viral pneumonia
Conditions
Interventions
experimental group:Clinical routine treatment+Fuzheng Jiedu Fang 20g/time, 2 times/day
control group:Clinical routine treatment+Fuzheng Jiedu Fang simulation agent 20g/time, 2 times/day
Sponsors
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Those who meet the diagnostic criteria of pneumonia according to the Guidelines for the Diagnosis and Treatment of Community Acquired Pneumonia in China (2016 Edition) issued by the Respiratory Branch of the Chinese Medical Association; (2) According to the Chinese medicine industry standards of the People's Republic of China, the Standards for the Diagnosis and Treatment of Diseases and Signs in Internal Medicine of Traditional Chinese Medicine (ZY/T001.1-94), the Guidelines for the Diagnosis and Treatment of Community acquired Pneumonia in Traditional Chinese Medicine (2018 Revision), and the Diagnosis and Treatment Plan for influenza (2020) are in line with the syndrome differentiation standards of wind warm lung fever, heat toxin Yongfei syndrome in traditional Chinese medicine; (3) Community onset, chest imaging examination showing new patchy infiltrative shadows, consolidation shadows, ground glass shadows, or interstitial changes, with or without pleural effusion; (4) Peripheral blood white blood cells are generally normal or low (37.3 ?); Recent coughing, expectoration, or worsening symptoms of existing respiratory diseases, with or without pus/chest pain/difficulty breathing/hemoptysis; Signs of lung consolidation and/or moist rales; (6) PSI scores ranging from II to IV; (7) The pathogen test confirmed that the patient was infected with virus (including influenza virus, parainfluenza virus, Rhinovirus, adenovirus, novel coronavirus, human metapneumovirus, respiratory syncytial virus, etc., and any of them was positive in the pathogen test); (8) Age 18-80 years old, regardless of gender; (9) The subjects voluntarily joined this study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients diagnosed with acute exacerbation of chronic bronchitis, bronchiectasis, pulmonary tuberculosis, severe interstitial lung disease, and other respiratory diseases; Patients diagnosed with bronchial asthma and requiring hormone therapy; (2) Traditional Chinese patent medicines and simple preparations or traditional Chinese medicine prescriptions whose main functions are clearing away heat, eliminating plague, detoxifying, relieving superficiality, anti-virus, strengthening the body and eliminating pathogenic factors have been clearly marked in the instructions used within 24 hours before screening; (3) According to the diagnostic criteria for severe pneumonia in the "Guidelines for the Diagnosis and Treatment of Chinese Adult Community Acquired Pneumonia (2016 Edition)", those who meet one of the following main criteria or = three secondary criteria: a. Main criteria: ? Mechanical ventilation treatment requires tracheal intubation; ? Septic shock still requires vasoactive drug treatment after active fluid resuscitation. b. Secondary criteria: ? respiratory rate = 30 times/min; ? Oxygenation index = 250mmHg (1mmHg=0133kPa); ? Multiple lobar infiltration; ? Consciousness disorders and/or orientation disorders; ? Blood urea nitrogen = 7.14 mmol/L; ? Systolic blood pressure2 times the upper limit of normal value, or total bilirubin>2 times the upper limit of normal value; AST or ALT>2 times the upper limit of normal value and total bilirubin>1.5 times the upper limit of normal value; History of liver cirrhosis; Late clinical manifestations of liver disease, such as ascites or hepatic encephalopathy; Neutropenia (neutrophils<0.5 × 10^9/L); Thrombocytopenia (platelet<50 × 10^9/L); Hemophilia and other coagulation disorders; NYHA cardiac function grading = Level III; Chronic kidney disease = stage 3; (6) Individuals who are known to be allergic to the c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall remission rate of major clinical symptoms (including fever, cough, expectoration, muscle soreness, and difficulty breathing) on the day of discontinuation of medication;Overall relief time for major clinical symptoms (including fever, cough, expectoration, muscle soreness, and difficulty breathing); | — |
Secondary
| Measure | Time frame |
|---|---|
| The time for fever patients' body temperature to return to normal;The temperature normalization rate of fever patients after 3, 5, 7 days of medication and the day of discontinuation of medication;Overall disappearance rate of main clinical symptoms;Overall disappearance time of main clinical symptoms;Clinical symptom relief rate after 3, 5, and 7 days of medication use;The disappearance rate and time of individual clinical symptoms after 3, 5, 7 days of medication and on the day of discontinuation of medication;Changes in all clinical symptom scores after 3 days, 5 days, 7 days of medication, and on the day of discontinuation of medication;Improvement of Traditional Chinese Medicine Syndrome Scale scores after medication for 3 days, 5 days, 7 days, and on the day of cessation of medication;Area under symptom time curve (AUC) for all clinical symptoms and individual clinical symptom scores compared to baseline;Changes in chest imaging after discontinuation of medication;Compared to baseline, changes in inflammatory cytokines after 3 days of medication and on the day of discontinuation of medication;Changes in lymphocyte subpopulations compared to baseline after 3 days of medication and on the day of discontinuation of medication;hospital stay;Viral nucleic acid conversion rate;Secondary bacterial infection rate;Concomitant medication situation; Severe conversion rate; | — |
Countries
China
Contacts
Public ContactFeng Jihong
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed