Traditional Chinese medicine composition for treating community-acquired severe pneumonia and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating community-acquired severe pneumonia (SCAP) and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition comprises ginseng, radix bupleuri, scutellaria baicalensis, dandelion, houttuynia cordata, radix paeoniae rubra, lumbricus, agastache rugosus, rhizoma atractylodis, cassia twig, bighead atractylodes rhizome, poria cocos, pericarpium citri reticulatae, rheum officinale and honey-fried licorice root. The traditional Chinese medicine composition provided by the invention has an ideal treatment effect on SCAP, can reduce the degree of organ function damage of a patient, can also reduce the treatment cost of the patient, and provides a new thought for treating SCAP.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition for treating community-acquired severe pneumonia and an application thereof. Background Art

[0002] Community-acquired severe pneumonia (SCAP) refers to severe lung infection acquired in a community setting. SCAP is characterized by the tendency to cause persistent hypoxemia, refractory shock, and multiple organ failure, and is the leading cause of death from infectious diseases.

[0003] At present, despite a series of positive measures taken to treat SCAP, such as the rational use of antibiotics in the early stage, appropriate fluid resuscitation, the use of vasoactive drugs, bedside invasive mechanical ventilation, blood purification treatment and other measures, the mortality rate is still as high as 22%, and the cost of treatment can be as high as 20,000 US dollars. This has brought a heavy economic burden to patients. Therefore, it is urgent to explore other treatment methods for SCAP.

[0004] In recent years, some studies have shown that traditional Chinese medicine can be used to treat SCAP, and it has a certain effect. The existing technology believes that: SCAP belongs to the category of "lung heat disease", "asthma and cough", "wind-heat lung heat disease" and other categories of traditional Chinese medicine, with the characteristics of rapid onset, rapid transmission and severe condition. The disease is located in the lungs, and the pathogenesis is that the wind-heat toxic evil invades the lungs, causing the lungs to fail to descend, the body fluid and qi are disordered, or the wind-cold evil enters the body to turn into heat, refines the body fluid into phlegm, or phlegm turbidity blocks the lungs, and turns into heat, which can all lead to phlegm-heat blocking the lungs, which will lead to heat evil not being resolved, hurting the body fluid and consuming qi, sinking into the blood, and heat sinking into the pericardium for a long time, further promoting the evil to advance and the body to decline, and the body qi is not solid, and the evil is trapped and the body is lost. Therefore, at present, the main principle of traditional Chinese medicine treatment for SCAP patients is to clear away heat and resolve phlegm, and expel evil to go out. For example, using Ma Xing Shi Gan Tang to treat SCAP patients with phlegm-heat blocking the lungs, using Huang Lian Jie Du Tang combined with Wei Jing Tang combined with Western medicine to treat SCAP patients with heat-toxic blocking the lungs, or using Tan Qing Ning, which clears the lungs and resolves phlegm, combined with Western medicine to treat SCAP patients with heat-toxic blocking the lungs. The existing technology for the treatment of SCAP patients with phlegm-heat blocking the lungs tends to focus on clearing heat and detoxifying, but it can only treat the symptoms but not the root cause, so the treatment effect is not ideal.

[0005] Therefore, it has become an urgent problem to be solved in the art to study the pathogenesis of SCAP and provide a Chinese medicine composition corresponding to the pathogenesis of SCAP for treating SCAP. Summary of the invention

[0006] In order to solve the problem that the effect of traditional Chinese medicine in the prior art for treating SCAP is not ideal, the present invention provides a traditional Chinese medicine composition for treating community-acquired severe pneumonia and its application. The traditional Chinese medicine composition of the present invention comprehensively targets the pathogenesis of SCAP, prescribes the right medicine for the right condition, achieves an ideal therapeutic effect, and reduces the treatment cost of SCAP. Specifically, it includes the following technical solutions:

[0007] A Chinese medicine composition, comprising the following raw materials by weight:

[0008] 15-25 parts of ginseng, 15-25 parts of bupleurum, 5-15 parts of scutellaria, 10-20 parts of dandelion, 10-20 parts of houttuynia, 5-15 parts of red peony root, 10-20 parts of earthworm, 5-10 parts of patchouli, 5-15 parts of atractylodes, 4-8 parts of cinnamon twig, 5-15 parts of white atractylodes, 10-14 parts of poria, 4-8 parts of tangerine peel, 4-8 parts of rhubarb and 4-8 parts of roasted liquorice.

[0009] Preferably, the following raw materials are included by weight:

[0010] 17-23 parts of ginseng, 17-23 parts of bupleurum, 7-13 parts of scutellaria, 12-18 parts of dandelion, 12-18 parts of houttuynia, 7-13 parts of red peony root, 12-18 parts of earthworm, 6-9 parts of patchouli, 7-13 parts of atractylodes, 5-7 parts of cinnamon twig, 7-13 parts of white atractylodes, 11-13 parts of poria, 5-7 parts of tangerine peel, 5-7 parts of rhubarb and 5-7 parts of roasted liquorice.

[0011] Preferably, the following raw materials are included by weight:

[0012] 20 parts of ginseng, 20 parts of bupleurum, 10 parts of scutellaria, 15 parts of dandelion, 15 parts of houttuynia, 10 parts of red peony root, 15 parts of earthworm, 9 parts of patchouli, 10 parts of atractylodes, 6 parts of cinnamon twig, 10 parts of atractylodes, 12 parts of poria, 6 parts of tangerine peel, 6 parts of rhubarb and 6 parts of roasted liquorice.

[0013] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0014] Mixing bupleurum, scutellaria, dandelion, houttuynia, red peony root, earthworm, atractylodes, cinnamon twig, atractylodes, tuckahoe, tangerine peel, rhubarb and licorice, and then boiling for the first time, filtering and separating the medicinal liquid and the medicinal residue to obtain the first medicinal liquid and the first medicinal residue;

[0015] The first medicinal residue is decocted for the second time, and Patchouli is added into the medicinal liquid of the second decoction before the second decoction is finished to obtain a second medicinal liquid;

[0016] Decoction of ginseng alone to obtain the third medicinal liquid;

[0017] The first medicinal liquid, the second medicinal liquid and the third medicinal liquid are mixed to obtain the traditional Chinese medicine composition.

[0018] Preferably, during the first and second decoctions, the total weight of Bupleurum, Scutellaria, Taraxacum, Houttuynia, Red Peony, Pheretima, Atractylodes, Cinnamon Twig, Atractylodes, Poria, Tangerine Peel, Rhubarb and Radix Glycyrrhizae and the liquid ratio of water are each 1g:5-10mL; and the time for the first decoction is 0.5-1h.

[0019] Preferably, the second decoction time is 0.5 to 1 hour; and the Patchouli is added 10 to 15 minutes before the end of the second decoction.

[0020] Preferably, the specific operation of separately decocting ginseng includes: separately decocting ginseng according to a material-liquid ratio of 1 g ginseng to 5 mL water.

[0021] Preferably, the separate decoction is: stewing ginseng over low heat for 2 hours.

[0022] The present invention also provides the use of the Chinese medicine composition as described above or the Chinese medicine composition prepared by the preparation method in preparing a medicine for treating community-acquired severe pneumonia.

[0023] The present invention also provides a combination medicine for treating community-acquired severe pneumonia, the combination medicine comprising a Chinese medicine composition and a Western medicine for treating community-acquired severe pneumonia;

[0024] The Chinese medicine composition is the Chinese medicine composition as described above or the Chinese medicine composition prepared by the preparation method;

[0025] The western medicine for treating community-acquired severe pneumonia includes any one or more of antibacterial drugs, anticoagulant drugs, and enteral nutrition suspension.

