traditional Chinese medicine composition combined with the traditional Chinese medicine wet compress therapy for preventing and treating postoperative complications of hemorrhoids. Summary of the Invention

[0005] To solve the above problems, the present invention provides a traditional Chinese medicine composition for preventing and treating postoperative complications of hemorrhoids, which is prepared from raw materials including the following parts by weight:

[0006] 6 - 11 parts of Rheum palmatum, 7 - 13 parts of Olibanum, 25 - 35 parts of Taraxacum mongolicum, 7 - 13 parts of Gardenia jasminoides, 25 - 35 parts of Phellodendron amurense, 25 - 35 parts of Spatholobus suberectus.

[0007] Further, it is prepared from raw materials including the following parts by weight:

[0008] 9 parts of Rheum palmatum, 10 parts of Olibanum, 30 parts of Taraxacum mongolicum, 10 parts of Gardenia jasminoides, 30 parts of Phellodendron amurense, 30 parts of Spatholobus suberectus.

[0009] Further, the gardenia is stir-fried gardenia.

[0010] Further, the raw materials also include 10 - 20 parts of honeysuckle flower and 10 - 20 parts of chrysanthemum flower, preferably 15 parts of honeysuckle flower and 15 parts of chrysanthemum flower.

[0011] Further, it is a preparation prepared from the medicinal powder of the raw materials, or the water or organic solvent extract of the raw materials as the active ingredient, plus pharmaceutically acceptable excipients.

[0012] Further still, the preparation is an external preparation; the external preparation includes ointment, patch, solution, spray, aerosol.

[0013] The present invention also provides a preparation method of the aforementioned traditional Chinese medicine composition, which includes the following steps:

[0014] (1) Weigh the raw materials according to the aforementioned ratio;

[0015] (2) Grind the raw materials into powder, or the water or organic solvent extract of the raw materials, add the excipients or auxiliary components commonly used in medicines, and you will get it.

[0016] Further, in step (2), rhubarb, frankincense, dandelion, gardenia, phellodendron bark and millettia reticulata in the raw materials are ground into fine powder, added to the honeysuckle water, stirred into a paste, and evenly spread on the gauze to obtain it;

[0017] The honeysuckle water is an aqueous solution prepared by decocting honeysuckle flower and chrysanthemum flower with water.

[0018] Further still, the mass - volume ratio of the fine powder to the honeysuckle water is 1g:2ml; the mass - volume ratio of honeysuckle flower, chrysanthemum flower, water and the aqueous solution is 15g:15g:300ml:100ml; the gauze is a sterile gauze with a size of 10 * 10cm.

[0019] Finally, the present invention provides the use of the aforementioned traditional Chinese medicine composition in the preparation of drugs for preventing and treating postoperative complications of hemorrhoids.

[0020] Further, the postoperative complications of hemorrhoids include perianal bleeding, defecation difficulty, dysuria, anal distension, perianal edema, perianal pain.

[0021] In the traditional Chinese medicine composition of the present invention, phellodendron bark: bitter, cold. It enters the kidney meridian and bladder meridian. Its functions are to clear heat, dry dampness, purge fire and detoxify. It can treat heat dysentery, diarrhea, polydipsia, red and swollen eyes, oral ulcers, sores and swelling toxins, etc. Hemorrhoids are mostly caused by damp - heat pouring downward to the local area of the anus and rectum, and phellodendron bark is good at removing damp - heat in the lower jiao. "Shennong's Herbal Classic": It is mainly used for treating heat in the five internal organs and intestines and stomach, jaundice, intestinal hemorrhoids; stopping diarrhea and dysentery, and treating sores caused by yin injury. Modern pharmacology finds that the main chemical components of phellodendron bark are flavonoids and alkaloids, and it has pharmacological effects such as anti - inflammation and antibacterial.

[0022] Dandelion: bitter, sweet, cold. Enters the liver and stomach meridians. Clears away heat and detoxifies, reduces swelling and resolves knots, promotes diuresis and relieves stranguria. Used for carbuncle, breast carbuncle, scrofula, red eyes, sore throat, lung carbuncle, intestinal carbuncle, damp-heat jaundice, and hot stranguria. "Ben Cao Zheng Yi" says: "Dandelion is cool in nature and can cure all carbuncle, carbuncle, redness, swelling, heat and toxicity. It can be taken orally or applied, and it is quite effective. Modern pharmacology has found that dandelion has a strong bactericidal effect on drug-resistant strains of Staphylococcus aureus and hemolytic streptococci, and also has a certain bactericidal effect on various bacteria such as Pneumococcus and meningococci.

