The efficacy of thymosin α1 as immunomodulatory treatment for sepsis: a systematic review of randomized controlled trials

BMC Infectious Diseases

Research Article

Tiansheng Wang¹  Xi Zhu²  Fang Liu³  Ya-Mei Zhang³  Hong-Mei Wang⁴ 

[1] Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmaceutical Sciences, Peking University, 100191, Beijing, China;Department of Critical Care Medicine, Peking University Third Hospital, 49 North Garden Road, Haidian District, 100191, Beijing, China;Department of Pharmacy, Peking University Third Hospital, 100191, Beijing, China;Department of Pharmacy, Peking University Third Hospital, 100191, Beijing, China;Department of Pharmacy, Yanqing Teaching Hospital of Capital Medical University/Yanqing County Hospital, 102100, Beijing, China;

关键词: Thymosin α1;    Sepsis;    Systematic review;    Immunomodulatory;   

DOI  :  10.1186/s12879-016-1823-5

 received in 2015-09-28, accepted in 2016-09-09,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundThymosin α1 (Tα1) as immunomodulatory treatment is supposed to be beneficial for the sepsis patients by regulating T cell subsets and inflammatory mediators. However, limited by the small sample size and the poor study design, the persuasive power of the single clinical studies is weak. This meta-analysis aimed to investigate the impact of Tα1 on the sepsis patients.MethodsWe searched for the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CBM, VIP, CNKI, WANFANG, Igaku Chuo Zasshi (ICHUSHI) and Korean literature databases reporting the effects of Tα1 on outcomes in sepsis patients.ResultsAmong 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria. Mortality events were reported in 10 RCTs included 530 patients, and the meta-analysis showed significant decrease in Tα1 group compared with control group (RR 0.59, 95 % CI 0.45 to 0.77, p = 0.0001). The subgroup analysis showed no difference 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 RCTs, with a total of 489 patients, Tα1 administered once per day decrease APACHE II score significantly (SMD −0.80, 95 % CI −1.14 to −0.47, p < 0.0001) while Tα1 twice per day showed no effect (SMD 0.30, 95 % CI-0.10 to 0.70, p = 0.14). However, the length of ICU stay, the incidence of multiple organ failure (MOF) and duration of mechanical ventilation were not significantly affected by Tα1 treatment (SMD −0.52, 95 % CI −1.06 to 0.11, p = 0.06; SMD −0.49, 95 % CI −1.09 to 0.11, p = 0.11; SMD −0.37, 95 % CI −0.90 to 0.17, p = 0.17, respectively). As to the immunological indicators, the level of HLA-DR were increased by Tα1 (SMD 1.23, 95 % CI 0.28 to 2.18, p = 0.01) according to the pooled analysis of 8 studies involving 721 patients. Lymphocyte subsets CD3, CD4 and cytokines IL-6, IL-10 and TNF-α were also beneficially affected by Tα1 treatment.ConclusionsTα1 may be beneficial to sepsis patients in reducing mortality and modulating inflammation reactions. However, the quality of evidence supporting the effectiveness is low considering the small sample sizes and inadequate adherence to standardized reporting guidelines for RCTs among the included studies.

【 授权许可】

CC BY   
© The Author(s). 2016