[0026] The beneficial effects of the present invention are:

[0027] The present invention provides a Chinese medicine composition for treating SCAP, including ginseng, bupleurum, scutellaria, dandelion, houttuynia, red peony root, earthworm, patchouli, atractylodes, cinnamon twig, atractylodes, tuckahoe, tangerine peel, rhubarb and licorice. From the perspective of traditional Chinese medicine, SCAP patients are mainly due to deficiency of vital energy and symptoms of phlegm and blood stasis. The present invention starts from the perspective of supporting vital energy, treating from the spleen, tonifying the spleen and benefiting the lungs, and combining the pathogenic mechanism of protecting body fluid in the stomach and clearing away heat and detoxifying, and develops the Chinese medicine composition as described above. The Chinese medicine composition described in the present invention has an ideal therapeutic effect on SCAP, returns the patient's physical indicators to normal, and can also reduce the patient's treatment cost, providing a new idea for treating SCAP. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required to be used in the embodiments are briefly introduced below.

[0029] Figure 1 This is a treatment flow chart of using Western medicine treatment methods and the Chinese medicine composition of the present invention together to treat SCAP patients in Example 5 of the present invention;

[0030] Figure 2 The TCM syndrome scores and SOFA scores of the control group and the experimental group before and after treatment in Example 5 of the present invention;

[0031] Figure 3 The results of the changes in PCT, IL-6, TNF-α and CRP levels in the SCAP patients in the control group and the experimental group before and after treatment in Example 5 of the present invention;

[0032] Figure 4 These are the results of the changes in lymphocyte counts, CD3+ cells, CD4+ cells, and CD8+ cell levels in the SCAP patients in the control group and the test group before and after treatment in Example 5 of the present invention. DETAILED DESCRIPTION

[0033] The present invention provides a traditional Chinese medicine composition, which comprises the following raw materials in parts by weight:

[0034] 15-25 parts of ginseng, 15-25 parts of bupleurum, 5-15 parts of scutellaria, 10-20 parts of dandelion, 10-20 parts of houttuynia, 5-15 parts of red peony root, 10-20 parts of earthworm, 5-10 parts of patchouli, 5-15 parts of atractylodes, 4-8 parts of cinnamon twig, 5-15 parts of white atractylodes, 10-14 parts of poria, 4-8 parts of tangerine peel, 4-8 parts of rhubarb and 4-8 parts of roasted liquorice.

[0035] In terms of weight, the weight of the ginseng of the present invention is 15 to 25 parts; as an embodiment, the weight of the ginseng is 17 to 23 parts. As an embodiment, the weight of the ginseng can be any one of 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts and 25 parts. In a specific embodiment, the weight of the ginseng is 20 parts. The disease of the SCAP patient is caused by the deficiency of the vital energy, so ginseng is used to replenish the vital energy, nourish the spleen and lungs, and expel the evil.

[0036] In terms of weight, the weight of the bupleurum of the present invention is 15 to 25 parts; as an embodiment, the weight of the bupleurum is 17 to 23 parts. As an embodiment, the weight of the bupleurum can be any one of 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts and 25 parts. In a specific embodiment, the weight of the bupleurum is 20 parts. SCAP patients often have internal water and dampness, which is caused by the poor bladder gasification, so bupleurum is added to relieve the exterior and interior.

[0037] In terms of weight, the weight of the Radix Scutellariae described in the present invention is 5 to 15 parts; as an embodiment, the weight of the Radix Scutellariae described is 7 to 13 parts. As an embodiment, the weight of the Radix Scutellariae described can be any one of 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts and 15 parts. In a specific embodiment, the weight of the Radix Scutellariae described is 10 parts. SCAP patients often have internal water retention, which is caused by the poor bladder gasification, so Radix Scutellariae is added to relieve the exterior and interior.

[0038] In terms of weight, the weight of the dandelion of the present invention is 10 to 20 parts; as an embodiment, the weight of the dandelion is 12 to 18 parts. As an embodiment, the weight of the dandelion can be any one of 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts and 20 parts. In a specific embodiment, the weight of the dandelion is 15 parts. The cause of SCAP patients is phlegm heat and blood stasis in the lungs, so adding dandelion can clear away heat and detoxify, eliminate carbuncle and disperse blood stasis.

[0039] In terms of weight, the weight of Houttuynia cordata of the present invention is 10 to 20 parts; as an embodiment, the weight of Houttuynia cordata is 12 to 18 parts. As an embodiment, the weight of Houttuynia cordata can be any one of 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts and 20 parts. In a specific embodiment, the weight of Houttuynia cordata is 15 parts. The cause of SCAP patients is phlegm heat and blood stasis in the lungs, so Houttuynia cordata is added to clear away heat and detoxify, eliminate carbuncle and disperse blood stasis.

[0040] In terms of weight, the weight of the red peony root of the present invention is 5 to 15 parts; as an embodiment, the weight of the red peony root is 7 to 13 parts. As an embodiment, the weight of the red peony root can be any one of 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts and 15 parts. In a specific embodiment, the weight of the red peony root is 10 parts. The cause of SCAP patients is phlegm heat and blood stasis in the lungs, so adding red peony root can clear away heat and detoxify, eliminate carbuncle and disperse blood stasis.

[0041] In terms of weight, the weight of the earthworm of the present invention is 10 to 20 parts; as an embodiment, the weight of the earthworm is 12 to 18 parts. As an embodiment, the weight of the earthworm can be any one of 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts and 20 parts. In a specific embodiment, the weight of the earthworm is 15 parts. SCAP patients often have symptoms of chest tightness, shortness of breath, nausea, and dry stools, so earthworms are added to relieve chest tightness, regulate qi, dredge meridians and relieve asthma, eliminate dampness and stop vomiting, and relieve constipation.

[0042] In terms of weight, the weight of Patchouli of the present invention is 5 to 10 parts; as an embodiment, the weight of Patchouli is 6 to 9 parts. As an embodiment, the weight of Patchouli can be any one of 5 parts, 6 parts, 7 parts, 8 parts, 9 parts and 10 parts. In a specific embodiment, the weight of Patchouli is 9 parts. Patients with SCAP often have symptoms of chest tightness, shortness of breath, nausea, and dry stools, so Patchouli is added to relieve chest tightness, regulate qi, dredge meridians and relieve asthma, eliminate dampness and stop vomiting, and relieve constipation.

[0043] In terms of weight, the weight of the Atractylodes lancea of ​​the present invention is 5 to 15 parts; as an embodiment, the weight of the Atractylodes lancea is 7 to 13 parts. As an embodiment, the weight of the Atractylodes lancea can be any one of 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts and 15 parts. In a specific embodiment, the weight of the Atractylodes lancea is 10 parts. The cause of SCAP patients is phlegm heat and blood stasis in the lungs, so Atractylodes lancea is added to clear away heat and detoxify, eliminate carbuncle and disperse blood stasis. SCAP patients often have symptoms of chest tightness, shortness of breath, nausea, and dry stools, so Atractylodes lancea is added to widen the chest and regulate qi, dredge the meridians and relieve asthma, eliminate dampness and stop vomiting, and relieve constipation.

