Severe Pneumonia
Conditions
Interventions
Intervention group: Xiyanping injection + standard care:Xiyanping injection combined with standard care (including antibiotics, antivirals, respiratory support, and corticosteroids if indicated)
Control group: Standard care alone:Standard care alone (including antibiotics, antivirals, respiratory support, and corticosteroids if indicated)
Sponsors
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for severe pneumonia, referring to the Management Guidelines for Severe Community-Acquired Pneumonia (sCAP) in Adults jointly issued by the European Respiratory Society (ERS), the European Society of Intensive Care Medicine (ESICM), the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), and the Latin American Thoracic Association (ALAT), as well as the Consensus Guidelines for the Management of Community-Acquired Pneumonia in Adults jointly published by the Infectious Diseases Society of America and the American Thoracic Society: 1) ICD-10 diagnosis of pneumonia, including viral pneumonia (J12.), bacterial pneumonia (J13.–J15., excluding J15.700), Mycoplasma pneumoniae pneumonia (J15.700), chlamydial pneumonia (J16.), and pathological/clinical classification pneumonia (J18.*); 2) Meeting 1 major criterion OR =3 minor criteria for severe pneumonia diagnosis; Major criteria: a. Requirement for endotracheal intubation and mechanical ventilation; b. Septic shock requiring vasopressors after adequate fluid resuscitation. Minor criteria: a. Respiratory rate =30 breaths/minute; b. Oxygenation index (PaO2/FiO2) =250 mmHg; c. Multilobar infiltrates; d. Altered mental status and/or disorientation; e. Blood urea nitrogen =20 mg/dL; f. Leukopenia (WBC <4.0×10^9/L); g. Thrombocytopenia (PLT <100×10^9/L); h. Core temperature <36°C; i. Hypotension requiring aggressive fluid resuscitation. 2.Age =18 years. 3.Complete medical records (including baseline data, treatment regimen, efficacy indicators, and safety indicators). 4.Patient treatment period falls within the coverage timeframe of the National Health Big Data (Eastern) Center (January 2020 – December 2023).
Exclusion criteria
Exclusion criteria: 1.Non-infectious pulmonary diseases (including: pulmonary fibrosis, active pulmonary tuberculosis, interstitial pneumonia, pulmonary tumor), or complicated with other severe diseases (including: severe arrhythmia, decompensated liver cirrhosis, nephrotic syndrome, primary immunodeficiency disease, AIDS). 2.Concurrent use of other traditional Chinese medicine injections with anti-inflammatory or antiviral effects (such as Tanreqing, Reduning, etc.) that may interfere with efficacy evaluation. 3.Severely incomplete medical records, rendering the evaluation of primary outcome indicators impossible. Pediatric patients aged <18 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day all-cause mortality;In-hospital mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospital stay;ICU length of stay;Duration of mechanical ventilation;White blood cell count;C-reactive protein;Procalcitonin;Arterial partial pressure of oxygen;Arterial blood pH;Arterial partial pressure of carbon dioxide;Serum albumin; | — |
Countries
China
Contacts
Public ContactZhifei Wang
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Outcome results
None listed