CN117257866A - Traditional Chinese medicine composition for treating community-acquired pneumonia and application thereof - Google Patents

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

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CN117257866A
CN117257866A CN202310415233.7A CN202310415233A CN117257866A CN 117257866 A CN117257866 A CN 117257866A CN 202310415233 A CN202310415233 A CN 202310415233A CN 117257866 A CN117257866 A CN 117257866A
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parts
raw
chinese medicine
traditional chinese
radix
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CN117257866B (en
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张炜
徐贵华
陈旋
郑月娟
孙萌
刘瑾
陈麒
史苗颜
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Shuguang Hospital Affiliated to Shanghai University of TCM
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
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    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
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    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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Abstract

The invention provides a traditional Chinese medicine composition for treating community-acquired pneumonia, which is prepared from the following raw materials in parts by weight: 26-34 parts of radix cynanchi wilfordii, 5-13 parts of white mulberry root-bark, 4-8 parts of raw ephedra herb, 5-13 parts of bitter apricot seed and raw gypsum Decocting first 26-34 parts of radix bupleuri, 5-13 parts of radix scutellariae, 4-8 parts of raw rheum officinale and 5-13 parts of raw liquorice. The invention also provides application of the traditional Chinese medicine composition. The advantages are that: the invention adopts the treatment principles of purging lung, purging viscera, and clearing and resolving, takes ephedra as a monarch drug, and releases lung to purge pathogenic heat; gypsum Fibrosum, cortex Mori, radix et rhizoma Rhei and rhizoma Fagopyri Dibotryis are used as ministerial drugs for clearing lung heat without keeping evil, eliminating phlegm turbid, and descending lung qi; bupleurum root, baikal skullcap root and bitter apricot seed are used as adjuvant drugs to relieve diarrheaLiver fire, preventing liver counter-restriction and lung counter-restriction embody the idea of 'treating disease' in traditional Chinese medicine; glycyrrhrizae radix is used as a guiding drug for invigorating qi and regulating stomach and harmonizing various drugs.

Description

Traditional Chinese medicine composition for treating community-acquired pneumonia and application thereof
[ field of technology ]
The invention relates to a traditional Chinese medicine composition for treating community-acquired pneumonia and application thereof, in particular to a Chinese patent medicine prepared by taking Chinese herbal medicines as raw materials.
[ background Art ]
Community-acquired Pneumonia, CAP) is a type of pneumonia that is caused by infection of many microorganisms, such as bacteria, viruses, chlamydia and mycoplasma, outside the hospital, and the main clinical symptoms are cough, with or without expectoration and chest pain, and the prodromal symptoms are mainly rhinitis-like symptoms or symptoms of upper respiratory tract infection, such as nasal obstruction, nasal discharge, sneeze, dry throat, pharyngalgia, pharyngeal foreign body sensation, hoarseness, headache, dizziness, eye thermal distension, lacrimation, and mild cough. Community-acquired pneumonia is one of the common infectious diseases threatening human health, and the composition and drug resistance characteristics of its pathogens vary significantly from country to country and from region to region, and also change over time.
At present, western medicine mainly adopts second and third generation cephalosporins, beta lactams and fluoroquinolones for treatment, and has certain curative effect, but the phenomenon of drug resistance is serious along with the transition of pathogenic microorganisms, and side effects are large, and part of drugs are expensive, so that the traditional Chinese medicine composition is difficult to popularize generally.
The Chinese patent document CN200710131244.3 discloses a traditional Chinese medicine for treating pneumonia, which is prepared from the following raw materials in parts by weight: the main prescription is as follows: 30 g of gypsum, 5g of ephedra, 15 g of almond, 5g of liquorice, 30 g of houttuynia cordata, 24 g of scutellaria baicalensis, 30 g of dandelion, 30 g of polygonum cuspidatum, 30 g of andrographis paniculata and 15 g of dyers woad leaf; auxiliary prescription: for chest pain patients, 10g of radix Curcumae, rhizoma corydalis and radix aucklandiae are added respectively; for patients with severe asthma, 10g of mulberry bark and 15 g of pepperweed seed are added; for patients with oliguria with yellowish and reddish urine, 15 g of plantain herb and 10g of amur corktree bark are added; for those with excessive heat and body fluid impairment, 15 g of radix trichosanthis, 30 g of reed rhizome, 10g of dwarf lilyturf tuber and dendrobium nobile are added.