[0044] In terms of weight, the weight of the cassia twig of the present invention is 4 to 8 parts; as an embodiment, the weight of the cassia twig is 5 to 7 parts. As an embodiment, the weight of the cassia twig can be any one of 4 parts, 5 parts, 6 parts, 7 parts and 8 parts. In a specific embodiment, the weight of the cassia twig is 6 parts. The SCAP patients often have internal water and dampness, which is caused by the unfavorable bladder gasification. Therefore, adding cassia twig can promote water and dampness, warm yang and transform qi, dredge the water and fire of the triple burner, and restore the normal distribution of body fluids.

[0045] In terms of weight, the weight of the Atractylodes macrocephala of the present invention is 5 to 15 parts; as an embodiment, the weight of the Atractylodes macrocephala is 7 to 13 parts. As an embodiment, the weight of the Atractylodes macrocephala can be any one of 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts and 15 parts. In a specific embodiment, the weight of the Atractylodes macrocephala is 10 parts. The cause of SCAP patients is phlegm heat and blood stasis in the lungs, so Atractylodes macrocephala is added to clear away heat and detoxify, eliminate carbuncle and disperse blood stasis. SCAP patients often have symptoms of chest tightness, shortness of breath, nausea, and dry stools, so Atractylodes macrocephala is added to promote diuresis and eliminate dampness, warm yang and transform qi, dredge the water and fire of the triple burner, and restore the normal distribution of body fluids.

[0046] In terms of weight, the weight of the Poria cocos of the present invention is 10 to 15 parts; as an embodiment, the weight of the Poria cocos is 11 to 13 parts. As an embodiment, the weight of the Poria cocos can be any one of 10 parts, 11 parts, 12 parts, 13 parts, 14 parts and 15 parts. In a specific embodiment, the weight of the Poria cocos is 12 parts. SCAP patients often have symptoms of chest tightness, shortness of breath, nausea, and dry stools. Therefore, adding Poria cocos can promote diuresis and eliminate dampness, warm yang and transform qi, dredge the water and fire of the three burners, and restore the normal distribution of body fluids.

[0047] In terms of weight, the weight of the dried tangerine peel of the present invention is 4 to 8 parts; as an embodiment, the weight of the dried tangerine peel is 5 to 7 parts. As an embodiment, the weight of the dried tangerine peel can be any one of 4 parts, 5 parts, 6 parts, 7 parts and 8 parts. In a specific embodiment, the weight of the dried tangerine peel is 6 parts. The SCAP patients often have chest tightness, shortness of breath, nausea, and dry stools, so the dried tangerine peel is added to relieve chest tightness, regulate qi, dredge meridians and relieve asthma, eliminate dampness and stop vomiting, and relieve constipation.

[0048] In terms of weight, the weight of the rhubarb of the present invention is 4 to 8 parts; as an embodiment, the weight of the rhubarb is 5 to 7 parts. As an embodiment, the weight of the rhubarb can be any one of 4 parts, 5 parts, 6 parts, 7 parts and 8 parts. In a specific embodiment, the weight of the rhubarb is 6 parts. The SCAP patients often have chest tightness, shortness of breath, nausea, and dry stools, so rhubarb is added to relieve chest tightness, regulate qi, dredge meridians and relieve asthma, eliminate dampness and stop vomiting, and relieve constipation.

[0049] In terms of weight, the weight of the licorice root of the present invention is 4 to 8 parts; as an embodiment, the weight of the licorice root is 5 to 7 parts. As an embodiment, the weight of the licorice root can be any one of 4 parts, 5 parts, 6 parts, 7 parts and 8 parts. In a specific embodiment, the weight of the licorice root is 6 parts. The SCAP patients often have internal water retention, which is caused by the poor bladder gasification, so the licorice root is added to relieve the exterior and interior.

[0050] The symptoms of SCAP patients include chest tightness, shortness of breath, pale complexion, fatigue, nausea, cough, poor appetite, dry and hard stool, less or yellow and black greasy tongue coating, and stringy and slippery pulse or stringy and rapid pulse. The Chinese medicine composition of the present invention can not only tonify the spleen and lung, clear lung heat, but also promote water and dampness, warm yang and transform qi, and can be used for the syndrome of phlegm-heat blocking the lung and triple energizer disorder, and can effectively treat SCAP.

[0051] The present invention also provides a method for preparing the Chinese medicine composition, comprising the following steps:

[0052] Bupleurum, scutellaria, dandelion, houttuynia, red peony root, earthworm, atractylodes, cinnamon twig, white atractylodes, poria, tangerine peel, rhubarb and roasted liquorice are mixed and decocted for the first time, and the medicinal liquid and the medicinal residue are separated by filtering to obtain a first medicinal liquid and a first medicinal residue; the first medicinal residue is decocted for the second time, and before the end of the second decoction, Patchouli is added to the medicinal liquid of the second decoction to obtain a second medicinal liquid; ginseng is decocted separately to obtain a third medicinal liquid; the first medicinal liquid, the second medicinal liquid and the third medicinal liquid are mixed to obtain the Chinese medicine composition.

[0053] As an embodiment, the present invention mixes Bupleurum, Scutellaria, Taraxacum, Houttuynia, Red Peony, Pheretima, Atractylodes, Cinnamon Twig, Atractylodes, Poria, Tangerine Peel, Rhubarb and Radix Glycyrrhizae for the first decoction, separates the medicinal liquid and the medicinal residue, and obtains the first medicinal liquid and the first medicinal residue; as an embodiment, the present invention adds water to the first medicinal residue for the second decoction, adds Patchouli before the end of the second decoction, removes the medicinal residue, and obtains the second medicinal liquid. As an embodiment, during the first decoction and the second decoction, the total weight of Bupleurum, Scutellaria, Taraxacum, Houttuynia, Red Peony, Pheretima, Atractylodes, Cinnamon Twig, Atractylodes, Poria, Tangerine Peel, Rhubarb and Radix Glycyrrhizae and the solid-liquid ratio of water are 1g:5-10mL respectively; the time of the first decoction is 0.5-1h. As another embodiment, during the first decoction and the second decoction, the total weight of Bupleurum, Scutellaria, Taraxacum, Houttuynia, Red Peony, Pheretima, Atractylodes, Cinnamon Twig, Atractylodes, Poria, Tangerine Peel, Rhubarb and Radix Glycyrrhizae and the solid-liquid ratio of water can be any one of 1g:5mL, 1g:6mL, 1g:7mL, 1g:8mL, 1g:9mL and 1g:10mL. As an embodiment, the time of the first decoction and the second decoction can be any one of 0.5h, 0.6h, 0.7h, 0.8h, 0.9h and 1h. As an embodiment, the Patchouli is added 10 to 15min before the end of the second decoction; as an embodiment, the Patchouli can be added 10min, 11min, 12min, 13min, 14min or 15min before the end of the second decoction. As an embodiment, during the first decoction, boil over high heat and then turn to low heat for decoction. In a specific embodiment, the total weight of the bupleurum, scutellaria, dandelion, houttuynia, red peony root, earthworm, atractylodes, cinnamon twig, white atractylodes, poria, tangerine peel, rhubarb and licorice root and the solid-liquid ratio of water is 1g:10mL, the first decoction time is 1h, after the first decoction is completed, the residue and the liquid are separated to obtain the first liquid and the first residue, water is added to the first residue at a solid-liquid ratio of 1g:10mL, and the second decoction is carried out, the second decoction time is 1h, patchouli is added 15min before the end of the second decoction, and the decoction is continued until the second decoction is completed, the residue is removed, and the second liquid is obtained.