[0023] Millettia reticulata: bitter, sweet, warm. Enters the liver and kidney meridians. Nourishes blood, activates blood circulation, and dredges collaterals. "New Reference to Medicinal Pieces": "Removes blood stasis, generates new blood, and circulates the meridians. Treats summer heat sha, wind and blood arthralgia." Modern pharmacology shows that it has pharmacological activities such as anti-inflammatory, anti-tumor, anticoagulant, immunomodulatory, and intestinal regulation. After hemorrhoid surgery, the meridians are damaged, and local blood stasis is inevitable. Millettia reticulata removes blood stasis and generates new blood, Phellodendron chinense clears heat and dries dampness, and Taraxacum officinale clears heat and detoxifies. The three are used together, which is in line with the pathogenesis of damp-heat and blood stasis after hemorrhoid surgery, and are all monarch drugs.

[0024] Gardenia: bitter, cold. Enters the heart, lung, and triple burner meridians. Functions: purging fire and relieving restlessness, clearing heat and promoting diuresis, cooling blood and detoxifying. Used for restlessness due to febrile diseases, jaundice and red urine, bloody and painful stranguria, vomiting and bleeding due to blood heat, red and swollen eyes, and fire poison sores; Gardenia can also relieve heat and dampness, and treat sprains and pain externally. Grind raw gardenia into powder, mix with flour and rice wine, and it has the effect of reducing swelling and activating collaterals. It can be used for falls, sprains, bruises, and painful skin. It helps Phellodendron chinense to clear heat and dry dampness, and helps Taraxacum officinale to clear heat and detoxify, and at the same time can reduce swelling and activate collaterals as a ministerial drug.

[0025] Frankincense: pungent, bitter, warm. Enters the heart, liver, and spleen meridians. Functions: promoting blood circulation and relieving pain. Used for various pains in the heart and abdomen, muscle spasms, injuries from falls, swelling and pain from sores and carbuncles; external use: reducing swelling and promoting tissue regeneration. "Compendium of Materia Medica": "It can eliminate various poisons from carbuncles and carbuncles, protect the heart, promote blood circulation and relieve pain, stretch the tendons, and treat difficult labor and fractures in women." It helps Millettia reticulata promote blood circulation and relieve pain, and also reduces swelling and promotes tissue regeneration, and is used as a minister drug together with Gardenia jasminoides.

[0026] Rhubarb: bitter, cold. Enters the spleen, stomach, large intestine, liver, and pericardium meridians. It clears away heat and clears the intestines, cools blood and detoxifies, and removes blood stasis and dredges the menstrual channels. It is used for constipation due to excess heat, abdominal pain due to accumulation, diarrhea, and jaundice due to damp heat. Rhubarb is a general's medicine with a rapid and powerful medicinal property. It clears away heat and removes blood stasis. Modern pharmacology has found that it has therapeutic effects on inflammation, burns, lower limb ulcers, etc. Therefore, a small dose of rhubarb is used in the prescription as an adjuvant.

[0027] Honeysuckle is sweet and cold, clears away heat and detoxifies, and cools and disperses wind and heat. It is used for carbuncle, furuncle, chrysanthemum, sweet, bitter, slightly cold, dispersing wind and clearing heat. The decoction of honeysuckle and chrysanthemum is used to prepare the medicine, taking its heat-clearing and detoxifying, dispersing nature, enhancing the efficacy, and is both a drug and an excipient.

[0028] The whole prescription can clear away heat, dry dampness, remove blood stasis and relieve pain, and is effective when used after hemorrhoid surgery.

[0029] Clinical application statistics prove that: the pharmaceutical composition of the present invention can effectively relieve the pain after hemorrhoid surgery, which is superior to simple TDP irradiation. At the same time, it can reduce postoperative bleeding and defecation difficulties, relieve the incidence of anal distension and perianal edema, and the effect is remarkable. In terms of the average length of hospital stay and the incision healing time, the use of the traditional Chinese medicine composition of the present invention for traditional Chinese medicine wet compress therapy intervention effectively reduces the occurrence of postoperative complications, improves local inflammation, promotes the healing of the wound surface, and significantly shortens the length of hospital stay. It has practical popularization and application value.

