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

Thymosin alpha 1 combined with sivelestat sodium and ambroxol showed a higher response rate and lower mortality in elderly patients with sepsis-associated ARDS, but further studies are needed to confirm these findings.

Summary and findings

This study assessed the efficacy and safety of thymosin alpha 1 (Tα1) combined with sivelestat sodium and ambroxol in 171 elderly patients with sepsis-associated ARDS over 7 days. The experimental group showed a higher overall response rate and lower mortality compared to the control group. No adverse event rate differences were reported between groups.

Abstract

<title>Abstract</title> <p><bold>Objective:</bold> To assess the efficacy and safety of thymosin alpha 1 (Tα1) combined with sivelestat sodium and ambroxol in elderly patients with sepsis-associated acute respiratory distress syndrome (ARDS). <bold>Methods:</bold> In this single-center randomized trial, 171 elderly patients with sepsis-associated ARDS were assigned to a control group (sivelestat sodium + ambroxol, n=86) or an experimental group (same regimen + Tα1, n=85) for 7 days, both receiving high-flow nasal cannula oxygen therapy. Primary outcomes included clinical response, mortality, survival, respiratory function, and safety. <bold>Results:</bold> The experimental group showed a higher overall response rate than the control group (85.9% vs. 72.1%, P<0.05), lower 28-day mortality (17.6% vs. 27.9%, P<0.05), and higher 90-day survival (77.6% vs. 62.8%, P<0.05). Respiratory function improved significantly, with no difference in adverse event rates between groups. <bold>Conclusions:</bold> Tα1 combined with sivelestat sodium and ambroxol enhances clinical outcomes and respiratory function, reduces mortality, and demonstrates a favorable safety profile in elderly sepsis-associated ARDS patients.</p>

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