A traditional Chinese medicine composition for treating community-acquired severe pneumonia and its application

Abstract

The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating severe community-acquired pneumonia (SCAP) and its application. The traditional Chinese medicine composition described in the present invention includes ginseng, bupleurum, scutellaria, dandelion, houttuynia cordata, red peony root, earthworm, pogostemon cablin, atractylodes lancea, cassia twig, atractylodes macrocephala, poria cocos, tangerine peel, rhubarb and roasted licorice root. The traditional Chinese medicine composition described in the present invention has an ideal therapeutic effect on SCAP, can reduce the degree of organ function damage of patients, and can also reduce the treatment cost of patients. The present invention provides a new idea for the treatment of SCAP.

Description

Technical Field

[0001] The present 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 and its application. Background Art

[0002] Community-acquired severe pneumonia (SCAP) refers to severe pulmonary infections acquired in the community environment. SCAP is characterized by refractory hypoxemia, refractory shock, multiple organ failure, etc., and is the leading cause of death from infectious diseases.

[0003] At present, despite a series of active measures taken for SCAP, such as rational use of antibiotics in the early stage, appropriate fluid resuscitation, use of vasoactive drugs, bedside invasive mechanical ventilation, blood purification therapy, etc., its mortality rate is still as high as 22%, and the treatment cost can be as high as $20,000. This brings 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 in the treatment of SCAP and has certain curative effects. The prior art believes that SCAP belongs to the categories of "pulmonary heat disease", "asthmatic cough", "wind-warm pulmonary heat disease", etc. in traditional Chinese medicine, and is characterized by acute onset, rapid transmission, and severe illness. The disease location is in the lung, and the pathogenesis is that wind-heat-toxic pathogens invade the lung, resulting in the failure of the lung to disperse and descend, and the disorder of body fluid and qi; or cold pathogens enter the interior and transform into heat, refining body fluid into phlegm; or phlegm turbidity obstructs the lung and transforms into heat, all of which can lead to phlegm-heat obstructing the lung. In the long term, it will lead to the failure of heat pathogens to dissipate, damage to body fluid and qi, invasion of nutrient and blood aspects, and heat invading the pericardium, further promoting the progression of pathogens and decline of healthy qi, and the failure of healthy qi to secure the exterior, resulting in the collapse of healthy qi due to the invasion of pathogens. Therefore, at present, the main principle of traditional Chinese medicine treatment for SCAP patients is to clear heat and resolve phlegm and expel pathogens. For example, using Mahuang Xingshi Gancao Decoction to treat SCAP patients with phlegm-heat obstructing the lung, applying Huanglian Jiedu Decoction combined with Weijing Decoction in combination with western medicine means to treat SCAP patients with heat-toxin obstructing the lung, or using Tanqingning for clearing lung and resolving phlegm in combination with western medicine to treat SCAP patients with heat-toxin obstructing the lung. The prior art treatment for SCAP patients with phlegm-heat obstructing the lung tends to focus on clearing heat and detoxifying, but often only treats the symptoms rather than the root cause, so the treatment effect is not ideal.

[0005] Therefore, delving into the pathogenesis of SCAP and providing a traditional Chinese medicine composition corresponding to the pathogenesis of SCAP for treating SCAP has become an urgent problem to be solved in this field. 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, when performing the first decoction and the second decoction, the total weight of bupleurum root, skullcap root, dandelion, houttuynia, red peony root, earthworm, atractylodes rhizome, cassia twig, white atractylodes rhizome, poria cocos, tangerine peel, rhubarb and roasted licorice root and the liquid ratio of the materials to water are each 1 g: 5-10 mL; the time for the first decoction is 0.5-1 h.

[0019] Preferably, the time for the second decoction is 0.5-1 h; patchouli is put in 10-15 min before the end of the second decoction.

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

[0021] Preferably, the separate decoction is: gently stewing ginseng for 2 h.

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

[0023] The present invention also provides a combined drug for treating community-acquired severe pneumonia, and the combined drug includes a traditional Chinese medicine composition and a western medicine for treating community-acquired severe pneumonia;

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

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

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

[0027] The present invention provides a traditional Chinese medicine composition for treating SCAP, which includes ginseng, bupleurum root, skullcap root, dandelion, houttuynia, red peony root, earthworm, patchouli, atractylodes rhizome, cassia twig, white atractylodes rhizome, poria cocos, tangerine peel, rhubarb and roasted licorice root. From the perspective of traditional Chinese medicine, the root cause of SCAP patients is deficiency of healthy qi, and the superficial manifestation is the intermingling of phlegm and stasis. Starting from the perspective of strengthening healthy qi, treating from the spleen, tonifying the spleen and benefiting the lung, combining with protecting the body fluid in the stomach and the pathogenic mechanism of clearing heat and detoxifying, the traditional Chinese medicine composition as described above is developed. The traditional Chinese medicine composition described in the present invention has an ideal therapeutic effect on SCAP, can make the physical indexes of patients return to normal, and can also reduce the treatment cost of patients, providing a new idea for the treatment of SCAP. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0029] Figure 1 It is the treatment flow chart of jointly using the Western medicine treatment method and the traditional Chinese medicine composition of the present invention for the treatment of SCAP patients in Example 5 of the present invention;

[0030] Figure 2 It is the results of the traditional Chinese medicine syndrome scores and SOFA scores before and after treatment of the control group and the experimental group in Example 5 of the present invention;

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

[0032] Figure 4 It is the results of the changes in the levels of lymphocyte count, CD3+ cells, CD4+ cells and CD8+ cells in the bodies of SCAP patients in the control group and the experimental group before and after treatment in Example 5 of the present invention. Detailed implementation manners

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

[0034] 15-25 parts of ginseng, 15-25 parts of bupleurum, 5-15 parts of scutellaria baicalensis, 10-20 parts of dandelion, 10-20 parts of houttuynia cordata, 5-15 parts of red peony root, 10-20 parts of earthworm, 5-10 parts of pogostemon cablin, 5-15 parts of atractylodes lancea, 4-8 parts of cassia twig, 5-15 parts of atractylodes macrocephala, 10-14 parts of poria cocos, 4-8 parts of tangerine peel, 4-8 parts of rhubarb and 4-8 parts of roasted licorice root.

