胸腺肽α1治疗恶性肿瘤的疗效和不良反应的Meta分析

Meta-analysis on the effect and adverse reaction of thymosin alpha-1 in the treatment of malignant tumor

目的：评价胸腺肽α1（Tα1）用于恶性肿瘤治疗的临床疗效和不良反应发生率。方法：检索Medline、中国医院知识仓库和中国生物医学文献数据库，收集有关胸腺肽α1用于恶性肿瘤治疗的临床对照研究，根据纳入和剔除标准汇集入文献，对肿瘤缓解率和不良反应发生率进行Meta分析。研究中对异质性检验采用X^2检验，具同质性者采用固定效应模型合并分析，不具同质性者采用随机效应模型合并分析并进行亚组分析。结果：疗效评价共纳入6个临床对照研究，缓解率胸腺肽α1组（70．63％）高于对照组（52．99％），优势比（OR）=1．28（95％可信区间为1．06～1．55）（P〈0．05），有显著性差异；安全性评价共纳入4个研究，胃肠道不良反应和乏力发生率胸腺肽α1组低于对照组（P〈0．05），有显著性差异，其他不良反应的发生率无显著性差异。结论：胸腺肽α1可能有提高抗肿瘤治疗疗效、减低不良反应的作用。由于相关文献少，尤其缺乏高质量临床随机对照研究，故胸腺肽α1用于恶性肿瘤治疗的有效性和安全性尚需更多高质量临床随机对照试验予以证实.

Objective ：To evaluate the effect and adverse reaction of thymosin α1 （Tα1） in the treatment of malignant tumor. Methods：MEDLINE, Chinese hospital knowledge database （CHKD）, Chinese Bi- omedical Database （CBM） were searched by key words, and the obtained references were screened for clinical controlled trials （CCT） on the introduction of Tα1 in therapy of malignant tumor. The CCT results of efficacy and safety were pooled and analyzed with a fixed or random effects model after Chi-Square testing for heterogeneity. Results：Six CCTs were included for efficacy analysis. It was found that the efficacy rate in Tα1 group （70.63%） was significantly higher than that in control group （52.99%）, and the value of odds ratio was 1.28 with the 95% confidence interval from 1.06 to 1.55 （P 〈0.05）. Four CCTs were included for safety analysis, it was found that the rates of gastrointestinal upset and hypodynamia in Tα1 group were significantly lower than those in control group （ P 〈 0.05 ）. Conclusion ：Tctl might be beneficial in treatment of malignant tumor, but its efficacy and safety need to be confirmed with high-quality randomized controlled trials.