[0030] Obviously, based on the above content of the present invention, according to the common general technical knowledge and customary means in the art, without departing from the above basic technical idea of the present invention, various other forms of modification, substitution or change can also be made.

[0031] The following is a further detailed description of the above content of the present invention through specific embodiments in the form of examples. However, this should not be construed as limiting the scope of the above subject matter of the present invention to the following examples. All technologies implemented based on the above content of the present invention belong to the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 Comparison of the latency time of the first licking of the perianal wound surface by rats in each group

[0033] Figure 2 Comparison of the number of writhing responses of rats in each group;

[0034] Figure 3 Comparison of the edema exudate score and the wound healing time of rats in each group. DETAILED DESCRIPTION OF THE INVENTION

[0035] Example 1. Preparation of the drug of the present invention

[0036] Formula: 9 g of Rheum palmatum, 10 g of Olibanum, 30 g of Taraxacum mongolicum, 10 g of fried Gardenia jasminoides, 30 g of Phellodendron amurense, 30 g of Spatholobus suberectus, 15 g of Lonicera japonica, 15 g of Chrysanthemum morifolium.

[0037] Preparation method:

[0038] (1) Weigh the raw materials according to the ratio, and grind Rheum palmatum, Olibanum, Taraxacum mongolicum, fried Gardenia jasminoides, Phellodendron amurense and Spatholobus suberectus into fine powder;

[0039] (2) Take Lonicera japonica and Chrysanthemum morifolium, add 300 ml of water and decoct to 100 ml to obtain the double-flower water;

[0040] (3) Take the fine powder prepared in step (1) and the double-flower water prepared in step (2), and stir evenly according to the ratio of 1:2 g / v to obtain a paste-like ointment;

[0041] (4) Apply the paste obtained in step (3) onto a double-layer sterile gauze of 10*10 cm to obtain the traditional Chinese medicine wet compress patch.

[0042] Usage method: Take the patch and apply it locally centered on the anus, and irradiate it with a TDP lamp for 30 minutes. The temperature should be appropriate for the patient to tolerate to avoid scalding.

[0043] Example 2. Preparation of the drug of the present invention

[0044] Formula: 6 g of rhubarb, 7 g of frankincense, 25 g of dandelion, 7 g of stir-fried gardenia, 25 g of phellodendron, 25 g of millettia reticulata, 10 g of honeysuckle, 10 g of chrysanthemum.

[0045] Preparation method and usage method: The same as in Example 1.

[0046] Example 3. Preparation of the drug of the present invention

[0047] Formula: 11 g of rhubarb, 13 g of frankincense, 35 g of dandelion, 13 g of stir-fried gardenia, 35 g of phellodendron, 35 g of millettia reticulata, 20 g of honeysuckle, 20 g of chrysanthemum.

[0048] Preparation method and usage method: The same as in Example 1.

[0049] The beneficial effects of the present invention are illustrated below through experimental examples.

[0050] Experimental example 1. Pharmacodynamic study based on animal experiments

[0051] 1 Experimental materials and animals

[0052] 1.1 Experimental animals

[0053] 63 12-week-old SD rats with a body weight of (160±20) g. Breeding conditions: room temperature 20-24°C, humidity 50-60%, artificial day and night alternating for 12 hours. This study was carried out strictly in accordance with the "Guidelines for the Experimentation of 6 Laboratory Animals of the National Institute of Health".

[0054] 1.2 Drugs

[0055] Rhubarb, frankincense, dandelion, stir-fried gardenia, phellodendron, millettia reticulata, honeysuckle, chrysanthemum. All the above drugs are from Luzhou Baoguang Pharmaceutical Co., Ltd.