[0035] By weight parts, the weight parts of ginseng in the present invention are 15-25 parts; as an implementation manner, the weight parts of ginseng are 17-23 parts. As an implementation manner, the weight parts of 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 parts of ginseng are 20 parts. The disease of the SCAP patients is due to the deficiency of vital qi, so ginseng is reused to greatly tonify the vital qi, invigorate the spleen and benefit the lung, and expel pathogenic factors.

[0036] By weight parts, the weight parts of bupleurum in the present invention are 15-25 parts; as an implementation manner, the weight parts of bupleurum are 17-23 parts. As an implementation manner, the weight parts of 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 parts of bupleurum are 20 parts. There is often excessive internal dampness in the bodies of SCAP patients, which is caused by the unfavorable qi transformation of the bladder, so bupleurum is added to harmonize the exterior and interior.

[0037] By weight parts, the weight parts of Scutellaria baicalensis Georgi in the present invention are 5 to 15 parts; as an implementation manner, the weight parts of Scutellaria baicalensis Georgi are 7 to 13 parts. As an implementation manner, the weight parts of Scutellaria baicalensis Georgi 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 parts of Scutellaria baicalensis Georgi are 10 parts. In patients with SCAP, there is often excessive internal dampness, which is caused by the unfavorable qi transformation of the bladder. Therefore, Scutellaria baicalensis Georgi is added to harmonize the exterior and interior.

[0038] By weight parts, the weight parts of Taraxacum mongolicum Hand.-Mazz. in the present invention are 10 to 20 parts; as an implementation manner, the weight parts of Taraxacum mongolicum Hand.-Mazz. are 12 to 18 parts. As an implementation manner, the weight parts of Taraxacum mongolicum Hand.-Mazz. 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 parts of Taraxacum mongolicum Hand.-Mazz. are 15 parts. The cause of SCAP patients is the accumulation of phlegm-heat and stasis in the lung. Therefore, Taraxacum mongolicum Hand.-Mazz. is added to clear heat and detoxify, disperse swelling and dissipate stasis.

[0039] By weight parts, the weight parts of Houttuynia cordata Thunb. in the present invention are 10 to 20 parts; as an implementation manner, the weight parts of Houttuynia cordata Thunb. are 12 to 18 parts. As an implementation manner, the weight parts of Houttuynia cordata Thunb. 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 parts of Houttuynia cordata Thunb. are 15 parts. The cause of SCAP patients is the accumulation of phlegm-heat and stasis in the lung. Therefore, Houttuynia cordata Thunb. is added to clear heat and detoxify, disperse swelling and dissipate stasis.

[0040] By weight parts, the weight parts of Paeonia lactiflora Pall. in the present invention are 5 to 15 parts; as an implementation manner, the weight parts of Paeonia lactiflora Pall. are 7 to 13 parts. As an implementation manner, the weight parts of Paeonia lactiflora Pall. 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 parts of Paeonia lactiflora Pall. are 10 parts. The cause of SCAP patients is the accumulation of phlegm-heat and stasis in the lung. Therefore, Paeonia lactiflora Pall. is added to clear heat and detoxify, disperse swelling and dissipate stasis.

[0041] By weight parts, the weight parts of the earthworm in the present invention are 10 to 20 parts; as an embodiment, the weight parts of the earthworm are 12 to 18 parts. As an embodiment, the weight parts 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 parts of the earthworm are 15 parts. SCAP patients often have symptoms such as chest distress, shortness of breath, nausea, and dry stools. Therefore, earthworms are added to soothe the chest and regulate qi, dredge collaterals and relieve asthma, resolve dampness and stop nausea, and induce defecation.

[0042] By weight parts, the weight parts of the pogostemon cablin in the present invention are 5 to 10 parts; as an embodiment, the weight parts of the pogostemon cablin are 6 to 9 parts. As an embodiment, the weight parts of the pogostemon cablin can be any one of 5 parts, 6 parts, 7 parts, 8 parts, 9 parts and 10 parts. In a specific embodiment, the weight parts of the pogostemon cablin are 9 parts. SCAP patients often have symptoms such as chest distress, shortness of breath, nausea, and dry stools. Therefore, pogostemon cablin is added to soothe the chest and regulate qi, dredge collaterals and relieve asthma, resolve dampness and stop nausea, and induce defecation.

[0043] By weight parts, the weight parts of the atractylodes lancea in the present invention are 5 to 15 parts; as an embodiment, the weight parts of the atractylodes lancea are 7 to 13 parts. As an embodiment, the weight parts 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 parts of the atractylodes lancea are 10 parts. The cause of SCAP patients is phlegm-heat stasis in the lung. Therefore, atractylodes lancea is added to clear heat and detoxify, disperse stasis and dissipate carbuncles. SCAP patients often have symptoms such as chest distress, shortness of breath, nausea, and dry stools. Therefore, atractylodes lancea is added to soothe the chest and regulate qi, dredge collaterals and relieve asthma, resolve dampness and stop nausea, and induce defecation.

[0044] By weight parts, the weight parts of the cassia twig in the present invention are 4 to 8 parts; as an embodiment, the weight parts of the cassia twig are 5 to 7 parts. As an embodiment, the weight parts 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 parts of the cassia twig are 6 parts. SCAP patients often have internal retention of water-dampness, which is caused by the unfavorable qi transformation of the bladder. Therefore, cassia twig is added to promote diuresis and percolate dampness, warm yang and transform qi, dredge the operation of triple energizer of water and fire, and restore the normal distribution of body fluids.

[0045] By weight parts, the weight parts of Atractylodes macrocephala Koidz. in the present invention are 5 - 15 parts; as an implementation manner, the weight parts of Atractylodes macrocephala Koidz. are 7 - 13 parts. As an implementation manner, the weight parts of Atractylodes macrocephala Koidz. 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 parts of Atractylodes macrocephala Koidz. are 10 parts. The cause of SCAP patients is phlegm-heat stasis in the lung, so Atractylodes macrocephala Koidz. is added to clear heat and detoxify, disperse stasis and dissipate carbuncles. SCAP patients often have symptoms such as chest tightness, shortness of breath, nausea, and dry stools, so Atractylodes macrocephala Koidz. is added to promote diuresis and remove dampness, warm yang and transform qi, dredge the operation of triple energizer of water and fire, and restore the normal distribution of body fluid.

