Background: Thymosin Ã?±1 (TÃ?±1) as immunomodulatory treatment is supposed to be beneficial for the sepsis\npatients by regulating T cell subsets and inflammatory mediators. However, limited by the small sample size and\nthe poor study design, the persuasive power of the single clinical studies is weak. This meta-analysis aimed to\ninvestigate the impact of TÃ?±1 on the sepsis patients.\nMethods: We searched for the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CBM, VIP, CNKI,\nWANFANG, Igaku Chuo Zasshi (ICHUSHI) and Korean literature databases reporting the effects of TÃ?±1 on outcomes\nin sepsis patients.\nResults: Among 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria. Mortality\nevents were reported in 10 RCTs included 530 patients, and the meta-analysis showed significant decrease in TÃ?±1\ngroup compared with control group (RR 0.59, 95 % CI 0.45 to 0.77, p = 0.0001). The subgroup analysis showed no\ndifference between the two dosages (RR 0.59, 95 % CI 0.43 to 0.81; RR 0.59, 95 % CI 0.35 to 0.98, respectively). In 9\nRCTs, with a total of 489 patients, TÃ?±1 administered once per day decrease APACHE II score significantly (SMD âË?â??0.\n80, 95 % CI âË?â??1.14 to âË?â??0.47, p < 0.0001) while TÃ?±1 twice per day showed no effect (SMD 0.30, 95 % CI-0.10 to 0.70,\np = 0.14). However, the length of ICU stay, the incidence of multiple organ failure (MOF) and duration of mechanical\nventilation were not significantly affected by TÃ?±1 treatment (SMD âË?â??0.52, 95 % CI âË?â??1.06 to 0.11, p = 0.06; SMD âË?â??0.49,\n95 % CI âË?â??1.09 to 0.11, p = 0.11; SMD âË?â??0.37, 95 % CI âË?â??0.90 to 0.17, p = 0.17, respectively). As to the immunological\nindicators, the level of HLA-DR were increased by TÃ?±1 (SMD 1.23, 95 % CI 0.28 to 2.18, p = 0.01) according to the\npooled analysis of 8 studies involving 721 patients. Lymphocyte subsets CD3, CD4 and cytokines IL-6, IL-10 and\nTNF-Ã?± were also beneficially affected by TÃ?±1 treatment.\nConclusions: TÃ?±1 may be beneficial to sepsis patients in reducing mortality and modulating inflammation\nreactions. However, the quality of evidence supporting the effectiveness is low considering the small sample sizes\nand inadequate adherence to standardized reporting guidelines for RCTs among the included studies.
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