Xinjia Dayuan San for MDR-GN pneumonia: A randomized controlled trial
Abstract
BACKGROUND
Multidrug-resistant Gram-negative (MDR-GN) pneumonia presents an urgent global health challenge, characterized by limited therapeutic options and high mortality rates. Traditional Chinese medicine (TCM) offers a rich source of multi-component interventions with potential multi-target effects, demanding rigorous evaluation as an alternative or adjunctive strategy.
METHODS
This multicenter, randomized, double-blind, head-to-head, placebo-controlled clinical trial was conducted by 4 hospitals in China (June 2022 - March 2025), evaluated Xinjia Dayuan San (XJDS), a standardized TCM formulation, against standard broad-spectrum antibiotics (imipenem/cilastatin [I/C] or cefoperazone/sulbactam [C/S]) in 224 adult patients with confirmed MDR-GN pneumonia. Patients were randomized (1:1) within antibiotic strata to receive either XJDS granules (3 g BID) plus intravenous antibiotic placebo (normal saline) or XJDS placebo plus active antibiotic for 7 days. Primary endpoints were 28-day all-cause mortality and 7-day reduction in sputum bacterial load score (Day 0 minus Day 7, 0-3 scale). Key secondary endpoints included changes in Clinical Pulmonary Infection Score (CPIS) and inflammatory markers. Safety was assessed throughout.
FINDINGS
In this trial of 224 critically ill patients, XJDS did not meet the primary endpoint of non-inferiority for 28-day all-cause mortality compared to standard antibiotics. However, XJDS demonstrated superiority in key secondary endpoints…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 224 participants or records.
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