[0056] 1.3 Model preparation

[0057] Modeling was carried out with reference to the "Preparation Specification (Draft) of Animal Models for Traditional Chinese Medicine Hemorrhoids" and the modeling method of Bin Donghua, etc.: When modeling, the body weight of the rats was (180±20) g per rat. The rats were anesthetized by intraperitoneal injection of 3% sodium pentobarbital solution. After anesthesia, the perianal area was disinfected 3 times from the periphery to the inside with 0.1% bromogeramine tincture solution. Using a syringe, 0.05 ml of 75% glacial acetic acid was injected subcutaneously at the 3, 7, and 11 o'clock positions in the lithotomy position of the anal margin of each rat in a fan shape. The perianal area was massaged locally to make the medicinal liquid fully disperse. After hemostasis by compression with a sterile cotton ball, the perianal area was disinfected and bandaged again. After 24 hours, the dressing was removed, and the skin of the anal margin of the rats was observed. A white ulcer surface accompanied by swelling and exudation could be seen. The wound surface was evaluated using the 4-level local symptom scoring method. Rats with local swelling and elevation of the anal margin skin ≥1 mm, ulcer area >0.3 cm², bottom width of the swollen area <0.5 cm, height <1 cm, and accompanied by more exudation were considered successful in modeling. Rats that did not meet the above conditions were considered failed in modeling and were excluded. The rats that were successful in hemorrhoid disease modeling were anesthetized again, and the ulcer surface and swollen area were removed with a scalpel until the muscular layer. The wound surface was trimmed into a triangular defect (bottom width 0.5 cm, height 1 cm), simulating the "open, acute, bleeding" injury wound after hemorrhoid resection surgery.

[0058] 2 Experimental methods

[0059] 2.1 Grouping and intervention

[0060] After 63 rats were adaptively raised for 1 week, perianal hair removal and staining and numbering were carried out. Using the random number table method, there were 9 rats in each group, and there were a total of 7 groups, namely Group A (blank group), Group B (model group), Group C (total formula group), Group D (sovereign drug group), Group E (sovereign drug plus ministerial drug 1 group), Group F (sovereign drug plus ministerial drug 2 group), and Group G (no sovereign drug group). Except for the blank group, the model group and other groups used glacial acetic acid and surgery to prepare the postoperative model of hemorrhoid disease. After successful preparation, each treatment group was given corresponding treatment. The model group only used TDP irradiation and did not use traditional Chinese medicine compress; the blank group was not treated. All mice could freely obtain water and food.

[0061] Among them, the prescription of the total formula group: 30 g of Phellodendron amurense, 30 g of Taraxacum mongolicum, 30 g of Caulis Spatholobi, 10 g of Olibanum, 10 g of Fructus Gardeniae, 9 g of Rheum officinale; the prescription of the sovereign drug group: 30 g of Phellodendron amurense, 30 g of Taraxacum mongolicum, 30 g of Caulis Spatholobi; the sovereign drug plus ministerial drug 1 group: 30 g of Phellodendron amurense, 30 g of Taraxacum mongolicum, 30 g of Caulis Spatholobi, 10 g of Olibanum; the sovereign drug plus ministerial drug 2 group: 30 g of Phellodendron amurense, 30 g of Taraxacum mongolicum, 30 g of Caulis Spatholobi, 10 g of Fructus Gardeniae; the no sovereign drug group: 10 g of Olibanum, 10 g of Fructus Gardeniae, 9 g of Rheum officinale

[0062] Intervention method:

[0063] Full formula group or monarch drug-free group: Grind all the above traditional Chinese medicines into fine powder and mix well for later use. Decoct 15 g each of honeysuckle and chrysanthemum with 300 ml of water to 100 ml to prepare honeysuckle water for later use. When using, put the powder into a container, add honeysuckle water according to the ratio of 1:2 = g / v, stir well to make a paste. Take double-layer sterile gauze, evenly apply the paste on the gauze, fix the rat, and apply it locally with the anus as the center. Irradiate with a TDP therapeutic lamp for 30 min, and the temperature should be appropriate for tolerance to avoid scalding.

[0064] Monarch drug group, monarch drug plus ministerial drug 1 group or monarch drug plus ministerial drug 2 group: The method is the same as that of the full formula group and the monarch drug-free group, except that normal saline is used instead of honeysuckle water.

[0065] Note: Equal amounts of drugs are evenly applied to the double-layer sterile gauze of each administration group.

[0066] 2.2 Observation indicators and methods

[0067] 2.2.1 Zoological behaviors related to pain in rats

[0068] After dressing change stimulation on the 1st, 4th, and 7th days, put the rats back into the cage alone, and record the latent time of the first licking of the perianal wound surface and the number of writhing reactions within 3 min.