The traditional Chinese medicine has great advantages in improving symptoms and signs, shortening treatment course and improving overall treatment effect, and the traditional Chinese medicine composition for effectively treating community-acquired pneumonia is very necessary for the research.
[ invention ]
The invention aims at overcoming the defects in the prior art and provides a traditional Chinese medicine composition for treating community-acquired pneumonia.
It is a further object of the present invention to provide a use of the above medicament.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
a traditional Chinese medicine composition for treating community-acquired pneumonia is prepared from the following raw materials in parts by weight: 26-34 parts of radix cynanchi wilfordii, 5-13 parts of white mulberry root-bark, 4-8 parts of raw ephedra herb, 5-13 parts of bitter apricot seed and raw gypsum Decocting first 26-34 parts of radix bupleuri, 5-13 parts of radix scutellariae, 4-8 parts of raw rheum officinale and 5-13 parts of raw liquorice;
preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 28-32 parts of radix cynanchi wilfordii, 7-11 parts of white mulberry root-bark, 5-7 parts of raw ephedra herb, 7-11 parts of bitter apricot seed and raw gypsum Decocting first 28-32 parts of radix bupleuri, 7-11 parts of radix scutellariae, 5-7 parts of raw rheum officinale and 7-11 parts of raw liquorice;
more preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of radix cynanchi wilfordii, 9 parts of white mulberry root-bark, 6 parts of raw ephedra herb, 9 parts of bitter apricot seed and plaster stone Decocting first 30 parts of bupleurum, 9 parts of scutellaria baicalensis, 6 parts of raw rheum officinale and 9 parts of raw liquorice.
Preferably, the use method of the traditional Chinese medicine composition comprises the following steps: soaking all the medicinal materials in purified water for 0.5-1.5 hours, controlling the water adding amount to be 2-3 cm higher than the surface of the medicinal materials, boiling with strong fire, decocting with slow fire for half an hour, removing residues and taking the juice; the filter residue is processed again by the method, and then 400ml of water decoction obtained by mixing the two times is taken orally, 2 times a day, 200ml each time.
Preferably, the medicament of the traditional Chinese medicine composition is decoction, tablets, capsules, granules, oral liquid, mixture or syrup.
In order to achieve the second purpose, the invention adopts the following technical scheme:
the application of the traditional Chinese medicine composition in preparing medicines for preventing/treating community-acquired pneumonia.
The invention has the advantages that:
the invention adopts the treatment principles of purging lung, purging viscera, and clearing and resolving, takes ephedra as a monarch drug, and releases lung to purge pathogenic heat; gypsum Fibrosum, cortex Mori, radix et rhizoma Rhei and rhizoma Fagopyri Dibotryis are used as ministerial drugs for clearing lung heat without keeping evil, eliminating phlegm turbid, and descending lung qi; bupleurum, scutellaria baicalensis and bitter apricot seed are used as adjuvant drugs to dispel liver fire and prevent liver counter-restriction of lung, thus embodying the idea of 'treating disease' in traditional Chinese medicine; glycyrrhrizae radix is used as a guiding drug for invigorating qi and regulating stomach and harmonizing various drugs.
[ detailed description ] of the invention
The following provides a detailed description of specific embodiments of the invention.
Example 1 Chinese medicinal composition for treating community-acquired pneumonia (I)
30 parts of radix cynanchi wilfordii, 9 parts of white mulberry root-bark, 6 parts of raw ephedra herb, 9 parts of bitter apricot seed and plaster stone Decocting first 30 parts of bupleurum, 9 parts of scutellaria baicalensis, 6 parts of raw rheum officinale and 9 parts of raw liquorice.
Example 2 Chinese medicinal composition for treating community-acquired pneumonia (II)
30 parts of radix cynanchi wilfordii, 7 parts of white mulberry root-bark, 7 parts of raw ephedra herb, 5 parts of bitter apricot seed and gypsum Decocting first 34 parts of bupleurum, 7 parts of baical skullcap root, 7 parts of raw rhubarb and 5 parts of raw liquoric root.