[0054] The main pharmacological effect of Patchouli is the volatile oil it contains, which is not resistant to high temperatures. Adding Patchouli to the second decoction and decocting it for a short time can effectively prevent excessive loss of volatile medicinal components and maintain the efficacy of the medicine.

[0055] As an embodiment, the present invention decocts ginseng separately to obtain the third medicinal liquid. As an embodiment, the specific operation of decoct ginseng separately includes: decoct ginseng separately according to the material-liquid ratio of ginseng to water of 1g:10mL, remove the medicinal residue, and obtain the third medicinal liquid. As an embodiment, the decoction separately is: stew ginseng for 2h over a low fire. Decoction of ginseng separately is conducive to the full dissolution of effective substances such as ginsenosides, polysaccharides and volatile oils in ginseng into the solution, so as to enhance the therapeutic effect on SCAP patients.

[0056] After obtaining the first medicinal liquid, the second medicinal liquid and the third medicinal liquid, the present invention mixes the first medicinal liquid, the second medicinal liquid and the third medicinal liquid to obtain the traditional Chinese medicine composition.

[0057] The present invention also provides the use of the Chinese medicine composition as described above or the Chinese medicine composition prepared by the preparation method in preparing a medicine for treating community-acquired severe pneumonia.

[0058] The present invention also provides a combination medicine for treating community-acquired severe pneumonia, the combination medicine comprising a Chinese medicine composition and a Western medicine for treating community-acquired severe pneumonia;

[0059] The Chinese medicine composition is the Chinese medicine composition as described above or the Chinese medicine composition prepared by the preparation method described above;

[0060] The western medicine for treating community-acquired severe pneumonia includes one or more of antibacterial drugs, anticoagulant drugs, and enteral nutrition suspension.

[0061] The Yellow Emperor's Classic of Internal Medicine states: "When positive energy is inside, evil cannot enter" and "Where evil gathers, the energy must be weak." The Comparative Study of Traditional Chinese Medicine Wei Qi and Western Medicine Immunology reveals that the body's positive energy and immune function are highly consistent. Positive energy is like the human immune system. A weak positive energy is very similar to a damaged immune system.

[0062] Toxic pathogens easily invade weak and elderly patients with weak lung defense and low immunity. Moreover, the clinical symptoms of patients with low immunity are mostly severe. Zhengqi is composed of Weiqi and Yingqi. Yingqi runs in the meridians, while Wei runs outside the meridians. "Pulses" refer to human blood vessels. The lymphatic system containing immune cells is distributed outside the blood vessels and runs closely with the blood vessels. It can be seen that the network formed by lymphatic vessels is very similar to the meridians that run Yingqi and Weiqi in traditional Chinese medicine.

[0063] From the perspective of the pathogenesis and etiology of traditional Chinese medicine, the pathogenic factors of SCAP patients are not on the surface, but between the surface and the interior. The reason why the pathogenic factors are trapped inside is mainly due to the deficiency of body fluid. The treatment should first strengthen the body, tonify the spleen and replenish qi, so as to regulate the functions of the internal organs and drive the pathogenic factors out. In addition, SCAP patients often have deficiency of the body's vital energy, combined with excess water and dampness, which is caused by the poor gasification of the bladder. Therefore, 15-25 parts of bupleurum, 5-15 parts of scutellaria, 4-8 parts of roasted licorice are used to reconcile the exterior and interior, 4-8 parts of cinnamon twig, 5-15 parts of white atractylodes, and 10-20 parts of poria are used to promote water and dampness, warm the yang and transform qi, dredge the water and fire of the three burners, and restore the normal distribution of body fluid. SCAP patients are due to deficiency of the body's vital energy, so 15-25 parts of ginseng are used to replenish the vital energy, tonify the spleen and benefit the lungs, and drive the pathogen out. Patients with chest tightness, shortness of breath, nausea, and dry stools can be treated with 10-20 parts of earthworms, 5-15 parts of patchouli, 5-15 parts of atractylodes, 4-8 parts of dried orange peel, and 4-8 parts of rhubarb to relieve chest tightness and regulate qi, dredge meridians and relieve asthma, eliminate dampness and stop vomiting, and relieve constipation. Patients with coughs have little or yellow, black and greasy tongue coating, and a stringy, slippery and rapid pulse. This is due to phlegm-heat stasis in the lungs, so 10-20 parts of dandelion, 10-20 parts of houttuynia cordata, and 5-15 parts of red peony root can be added to clear away heat and detoxify, eliminate carbuncle and disperse blood stasis. In the Chinese medicine composition of the present invention, ginseng is used as the main ingredient, which can greatly replenish vital energy, invigorate the spleen and benefit the lungs, and expel evil spirits; bupleurum and scutellaria are used as the assistant ingredients, which can resolve the evil spirits that are half superficial and half internal; adjuvants include earthworm, patchouli, atractylodes, rhubarb, and tangerine peel, which can relieve chest tightness and regulate qi, dredge meridians and relieve asthma, eliminate dampness and stop vomiting, and have laxative effects; adjuvants include houttuynia cordata, dandelion, and red peony root can clear away heat and detoxify, eliminate carbuncle and disperse blood stasis; adjuvants include cinnamon twig, atractylodes macrocephala, and poria can warm yang and transform qi, invigorate the spleen and promote diuresis; and roasted liquorice is used as the messenger to harmonize the various medicines.

[0064] The Chinese medicine composition of the present invention can restore the balance of pro-inflammatory and anti-inflammatory factors in SCAP patients, while upregulating the level of T lymphocytes, thereby promoting the recovery of SCAP patients by supporting the patient's vital energy and reducing the degree of damage to the internal organs.

[0065] To further illustrate the present invention, a Chinese medicine composition for treating community-acquired severe pneumonia and its application provided by the present invention are described in detail below in conjunction with the accompanying drawings and examples, but they should not be construed as limiting the scope of protection of the present invention.

[0066] Embodiment 1 A kind of Chinese medicine composition

[0067] The raw materials of the Chinese medicine composition are as follows by weight:

[0068] 15 parts of ginseng, 15 parts of bupleurum, 5 parts of scutellaria, 10 parts of dandelion, 10 parts of houttuynia, 5 parts of red peony root, 10 parts of earthworm, 5 parts of patchouli, 5 parts of atractylodes, 4 parts of cinnamon twig, 5 parts of atractylodes, 10 parts of poria, 4 parts of tangerine peel, 4 parts of rhubarb and 4 parts of roasted liquorice.

[0069] Embodiment 2 A kind of Chinese medicine composition

[0070] 20 parts of ginseng, 20 parts of bupleurum, 10 parts of scutellaria, 15 parts of dandelion, 15 parts of houttuynia, 10 parts of red peony root, 15 parts of earthworm, 9 parts of patchouli, 10 parts of atractylodes, 6 parts of cinnamon twig, 10 parts of atractylodes, 12 parts of poria, 6 parts of tangerine peel, 6 parts of rhubarb and 6 parts of roasted liquorice.

[0071] Embodiment 3 A kind of Chinese medicine composition

[0072] The raw materials of the Chinese medicine composition are as follows by weight:

[0073] 25 parts of ginseng, 25 parts of bupleurum, 15 parts of scutellaria, 20 parts of dandelion, 20 parts of houttuynia, 15 parts of red peony root, 20 parts of earthworm, 10 parts of patchouli, 15 parts of atractylodes, 8 parts of cinnamon twig, 15 parts of atractylodes, 14 parts of poria, 8 parts of tangerine peel, 8 parts of rhubarb and 8 parts of roasted liquorice.

