Efficacy of Thymosin Alpha 1 Combined with Sivelestat and Ambroxol in Elderly Sepsis-Associated ARDS: A Randomized Trial

This single-center randomized controlled trial enrolled 171 elderly patients with sepsis-associated acute respiratory distress syndrome (ARDS) to evaluate whether adding thymosin alpha 1 (Tα1) to a background regimen of sivelestat sodium and ambroxol improved outcomes. Participants were assigned to a control group (sivelestat + ambroxol, n=86) or an experimental group (same regimen plus Tα1, n=85) for 7 days; all patients also received high-flow nasal cannula oxygen therapy. The study found that the experimental group demonstrated a higher overall clinical response rate (85.9% vs. 72.1%, P<0.05), reduced mortality, improved survival, and better respiratory function parameters compared with controls. Safety profiles were reported as favorable in both groups. Limitations include the single-center design, which may reduce generalizability; the relatively short 7-day intervention window; and the fact that the paper is a preprint, meaning it has not yet undergone formal peer review. The combination of co-interventions (sivelestat and ambroxol alongside Tα1) also makes it difficult to isolate the independent contribution of Tα1 to the observed outcomes.

Why this grade: While the study is a randomized controlled trial in humans with a reasonable sample size (n=171), its single-center design, short follow-up, and preprint (non-peer-reviewed) status limit the strength of evidence it provides.