Example 3 Chinese medicinal composition for treating community-acquired pneumonia (III)
28 parts of radix cynanchi wilfordii, 11 parts of white mulberry root-bark, 4 parts of raw ephedra herb, 13 parts of bitter apricot seed and plaster stone Decocting first 30 parts of bupleurum, 7 parts of radix scutellariae, 11 parts of raw rheum officinale, 4 parts of raw liquorice and 13 parts of raw liquorice.
Example 4 Chinese medicinal composition for treating community-acquired pneumonia (IV)
32 parts of radix cynanchi wilfordii, 5 parts of white mulberry root-bark, 8 parts of raw ephedra herb, 9 parts of bitter apricot seed and plaster stone Decocting first 28 parts of radix bupleuri, 11 parts of radix scutellariae, 5 parts of raw rheum officinale, 8 parts of raw liquorice and 9 parts of raw liquorice.
Example 5 Chinese medicinal composition for treating community-acquired pneumonia (five)
26 parts of radix cynanchi wilfordii, 13 parts of white mulberry root-bark, 6 parts of raw ephedra herb, 7 parts of bitter apricot seed and plaster stone Decocting first 32 parts of radix bupleuri, 5 parts of radix scutellariae, 13 parts of raw rheum officinale, 6 parts of raw liquorice and 7 parts of raw liquorice.
Example 6 Chinese medicinal composition for treating community-acquired pneumonia (six)
34 parts of radix cynanchi wilfordii, 9 parts of white mulberry root-bark, 5 parts of raw ephedra herb, 11 parts of bitter apricot seed and plaster stone Decocting first 26 parts of radix bupleuri, 13 parts of radix scutellariae, 9 parts of raw rheum officinale, 5 parts of raw liquorice and 11 parts of raw liquorice.
Example 7 Chinese medicinal composition for treating community-acquired pneumonia (seven)
30 parts of radix cynanchi wilfordii, 11 parts of white mulberry root-bark, 4 parts of raw ephedra herb, 13 parts of bitter apricot seed and plaster stone Decocting first 30 parts of bupleurum, 7 parts of radix scutellariae, 11 parts of raw rheum officinale, 4 parts of raw liquorice and 13 parts of raw liquorice.
Example 8 Chinese medicinal composition for treating community-acquired pneumonia (eight)
28 parts of radix cynanchi wilfordii, 5 parts of white mulberry root-bark, 8 parts of raw ephedra herb, 9 parts of bitter apricot seed and plaster stone Decocting first 28 parts of radix bupleuri, 11 parts of radix scutellariae, 5 parts of raw rheum officinale, 8 parts of raw liquorice and 9 parts of raw liquorice.
Example 9 Chinese medicinal composition for treating community-acquired pneumonia (nine)
32 parts of radix cynanchi wilfordii, 13 parts of white mulberry root-bark, 6 parts of raw ephedra herb, 7 parts of bitter apricot seed and plaster stone Decocting first 32 parts of radix bupleuri, 5 parts of radix scutellariae, 13 parts of raw rheum officinale, 6 parts of raw liquorice and 7 parts of raw liquorice.
Example 10 Chinese medicinal composition for treating community-acquired pneumonia (ten)
26 parts of radix cynanchi wilfordii, 9 parts of white mulberry root-bark, 5 parts of raw ephedra herb, 11 parts of bitter apricot seed and plaster stone Decocting first 26 parts of radix bupleuri, 13 parts of radix scutellariae, 9 parts of raw rheum officinale, 5 parts of raw liquorice and 11 parts of raw liquorice.
Example 11 Chinese medicinal composition for the treatment of community-acquired pneumonia (eleven)
34 parts of radix cynanchi wilfordii, 7 parts of white mulberry root-bark, 7 parts of raw ephedra herb, 5 parts of bitter apricot seed and raw gypsum Decocting first 34 parts of bupleurum, 7 parts of baical skullcap root, 7 parts of raw rhubarb and 5 parts of raw liquoric root.
EXAMPLE 12 preparation of Chinese medicinal composition tablet/Capsule for treating community-acquired pneumonia
Taking the traditional Chinese medicine composition in any one of embodiments 1-11, adding 9-11 times of water, decocting for 2-3.5 hours, and filtering out the decoction. Adding 9 times of water, decocting for 2.5 hr, filtering to obtain decoction, mixing the two decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 3 times of ethanol, and stirring to precipitate overnight. Collecting supernatant, concentrating to obtain soft extract; adding pharmaceutical adjuvants, vacuum drying, pulverizing, granulating, and making into tablet or capsule.
