2019 年第 7 期 第 14 卷

中药联合化疗治疗晚期乳腺癌随机对照试验的Meta分析

Efficacy of Chinese medicine combined with chemotherapy in treatment of advanced breast cancer: a meta-analysis of randomized controlled trials

作者：吴晓晴李娟卢雯平

英文作者：

单位：100029北京中医药大学研究生院（吴晓晴）；100053北京，中国中医科学院广安门医院肿瘤科（李娟、卢雯平）

英文单位：

关键词：晚期乳腺癌；中药；化疗；Meta分析

英文关键词：

• 摘要：

• 【摘要】目的    系统评价中药联合化疗对晚期乳腺癌的疗效和安全性。方法    在中国知网、万方数据、维普数据库、中国生物医学文献数据库、PubMed、Cochrane Library检索以临床随机对照试验（RCT）为基础的文献，研究对象为Ⅲ～Ⅳ期乳腺癌患者，观察组干预措施为中药联合化疗，对照组干预措施为单纯化疗，化疗方案与观察组相同，检索时间截至2018年12月。提取纳入文献的数据并进行质量评价，使用Stata 12.0软件进行Meta分析，主要结局为实体瘤总有效率，次要结局为中医证候积分变化和消化道不良反应发生率。结果    共纳入25项RCT研究，共计1 553例患者。与化疗组相比，中药联合化疗组总有效率明显提高，相对危险度＝1.27（95%置信区间：1.16～1.39）；中医证候积分改善明显，相对危险度＝1.40（95%置信区间：1.20～1.62）；经过辨证论治的中药联合化疗消化系统不良反应发生率较低，相对危险度＝0.67（95%置信区间：0.55～0.82）（均P<0.01）。结论    中药联合化疗能提高晚期乳腺癌患者实体瘤总有效率，改善中医病理证候，减少消化系统不良反应。

• 【Abstract】Objective    To systematically evaluate the efficacy and safety of traditional Chinese medicine（TCM） combined with chemotherapy in the treatment of advanced breast cancer. Methods    Clinical randomized controlled trials（RCTs） of TCM combined with chemotherapy treating grade Ⅲ-Ⅳ breast cancer published before December 2018 were searched in CNKI, Wanfang, VIP, Chinese BioMedical Literature Database, PubMed and Cochrane Library; the control group was treated with same chemotherapy scheme alone. Valid data were extracted and quality of literatures was evaluated. Stata 12.0 software was used for meta-analysis. Main endpoint was overall response rate; secondary outcomes were TCM syndrome score and digestive adverse reaction. Results    A total of 25 RCTs involving 1 553 patients were included. Meta-analysis showed that compared to chemotherapy-alone, TCM combined with chemotherapy significantly increased the overall response rate, the relative risk＝1.27（95% confidence interval： 1.16-1.39）; TCM syndrome score was significantly improved, the relative risk＝1.40（95% confidence interval： 1.20-1.62）; TCM therapy according to syndrome differentiation combined with chemotherapy could reduce digestive adverse reactions, the relative risk＝0.67（95% confidence interval： 0.55-0.82）（all P<0.01）. Conclusion    TCM combined with chemotherapy treating advanced breast cancer can improve the overall response rate, relieve syndromes and reduce digestive adverse reactions.