胸腺五肽辅助治疗慢性阻塞性肺疾病临床有效性及安全性的Meta分析

目的：采用Meta分析方法对胸腺五肽辅助治疗慢性阻塞性肺疾病（COPD）的临床疗效及安全性进行评价，为临床应用及辅助用药管理提供循证参考。方法：计算机检索PubMed、Embase、Cochrane Library、中国期刊全文数据库（CNKI）、万方数据库、维普数据库（VIP）、中国生物医学文献数据库（各数据库检索时间均从建库至2016年1月），收集胸腺五肽辅助治疗COPD的随机对照试验。由2名研究者按照纳入与排除标准独立筛选试验、提取资料、评价方法学质量，采用RevMan 5.3软件进行统计分析。结果：共纳入16 项研究，对研究进行合并分析，结果显示，胸腺五肽辅助治疗COPD，有效性高于常规治疗组RR=1.18， 95%CI（1.05， 1.32），P=0.004]，可使患者FEV₁得到显著改善SMD=0.64， 95%CI（0.20，1.09），P=0.005]，使患者外周血CD4⁺水平WMD=6.25，95%CI（3.02，9.48），P=0.000 1]及CD8⁺水平显著降低WMD=-4.60，95%CI（-7.26，-1.94），P=0.000 7]，CD4⁺/CD8⁺水平显著升高WMD=0.42，95%CI（0.24，0.59），P<0.000 01]。结论：基于现有临床证据，胸腺五肽辅助治疗COPD具有一定临床疗效，但由于纳入研究证据强度较低，存在一定的偏倚风险，本研究结论尚需设计严格的临床对照试验进一步验证。

Efficacy and safety of thymopentin as adjuvant therapy in the treatment of COPD:a Meta-analysis

OBJECTIVE To evaluate the efficacy and safety of thymopentin as adjuvant therapy in the treatment of COPD by Meta-analysis, to provide an evidence-based reference for clinical treatment and adjuvant drug management.METHODS The Cochrane Library, PubMed, Embase, CNKI, Wan-Fang data, VIP, CBM (from the inception to January 2016) were searched for the randomized controlled trials (RCTs) of thymopentin as adjuvant therapy in the treatment of patients with COPD. Two reviewers independently retrieved the RCTs according to the inclusion and exclusion criteria, assessed the methodological quality of the included trials, and performed statistical analysis on the data using RevMan 5.3 software.RESULTS A total of 16 studies were included. The results of the combined analysis showed that thymopentin as adjuvant therapy in the treatment of COPD could significantly improve the efficacyRR=1.18, 95%CI (1.05, 1.32), P=0.004] and the level of FEV₁SMD=0.64, 95%CI (0.20, 1.09), P=0.005], increase the level of CD4⁺WMD=6.25,95%CI (3.02,9.48),P=0.000 1], CD4⁺/CD8⁺WMD=0.42, 95%CI (0.24,0.59),P<0.000 01] and reduce the level of CD8⁺WMD=-4.60,95%CI (-7.26,-1.94),P=0.000 7] in the serum of patients.CONCLUSION The current available results show that Thymopentin as adjuvant therapy in the treatment of COPD has some clinical effects. However, the strength of evidence is low due to high risk of bias of the included studies. More rigorous studies are needed to verify the above conclusion.