EXAMPLE 13 preparation of Chinese medicinal composition particles for treating community-acquired pneumonia
Taking the traditional Chinese medicine composition in any one of embodiments 1-11, adding 8-10 times of water, decocting for 3 hours, and filtering out the decoction. Adding 10 times of water, decocting for 2.5 hr, filtering to obtain decoction, mixing the two decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 2 times of ethanol, and stirring to precipitate overnight. Collecting supernatant, concentrating to obtain soft extract; adding proper pharmaceutical adjuvants, granulating, drying, grading to obtain 20g granule, and packaging into 10 g/bag.
EXAMPLE 14 preparation of Chinese medicinal composition mixture/oral liquid/syrup for treating community-acquired pneumonia
Taking the traditional Chinese medicine composition in any one of embodiments 1-11, adding 8-11 times of water, decocting for 3 hours, and filtering out the decoction. Adding 8 times of water, decocting for 3 hr, filtering to obtain decoction, mixing the two decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 3.5 times of ethanol, and stirring to precipitate overnight. Collecting supernatant, concentrating to obtain soft extract; adding proper pharmaceutical adjuvants, and making into mixture, oral liquid or syrup.
Example 15 animal experiment
1. Experimental materials
1.1 drugs and Agents
Treatment group one preparation: 30 parts of radix cynanchi wilfordii, 9 parts of white mulberry root-bark, 6 parts of raw ephedra herb, 9 parts of bitter apricot seed and plaster stone Decocting first 30 parts of bupleurum, 9 parts of scutellaria baicalensis, 6 parts of raw rheum officinale and 9 parts of raw liquorice;
treatment group two preparation: 28 parts of radix cynanchi wilfordii, 11 parts of white mulberry root-bark, 4 parts of raw ephedra herb and bitter taste13 parts of almond and gypsum Decocting first 30 parts of bupleurum, 7 parts of radix bupleuri, 11 parts of radix scutellariae, 4 parts of raw rheum officinale and 13 parts of raw liquorice;
control group one preparation: 30 parts of radix polygoni multiflori, 9 parts of pericarpium arecae, 6 parts of raw ephedra, 9 parts of bitter apricot seed and gypsum Decocting first 30 parts of kudzuvine root 9 parts, phellodendron bark 9 parts, raw rhubarb 6 parts and raw liquorice 9 parts;
control group two preparation: 28 parts of dandelion, 11 parts of white mulberry root-bark, 4 parts of raw ephedra herb, 13 parts of bitter apricot seed and gypsum Decocting first 30 parts of bupleurum root, 7 parts of ash bark, 11 parts of raw rhubarb, 4 parts of raw liquorice and 13 parts of raw liquorice;
blank group: physiological saline;
model group: physiological saline.
1.2 animals
60 mice, male and female halves, weighing 20+ -5 g, were purchased from Shanghai Sipulel-BiKai laboratory animal Co.
1.3 major reagents and instruments
An LPS solution; TNF-alpha kit, IL-1 beta kit and IL-6 kit are all products of RB company in the United states.
2. Method and results
2.1 grouping
The 60 mice were grouped into model, treatment two, control one, control two, and blank.
2.2 moulding and administration
Nose drops of LPS (10 mg/kg body weight) are adopted for molding, and water is not forbidden after 12 hours of fasted before molding. Injecting 3% barbital sodium solution into the abdominal cavity of a mouse for anesthesia, accurately sucking LPS solution with the concentration of 10mg/mL by using a pipettor, controlling the head of the mouse by a left hand, slightly pushing the liquid device by a right hand, enabling the gun head to see sucked small liquid drops, slightly leaning against the right nostril of the mouse, immediately and forcefully lifting up by about 30cm by the left hand, slowly and slightly returning to the left hand starting position, carrying out back and forth 10 times, then dripping the small liquid drops into the left nostril of the mouse by the same operation, sequentially dripping the left nostril and the right nostril until liquid instillation is completed, finally loosening the mouse, placing the mouse on a mouse plate, keeping the body position with the abdomen upwards and the head upwards for more than 30min, and placing the mouse back to the original cage for feeding observation for resuscitation. After the molding, each group was administered with 0.1mL/10g (corresponding to 1.2mg/10g crude drug amount) of the extract of the corresponding drug, 1 time/day, and 14 days. Normal control and model groups were given equal amounts of physiological saline. Whole blood was collected from each group of mice at 15d for serum inflammatory factor determination.
