中药注射剂联合 CF 化疗方案治疗乳腺癌有效性及安全性的网状 Meta 分析和试验序贯分析

摘要

Objective To assess the efficacy and safety of traditional Chinese medicine injection(TCMI)combined with CF chemotherapy(TCMI + CF)for breast cancer. Methods In October 2014,a computer - based retrieval was performed including CNKI,CBM,Wangfang Data knowledge Service Platform,VIP database,ISI Web of Knowledge,EMBase,PubMed and Cochrane Library,to include RCTs that comparing TCMI + CF and pure CF chemotherapy for breast cancer. Two evaluators conducted data extraction and quality evaluation separately. Stata 12. 0,WinBUGS 1. 4 and TSA were used to conduct network Meta analysis and trial sequential analysis. Results We included 26 RCTs involving 1 884 patients and 6 kinds of TCMI(Fufang Kushen injection,Kang'ai injection,Kanglaite injection,Aidi injection,Huachansu injection,Shenqifuzheng injection). The results of network Meta - analysis showed that Fufang Kushen and Kanglaite combined with CF chemotherapy were better than other injections in the improvement of overall effectiveness index and quality of life. However,Shenqifuzheng and Aidi combined with CF chemotherapy were better in reducing nausea and vomiting( grade Ⅲ - Ⅳ)and decrease in white blood cell count (grade Ⅲ - Ⅳ). Conclusion At present,there is still no strong evident that TCMI + CF is the best therapy in effective rate, improving quality of life,reducing nausea and vomiting,and inhibiting decrease in white blood cell count. Therefore,rational choice of drug should be made for patients in clinical practice.%目的：探讨中药注射剂联合 CF 化疗方案治疗乳腺癌的有效性和安全性。方法2014年10月，计算机检索中国知网（CNKI）、中国生物医学文献数据库（CBM）、万方数据知识服务平台、维普网、ISI Web of Knowledge、EMBase、PubMed 和 Cochrane Library，纳入中药注射剂联合 CF 化疗方案对比 CF 化疗方案治疗乳腺癌的随机对照试验（RCTs），由2名评价员独立提取数据和质量评价，采用 Stata 12.0、WinBUGS 1.4统计学软件和试验序贯分析统计学软件分别执行网状 Meta 分析和试验序贯分析。结果最终纳入26篇 RCTs，包含1884例患者，共涉及6种中药注射剂（复方苦参注射液、康艾注射液、康莱特注射液、艾迪注射液、华蟾素注射液、参芪扶正注射液）。网状 Meta 分析结果和概率排序结果显示复方苦参、康莱特联合 CF 化疗方案在提高有效性指标和改善患者生活质量方面优于其他方案，然而，在降低恶心呕吐（Ⅲ~Ⅳ级）和白细胞计数减少（Ⅲ~Ⅳ级）发生率方面参芪扶正、艾迪联合 CF 化疗方案效果更好。结论目前尚无有力证据显示在提高乳腺癌治疗有效性指标、生活质量，降低患者恶心呕吐和白细胞计数减少等方面的最佳中药注射剂联合 CF 化疗方案，临床实践中应当根据患者的病情合理选择用药。