[0046] By weight parts, the weight parts of Poria cocos (Schw.) Wolf in the present invention are 10 - 15 parts; as an implementation manner, the weight parts of Poria cocos (Schw.) Wolf are 11 - 13 parts. As an implementation manner, the weight parts of Poria cocos (Schw.) Wolf can be any one of 10 parts, 11 parts, 12 parts, 13 parts, 14 parts and 15 parts. In a specific embodiment, the weight parts of Poria cocos (Schw.) Wolf are 12 parts. SCAP patients often have symptoms such as chest tightness, shortness of breath, nausea, and dry stools, so Poria cocos (Schw.) Wolf is added to promote diuresis and remove dampness, warm yang and transform qi, dredge the operation of triple energizer of water and fire, and restore the normal distribution of body fluid.

[0047] By weight parts, the weight parts of dried tangerine peel in the present invention are 4 - 8 parts; as an implementation manner, the weight parts of dried tangerine peel are 5 - 7 parts. As an implementation manner, the weight parts of 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 parts of dried tangerine peel are 6 parts. The SCAP patients often have chest tightness, shortness of breath, nausea, and dry stools, so dried tangerine peel is added to relieve chest distress and regulate qi, dredge collaterals and relieve asthma, eliminate dampness and stop vomiting, and induce purgation and relieve constipation.

[0048] By weight parts, the weight parts of Rheum palmatum L. in the present invention are 4 - 8 parts; as an implementation manner, the weight parts of Rheum palmatum L. are 5 - 7 parts. As an implementation manner, the weight parts of Rheum palmatum L. can be any one of 4 parts, 5 parts, 6 parts, 7 parts and 8 parts. In a specific embodiment, the weight parts of Rheum palmatum L. are 6 parts. The SCAP patients often have chest tightness, shortness of breath, nausea, and dry stools, so Rheum palmatum L. is added to relieve chest distress and regulate qi, dredge collaterals and relieve asthma, eliminate dampness and stop vomiting, and induce purgation and relieve constipation.

[0049] In parts by weight, the weight of the prepared licorice root in the present invention is 4 to 8 parts; as an embodiment, the weight of the prepared licorice root is 5 to 7 parts. As an embodiment, the weight of the prepared 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 prepared licorice root is 6 parts. SCAP patients often have internal retention of dampness and fluid, which is caused by the unfavorable qi transformation of the bladder. Therefore, prepared licorice root is added to harmonize the exterior and interior.

[0050] SCAP patients present with symptoms such as chest distress, shortness of breath, pale complexion, fatigue, nausea, vomiting, cough, poor appetite, dry stools, less or yellowish-black greasy tongue coating, and string-taut slippery or string-taut rapid pulse. The traditional Chinese medicine composition of the present invention can both invigorate the spleen and benefit the lung, clear the lung heat, promote diuresis and resolve dampness, warm yang and transform qi, and can be used for the syndrome of phlegm-heat congesting the lung and disharmony of the triple energizer, and can effectively treat SCAP.

[0051] The present invention also provides a preparation method of a traditional Chinese medicine composition, comprising the following steps:

[0052] Mix bupleurum root, skullcap root, dandelion, houttuynia cordata, red peony root, earthworm, atractylodes lancea, cassia twig, bighead atractylodes rhizome, poria cocos, tangerine peel, rhubarb and prepared licorice root, and conduct the first decoction, filter and separate the medicinal liquid and the medicinal residues to obtain the first medicinal liquid and the first medicinal residues; conduct the second decoction on the first medicinal residues, and put agastache rugosa into the medicinal liquid during the second decoction before the end to obtain the second medicinal liquid; decoct ginseng alone to obtain the third medicinal liquid; mix the first medicinal liquid, the second medicinal liquid and the third medicinal liquid to obtain the traditional Chinese medicine composition.

[0053] As an implementation manner, the present invention mixes bupleurum root, skullcap root, dandelion, houttuynia cordata, red peony root, earthworm, atractylodes lancea, cassia twig, bighead atractylodes rhizome, poria cocos, dried tangerine peel, rhubarb and roasted licorice root and then conducts the first decoction, separates the medicinal liquid and the medicinal residues, and obtains the first medicinal liquid and the first medicinal residues; as an implementation manner, the present invention adds water to the first medicinal residues again for the second decoction, puts pogostemon cablin before the end of the second decoction, removes the medicinal residues, and obtains the second medicinal liquid. As an implementation manner, during the first decoction and the second decoction, the total weight of bupleurum root, skullcap root, dandelion, houttuynia cordata, red peony root, earthworm, atractylodes lancea, cassia twig, bighead atractylodes rhizome, poria cocos, dried tangerine peel, rhubarb and roasted licorice root and the material-liquid ratio of water are each 1 g: 5-10 mL; the time for the first decoction is 0.5-1 h. As another implementation manner, during the first decoction and the second decoction, the total weight of bupleurum root, skullcap root, dandelion, houttuynia cordata, red peony root, earthworm, atractylodes lancea, cassia twig, bighead atractylodes rhizome, poria cocos, dried tangerine peel, rhubarb and roasted licorice root and the material-liquid ratio of water can each be any one of 1 g: 5 mL, 1 g: 6 mL, 1 g: 7 mL, 1 g: 8 mL, 1 g: 9 mL and 1 g: 10 mL. As an implementation manner, the time for the first decoction and the second decoction can be any one of 0.5 h, 0.6 h, 0.7 h, 0.8 h, 0.9 h and 1 h. As an implementation manner, the pogostemon cablin is put in 10-15 min before the end of the second decoction; as an implementation manner, the pogostemon cablin can be put in at 10 min, 11 min, 12 min, 13 min, 14 min or 15 min before the end of the second decoction. As an implementation manner, during the first decoction, after boiling with strong fire, turn to slow fire for decoction. In a specific embodiment, the total weight of bupleurum root, skullcap root, dandelion, houttuynia cordata, red peony root, earthworm, atractylodes lancea, cassia twig, bighead atractylodes rhizome, poria cocos, dried tangerine peel, rhubarb and roasted licorice root and the material-liquid ratio of water is 1 g: 10 mL, the time for the first decoction is 1 h, after the first decoction ends, separate the medicinal residues and the medicinal liquid, obtain the first medicinal liquid and the first medicinal residues, add water to the first medicinal residues according to the material-liquid ratio of 1 g: 10 mL, conduct the second decoction, the time for the second decoction is 1 h, add pogostemon cablin 15 min before the end of the second decoction, continue to decoct until the second decoction ends, remove the medicinal residues, and obtain the second medicinal liquid.