[0069] 2.2.2 Incision edema and exudate score

[0070] The edema curative effect scoring standard is formulated based on years of clinical observation and reference to previous literature research

[0071] 0 point: No edema and no exudate on the wound surface;

[0072] 1 point: No obvious edema of granulation tissue on the wound surface, and normal exudate;

[0073] 2 points: Mild edema of granulation tissue on the wound surface, and more exudate;

[0074] 3 points: Severe edema of granulation tissue on the wound surface, the wound surface is moist, and the exudate is severe.

[0075] 2.2.3 Incision complete healing time

[0076] Record the complete healing time of the wound surface of rats in each group

[0077] 3 Results

[0078] 3.1 Modeling situation: Among them, 50 cases were successfully modeled, and the modeling success rate was 88.9%. 1 case was excluded from group B, 1 case from group D, 1 case from group E, and 1 case from group G.

[0079] 3.2 Comparison of zoological behaviors related to pain in rats

[0080] The latency of the first licking of the perianal wound surface can reflect the pain degree of rats after dressing change and the analgesic effects of each treatment group. By comparing the latency of the first licking of the perianal wound surface in each group of rats after dressing change stimulation, it can be seen that on the 1st day, the latency of the perianal wound surface licking in the model group was significantly shorter than that in each treatment group, indicating that the Chinese medicine wet compress effectively relieved the pain after dressing change (p < 0.05), while the latency of the perianal wound surface licking in the whole formula group was significantly higher than that in the model group and other groups (p < 0.05), indicating that the whole formula group had better analgesic efficacy. The latency of the first licking of the perianal wound surface on the 4th day and the 7th day also showed the same difference. In addition, due to the lack of a complete compatibility of monarch, minister, assistant, and courier herbs in the monarch herb group and the non-monarch herb group, the drug efficacy was not good, and there was no significant advantage in analgesia compared with the model group on the 7th day. See Table 1, Figure 1 A - C.

[0081] Table 1 Comparison of the latency of the first licking of the perianal wound surface in each group of rats

[0082]

[0083] Note: *P < 0.05 (compared with the model group); # P < 0.05 (compared with the whole formula group), and the marks in the figure are the same.

[0084] The number of writhing responses can also reflect the pain degree of rats after dressing change and the analgesic effects of each treatment group. On the 1st day, the number of obvious writhing responses in the model group was higher than that in each treatment group, indicating that the Chinese medicine wet compress effectively relieved the pain after dressing change (p < 0.05), while the number of writhing responses in the whole formula group was significantly lower than that in the model group and other groups (p < 0.05), indicating that the whole formula group had better analgesic efficacy. The number of writhing responses on the 4th day and the 7th day also showed the same difference. In addition, due to the lack of a complete compatibility of monarch, minister, assistant, and courier herbs in the monarch herb group and the non-monarch herb group, the drug efficacy was not good, and there was no significant advantage in analgesia compared with the model group on the 1st day. On the 7th day, perhaps due to the incision tending to heal, and the group of monarch herb plus minister herb 1 and the group of monarch herb plus minister herb 2 had the most basic monarch-minister combination of the prescription, so although the number of writhing responses was lower than that in the whole formula group, no statistically significant difference was formed. See Table 2, Figure 2 A - C.

[0085] Table 2 Comparison of the number of writhing responses in each group of rats

[0086]

[0087] Note: *P < 0.05 (compared with the model group); #P < 0.05 (compared with the whole formula group), and the marks in the figure are the same.

[0088] In comparing the edema and exudate conditions of the rat wounds, the edema and exudate scores of the model group were higher than those of the model group, the group with the sovereign drug plus ministerial drug 1, and the group with the sovereign drug plus ministerial drug 2. This indicates that Chinese medicine wet compress effectively reduces wound edema and exudate (p < 0.05). Since the sovereign drug group and the group without the sovereign drug lack the complete compatibility of sovereign, ministerial, assistant, and envoy drugs, the drug efficacy is poor, and no significant advantage is shown compared with the model group in reducing edema and exudate. The edema and exudate score of the full formula group was significantly lower than that of the model group and other groups (p < 0.05), indicating that the full formula group has a better effect in reducing wound edema and exudate.