2.3 detection index
(1) Observing the mental state and the activity state of each group of mice;
(2) The levels of TNF- α, IL-1β, and IL-6 in the serum of each group of mice were determined.
2.4 statistical methods
Data were statistically processed using SPSS25.0 software. The measurement data is expressed by (x+ -s), and the t-test is applied to the normal distributor.
2.5 results
2.5.1 comparison of mental State and Activity State of mice of groups
Mice in the treatment group and the control group are normal in performance, smooth in hair, relatively active, uniform in breathing and sensitive in response; model group mice have poor mental state, slow response, disordered hair, a bundle of wound, auscultation and lung roar finding, etc. Compared with the model group, the different administration groups have better overall condition, and especially mice in the treatment group have more frequent movements and more sensitive response.
2.5.2 comparison of TNF-alpha, IL-1 beta and IL-6 levels in serum from mice of groups
Mouse blood samples were taken and assayed for TNF- α, IL-1β, and IL-6 levels in serum by performing the procedure described in ELISA kit. The levels of TNF- α, IL-1β and IL-6 were significantly increased in the serum of mice in the model group compared to the blank group (p < 0.01); the levels of TNF-alpha, IL-1 beta and IL-6 in the serum of mice in the treatment group, control group were significantly reduced compared to the model group (p <0.01, p < 0.05); the serum levels of TNF- α, IL-1β and IL-6 were reduced in the treated mice compared to the control group (p < 0.05), and there was no significant difference in IL-6 in the treated mice compared to the control group, and the results are shown in Table 1.
TABLE 1 comparison of TNF-alpha, IL-1 beta and IL-6 content in serum of mice of each group
Note that: 1) compared with blank group, p<0.01; 2) Compared with the model group, (p)<0.01、p<0.05); 3) Compared with the control group, (p)<0.05)。
Example 16 clinical trials
1. Data and method
1.1 clinical data
The study cases were obtained from pneumology community-acquired pneumonic phlegm-heat-accumulation lung type patients in the period of 1 month-2021 month in 2020, and 180 cases were randomly divided into 90 treatment groups and 90 control groups.
1.2 diagnostic criteria
1.2.1 Western diagnostic criteria: reference is made to the guidelines for diagnosis and treatment of acquired pneumonia in the chinese adult community (2016 edition):
(1) Community morbidity;
(2) Pneumonia-related clinical manifestations: (1) cough, expectoration or exacerbation of the symptoms of the original respiratory disease are newly developed with or without purulent sputum/chest pain/dyspnea/hemoptysis. (2) Heating. (3) Syndrome of lung-excess type and/or smelling and wetting the rales. (4) Peripheral blood White Blood Cells (WBC) > 10×10 9 individual/L or < 4×10 9 Left shift of cell nucleus with or without cell/L;
(3) Chest imaging showed new appearance of patchy infiltrates, leaf/segment solid lesions, ground glass shadows or interstitial changes with or without pleural effusions.
The clinical diagnosis can be established after meeting any 1 in (1), (2) and (3) and excluding tuberculosis, lung tumor, noninfectious pulmonary interstitial disease, pulmonary edema, pulmonary atelectasis, pulmonary embolism, eosinophilic infiltration, pulmonary vasculitis and the like.
1.2.2 diagnostic criteria for severe pneumonia (severepneumia)
Severe pneumonia can be diagnosed if CAP meets the following 1 primary standard or ≡3 secondary standards.
The main standard is as follows: (1) mechanical ventilation treatment of the trachea cannula is needed; (2) vascular active drug therapy is still required after septic shock is resuscitated by aggressive fluid.
Secondary standard: (1) the respiratory frequency is more than or equal to 30 times/minute; (2) pa02/Fi02 is less than or equal to 250mmHg (1 mmHg=0.133 kPa); (3) infiltration of multiple lung lobes; (4) a disturbance of consciousness and/or a disturbance of orientation; (5) blood urea nitrogen is more than or equal to 20mg/dl (7.14 mmol/L); (6) systolic pressure < 90mmHg, active fluid resuscitation is required.