[0074] Example 4 Preparation method of a Chinese medicine composition

[0075] The preparation method of the Chinese medicine composition comprises the following steps:

[0076] Prepared by using any group of raw materials in Examples 1 to 3;

[0077] Mix bupleurum, scutellaria, dandelion, houttuynia, red peony root, earthworm, atractylodes, cinnamon twig, atractylodes, poria, tangerine peel, rhubarb and licorice, mix the above Chinese medicine components with water at a solid-liquid ratio of 1g:10mL, and then perform the first decoction, first decoct over high heat until the water boils, then turn to low heat and decoct for a total of 1h, and after the decoction is completed, separate the medicinal liquid and the medicinal residue to obtain the first medicinal liquid and the first medicinal residue;

[0078] After obtaining the first medicinal residue, water is added to the first medicinal residue at a material-liquid ratio of 1 g: 10 mL, and a second decoction is performed. The second decoction lasts for 1 hour. Patchouli is added 15 minutes before the end of the second decoction, and the decoction is continued until the end of the second decoction. After the second decoction is completed, the medicinal residue is removed to obtain a second medicinal liquid;

[0079] Mix ginseng with water at a material-liquid ratio of 1 g:10 mL, and boil over low heat for 2 h. After boiling, remove the residue to obtain a third liquid.

[0080] The first medicinal liquid, the second medicinal liquid and the third medicinal liquid are mixed to obtain the traditional Chinese medicine composition.

[0081] Example 5: Experimental verification of the therapeutic effect of the Chinese medicine composition of the present invention on SCAP patients

[0082] SCAP patients have the pathological mechanism of evil qi entering the body, damage to the righteous qi, and deficiency of the internal organs. In the preliminary clinical study on the pathogenesis of SCAP, it was found that the Chinese medicine composition prepared by the present invention reduced the organ failure score and the quantitative score of TCM symptoms of SCAP patients by downregulating the level of pro-inflammatory factors and upregulating the total number of T lymphocytes.

[0083] Based on the above research, the present invention proposes the following research hypothesis: the Chinese medicine composition of the present invention may play a role in supporting the positive energy of SCAP patients by reducing the expression of proinflammatory factors, increasing the level of T lymphocytes, downregulating inflammatory response, and improving immune function, and ultimately achieve the efficacy of alleviating organ failure, improving symptoms, and promoting recovery in SCAP patients. This study used enzyme-linked immunosorbent assay and flow cytometric analysis technology to conduct this prospective randomized controlled study to verify the research hypothesis.

[0084] Prospective randomized controlled studies:

[0085] In this example, 160 consecutive patients with severe pneumonia who are admitted to the Department of Critical Care Medicine and meet the criteria for SCAP are required to meet the following conditions:

[0086] 1. Western medicine diagnostic criteria and traditional Chinese medicine diagnostic criteria:

[0087] (1) Western medicine diagnostic criteria:

[0088] According to the diagnosis and treatment guidelines for community-acquired pneumonia (CAP) developed by the Respiratory Diseases Branch of the Chinese Medical Association in 2006:

[0089] The clinical diagnosis of CAP is based on the following: ① new onset of cough and expectoration, or aggravation of existing respiratory diseases with the appearance of purulent sputum; with or without chest pain; ② fever; ③ signs of pulmonary consolidation and / or moist rales; ④ WBC>10×10 9 / L or <4×10 9 / L, with or without nuclear left shift; ⑤ Chest X-ray examination shows flake-like or patchy infiltrative shadows or interstitial changes, with or without pleural effusion. A clinical diagnosis can be established if any one of the above items ① to ④ plus item ⑤ is present, and pulmonary tuberculosis, lung tumor, pulmonary embolism, pulmonary eosinophil infiltration and pulmonary vasculitis are excluded.

[0090] SCAP is diagnosed when at least one of the following seven diagnostic criteria is met:

[0091] ① Impaired consciousness; ② Respiratory rate >30 times / min; ③ Pa02 <60mmHg, oxygenation index <300, requiring mechanical ventilation; ④ Systolic arterial pressure <90mmHg; ⑤ Concurrent septic shock; ⑥ Chest X-ray shows bilateral or multiple lobes involved, or lesions expand ≥50% within 48 hours of admission; ⑦ Oliguria: urine volume <20mL / h, or <80mL / 4h, or acute renal failure requiring dialysis treatment.

[0092] (2) TCM diagnostic criteria:

[0093] According to the 2018 edition of the TCM Diagnosis and Treatment Guidelines for Community-Acquired Pneumonia compiled by the Professional Committee of the Pulmonary Disease Branch of the Chinese Association of Traditional Chinese Medicine, the TCM diagnostic criteria for SCAP with phlegm-heat obstructing the lungs are as follows:

[0094] SCAP can be diagnosed if two of the following diagnostic criteria 1) and 2) are met, and any two of the following diagnostic criteria 3), 4), and 5) are met.

[0095] ① Main symptoms: cough, excessive sputum, yellow sputum, white, dry and sticky sputum, chest pain, red tongue, yellow and greasy tongue coating, slippery and rapid pulse.

[0096] ② Secondary symptoms: fever, thirst, flushed face, yellow urine, dry and hard stools, and abdominal distension.

[0097] ③ Diagnosis: 1) Severe cough with chest pain; 2) Yellow or white dry and sticky sputum; 3) Fever and thirst; 4) Dry and hard stools or abdominal distension; 5) Red tongue with yellow or greasy tongue coating and rapid or slippery pulse.

[0098] Patients included in the trial must meet the following conditions: SCAP patients who meet both the above-mentioned Western medicine diagnostic criteria and the traditional Chinese medicine diagnostic criteria; aged between 18 and 85 years old; the patient's family members (when the patient has mental disorders) or the patient himself (when the patient does not have mental disorders) signed the informed consent for this study.

[0099] 2. SCAP patient sample deletion criteria:

[0100] (1) SCAP patients have other respiratory diseases (including interstitial pneumonia, pulmonary embolism, and lung tumors); (2) SCAP patients have other malignant tumors; (3) SCAP patients who have undergone cardiopulmonary resuscitation; (4) SCAP patients who have received intensive treatment in the intensive care unit and have been transferred out need to be re-admitted to the ICU due to their condition.

[0101] 3. SCAP patient exclusion and dropout criteria:

[0102] ① Subjects who have obtained informed consent, signed relevant consent forms, met the inclusion criteria, and did not meet the exclusion criteria and entered the randomized trial, but were unable to complete the treatment course and observation period of this program due to various major objective reasons, were excluded as dropout cases. The major objective reasons include: misdiagnosis, serious adverse reactions or sudden other serious diseases during the treatment of the subjects, and incomplete case data.

[0103] 4. Sample size calculation:

[0104] ① According to previous clinical studies, the mean score of multiple organ failure in patients with severe pneumonia who were treated with the Chinese medicine composition of the present invention on the basis of Western medicine treatment was 2±1 points, while the score of multiple organ failure in the Western medicine treatment group alone was 6±4 points. The probability of type I error α=0.05, the probability of type II error β=0.10, and the test efficiency was 90%. ② The patients who met the enrollment conditions were matched in a 1:1 ratio, and the PASS software was used to calculate that there were 72 patients in the Chinese medicine composition combined with Western medicine group and 72 patients in the Western medicine control group. Considering that some patients with severe pneumonia may die within 3 days in the actual clinical process, the number of patients enrolled was appropriately increased, and each group had 80 patients.