[0054] The main pharmacological action of pogostemon cablin is the volatile oil it contains, which has the characteristic of being intolerant to high temperature. When pogostemon cablin is added in the second decoction, short-time decoction of pogostemon cablin can effectively prevent excessive loss of volatile medicinal components and maintain the medicinal effect.

[0055] As an implementation manner, the present invention decocts ginseng alone to obtain a third medicinal liquid. As an implementation manner, the specific operation of the alone decocting of ginseng includes: decocting alone according to the material-liquid ratio of ginseng to water of 1 g: 10 mL, removing the medicinal residues, and obtaining the third medicinal liquid. As an implementation manner, the alone decocting is: simmering ginseng over a slow fire for 2 h. Alone decocting ginseng is beneficial 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 application of the traditional Chinese medicine composition as described above or the traditional Chinese medicine composition prepared by the preparation method in the preparation of a drug for treating community-acquired severe pneumonia.

[0058] The present invention also provides a combined drug for treating community-acquired severe pneumonia, and the combined drug includes a traditional Chinese medicine composition and a western medicine for treating community-acquired severe pneumonia;

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

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

[0061] Huangdi Neijing says: "When healthy qi exists inside the body, pathogenic factors cannot invade", and "where pathogenic factors gather, the qi of the body must be deficient". It is disclosed in Comparative Study on Traditional Chinese Medicine Weiqi and Western Medicine Immunity that the healthy qi of the body is highly consistent with the immune function. The healthy qi is like the immune system of the human body. When the healthy qi is weak, it is extremely similar to immune impairment.

[0062] Pathogenic toxins are likely to invade the elderly and infirm patients with weak lung defense and low immunity. Moreover, for patients with low immunity, their clinical symptoms are mostly severe. The healthy qi is composed of defensive qi, nutrient qi, etc. The nutrient qi circulates in the vessels, and the defensive qi circulates outside the vessels. The "vessels" refer to the blood vessels of the human body. The lymphatic vessel system containing immune cells is distributed outside the blood vessels and runs closely along with the blood vessels. It can be seen that the network formed by the lymphatic vessels is extremely similar to the meridians that circulate nutrient qi and defensive qi 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 for the inward invasion of pathogenic factors mainly lies in the deficiency of body fluids. The first step in treatment is to strengthen the healthy qi, invigorate the spleen and replenish qi, thereby regulating the functions of the zang-fu organs and expelling pathogenic factors. In addition, SCAP patients often originate from the deficiency of the healthy qi and the accumulation of internal dampness, which is caused by the unfavorable qi transformation of the bladder. Therefore, 15-25 parts of Bupleurum chinense, 5-15 parts of Scutellaria baicalensis, and 4-8 parts of roasted Glycyrrhiza uralensis are used to harmonize the interior and exterior; 4-8 parts of Cinnamomum cassia, 5-15 parts of Atractylodes macrocephala, and 10-20 parts of Poria cocos are used to promote diuresis and remove dampness, warm yang and transform qi, dredge the movement of water and fire in the triple energizer, and restore the normal distribution of body fluids. Since SCAP patients are due to the deficiency of the healthy qi, 15-25 parts of ginseng are used to greatly tonify the primordial qi, invigorate the spleen and benefit the lungs, and expel pathogenic factors. If the patient has chest tightness, shortness of breath, nausea, and dry stools, 10-20 parts of Pheretima aspergillum, 5-15 parts of Pogostemon cablin, 5-15 parts of Atractylodes lancea, 4-8 parts of Citrus reticulata, and 4-8 parts of Rheum palmatum are added to soothe the chest and regulate qi, dredge the collaterals and relieve asthma, eliminate dampness and stop nausea, and induce laxation. If the patient has cough, less or yellowish-black greasy tongue coating, and string-taut, slippery and rapid pulse, this is due to the binding of phlegm-heat and stasis in the lungs. Therefore, 10-20 parts of Taraxacum mongolicum, 10-20 parts of Houttuynia cordata, and 5-15 parts of Paeonia lactiflora are added to clear heat and detoxify, disperse swelling and dissipate stasis. In the traditional Chinese medicine composition of the present invention, ginseng is used as the monarch drug to greatly tonify the primordial qi, invigorate the spleen and benefit the lungs, and expel pathogenic factors; Bupleurum chinense and Scutellaria baicalensis are used as the ministerial drugs to relieve the pathogenic factors in the half-exterior and half-interior; the adjuvant drugs Pheretima aspergillum, Pogostemon cablin, Atractylodes lancea, Rheum palmatum, and Citrus reticulata are used to soothe the chest and regulate qi, dredge the collaterals and relieve asthma, eliminate dampness and stop nausea, and induce laxation; the adjuvant drugs Houttuynia cordata, Taraxacum mongolicum, and Paeonia lactiflora are used to clear heat and detoxify, disperse swelling and dissipate stasis; the adjuvant drugs Cinnamomum cassia, Atractylodes macrocephala, and Poria cocos are used to warm yang and transform qi, strengthen the spleen and promote diuresis; roasted Glycyrrhiza uralensis is used as the guiding drug to harmonize various drugs.

[0064] The traditional Chinese medicine composition of the present invention can restore the balance of pro-inflammatory and anti-inflammatory factors in SCAP patients, and at the same time up-regulate the level of T lymphocytes. By strengthening the healthy qi of the patients, it reduces the degree of damage to the functions of the zang-fu organs, and thus promotes the recovery of SCAP patients.

