复方苦参注射液辅助治疗乳腺癌的Meta分析

目的:系统评价复方苦参注射液辅助治疗乳腺癌的疗效及安全性。方法:计算机检索Medline、Cochrane图书馆、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、中文科技期刊全文数据库(VIP)、万方数字化期刊全文数据库(Wan-fang),纳入在常规化疗基础上加用复方苦参注射液辅助治疗乳腺癌的随机对照试验(RCT),对纳入研究进行方法学偏倚风险评价,对同质性结果数据进行合并分析。结果:共纳入8项RCT,合计622例患者。Meta分析结果显示,2组有效率比较差异无统计学意义RR=1.18,95%CI(0.93,1.51),P=0.17];2组患者生存质量改善率比较,差异有统计学意义RR=1.78,95%CI(1.04,3.03),P=0.03];2组毒副作用发生率比较,差异无统计学意义。结论:在常规化疗基础上加用复方苦参注射液辅助治疗乳腺癌患者,虽未明显提高有效率,但可明显改善患者的生存质量,且安全性较好,期待后续高质量研究进一步探索。

Meta-analysis of Compound Sophora flavescens Injection as Adjunctive Treatment for Breast Cancer

OBJECTIVE： To evaluate the effectiveness and safety of Compound Sophoraflavescens injection as adjunctive treatment for breast cancer. METHODS： Databases of Medline, the Cochrane Library, CNKI, CBM, VIP and Wanfang were searched, and randomized controlled trials （RCT） of Compound S. flavescens injection as adjunctive treatment for breast cancer were included. Bias risks of included RCT were evaluated and homogeneity studies were Meta-analyzed. RESULTS： 8 studies involving 622 patients were gathered, Meta-analysis results indicated that the difference of effective rate was not significant RR= 1.18, 95%CI（0.93, 1.51）, P=0.17]; however, the quality of life improvement rate was significant different RR=1.78, 95%CI （1.04, 3.03）, P=0.03]. The difference in the incidence of toxic side effect had no statistical significance. CONCLUSIONS： Based on recent evidence, Compound S. flavescens injection as adjunctive treatment for breast cancer could not increase effective rate, but improve quality of life. Further high quality studies are expected.