目的 基于网状Meta分析方法比较10种口服中成药联合化疗治疗乳腺癌的疗效和安全性。方法 检索CNKI、Wanfang、VIP、SinoMed、PubMed、EMbase、Web of Science、Cochrane Library数据库中相关口服中成药治疗乳腺癌的随机对照试验（randomized controlled trial，RCTs），检索时间为建库至2021年1月1日。2人独立对文献进行筛选、提取数据和质量评价。采用RevMan5.3、Stata14.0、Gemtc14.3软件进行数据分析。结果 共纳入61项RCTs，涉及10种口服中成药。网状Meta分析结果显示，以化疗为共同干预措施，口服中成药改善乳腺癌I～III期患者客观缓解率（objective response rate，ORR）的疗效排序为参一胶囊>金龙胶囊>西黄丸/胶囊>平消胶囊>复方斑蝥胶囊>华蟾素胶囊>槐耳颗粒>小金片/丸；改善I～III期患者疾病控制率（disease control rate，DCR）的疗效排序为金龙胶囊>西黄丸/胶囊>华蟾素胶囊>平消胶囊>复方斑蝥胶囊>槐耳颗粒>小金片/丸；改善Ⅲ～Ⅳ期患者ORR的疗效排序为槐耳颗粒>西黄丸/胶囊>参一胶囊>华蟾素胶囊>平消胶囊>小金片/丸；改善III～IV期患者DCR的疗效排序为平消胶囊>参一胶囊>西黄丸/胶囊>华蟾素胶囊>槐耳颗粒>小金片/丸；生活质量（quality of life，QOL）改善率的疗效排序为西黄丸/胶囊>槐耳颗粒>参一胶囊>华蟾素胶囊>金龙胶囊>复方斑蝥胶囊>平消胶囊；西黄丸有益于提高乳腺癌患者的疾病无进展生存期（progression free survival，PFS）和患者总生存期（overall survival，OS），平消胶囊有益于提高OS；缓解白细胞减少发生率的疗效排序为参一胶囊>槐耳颗粒>华蟾素胶囊>西黄丸/胶囊>贞芪扶正颗粒>平消胶囊>复方斑蝥胶囊>小金片/丸；减少消化道反应发生率的疗效排序为贞芪扶正颗粒>西黄丸/胶囊>槐耳颗粒和参一胶囊>平消胶囊>华蟾素胶囊>小金片/丸>复方斑蝥胶囊。结论 对于I～III期患者，参一胶囊联合化疗改善ORR的效果显著，金龙胶囊联合化疗改善DCR效果最明显；对于III～IV期患者，槐耳颗粒联合化疗改善ORR效果最明显，平消胶囊和参一胶囊联合化疗改善DCR方面有较好效果。西黄丸在改善患者生活质量方面更明显，参一胶囊有助于降低乳腺癌患者白细胞减少的发生率。贞芪扶正颗粒在降低乳腺癌患者消化道反应发生率方面更有优势。

Objective To compare the efficacy and safety of 10 kinds of oral Chinese patent medicine combined with chemotherapy in the treatment of breast cancer, a network Meta-analysis was performed. Methods CNKI, Wanfang, VIP, SinoMed, PubMed, Embase, Web of Science and Cochrane Library database were searched from inception to January 1, 2021. The inclusion criteria were the randomized controlled trials (RCTs) of Chinese patent medicine plus chemotherapy for breast cancer. Literature screening, data extraction, the quality assessment was independently conducted by two authors. RevMan5.3, Stata14.0 and Gemtc14.3 were used for data analysis. Results A total of 61 RCTs were eventually included, involving 10 oral Chinese patent medicines. The results of network Meta-analysis showed that, combined with chemotherapy, in terms of improving ORR (I-III stage), the order of efficacy was Shenyi Capsule (参一胶囊) > Jinlong Capsule (金龙胶囊) > Xihuang Pill/Capsule (西黄丸/胶囊) > Pingxiao Capsule (平消胶囊) > Compound Cantharis Capsule (复方斑蝥胶囊) > Cinobufagin Capsule (华蟾素胶囊) > Huaier Granule (槐耳颗粒) > Xiaojin Tablet/Pill (小金片/丸); In terms of improving DCR (I-III stage), the order of efficacy was Jinlong Capsule > Xihuang Pill/Capsule > Cinobufagin Capsule > Pingxiao Capsule > Compound Cantharis Capsule > Huaier Granule > Xiaojin Tablet/Pill; In terms of improving ORR (III-IV stage), the order of efficacy was Huaier Granule > Xihuang Pill/Capsule > Shenyi Capsule > Cinobufagin Capsule > Pingxiao Capsule > Xiaojin Tablet/Pill; In terms of improving DCR (III-IV stage), the order of efficacy was Pingxiao Capsule > Shenyi Capsule > Xihuang Pill/Capsule > Cinobufagin Capsule > Huaier Granule > Xiaojin Tablet/Pill; In terms of improving QOL, the order of efficacy was Xihuang Pill/Capsule > Huaier Granule > Shenyi Capsule > Cinobufagin Capsule > Jinlong Capsule > Compound Cantharis Capsule; Xihuang Pill/Capsule was beneficial in improving PFS and OS of breast cancer patients, Pingxiao Capsule was beneficial in improving OS of breast cancer patients; In terms of reducing the incidence rate of leukocyte decline, the order of efficacy was Shenyi Capsule > Huaier Granule > Cinobufagin Capsule > Xihuang Pill/Capsule > Zhenqifuzheng Granule (贞芪扶正颗粒) > Pingxiao Capsule > Compound Cantharis Capsule > Xiaojin Tablet/Pill; In terms of alleviating the incidence of gastrointestinal reactions, the order of efficacy was Zhenqifuzheng Granule > Xihuang Pill/Capsule > Huaier Granule and Shenyi Capsule > Pingxiao Capsule > Cinobufagin Capsule > Xiaojin Tablet/Pill > Compound Cantharis Capsule. Conclusions Shenyi Capsule increased ORR more significantly than other Chinese patent medicines and Jinlong Capsule increased DCR more significantly than other Chinese patent medicines for I-III stage breast cancer. Huaier Granule increased ORR more significantly than other Chinese patent medicines and, Pingxiao Capsule and Shenyi Capsule increased DCR more significantly than other Chinese patent medicines for III-IV stage breast cancer patients. Xihuang Pill/Capsule can improve the QOL of patients with breast cancer more significantly than other Chinese patent medicines and. Shenyi Capsule can alleviate the incidence of leukocyte decline. Zhenqi Fuzheng Granule can alleviate the incidence of gastrointestinal reactions.

R285.64

国家自然科学基金面上项目（817743191001982）