Severe Pneumonia
Conditions
Interventions
Treatment Group (Experimental Group):Standardized anti-infective Western medical treatment combined with the formula granules of full-effective components based on the principle of strengthening vital
Control Group (Placebo Group):Standardized anti-infective Western medical treatment combined with placebo granules
Sponsors
The Third Affiliated Hospital of Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: Here is the academic English translation of the provided inclusion criteria: 1. Inclusion Criteria 1.1 Diagnosis of Severe Pneumonia Diagnosis is based on the"Chinese Adult Community-Acquired Pneumonia Diagnosis and Treatment Guidelines (2016 Edition)" from the Chinese Thoracic Society (CTS), the "Chinese Adult Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia Diagnosis and Treatment Guidelines (2018 Edition)," and the "Clinical Practice Guidelines for Emergency Adult Community-Acquired Pneumonia (2024 Edition)" from the Emergency Physicians Branch of the Chinese Medical Doctor Association, the Chinese Emergency Medical Association, and the Beijing Emergency Medicine Society. Severe pneumonia is diagnosed if a patient meets 1 major criterion or =3 minor criteria. · Major Criteria: 1) Invasive mechanical ventilation required. 2) Septic shock requiring vasoactive agents despite adequate fluid resuscitation. · Minor Criteria: 1) Respiratory rate = 30 breaths/min. 2) PaO2/FiO2 ratio = 250 mmHg. 3) Multilobar infiltrates. 4) Confusion and/or disorientation. 5) Blood urea nitrogen (BUN) = 7.14 mmol/L. 6) Systolic blood pressure (ZY/T001.1-94)." · Diagnostic Basis for Wind-Warmth Lung-Heat Disease: 1) Main manifestations: fever, cough, thirst, or accompanied by dyspnea and chest pain. 2) Severe cases may present with high fever, flushed face, irritability, delirium, or cold limbs. 3) Frequently occurs in winter and spring, characterized by acute onset, rapid progression, and short course. 4) Elevated total white blood cell count and neutrophils suggest bacterial infection. 5) Pulmonary consolidation signs or dry/moist rales upon auscultation. 6) Pathogens may be identified through sputum smear or culture. 7) Chest X-ray or radiograph reveals inflammatory shadows in one or both lung lobes or segments. · Referring to the "Diagnostic Criteria for TCM Syndromes of Community-Acquired Pneumonia (2011 Edition)," the diagnostic criteria for Phlegm-Heat Obstructing the Lungs combined with Dual Deficiency of Qi and Yin are as follows: · Primary Symptoms: Cough, copious sputum, yellow sputum, dry and sticky white sputum, chest pain, shortness of breath, fatigue, red tongue with a thin body, yellow tongue coating, and a slippery, thready, and rapid pulse. · Secondary Symptoms: Fever, thirst, difficulty expectorating sputum, flushed face, spontaneous sweating, night sweats, heat sensation in palms and soles, abdominal distension, dark urine, constipation, pale or red tongue, thin or peeling tongue coating, and a rapid pulse. 1.3 Age = 65 years. 1.4 The patient or their legal guardian provides informed consent and signs the informed consent form. Note: Patients must meet all four of the above criteria for inc
Exclusion criteria
Exclusion criteria: 2. Exclusion Criteria (Patients meeting any of the following criteria should be excluded): 2.1 Complicated by severe primary diseases of the heart, liver, kidney, or hematopoietic system; malignant tumors; or other underlying diseases that may affect the survival cycle; psychiatric patients. 2.2 Patients diagnosed with fungal pneumonia, pulmonary tuberculosis, HIV-associated Pneumocystis pneumonia (PCP), or pulmonary embolism. 2.3 Discharge within 2 days of admission or requirement for major surgery. 2.4 Participation in other clinical trials within the past 4 months or current participation in such trials. 2.5 Known allergies or hypersensitivity to the medications used in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day mortality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 14-day all-cause mortality;28-day all-cause mortality;reatment failure rate ;Duration of mechanical ventilation ;Mean ICU length of stay;Acute Physiology and Chronic Health Evaluation II;Sequential Organ Failure Assessment;Clinical Pulmonary Infection Score (CPIS);TCM syndrome score scale Laboratory ;Changes in neutrophil-to-lymphocyte count ratio before and after treatment;Changes in albumin before and after treatment;Changes in hemoglobin before and after treatment;Changes in procalcitonin before and after treatment;Changes in C-reactive protein before and after treatment;Changes in interleukin-6 before and after treatment;Changes in D-dimer before and after treatment;Antibiotic use density (AUD);Total antibiotic dose / total hospital days;Total hospitalization costs; | — |
Countries
CHINA
Contacts
Public Contacthongri xu
: The Third Affiliated Hospital of Beijing University of Chinese Medicine
Outcome results
None listed