[0105] According to the above specimens, the present invention intends to include 160 SCAP subjects who meet the criteria and are continuously admitted to the Department of Critical Care Medicine of Changsha Hospital of Traditional Chinese Medicine (Changsha No. 8 Hospital). Researchers who are not involved in clinical treatment and outcome evaluation are requested to use SAS9.2 software to generate a random sequence, and the patients are allocated to the Western medicine treatment group and the Western medicine combined with the Chinese medicine composition treatment group in a ratio of 1:1, with 80 people in each group, and allocation concealment is achieved through opaque random envelopes. This embodiment does not blind the doctor, but blinds the data statistician and the outcome evaluator.

[0106] 5. Medication regimen for SCAP patients in the control and experimental groups

[0107] Control group: Western medicine treatment group, the treatment content is as follows:

[0108] ① Rationally use antibiotics for anti-infection treatment, and adjust the type of antibiotics used in time according to the results of microbial culture.

[0109] ② Use or adjust ventilator parameters in a timely manner according to the patient's respiratory function and blood gas analysis results.

[0110] ③ Rationally use anticoagulant drugs based on coagulation function, platelet count, DD dimer level and thrombosis score.

[0111] ④ Provide appropriate symptomatic supportive treatment according to the combined condition. For example, bedside blood purification treatment may be required for combined acute renal failure.

[0112] The western medicine treatment includes: using piperacillin-tazobactam 4.5g intravenous infusion once every 8 hours; using levofloxacin injection 1.0g intravenous infusion once a day; using meropentam 1.0g intravenous infusion once every 8 hours.

[0113] Experimental group: The Chinese medicine composition of the present invention combined with Western medicine treatment group, the treatment content is as follows:

[0114] On the basis of the above-mentioned western medicine treatment, the Chinese medicine composition of the present invention is given by nasogastric feeding, 7 doses as a course of treatment, 1 dose per day, twice a day, morning and evening, nasogastric feeding in the form of decoction, about 100 mL each time. The Chinese medicine composition of the present invention is the composition described in Example 2, and the Chinese medicine composition described in the test is uniformly boiled. The treatment process of SCAP patients in the test group is as follows Figure 1 shown.

[0115] SCAP patients have the characteristics of insufficient positive energy, which is manifested by a decrease in the level of T lymphocytes in peripheral blood and an imbalance in the ratio of cytokines that promote and antagonize inflammatory responses. The total number of T lymphocytes, CD4+T lymphocytes, and CD8+T lymphocytes in the peripheral blood of SCAP patients are significantly lower than those of patients with ordinary pneumonia; the levels of interleukin-6, tumor necrosis factor, and procalcitonin are significantly increased, resulting in a significant increase in the incidence of multiple organ failure, sequential organ failure scores, and patient mortality in SCAP patients.

[0116] Fibroblast growth factor 21 (FGF21), which antagonizes inflammatory response, increases significantly in SCAP patients and decreases dynamically as the disease improves. The dynamic changes of FGF21 are new biomarkers for judging SCAP patients.

[0117] In summary, the present invention performs the following index tests on the SCAP patients in the control group and the test group:

[0118] 6. Record the demographic characteristics of all patients in the control group and the experimental group at the time of enrollment

[0119] For example: the patient's gender, age, presence or absence of underlying diseases (hypertension, coronary heart disease, cerebral infarction or cerebral hemorrhage, chronic renal failure, type 2 diabetes, rheumatic autoimmune diseases), medication history, surgical history, and the patient's basic vital signs (body temperature, blood pressure, respiration, pulse, consciousness, and blood oxygen saturation).

[0120] 7. Record the diagnostic indicators of all patients in the control group and the experimental group at the time of enrollment

[0121] The diagnostic indicators are as follows:

[0122] ① On the first day of enrollment, patients were tested for routine blood tests, myocardial enzymes, cardiac troponin, liver function (alanine aminotransferase, ALT, aspartate aminotransferase, AST), kidney function (creatinine, SCR, urea nitrogen, BUN, uric acid, UA), coagulation function, and DD dimer, and the results were recorded.

[0123] ② Blood gas analysis was performed on the first day of patient enrollment and the results were recorded.

[0124] ③ Enzyme-linked immunosorbent assay was used to detect the baseline levels of IL-6, TNF-α, PCT, CRP, and fibroblast growth factor 21 (FGF21) in SCAP patients. FGF21 was used as an example to illustrate the main steps. The detection of other items was carried out using similar methods, but the difference was that different kits were used.

[0125] a: Draw 5 mL of peripheral venous blood from the patient and extract serum according to conventional methods.

[0126] b: The serum FGF21 concentration was measured according to the method in the instructions of the enzyme-linked immunosorbent assay (ELISA) human kit (produced by Abcam, USA).

[0127] The specific steps of the test are as follows: 1) Sample addition: add 50μL of standard or serum respectively, be careful not to have bubbles, add the sample to the bottom of the ELISA plate, try not to touch the wall of the well, and gently shake to mix. Cover the ELISA plate with a film and incubate at 37°C for 60 minutes. 2) Discard the liquid in the well, spin dry, add 350μL of washing buffer to each well, soak for 1-2 minutes, wash the plate once, spin dry and tap the liquid in the well on absorbent paper. Repeat three times. 3) Add 100μL of substrate solution tetramethylbenzidine (TMB) to each well, and incubate the ELISA plate with a film at 37°C in the dark for about 10 minutes (shorten or extend as appropriate according to the actual color development, but not more than 30 minutes. When a clear gradient appears in the standard well, it can be stopped). 4) Add 100μL of stop solution to each well to stop the reaction, and the blue color immediately turns yellow. The order of adding the stop solution should be as consistent as possible with the order of adding the substrate solution. 5) Immediately measure the optical density (OD) of each well at 450nm using an ELISA reader. The ELISA reader should be powered on in advance, the instrument should be preheated, and the detection program should be set. 6) Finally, calculate the FGF21 concentration corresponding to each well.

[0128] ④ Flow cytometry was used to detect the peripheral blood CD3 + T cells, CD4 + T cells, CD8 + T cell counting.

[0129] The detection method is as follows:

[0130] a: Main reagents: Trypan blue dye (Sigma, USA); Pecoll layering fluid (GE, USA); PBS buffer. Flow cytometry fluorescent labeling antibodies: mouse anti-human CD3-FITC, mouse anti-human CD4-PerCP, mouse anti-human CD8-PE, isotype control is mouse anti-human IgG3-FITC, mouse anti-human CD4-PerCP isotype control mouse anti-human-CD8-PE (BD, USA).

[0131] b: Main instruments: flow cytometer (FACSAriaⅢ, BD Company, USA); microscope (BX60, Olympus Company, Japan); desktop high-speed refrigerated horizontal centrifuge (Legend RT-Plus, Thermo Company, USA).

[0132] c: Main steps:

[0133] c1: Draw 5 mL of peripheral venous blood from the patient to obtain peripheral blood, which is sterile and dried with heparin anticoagulation.

[0134] c2: Preparation of peripheral blood mononuclear cells (PBMC): Use a syringe needle to draw 5 mL of 60% Pecoll layering solution (specific gravity 1.077 g / mL) and add it to a centrifuge tube, then slowly add 5 mL of heparin anticoagulated peripheral blood (peripheral blood is diluted 1 / 2 with PBS buffer) along the tube wall to form a clear interface. Centrifuge in a high-speed refrigerated horizontal centrifuge at 2000 r / min for 20 minutes, carefully draw the annular milky white layer on the Pecoll layering solution interface, and resuspend it with 2 mL of PBS buffer. Detect on a flow cytometer within 6 hours. Take 15 μL of the cell suspension and add it to the abalone counting plate, and count the total number of cells in the 4 large squares under a microscope.

[0135] c3: Flow cytometry detection and sorting:

[0136] The concentration of the two tubes is 1×10 10100 μL of PBMC / L, add 20 μL of anti-IgG3-FITC and anti-IgG1-PerCP flow cytometry fluorescent labeling antibodies to one tube, and add 20 μL of CD3-FITC, anti-CD4-PerCP, and anti-CD8-PE flow cytometry fluorescent labeling antibodies to another tube; mix well, incubate at 25℃ in the dark for 30 minutes, centrifuge at 4℃ for 10 minutes at 2000r / min, discard the supernatant, add 500 μL of PBS buffer to the precipitate and gently blow to wash away excess unbound antibodies, centrifuge at 4℃ for 10 minutes again, repeat twice; suspend with 400 μL of PBS buffer and load the machine, adjust the flow cytometer to the best working state, load the negative isotype control group of IgG3-FITC and anti-IgG1-PerCP flow cytometry fluorescent labeling antibodies first, and then load the sample group of CD3-FITC and anti-CD4-PerCP, CD8-PE flow cytometry fluorescent labeling antibodies.

[0137] ⑤ Test SCAP patients at the bedside in the ICU ward and complete X-rays.

[0138] ⑥ Calculate the score according to the TCM clinical symptom score scale of pneumonia as shown in Table 1. The TCM clinical symptoms of pneumonia are determined by referring to the TCM disease diagnosis and efficacy standards of the State Administration of Traditional Chinese Medicine.

[0139] Table 1 Pneumonia Clinical TCM Symptom Score Evaluation Table

[0140]

[0141]

[0142]

[0143] Note: In Table 1, 0 points indicate normal, 1 point indicates mild, 2 points indicate moderate, and 3 points indicate severe;

[0144] The TCM syndrome efficacy rate before and after treatment was calculated according to the scoring standard shown in Table 1, and the clinical efficacy was evaluated using the nimodipine method. The calculation formula was: syndrome efficacy rate = (score before treatment - score after treatment) / score before treatment × 100%;

[0145] ⑦ The therapeutic effect of SCAP patients in the control group and the experimental group after treatment was evaluated. The evaluation criteria were as follows:

[0146] Clinical control: After treatment, symptoms and signs basically disappear, the patient can participate in normal activities and work, and the syndrome efficacy rate is ≥90%;

[0147] Markedly effective: symptoms, signs and auxiliary examination results are significantly improved after treatment, 60% ≤ syndrome efficacy rate < 90%;

[0148] Effective: After treatment, symptoms, signs and auxiliary examination results have improved, 30% ≤ syndrome efficacy rate < 60%;

[0149] Ineffective: Symptoms, signs and auxiliary examination results after treatment were not improved compared with those before treatment, and the syndrome efficacy rate was less than 30%.

[0150] 8. Detect and record the safety indicators of SCAP patients in the control group and the experimental group during the intervention follow-up

[0151] ① During the entire process of ICU treatment, the blood gas analysis of SCAP patients was dynamically reviewed daily; blood routine, myocardial enzymes, cardiac troponin, ALT, AST, TBIL, SCR, BUN, UA, coagulation function, and DD dimer of SCAP patients were reviewed on the 3rd, 5th, 7th, and 14th days. The electrocardiogram changes of patients were monitored in real time for 24 hours. Mechanical ventilation parameters: tidal volume, pressure, end-expiratory pressure, inspiratory time, inspiratory expiratory time ratio, etc.

[0152] ② During ICU treatment, record whether the patient has malignant arrhythmia, gastrointestinal bleeding, rash, or allergic reaction.

[0153] 9. Detect and record the efficacy indicators of SCAP patients in the control group and the experimental group during the follow-up of the intervention

[0154] ① The levels of IL-6, TNF-α, PCT, CRP, and FGF21 in SCAP patients were rechecked on the 3rd, 5th, 7th, and 14th days of follow-up, and the levels of IL-6, TNF-α, PCT, and CRP before treatment and on the 14th day after treatment were statistically analyzed. The results are as follows: Figure 3 shown.

[0155] ②On the 14th day of follow-up, flow cytometry was used to detect the peripheral blood CD3 + T cells, CD4 + T cells, CD8 + T cell counts were performed and the indicators of patients before and after treatment were analyzed. Figure 4 shown.

[0156] ③ The TCM clinical symptom scores were calculated on the 3rd, 5th, 7th and 14th days of follow-up, and the TCM clinical symptom scores calculated before treatment and on the 14th day after treatment were statistically analyzed. The results are as follows: Figure 2 shown.

[0157] Will Figures 2 to 4 The contents are summarized in Table 3 to compare the therapeutic effects of the two groups of patients.

[0158] 10. Detect and record the economic and health indicators of SCAP patients in the control group and the experimental group

[0159] ① The total number of days the patient was hospitalized and the total number of days the patient was hospitalized in the ICU ward.

[0160] ②The total cost of the patient's hospitalization.

[0161] 11. Statistics of the test results of the above test items

[0162] Combined with the results of the above-mentioned test items, the sequential organ failure score (SOFA) was scored according to the scoring criteria described in Table 2, and the above results were statistically analyzed. The results are shown in Table 3, Figure 2 , Figure 3 and Figure 4 .

[0163] SPSS24.0 (IBM Corporation) software was used for statistical analysis, and the significance level of all tests was defined as P value < 0.05 (two-sided test). All numerical continuous variable data were first subjected to the normality Kolmogorov-Smirnov test. The data that met the normal distribution were compared with repeated measures variance analysis at different time points. The data that did not meet the normal distribution were compared with the Kruskal-Wallis test at different time points. The chi-square test was used to compare the rates.

[0164] Table 2 Sequential organ failure quantitative score

[0165]

[0166]

[0167] Note: 1. The worst value of the day should be taken for daily assessment; 2. The higher the score, the worse the prognosis.

[0168] Table 3 Results of various test parameters of SCAP patients in the control group and experimental group at the time of enrollment

[0169] parameter Western medicine treatment group Western medicine treatment + Bufei Jiedu Decoction group SOFA score 5(2～12) 5(2～9) TCM Syndrome Scoring 15(12～21) 17(12～24) PCT (ng / ml) 2.11(0.08～22.69) 1.97(0.03～55.96) CRP (mg / L) 98.7(7.6～166.4) 78.3(1.2～165.4) IL-6 (pg / ml) 92.2(6.9～389.6) 82.3(4.4～237.6) TNF-a (pg / ml) 9.9(1.3～30.2) 8.9(1.1～25.2) CD3+T cells (cells / μL) 242(153～1813) 251(84～486) CD4+T cells (cells / μL) 157(106～1146) 178(65～312) CD8+T cells (cells / μL) 75(34～601) 78(15～176)

[0170] Note: The data in brackets for the Western medicine treatment group alone and the Western medicine treatment + Bufei Jiedu Decoction group in Table 3 represent the patients' score ranges.

