5-氟尿嘧啶或卡培他滨联合奥沙利铂治疗转移性结直肠癌有效性及安全性的Meta分析

A Meta-analysis of capecitalbine or 5-Fu combined with oxaliplatin therapy for metastatic colorectal cancer：

目的比较5-氟尿嘧啶（5-Fu）或卡培他滨联合奥沙利铂治疗转移性结直肠癌的临床疗效和安全性。方法以转移性结直肠癌、奥沙利铂、5-Fu、卡培他滨为检索词，查阅2011年6月前发表的有关5-Fu或卡培他滨联合奥沙利铂治疗转移性结直肠癌的随机对照研究。由2名作者各自独立对入选文献中试验设计、研究对象的特征、研究结果等内容按照预先制订的数据表进行摘录。采用RevMan4．2软件进行统计分析。结果按照筛选标准，共有6篇文献入选，全部研究共计2189例转移性结直肠癌患者。两组患者基本特征均衡可比。临床疗效方面，有效率合并相对危险度（RR）为0．92[95％CI（0．82，1．02），P=0．121，中位无疾病进展生存时间、中位生存时间合并加权均数差（WMD）分别为-0．19[95％CI（-0．73，0．35），P=0．49]，-1．91[95％CI（-2．53，0．16），P：0．08]，综合分析结果两组间均无优劣。Ⅲ～Ⅳ级毒副作用的比较中，中性粒细胞减少的综合分析显示卡培他滨组的发生率显著低于5-Fu组，合并RR为0．24[95％a（0．11，0．55），P=0．0007]，而手足症状发生率高于5-Fu组，合并RR为2．83[95％a（1．66，4．82），19=0．0001]。结论5-Fu或卡培他滨联合奥沙利铂治疗转移性结直肠癌疗效无优劣。在Ⅲ～Ⅳ级毒性方面中性粒细胞减少在5-Fu组更易发生，卡培他滨组主要以手足症状为主。

Objectives To compare clinical outcomes and safety of 5-Fu or capecitabine combined with oxaliplatin therapy for metastatic colorectal cancer. Methods Literature search were performed by key words, such as metastatic colorectal cancer, capecitabine, oxaliplatin, 5-Fu on all randomized controlled trails reported on 5-Fu or capecitabine combined with oxaliplatin therapy for metastatic colorectal cancer before Jun. 2011. Two authors drew the details of trail design, characteristics of patients, outcomes and so on from the studies included. Data analysis was performed by RevMan 4.2. Results According to the same screening criteria, 6 clinical studies were included in this Meta-analysis. Sample volume in this Meta-analysis was 2189 colorectal cancer cases. The baseline characteristics of 5-Fu group were similar to those of capecitabine group. The short-term outcome such as response rate, RR was 0.92 [95 %CI（0.82, 1.02）, P= 0.12], and the long-term outcome such as median overall survival, median progression-free survival and the WMD was =0.19 [95 %CI（-0.73,0.35）, P=0.49], -1.91 [95 %CI（-2.53, 0.16）, P=0.08],respectively, two groups weresimilar. In the comparison of m-Iv grade toxicity between the two groups, the incidences of neutropenic in 5-Fu group were higher than those in capecitabine group, and the RR was 0.24 [95 %CI（0.11, 0.55）, P=0.0007]. However, the incidence of wand-foot symptoms in 5-Fu group was lower than those in capecitabine group, the RR was 2.83 [95%CI （1.66,4.82）, P=0.0001]. Conclusion Both 5-Fu and capecitabine were similarly effective in the therapy of metastatic colorectal cancer. And the m-IV grade toxicity such as neutropenic was easier to happen in 5-Fu group,while the incidence of hand-foot symptoms was on the other hand.