CURB-65 is recommended as a criterion for determining whether a CAP patient needs hospitalization. CURB-65 total five indexes, satisfying 1 to obtain 1 score: (1) a disturbance of consciousness; (2) urea nitrogen > 7mmol/L; (3) the respiratory frequency is more than or equal to 30 times/minute; (4) systolic pressure is less than 90mmHg or diastolic pressure is less than or equal to 60mmHg; (5) the age is more than or equal to 65 years old. Scoring 0-1 score, in principle outpatient treatment; hospitalization or off-hospital treatment under strict follow-up is recommended 2 points; hospitalization should be performed for 3-5 minutes. Meanwhile, the comprehensive judgment of the age, basic diseases, social and economic conditions, gastrointestinal functions, treatment compliance and the like of the patient should be combined.
1.2.3 diagnostic criteria for chinese medicine: determining phlegm-heat obstructing lung type CAP diagnosis standard according to the Community acquired pneumonia traditional Chinese medicine diagnosis and treatment guide (2018 revision), specifically comprising the following steps:
the traditional Chinese medicine syndrome waiting diagnosis: wind-warm lung-heat disease-syndrome of phlegm-heat obstructing the lung.
Main symptoms are as follows: cough, excessive phlegm, yellow phlegm, dry and sticky phlegm and chest pain.
Secondary symptoms: fever, thirst, flushed face, yellow urine, dry stool and abdominal distention.
Tongue pulse: a red tongue with yellow and greasy coating and a slippery and rapid pulse.
Diagnosis: (1) cough and even chest pain; (2) yellow or white dry sticky sputum; (3) fever, thirst; (4) dry stool or abdominal distension; (5) the tongue is reddish, yellow or yellow and greasy coating, and the pulse is rapid or slippery and rapid. The method comprises 2 items (1) and (2), and 2 items (3), (4) and (5).
1.3 inclusion criteria
(1) Meets the CAP Western diagnosis standard;
(2) Meets the traditional Chinese medicine diagnosis standard of phlegm-heat obstructing lung;
(3) Age 18-85 years;
(4) Those who have not used antibiotic drugs within 72 hours after the current illness;
(5) The patient voluntarily participates and signs informed consent.
1.4 methods of treatment
Control group: the basic treatment of CAP guidelines is given to resist infection, relieve fever, eliminate phlegm and relieve airway spasm;
treatment group: based on basic treatment, the pneumonia clearing mixture is orally taken. Observing the symptoms such as body temperature, cough, expectoration and the like before and after the treatment of patients and the change of inflammatory indexes.
1.5 evaluation of therapeutic Effect
1.5.1 therapeutic Effect Observation index
The main curative effect index is as follows: baseline and treatment for 7 days.
Secondary efficacy index:
(1) Peripheral blood WBC, percent neutrophil (NEUT%), C-reactive protein (CRP), serum Amyloid A (SAA), procalcitonin (PCT) changes: record before treatment and day 7 of treatment;
(2) Chest CT: recording lung image change before and on day 7 of treatment;
(3) Detecting novel coronavirus nucleic acid by real-time fluorescent RT-PCR (once before and after treatment) of samples such as sputum, throat swab, lower respiratory tract secretion and the like;
(4) Baseline and 7 days of disease combined outcome (severe pneumonia conversion, pneumonia outcome index, etc.);
(5) Average number of hospitalization days, total hospitalization cost, etc.
1.5.2 therapeutic efficacy criterion
And (3) formulating curative effect judgment standards according to the guidelines of clinical research on new traditional Chinese medicines.
(1) The comprehensive curative effect of the disease is that (1) the respiratory tract symptoms and the lung signs disappear, the fever is no longer generated, and the related physicochemical indexes are recovered to cure; (2) the respiratory tract symptoms and the lung physical signs are obviously improved, no fever is generated any more, and the related physicochemical index level is obviously optimized to be obvious; (3) the improvement comprises the effective improvement of respiratory symptoms and pulmonary signs, the gradual recovery of the body temperature, and the recovery of relevant physicochemical indexes; (4) invalidation: no change in respiratory symptoms or pulmonary signs was ineffective.