[0065] In order to further illustrate the present invention, the following will describe in detail a traditional Chinese medicine composition for treating community-acquired severe pneumonia and its application provided by the present invention in conjunction with the accompanying drawings and embodiments, but they cannot be understood as limiting the protection scope of the present invention.

[0066] Example 1 A traditional Chinese medicine composition

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

[0068] 15 parts of ginseng, 15 parts of Bupleurum chinense, 5 parts of Scutellaria baicalensis, 10 parts of Taraxacum mongolicum, 10 parts of Houttuynia cordata, 5 parts of Paeonia lactiflora, 10 parts of Pheretima aspergillum, 5 parts of Pogostemon cablin, 5 parts of Atractylodes lancea, 4 parts of Cinnamomum cassia, 5 parts of Atractylodes macrocephala, 10 parts of Poria cocos, 4 parts of Citrus reticulata, 4 parts of Rheum palmatum, and 4 parts of roasted Glycyrrhiza uralensis.

[0069] Example 2 A traditional Chinese medicine composition

[0070] 20 parts of ginseng, 20 parts of bupleurum, 10 parts of scutellaria baicalensis, 15 parts of dandelion, 15 parts of houttuynia cordata, 10 parts of red peony root, 15 parts of earthworm, 9 parts of pogostemon cablin, 10 parts of atractylodes lancea, 6 parts of cassia twig, 10 parts of atractylodes macrocephala, 12 parts of poria cocos, 6 parts of dried tangerine peel, 6 parts of rhubarb, and 6 parts of roasted licorice root.

[0071] Example 3 A traditional Chinese medicine composition

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

[0073] 25 parts of ginseng, 25 parts of bupleurum, 15 parts of scutellaria baicalensis, 20 parts of dandelion, 20 parts of houttuynia cordata, 15 parts of red peony root, 20 parts of earthworm, 10 parts of pogostemon cablin, 15 parts of atractylodes lancea, 8 parts of cassia twig, 15 parts of atractylodes macrocephala, 14 parts of poria cocos, 8 parts of dried tangerine peel, 8 parts of rhubarb, and 8 parts of roasted licorice root.

[0074] Example 4 A preparation method of a traditional Chinese medicine composition

[0075] The steps of the preparation method of the traditional Chinese medicine composition are as follows:

[0076] Prepare with the raw materials of any one group in Examples 1 - 3;

[0077] Mix bupleurum, scutellaria baicalensis, dandelion, houttuynia cordata, red peony root, earthworm, atractylodes lancea, cassia twig, atractylodes macrocephala, poria cocos, dried tangerine peel, rhubarb, and roasted licorice root, and mix the above traditional Chinese medicine components with water according to the material - liquid ratio of 1 g:10 mL, then conduct the first decoction. When decocting, first use high heat to decoct until the water boils, then turn to low heat and decoct for a total of 1 h. After the decoction is completed, separate the medicinal liquid and the medicinal residues to obtain the first medicinal liquid and the first medicinal residues;

[0078] After obtaining the first medicinal residues, add water to the first medicinal residues according to the material - liquid ratio of 1 g:10 mL for the second decoction. The duration of the second decoction is 1 h. Put pogostemon cablin into the decoction 15 min before the end of the second decoction and continue to decoct until the end of the second decoction. After the second decoction is completed, remove the medicinal residues to obtain the second medicinal liquid;

[0079] Mix ginseng with water according to the material - liquid ratio of 1 g:10 mL, and decoct with low heat alone for 2 h. After the decoction is completed, remove the medicinal residues to obtain the third medicinal liquid;

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

[0081] Example 5 Verification test on the therapeutic effect of the traditional Chinese medicine composition of the present invention on SCAP patients

[0082] In patients with SCAP, there is a pathogenesis of pathogenic factors invading the interior, healthy qi being damaged, and viscera being deficient. In the preliminary clinical study of the pathogenesis of SCAP, it was found that the traditional Chinese medicine composition prepared in the present invention reduced the scores of organ failure and the quantitative scores of traditional Chinese medicine syndromes in SCAP patients by downregulating the levels of pro-inflammatory factors and upregulating the total number of T-lymphocyte immune cells.

[0083] Based on the above research, the present invention proposes the following research hypothesis: The traditional Chinese medicine composition described in the present invention may play a role in supporting the healthy qi of SCAP patients by reducing the expression of pro-inflammatory factors, increasing the level of T lymphocytes, downregulating the inflammatory response, and enhancing the immune function, and finally achieve the curative effects of reducing organ failure in SCAP patients, improving their symptoms, and promoting their recovery. In this study, enzyme-linked immunosorbent assay and flow cytometry analysis techniques were used to conduct this prospective randomized controlled study to verify the research hypothesis.

[0084] Prospective randomized controlled study:

[0085] The SCAP patients, who are the subjects of severe pneumonia meeting the criteria and are planned to be included in 160 consecutive inpatients in the intensive care unit in this example, need 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 Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia (CAP) formulated by the Respiratory Disease Branch of the Chinese Medical Association in 2006:

[0089] Clinical diagnostic basis for CAP: ① New onset of cough, expectoration, or exacerbation of pre-existing respiratory diseases with 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 left shift of the nucleus; ⑤ Chest X-ray examination shows patchy or patchy infiltrative shadows or interstitial changes, with or without pleural effusion. Any one of items ① to ④ plus item ⑤, and excluding pulmonary tuberculosis, lung tumors, pulmonary embolism, pulmonary eosinophilic infiltration, and pulmonary vasculitis, etc., can establish a clinical diagnosis.