[0171] From Table 3 and Figure 2It can be seen that the multiple organ failure score of SCAP patients after treatment decreased by 50% compared with the multiple organ failure score before treatment. Before treatment, there was no statistical difference in SOFA score and TCM symptom score between the control group: Western medicine group and the experimental group: Western medicine combined with Bufei Jiedu Decoction (i.e., the Chinese medicine composition of the present invention) group; after 14 days of treatment, the TCM symptom score of the Western medicine combined with Bufei Jiedu Decoction group was significantly lower than that of the Western medicine treatment group (P<0.001), and the SOFA score of 2 points (1-4 points) was lower than that of 5 points (2-20 points) of the Western medicine group, with a statistical difference, P value = 0.001.

[0172] From Table 3 and Figure 3 It can be seen that before treatment, there was no statistical difference in PCT, CRP, IL-6, and TNF-α between the Western medicine group and the Western medicine combined with Bufei Jiedu Decoction group. After 14 days of treatment, the PCT in the Western medicine combined with Bufei Jiedu Decoction group was 0.22 (0.08-4.5) ng / mL, which was lower than 4.5 (0.65-37.3) ng / mL in the Western medicine group, with a statistical difference, P value = 0.005. The CRP in the Western medicine combined with Bufei Jiedu Decoction group was 78.3 (1.2-152.0) mg / L, which was lower than 98.7 (7.6-163.4) mg / L in the Western medicine group, with a statistical difference, P value < 0.001. The IL-6 in the Western medicine combined with Bufei Jiedu Decoction group was 82.4 (4.3-227.5) pg / mL, which was lower than 192.2 (6.8-358.8) pg / mL in the Western medicine group, with a statistical difference, P value = 0.001.

[0173] From Table 3 and Figure 4 It can be seen that before treatment, there was no statistical difference between the Western medicine group and the Western medicine combined with Bufei Jiedu Decoction group. After 14 days of treatment, the total lymphocyte count and CD3 + T cells, CD4 + T cells, CD8 + There was no statistical difference in T cell levels. After 14 days of treatment, the total lymphocyte count in the Western medicine combined with Bufei Jiedu Decoction group was 1019 cells / μL (295-1924) cells / μL, which was higher than that in the Western medicine group (361 / μL (212-1927) cells / μL), with a statistically significant difference (P value = 0.002). + The T cell count was 657 / μL (151-1716) / μL, which was higher than that of the Western medicine group (192 / μL (120-1359) / μL), with a statistically significant difference (P value = 0.003). + The T cell count was 415 / μL (124-1457) / μL, which was higher than that of the Western medicine group (148 / μL (53-877) / μL), with a statistically significant difference (P value = 0.002). +The T cell count was 150 / μL (31-239) / μL, which was higher than that of the Western medicine group (59 / μL (33-449) / μL), with a statistically significant difference (P value = 0.007).

[0174] In summary, when the Chinese medicine composition of the present invention is combined with Western medicine to treat SCAP patients, its efficacy is better than that of Western medicine alone, and the present invention is a beneficial supplement to the current treatment of severe pneumonia. The Chinese medicine composition provided by the present invention is a Qi-invigorating and strengthening prescription, which combines the prescription with Western medicine treatment to reduce the pro-inflammatory response in SCAP patients, improve the immune function of patients, and regulate the ratio of helper T cell subtypes (i.e., the ratio of Th1 (Thelper 1 cell) to Th2 (T helper 2 cell)), and the proportion of patients with severe pneumonia treated with Chinese medicine is balanced; the degree of organ failure in patients is reduced. The Chinese medicine composition, i.e., the treatment regimen, described in the present invention can reduce the total cost of treating SCAP patients, shorten the recovery period of patients, and thus shorten the length of hospital stay of patients, improve the satisfaction of patients with medical treatment, and be conducive to the high-quality development of the national economy.

[0175] Although the above embodiment describes the present invention in detail, it is only a part of the embodiments of the present invention, not all of the embodiments. People can also obtain other embodiments like this embodiment without creativity, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A Chinese medicine composition, characterized in that: The raw materials are as follows, by weight: 15-25 parts of ginseng, 15-25 parts of bupleurum, 5-15 parts of scutellaria, 10-20 parts of dandelion, 10-20 parts of houttuynia, 5-15 parts of red peony root, 10-20 parts of earthworm, 5-10 parts of patchouli, 5-15 parts of atractylodes, 4-8 parts of cinnamon twig, 5-15 parts of white atractylodes, 10-14 parts of poria, 4-8 parts of tangerine peel, 4-8 parts of rhubarb and 4-8 parts of roasted liquorice.

2. The Chinese medicine composition according to claim 1, characterized in that The raw materials are as follows, by weight: 17-23 parts of ginseng, 17-23 parts of bupleurum, 7-13 parts of scutellaria, 12-18 parts of dandelion, 12-18 parts of houttuynia, 7-13 parts of red peony root, 12-18 parts of earthworm, 6-9 parts of patchouli, 7-13 parts of atractylodes, 5-7 parts of cinnamon twig, 7-13 parts of white atractylodes, 11-13 parts of poria, 5-7 parts of tangerine peel, 5-7 parts of rhubarb and 5-7 parts of roasted liquorice.

3. The Chinese medicine composition according to claim 1, characterized in that: The raw materials are as follows, by weight: 20 parts of ginseng, 20 parts of bupleurum, 10 parts of scutellaria, 15 parts of dandelion, 15 parts of houttuynia, 10 parts of red peony root, 15 parts of earthworm, 9 parts of patchouli, 10 parts of atractylodes, 6 parts of cinnamon twig, 10 parts of atractylodes, 12 parts of poria, 6 parts of tangerine peel, 6 parts of rhubarb and 6 parts of roasted liquorice.

4. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The steps include: Mixing bupleurum, scutellaria, dandelion, houttuynia, red peony root, earthworm, atractylodes, cinnamon twig, atractylodes, tuckahoe, tangerine peel, rhubarb and licorice, and then boiling for the first time, filtering and separating the medicinal liquid and the medicinal residue to obtain the first medicinal liquid and the first medicinal residue; The first medicinal residue is decocted for the second time, and Patchouli is added into the medicinal liquid of the second decoction before the second decoction is finished to obtain a second medicinal liquid; Decocting ginseng separately to obtain the third medicinal liquid; The first medicinal liquid, the second medicinal liquid and the third medicinal liquid are mixed to obtain the traditional Chinese medicine composition.

5. The preparation method according to claim 4, characterized in that: During the first and second decoctions, the total weight of Bupleurum, Scutellaria, Taraxacum, Houttuynia, Red Peony, Pheretima, Atractylodes, Cinnamon Twig, Atractylodes, Poria, Tangerine Peel, Rhubarb and Radix Glycyrrhizae and the liquid-to-water ratio are 1g:5-10mL respectively; the time for the first decoction is 0.5-1h.

6. The preparation method according to claim 4, characterized in that: The second decoction time is 0.5 to 1 hour; the patchouli is added 10 to 15 minutes before the end of the second decoction.

7. The preparation method according to claim 4, characterized in that: The specific operation of decocting ginseng separately includes: decocting ginseng separately according to the material-liquid ratio of ginseng to water of 1g:5mL.

8. The preparation method according to claim 7, characterized in that: The separate decoction is as follows: simmering the ginseng over low heat for 2 hours.

9. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 8 in the preparation of a medicament for treating community-acquired severe pneumonia.

10. A combination drug for treating community-acquired severe pneumonia, characterized in that: The combination drug includes a Chinese medicine composition and a Western medicine for treating community-acquired severe pneumonia; The Chinese medicine composition is the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 8; The western medicine for treating community-acquired severe pneumonia includes any one or more of antibacterial drugs, anticoagulant drugs, drugs for correcting metabolic disorders, and enteral nutrition suspensions.

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