[目的]评价化疗联合靶向药物治疗在晚期胆道系统肿瘤(BTC)中的作用.[方法]通过检索MEDLINE、EMBASE等国内外的数据库,搜集晚期BTC的随机对照试验(RCT),其中观察组为采用化疗联合靶向治疗的患者,对照组为单纯化疗.对两组患者的客观缓解率、中位总生存期(OS)、无进展生存期(PFS)和不良反应进行 Meta分析.[结果]纳入 RCT共有 8 项,总计 1052 例患者,其中观察组为 549 例,对照组为 503 例.观察组客观缓解率显著高于对照组(P ＜0.05),但 OS、半年 PFS和 1 年 PFS两组相比较差异无显著性(P ＞0.05).恶心/呕吐和骨髓毒性发生率两组相比较差异无显著性(P ＞0.05).观察组的皮肤毒性和腹泻发生率高于对照组(P ＜0.05),但患者基本能耐受.[结论]基于最新 RCT的 Meta分析显示,化疗联合靶向治疗可提高晚期BTC的客观缓解率,但未取得显著的生存获益.“,”[Objective]To evaluate the role of chemotherapy and targeted drug treatment in advanced bili-ary tract cancer (BTC).[Methods]By searching MEDLINE,EMBASE and other domestic and foreign data-bases,a randomized controlled trial (RCT)for advanced BTC was conducted.The patients in the observation group were treated with chemotherapy combined with targeted drugs,while the patients in the control group received chemotherapy alone.Meta analysis on the objectiv remission rates,median overall survival (OS), progression free survival (PFS),and adverse events was performed in both groups.[Results]A total of 8 RCTs were enrolled,including 1052 patients in total.There were 549 patients in the observation group and 503 patients in the control group.The objective remission rate in the observation group was significantly higher than that in the control group (P＜0.05).However,there were no significant differences in OS,the first half year of PFS and one year PFS between the two groups (P ＞0.05).The incidence of nausea/vomiting and bone marrow toxicity was not significantly different between the two groups (P＞0.05).The incidence of skin toxicity and diarrhea in the observation group was higher than that in the control group (P ＜0.05).[Conclu-sion]Based on the latest RCTs,meta-analysis shows that chemotherapy combined with targeted therapy can improve the objective response rate of late BTC.However,it does not have significant survival benefits.