[0090] CAP that meets at least one of the following 7 diagnostic criteria is diagnosed as SCAP:

[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, after giving informed consent, signed the relevant consent forms, met the inclusion criteria and did not meet the exclusion criteria, and entered the randomized trial but could not complete the treatment course and observation period of this protocol due to various major objective reasons were regarded as drop-out cases for exclusion. The major objective reasons include: misdiagnosis, occurrence of serious adverse reactions or sudden onset of 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 in the group treated with the traditional Chinese medicine composition of the present invention in addition to Western medicine treatment was 2 ± 1 points, while the score of multiple organ failure in the pure Western medicine treatment group was 6 ± 4 points. Taking the probability of type I error α = 0.05 and the probability of type II error β = 0.10, the test power was 90%. ② The patients meeting the inclusion criteria were matched in a 1:1 ratio. Using the PASS software, it was calculated that the number of enrolled patients in the group treated with the traditional Chinese medicine composition of the present invention combined with Western medicine was 72 cases, and the Western medicine control group was 72 cases. Considering that some patients with severe pneumonia may experience death events within 3 days in the actual clinical process, the number of enrolled patients was appropriately increased, with 80 cases in each group.

[0105] According to the above samples, the present invention intends to enroll 160 eligible SCAP subjects who are continuously admitted to the Intensive Care Unit of Changsha Hospital of Traditional Chinese Medicine (Changsha Eighth Hospital). Researchers who do not participate in clinical treatment and outcome evaluation use the 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 traditional Chinese medicine composition treatment group of the present invention in a 1:1 ratio, with 80 people in each group, and allocation concealment is achieved through opaque random envelopes. In this example, the doctors are not blinded, while the data statisticians and outcome evaluators are blinded.

[0106] 5. Medication regimens for SCAP patients in the control group and the experimental group

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

[0108] ① Reasonably use antibacterial drugs for anti-infection treatment, and the types of antibacterial drugs can be adjusted in a timely manner according to the results of microbial culture.

[0109] ② Timely use or adjust the ventilator parameters according to the patient's respiratory function and blood gas analysis results.

[0110] ③ Reasonably use anticoagulant drugs according to the coagulation function, platelet count, D-D dimer level and thrombus score.

[0111] ④ Give corresponding symptomatic support treatment according to the combined conditions. For example, if acute renal failure is combined, bedside blood purification treatment may be required.

[0112] The Western medicine treatment includes, for example: intravenous infusion of piperacillin / tazobactam 4.5 g every 8 hours; intravenous infusion of levofloxacin injection 1.0 g once a day; intravenous infusion of meropenem 1.0 g every 8 hours.

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

[0114] On the basis of the above Western medicine treatment, the traditional Chinese medicine composition of the present invention was given by nasal feeding. 7 doses were taken as a course of treatment, 1 dose per day, divided into two times in the morning and evening, and administered by nasal feeding in the form of decoction, about 100 mL each time. The traditional Chinese medicine composition of the present invention is the composition described in Example 2, and the traditional Chinese medicine composition tested was decocted uniformly. The treatment process of SCAP patients in the experimental group is as Figure 1 shown.

[0115] SCAP patients have the characteristic of insufficient healthy qi, manifested as a decrease in the level of T lymphocytes in peripheral blood, promoting inflammatory reactions and a disorder in the ratio of cytokines antagonizing inflammatory reactions. The total number of T lymphocytes, CD4+ T lymphocytes, and CD8+ T lymphocytes in the peripheral blood of SCAP patients are significantly decreased compared with those of patients with common 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, the score of sequential organ failure, and the mortality rate of patients in SCAP patients.

[0116] Fibroblast growth factor 21 (FGF21), which antagonizes inflammatory reactions, is significantly increased in the body of SCAP patients and decreases dynamically with the improvement of the condition. The dynamic change of FGF21 is a new biomarker for judging SCAP patients.

[0117] In summary, the following indicators were detected for SCAP patients in the control group and the experimental group of the present invention:

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

[0119] Such as: the gender, age, presence or absence of underlying diseases (hypertensive disease, coronary heart disease, cerebral infarction or cerebral hemorrhage, chronic renal insufficiency, type 2 diabetes, rheumatic immune diseases), medication history, surgical history, and basic vital signs of the patients (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 detection items of diagnostic indicators are as follows:

[0122] ① On the first day when the patient is enrolled, perform tests on blood routine, myocardial enzyme, cardiac troponin, liver function (alanine aminotransferase, ALT, aspartate aminotransferase, AST), kidney function (creatinine, SCR, blood urea nitrogen, BUN, uric acid, UA), coagulation function, and D-dimer, and record the results.

[0123] ② On the first day when the patient is enrolled, conduct blood gas analysis and record the results.

[0124] ③ Use enzyme-linked immunosorbent assay to detect the baseline levels of IL-6, TNF-α, PCT, CRP, and fibroblast growth factor 21 (FGF21) in SCAP patients. Taking FGF21 as an example to illustrate the main steps, the detection of the other items uses a similar method, except for the different kits used.

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

[0126] b: Determine the serum FGF21 concentration according to the method described in the instruction manual of the enzyme-linked immunosorbent assay (ELISA) human kit (produced by Abcam, USA).

[0127] The specific steps of the detection are as follows: 1) Sample addition: Add 50 μL of the standard product or serum respectively, taking care not to have air bubbles. When adding the sample, add it to the bottom of the enzyme-labeled plate, try not to touch the well wall, and gently shake to mix evenly. Cover the enzyme-labeled plate with a film and incubate at 37 °C for 60 minutes. 2) Discard the liquid in the wells, shake dry, add 350 μL of washing buffer to each well, soak for 1 - 2 minutes, wash the plate once, shake dry and gently pat on the absorbent paper to pat dry the liquid in the wells. Repeat three times. 3) Add 100 μL of the substrate solution tetramethylbenzidine (TMB) to each well, cover the enzyme-labeled plate with a film and incubate at 37 °C in the dark for about 10 minutes (shorten or extend as appropriate according to the actual color development situation, but not exceeding 30 minutes. When an obvious gradient appears in the standard wells, the reaction can be terminated). 4) Add 100 μL of the stop solution to each well to terminate the reaction, and at this time, the blue color immediately turns yellow. The addition order of the stop solution should be as consistent as possible with the addition order of the substrate solution. 5) Immediately measure the optical density (OD) value of each well with an enzyme-labeled instrument at a wavelength of 450 nm. The power supply of the enzyme-labeled instrument should be turned on in advance, the instrument should be preheated, and the detection program should be set. 6) Finally, calculate the corresponding FGF21 concentration of each well.

