目的：评价西妥昔单抗联合化疗治疗晚期结直肠癌的临床疗效和不良反应。方法：在PubMed、EMBASE、CENTRAL（Cochrane central register of controlled trials）、中国生物医学文献数据库（Chinese biomedical abstract database，CBM）和中国期刊全文数据库（China national knowledge infrastructure database，CNKI）中检索从建库以来至2011年12月关于西妥昔单抗联合化疗治疗晚期结直肠癌的随机对照试验，然后对这些文献进行筛选和质量评价，并对符合标准的文献进行meta分析。结果：纳入5项研究，共3 479例晚期结直肠癌患者。西妥昔单抗联合化疗组（联合组）和化疗组的合并缓解率分别为28.85%和18.63%，合并后的相对危险度（relative risk，RR）（95%可信区间）为2.18 （1.24~3.85, P=0.007）。联合组和化疗组3~4级乏力发生率分别为10.91%和7.37%，合并RR值（95%可信区间）为1.46（1.19~1.79，P<0.01）；3~4级腹泻发生率分别为20.41%和12.53%，合并RR值（95%可信区间）为1.62（1.37~1.92，P<0.01）。结论：西妥昔单抗联合化疗可以明显提高晚期结直肠癌患者的缓解率，但也增加了3~4级乏力和腹泻的发生率。

Objective:To evaluate the clinical outcome and adverse reaction induced by cetuximab combined with chemotherapy in the treatment of advanced colorectal cancer. Methods: In PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), Chinese Biomedical Abstract Database (CBM) and China National Knowledge Infrastructure Database (CNKI), we searched randomized controlled trials of cetuximab combined with chemotherapy in the treatment of advanced colorectal cancer up to December 2011 and then decided whether the trials met the selection standard and evaluate the quality of these trails. A meta-analysis was performed on the recruited trails. Results: Five reports, including 3 479 advanced colorectal cancer patients, were selected based on our standard. The pooled relative risks (RRs) for overall response rate in all studies were 28.85% in the cetuximab combined with the chemotherapy treatment group and 18.63% in the control chemotherapy group, and the pooled RR \[95% confidence interval (CI)\] was 2.18 (1.24-3.85, P<0.001). The incidence rate of grade 3-4 fatigue was 10.91% in the combined treatment group and 737% in the control group, and the pooled RR (95%CI) was 1.46 (1.19-1.79, P<0.001). The incidence rate of grade 3-4 diarrhea was 20.41% in the combined treatment group and 12.53% in the control group, and the pooled RR (95%CI) was 1.62 (1.37-1.92, P<0.001). Conclusion:Cetuximab combined with chemotherapy obviously elevates the response rate of advanced colorectal cancer patients. However, it also increases the incidence rate of grade 3-4 fatigue and diarrhea.

国家自然科学基金资助项目(No. 30771838)