Efficacy of thymosin α1 for sepsis: a systematic review and meta-analysis of randomized controlled trials

作者：Bin Gu, Yu Zhou, Yao Nie, Luhao Wang, Liqun Liang, Zihuai Liao, Jingyi Wen, Xiangdong Guan, Minying Chen, Jianfeng Wu, Fei Pei · 发表于：Frontiers in Cellular and Infection Microbiology · 年份：2025 · DOI：10.3389/fcimb.2025.1673959 · 被引用次数：1 · 研究领域：Cellular Mechanics and Interactions、Sepsis Diagnosis and Treatment、Neutrophil, Myeloperoxidase and Oxidative Mechanisms

Background Despite advances in understanding sepsis pathophysiology and extensive research, few treatments effectively target its underlying immune dysfunction. Thymosin α1 (Tα1) shows promise as an immunomodulator, but its impact on sepsis remains unclear. Methods A search strategy was designed to include any prospective clinical studies using Tα1 for assessing 28-day mortality in patients with sepsis, excluding combination therapy studies. We conducted trial sequential analysis (TSA) to assess the robustness of meta-analyses findings. Heterogeneity of treatment effects (HTE) was conducted based on individual data from two multicenter randomized clinical trials (RCTs), with result credibility assessed through the instrument to assess the credibility of effect modification analyses (ICEMAN). Results Out of 3003 identified studies, 11 RCTs met the inclusion criteria (967 patients in Tα1 group and 960 patients in control group). The comprehensive meta-analysis demonstrated a significant reduction in 28-day mortality associated with Tα1 administration (OR 0.73, 95%CI: 0.59-0.90, P = 0.003). Nonetheless, analyses of high-quality (OR 0.82, 95%CI: 0.65-1.03, P = 0.09) and multi-center (OR 0.86, 95%CI: 0.68-1.08, P = 0.20) subgroups did not reveal a mortality benefit. The HTE analysis of multiple subgroups in two large RCTs (representing 75% of the total patients) showed heterogeneity. Potential benefits were noted in subgroups of cancer (moderate credibility), diabetes (low credibi...