[0128] ④ Use flow cytometry to detect the counts of CD3 + T cells, CD4 + T cells, CD8 + T cells in the peripheral blood of the patient.

[0129] The detection method is as follows:

[0130] a: Main reagents: Trypan blue dye (Sigma, USA); Pecoll density gradient medium (GE, USA); PBS buffer. Flow cytometry fluorescent labeled antibodies: Mouse anti-human CD3-FITC, Mouse anti-human CD4-PerCP, Mouse anti-human CD8-PE, and the isotype controls are 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 (BD FACSAria Ⅲ, USA); Microscope (Olympus BX60, Japan); Desktop high-speed refrigerated centrifuge (Thermo Legend RT-Plus, USA).

[0132] c: Main steps:

[0133] c1: Draw 5 mL of peripheral venous blood from the patient to obtain peripheral blood, and anticoagulate it with heparin in a sterile and dry manner.

[0134] c2: Prepare peripheral blood mononuclear cells (PBMC): Use a syringe needle to aspirate 5 mL of 60% Pecoll density gradient medium (specific gravity 1.077 g / mL) and add it to a centrifuge tube. Then, slowly add 5 mL of heparin-anticoagulated peripheral blood (the peripheral blood is diluted 1:1 with PBS buffer) along the tube wall to form a clear interface. Centrifuge at 2000 r / min for 20 minutes using a high-speed refrigerated centrifuge. Carefully aspirate the milky white layer at the interface of the Pecoll density gradient medium, and resuspend it with 2 mL of PBS buffer. Perform flow cytometry detection within 6 hours. Take 15 μL of the cell suspension and add it to a Neubauer counting chamber, and count the total number of cells in 4 large squares under a microscope.

[0135] c3: Flow cytometry detection and sorting:

[0136] Two tubes with a concentration of 1×10 10100 μL of PBMC per liter, add 20 μL each of anti-IgG3-FITC and anti-IgG1-PerCP flow cytometry fluorescent labeling antibodies to one tube, and add 20 μL each of CD3-FITC, anti-CD4-PerCP, and anti-CD8-PE flow cytometry fluorescent labeling antibodies to the other tube; mix well, incubate at 25 °C in the dark for 30 min, then centrifuge at 2000 r / min for 10 min using a 4 °C centrifuge, discard the supernatant, add 500 μL of PBS buffer to the precipitate and gently blow and wash to remove excess unbound antibodies, centrifuge again at 2000 r / min for 10 min using a 4 °C centrifuge, repeat 2 times; resuspend with 400 μL of PBS buffer and load onto the machine. Adjust the flow cytometer to the optimal working state, first load the negative isotype control group of IgG3-FITC and anti-IgG1-PerCP flow cytometry fluorescent labeling antibodies, and then load the sample group of CD3-FITC, anti-CD4-PerCP, and CD8-PE flow cytometry fluorescent labeling antibodies.

[0137] ⑤ At the bedside in the ICU ward, detect SCAP patients and complete X-ray films.

[0138] ⑥ According to the TCM clinical symptom score scale for pneumonia shown in Table 1, calculate its score. The TCM clinical symptoms of pneumonia are determined with reference to the Diagnostic and Therapeutic Criteria for TCM Syndromes by the State Administration of Traditional Chinese Medicine.

[0139] Table 1 Evaluation Table of TCM Clinical Symptoms Score for Pneumonia

[0140]

[0141]

[0142]

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

[0144] Calculate the therapeutic efficiency of TCM syndromes before and after treatment according to the scoring criteria shown in Table 1, and conduct clinical efficacy evaluation using the Nimodipine method. The calculation formula is: syndrome therapeutic efficiency = (pre-treatment score - post-treatment score) / pre-treatment score × 100%.

[0145] ⑦ Evaluate the treatment effects of SCAP patients in the control group and the experimental group after treatment. The evaluation criteria are as follows:

[0146] Clinical control: After treatment, symptoms and signs basically disappear, can participate in normal activities and work, and syndrome therapeutic efficiency ≥ 90%;

[0147] Marked effect: After treatment, symptoms, signs, and auxiliary examination results are significantly improved, and 60% ≤ syndrome therapeutic efficiency < 90%;

[0148] Effective: After treatment, the symptoms, signs and results of auxiliary examinations improved to some extent, and 30% ≤ syndrome treatment efficiency < 60%;

[0149] Ineffective: After treatment, the symptoms, signs and results of auxiliary examinations showed no improvement compared with those before treatment, and the syndrome treatment efficiency < 30%.

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

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

[0152] ② During the ICU treatment process, record whether the patients had malignant arrhythmia, gastrointestinal bleeding, skin rash, and allergic reaction.

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

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

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

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

[0157] The content in Figures 2 to 4 was summarized in Table 3 for comparison of the treatment effects of patients in the two groups.

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

[0159] ① The total number of days of hospitalization of the patients and the total number of days of hospitalization of the patients in the ICU ward.

[0160] ② The total hospitalization cost of the patients.

[0161] 11. Statistically analyze the test results of the above-mentioned test items

[0162] Combined with the results of the above-mentioned test items, perform a sequential organ failure assessment (sequential organ failure score, SOFA) according to the scoring criteria described in Table 2, and perform a statistical analysis on the above results. The results are shown in Table 3 Figure 2 、 Figure 3 and Figure 4 。

[0163] Statistical analysis was performed using SPSS 24.0 (IBM Corporation) software. The significance level of all tests was defined as P < 0.05 (two-sided test). For all numerical continuous variable data, a normal Kolmogorov-Smirnov test was first performed. For data that conformed to a normal distribution, a repeated measures analysis of variance was used to compare whether there were differences in indicators at different time points; for data that did not conform to a normal distribution, a Kruskal-Wallis test was used to compare whether there were differences in indicators at different time points. The comparison of rates was performed using a chi-square test.