Total effective rate = cure rate + apparent efficiency.
(2) The nimodipine method is adopted to evaluate the curative effect of the traditional Chinese medicine symptoms: efficacy index = difference between post-treatment and pre-treatment scores/pre-treatment score x 100%. The curative effect indexes of cure, obvious effect, effective and ineffective are respectively more than or equal to 95%, 70% -95% (excluding 95%), 30% -70% (excluding 70%) and less than 30%.
2. Results
2.1 evaluation of efficacy
The total effective rate of the treated group is obviously improved (96.7 percent, 58/60) after treatment, which is obviously higher than that of the control group (85.0 percent, 51/60), and the difference between the two groups has statistical significance (p < 0.05).
Table 3 comparison of total efficacy for two groups of patients [ example (%)
Note that: p <0.05 compared to the control group.
2.2 comparison of fever time
The treatment group had significantly shorter duration of heat than the control group (p < 0.05).
Table 4 comparative antipyretic time of two groups of patients
Note that: p <0.05 compared to the control group.
2.3 cough disappearance time comparison
The cough disappearance time was significantly improved in the treated group compared to the control group (p < 0.05).
Table 5 comparison of cough disappearance times in two groups of patients
Note that: p <0.05 compared to the control group.
3. Conclusion(s)
The pneumonia clear compound agent has obvious anti-inflammatory effect, shortens the fever and cough relieving time of patients with community-acquired pneumonia phlegm-heat syndrome, has obvious curative effect on relieving symptoms such as expectoration, thirst, constipation and the like, can accelerate and reduce inflammatory reaction, improves treatment effect, and has good safety.
The foregoing is merely a preferred embodiment of the present invention, and it should be noted that modifications and additions may be made to those skilled in the art without departing from the method of the present invention, which modifications and additions are also to be considered as within the scope of the present invention.

Claims (6)

1. The traditional Chinese medicine composition for treating community-acquired pneumonia is characterized by being prepared from the following raw materials in parts by weight: 26-34 parts of radix cynanchi wilfordii, 5-13 parts of white mulberry root-bark, 4-8 parts of raw ephedra herb, 5-13 parts of bitter apricot seed and raw gypsum Decocting first 26-34 parts of radix bupleuri, 5-13 parts of radix scutellariae, 4-8 parts of raw rheum officinale and 5-13 parts of raw liquorice.
2. The traditional Chinese medicine composition according to claim 1, which is characterized by being prepared from the following raw materials in parts by weight: 28-32 parts of radix cynanchi wilfordii, 7-11 parts of white mulberry root-bark, 5-7 parts of raw ephedra herb, 7-11 parts of bitter apricot seed and raw gypsum Decocting first 28-32 parts of radix bupleuri, 7-11 parts of radix scutellariae, 7-11 parts of raw rheum officinale, 5-7 parts of raw liquorice and 7-11 parts of raw liquorice.
3. The traditional Chinese medicine composition according to claim 2, which is characterized by being prepared from the following raw materials in parts by weight: 30 parts of radix cynanchi wilfordii, 9 parts of white mulberry root-bark, 6 parts of raw ephedra herb, 9 parts of bitter apricot seed and plaster stone Decocting first 30 parts of bupleurum, 9 parts of scutellaria baicalensis, 6 parts of raw rheum officinale and 9 parts of raw liquorice.
4. The traditional Chinese medicine composition according to any one of claims 1-3, wherein the use method of the traditional Chinese medicine composition is as follows: soaking all the medicinal materials in purified water for 0.5-1.5 hours, controlling the water adding amount to be 2-3 cm higher than the surface of the medicinal materials, boiling with strong fire, decocting with slow fire for half an hour, removing residues and taking the juice; the filter residue is processed again by the method, and then 400ml of water decoction obtained by mixing the two times is taken orally, 2 times a day, 200ml each time.
5. The Chinese medicinal composition according to any one of claims 1 to 3, wherein the medicament of the Chinese medicinal composition is a decoction, a tablet, a capsule, a granule, an oral liquid, a mixture or a syrup.
6. Use of the Chinese medicinal composition according to any one of claims 1-3 in the preparation of a medicament for the prevention/treatment of community-acquired pneumonia.
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