复方皂矾丸或联合西药治疗血液病疗效和安全性的Meta分析

Meta-analysis of the efficacy and safety of compound Zaofan Pills alone or combined with Western medicine in the treatment of blood diseases

目的系统评价复方皂矾丸或联合西药治疗血液病的疗效和安全性。方法计算机检索国内外常用七大权威数据库,收集从建库至2018年1月间复方皂矾丸或联合西药治疗血液病的随机对照临床试验相关文献,对其进行数据提取和质量评价,采用Review Manager 5. 3软件进行Meta分析。结果最终纳入15篇合格文献,再生障碍性贫血11篇,骨髓增生异常综合征3篇,免疫性血小板减少症1篇。Meta分析结果显示:(1)总体疗效评价显示复方皂矾丸或联合西药明显优于单纯西药(P <0. 000 01)。(2)复方皂矾丸或联合西药治疗再生障碍性贫血疗效优于单纯西药(P <0. 000 01)。(3)复方皂矾丸或联合西药治疗骨髓增生异常综合征疗效优于单纯西药(P=0. 002)。(4)有6篇文献报道了治疗相关不良反应,主要为轻度消化道反应和轻度肝功能损害,但均发生在联合用药组,故不能确定为复方皂矾丸导致。结论复方皂矾丸或联合西药治疗再生障碍性贫血、骨髓增生异常综合征疗效优于单纯西药治疗,具有良好的安全性。

Objective To evaluate the efficacy and safety of compound Zaofan pills alone or combined with Western medicine in the treatment of blood diseases. Methods The researchers retrieved the seven authoritative databases commonly used,and searched published randomized controlled clinical trials on compound Zaofan pills alone or combined with Western medicine in the treatment of blood diseases from the establishment of the library to January 2018,and carried out data extraction and quality evaluation,and then the Review Manager 5. 3 software was used for Meta analysis. Results Finally,15 qualified clinical studies were included,among which 11 were aplastic anemia,3 were myelodysplasia syndromes,and 1 was immune thrombocytopenia. Meta-analysis showed that：（1） The overall efficacy evaluation showed that the compound Zaofan pills alone or combined with Western medicine was superior to Western medicine alone（ P〈0. 000 01）.（2） The efficacy of compound Zaofan pills alone or combined with Western medicine in the treatment of aplastic anemia was better than that of Western medicine alone（ P〈0. 000 01）.（3）The efficacy of compound Zaofan pills alone or combined with Western medicine in the treatment of myelodysplastic syndrome was better than that of Western medicine alone（ P = 0. 002）.（4）Six studies reported treatment-related adverse reactions,mainly mild gastrointestinal reaction and mild liver function damage,but all of them occurred in the combined treatment group,so it could not be determined as the result of compound Zaofan pills. Conclusion Compound Zaofan pills alone or combined with Western medicine seems to be more effective than Western medicine alone in the treatment of aplastic anemia and myelodysplastic syndrome with safety.