[0089] In comparing the wound healing time of the rats, the healing time of the model group was longer than that of the model group, the group with the sovereign drug plus ministerial drug 1, and the group with the sovereign drug plus ministerial drug 2. This indicates that Chinese medicine wet compress can effectively shorten the wound healing time (p < 0.05). Since the sovereign drug group and the group without the sovereign drug lack the complete compatibility of sovereign, ministerial, assistant, and envoy drugs, the drug efficacy is poor, and no significant advantage is shown compared with the model group in terms of wound healing time. The wound healing time of the full formula group was significantly lower than that of the model group and other groups (p < 0.05), indicating that the full formula group can effectively shorten the wound healing time. See Table 3. Figure 3 A - B.

[0090] Table 3 Comparison of edema and exudate scores and wound healing time of rats in each group

[0091]

[0092] Note: *P < 0.05 (compared with the model group); #P < 0.05 (compared with the full formula group), and the markings in the figure are the same.

[0093] 4 Results

[0094] The Chinese medicine wet compress formula of the present invention can effectively relieve the pain after hemorrhoid surgery, reduce edema and exudate, and shorten the wound healing time. Among them, the full formula group shows obvious advantages over other sovereign drug groups, the group with the sovereign drug plus ministerial drug 1, the group with the sovereign drug plus ministerial drug 2, and the group without the sovereign drug in terms of postoperative pain, edema, exudate, and overall wound healing time, verifying the accuracy and science of the formula, and the full formula works synergistically to exert the maximum efficacy.

[0095] Experimental Example 1 Clinical Application Research of the Present Invention

[0096] 1. General Information

[0097] All the selected cases were patients who visited the Department of Traditional Chinese Medicine of the Affiliated Hospital of Southwest Medical University from January 2019 to December 2019, were diagnosed with mixed hemorrhoids and completed relevant preoperative examinations, and were scheduled for hemorrhoid surgery. A total of 120 patients were randomly divided into two groups. The treatment group consisted of 60 cases, including 22 males and 38 females, aged from 18 to 75 years; the control group consisted of 60 cases, including 34 males and 26 females, aged from 20 to 72 years. There were no statistically significant differences between the two groups in terms of age, gender, and degree of hemorrhoid disease, and they were comparable.

[0098] Inclusion criteria: Meeting the standards of mixed hemorrhoids in the 2020 edition of the diagnosis and treatment guidelines for hemorrhoids. Exclusion criteria: Complicated with other anorectal diseases such as anal fissure, abscess, anal fistula, etc., complicated with serious diseases of the heart, liver, and kidney, and those who could not tolerate surgery.

[0099] 2. Intervention methods and observations

[0100] 2.1 Intervention methods

[0101] The preoperative preparations of the two groups were the same. The surgical anesthesia consent form was signed before surgery, the enema was given once for preoperative cleansing, and antibiotics were prophylactically used half an hour before surgery. Subarachnoid block anesthesia was used, and the lithotomy position was adopted during the operation. Hemorrhoidectomy + hemorrhoid sclerosing agent injection + internal hemorrhoid hard injection were performed. Postoperative anti-inflammatory and hemostatic treatments were carried out. The perioperative management of the two groups was the same.

[0102] Treatment group: Starting from the first day after surgery, the patch prepared in Example 1 was used for traditional Chinese medicine wet compress treatment every day, once a day.

[0103] Control group: Starting from the first day after surgery, only TDP lamp irradiation was used. The temperature and time were the same as those in the treatment group.

[0104] 2.2 Observation indicators

[0105] The visual analogue score (VAS) with a pain intensity of 11 points (0 - 10) was used, and the patient was asked to grade the "most severe pain level in the past 24 hours (before analgesic intervention)". The VAS scores on the 1st, 3rd, and 5th days after surgery were recorded.

[0106] Referring to the 4 - level weighted scoring method for clinical efficacy evaluation (none, mild, moderate, severe) in the "Guiding Principles for Clinical Research of New Chinese Medicines", and combining with clinical practice, simple quantification and scoring were carried out for each complication index, specifically including: ① Bleeding: none (0 points), bloodstaining on toilet paper (1 point), dripping blood during defecation (2 points), still bleeding after defecation (3 points); ② Difficulty in defecation: none (0 points), defecation is not smooth but can be done by oneself (1 point), defecation is not smooth and requires glycerin enema or enema assistance (2 points); ③ Difficulty in urination: none (0 points), urination is not smooth but can be done by oneself (1 point), difficulty in urination requires catheterization (2 points); ④ Anorectal distending sensation: none (0 points), the distending sensation can be tolerated (1 point), the distending sensation is intolerable and requires drug relief (2 points); ⑤ Anal margin edema: none (0 points), mild edema does not affect the incision alignment (1 point), obvious edema or requires trimming (2 points). The situation of urination and anorectal distending sensation on the first day after surgery was recorded, and the situation of defecation, bleeding and anal margin edema during the first defecation after surgery was recorded.