[0164] Table 2 Sequential organ failure quantitative score

[0165]

[0166]

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

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

[0169] Parameter Pure Western Medicine Treatment Group Western Medicine Treatment + Bufei Jiedu Decoction Group SOFA Score 5(2～12) 5(2～9) Traditional Chinese Medicine Syndrome Score 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 parentheses in the simple western medicine treatment group and the western medicine treatment + Bufei Jiedu Decoction group in Table 3 represent the score intervals of the patients.

[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 that before treatment. Before treatment, in the control group: Western medicine group and the experimental group: Western medicine combined with Bufei Jiedu Decoction (i.e., the traditional Chinese medicine composition described in the present invention) group, there were no statistically significant differences in SOFA scores and traditional Chinese medicine syndrome scores. After 14 days of treatment, the traditional Chinese medicine syndrome 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 was 2 points (1 - 4 points), lower than 5 points (2 - 20 points) of the Western medicine group, with a statistically significant difference, P value = 0.001.

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

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

[0174] In summary, when the traditional Chinese medicine composition of the present invention is combined with Western medicine to treat SCAP patients, its curative effect is better than that of Western medicine treatment alone. The present invention is a beneficial supplement to the current treatment of severe pneumonia. The traditional Chinese medicine composition provided by the present invention is the Yiqi Fuzheng Prescription. Combining this prescription with Western medicine treatment reduces the pro-inflammatory response in the body of SCAP patients, enhances the immune function of patients, regulates the ratio of helper T cell subtypes (i.e., the ratio of Th1 (T helper 1 cell) to Th2 (T helper 2 cell)), and balances the proportion of severe pneumonia patients receiving traditional Chinese medicine treatment; reduces the degree of organ failure in patients. The traditional Chinese medicine composition and treatment plan described in the present invention can reduce the total cost of treating SCAP patients, shorten the recovery period of patients, thereby shortening the hospital stay of patients, improving the satisfaction of patients seeking medical treatment, and being conducive to the high-quality development of the national economy.

[0175] Although the above embodiments have described the present invention in detail, they are only a part of the embodiments of the present invention, not all embodiments. People can also obtain other embodiments without creative efforts as in this embodiment, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating community-acquired severe pneumonia, characterized in that, By weight parts, the raw materials are as follows: 15 - 25 parts of ginseng, 15 - 25 parts of bupleurum, 5 - 15 parts of scutellaria baicalensis, 10 - 20 parts of dandelion, 10 - 20 parts of houttuynia cordata, 5 - 15 parts of red peony root, 10 - 20 parts of earthworm, 5 - 10 parts of agastache rugosa, 5 - 15 parts of atractylodes lancea, 4 - 8 parts of cassia twig, 5 - 15 parts of atractylodes macrocephala, 10 - 14 parts of poria cocos, 4 - 8 parts of dried tangerine peel, 4 - 8 parts of rhubarb, and 4 - 8 parts of roasted licorice root.

2. The traditional Chinese medicine composition according to claim 1, characterized in that By weight parts, the raw materials are as follows: 17 - 23 parts of ginseng, 17 - 23 parts of bupleurum, 7 - 13 parts of scutellaria baicalensis, 12 - 18 parts of dandelion, 12 - 18 parts of houttuynia cordata, 7 - 13 parts of red peony root, 12 - 18 parts of earthworm, 6 - 9 parts of agastache rugosa, 7 - 13 parts of atractylodes lancea, 5 - 7 parts of cassia twig, 7 - 13 parts of atractylodes macrocephala, 11 - 13 parts of poria cocos, 5 - 7 parts of dried tangerine peel, 5 - 7 parts of rhubarb, and 5 - 7 parts of roasted licorice root.

3. The traditional Chinese medicine composition according to claim 1, wherein By weight parts, the raw materials are as follows: 20 parts of ginseng, 20 parts of bupleurum, 10 parts of scutellaria baicalensis, 15 parts of dandelion, 15 parts of houttuynia cordata, 10 parts of red peony root, 15 parts of earthworm, 9 parts of agastache rugosa, 10 parts of atractylodes lancea, 6 parts of cassia twig, 10 parts of atractylodes macrocephala, 12 parts of poria cocos, 6 parts of dried tangerine peel, 6 parts of rhubarb, and 6 parts of roasted licorice root.

4. The preparation method of the traditional Chinese medicine composition for treating community-acquired severe pneumonia according to any one of claims 1 to 3, characterized in that It includes the following steps: Mix bupleurum, scutellaria baicalensis, dandelion, houttuynia cordata, red peony root, earthworm, atractylodes lancea, cassia twig, atractylodes macrocephala, poria cocos, dried tangerine peel, rhubarb, and roasted licorice root, and conduct the first decoction, then filter and separate the medicinal liquid and the medicinal residues to obtain the first medicinal liquid and the first medicinal residues; Conduct the second decoction on the first medicinal residues, and put agastache rugosa into the medicinal liquid during the second decoction before it ends to obtain the second medicinal liquid; Decoct ginseng alone to obtain the third medicinal liquid; Mix the first medicinal liquid, the second medicinal liquid, and the third medicinal liquid to obtain the traditional Chinese medicine composition.

5. The preparation method according to claim 4, characterized in that, During the first decoction and the second decoction, the total weight of bupleurum, scutellaria baicalensis, dandelion, houttuynia cordata, red peony root, earthworm, atractylodes lancea, cassia twig, atractylodes macrocephala, poria cocos, dried tangerine peel, rhubarb, and roasted licorice root and the material - liquid ratio of water are each 1g: 5 - 10 mL; the time for the first decoction is 0.5 - 1 h.

6. The preparation method according to claim 4, wherein The time for the second decoction is 0.5 - 1 h; agastache rugosa is put in 10 - 15 min before the second decoction ends.

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

8. The preparation method according to claim 7, characterized in that, The separate decoction is: stewing ginseng with slow fire for 2 h.

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

10. A combined drug for treating community-acquired severe pneumonia, characterized in that, The combined drug is a traditional Chinese medicine composition and a western medicine for treating community - acquired severe pneumonia; The traditional Chinese medicine composition is the traditional Chinese medicine composition according to any one of claims 1 - 3 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 4 - 8; The western medicine for treating community - acquired severe pneumonia is an antibacterial drug.

Images