[0107] 3 Results

[0108] The specific results are shown in Tables 4 and 5.

[0109] Table 4: Comparison of pain, bleeding, difficulty in defecation, difficulty in urination, anorectal distending sensation, and anal margin edema between the two groups

[0110]

[0111]

[0112] Note: P * <0.05

[0113] Table 5 Comparison of hospital stay and healing time between the two groups

[0114]

[0115] Note: P * <0.05

[0116] 4 Conclusions

[0117] The Chinese medicine compress therapy with the Chinese medicine compress formula of the present invention applied to the affected area for postoperative hemorrhoids can effectively relieve the postoperative pain, which is better than simple TDP irradiation. At the same time, it can reduce postoperative bleeding and difficulty in defecation, reduce the incidence of anorectal distending sensation and anal margin edema, and the effect is remarkable. In terms of the average hospital stay and incision healing time, the Chinese medicine compress intervention effectively reduces the occurrence of postoperative complications, improves local inflammation, and promotes the healing of the wound surface, thus significantly shortening the hospital stay. There is little difference between the two in improving difficulty in urination, which may be related to the fact that difficulty in urination mostly occurs within 24 hours after surgery, and the Chinese medicine compress starts to intervene on the first day after surgery, so the improvement is not obvious. In the later stage, corresponding traditional Chinese medicine characteristic therapies can be studied for postoperative difficulty in urination.

[0118] In summary, the traditional Chinese medicine wet compress formula of the present invention can effectively relieve postoperative complications after hemorrhoid surgery and is worthy of clinical promotion and application.

Claims

1. A Chinese medicine composition for preventing and treating postoperative complications of hemorrhoids, characterized in that: It is prepared from the following raw materials by weight: 6-11 parts of rhubarb, 7-13 parts of frankincense, 25-35 parts of dandelions, 7-13 parts of gardenia, 25-35 parts of phellodendron, 25-35 parts of millettia reticulata, 10-20 parts of honeysuckle, and 10-20 parts of chrysanthemum.

2. The Chinese medicine composition according to claim 1, characterized in that: It is prepared from the following raw materials by weight: 9 parts of rhubarb, 10 parts of frankincense, 30 parts of dandelions, 10 parts of gardenia, 30 parts of phellodendron, 30 parts of millettia reticulata, 15 parts of honeysuckle, and 15 parts of chrysanthemum.

3. The Chinese medicine composition according to claim 1 or 2, characterized in that: The gardenia is fried gardenia.

4. The Chinese medicine composition according to claim 1, characterized in that: It is a preparation prepared from the powder of the raw material medicine, or the water or organic solvent extract of the raw material medicine as the active ingredient, and pharmaceutically acceptable excipients; the preparation is an external preparation; the external preparation is an ointment, a patch, a solution, a spray, and an aerosol.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: It includes the following steps: (1) Weigh the API according to the ratio; (2) The raw material drug is ground into powder, or the water or organic solvent extract of the raw material drug is added with excipients or auxiliary ingredients commonly used in pharmaceuticals.

6. The preparation method according to claim 5, characterized in that: Step (2) The rhubarb, frankincense, dandelion, gardenia, phellodendron and millettia reticulata in the raw materials are ground into fine powder, added into double flower water, stirred into a paste, and evenly applied on gauze to obtain; The double flower water is a water solution prepared by decocting honeysuckle and chrysanthemum with water.

7. The preparation method according to claim 6, characterized in that: The mass volume ratio of the fine powder to double flower water is 1g:2ml; the mass volume ratio of the honeysuckle, chrysanthemum, water and aqueous solution is 15g:15g:300ml:100ml; the gauze is sterile gauze with a size of 10*10cm.

8. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for preventing and treating postoperative complications of hemorrhoids.

9. The use according to claim 8, characterized in that: The postoperative complications of hemorrhoid surgery include perianal bleeding, difficulty in defecation, difficulty in urination, anal swelling, anal margin edema, and perianal pain.

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