目的：系统评价不同时序放化疗治疗直肠癌的有效性及安全性，为临床实践与研究提供参考。方法计算机检索 Cochrane Library、PubMed、EMBase、Web of Science 以及中国生物医学文献数据库（ CBM）、中国知网（CNKI）、维普期刊数据库（VIP）和万方期刊数据库（Wanfang）相关文献，进一步进行文献筛选，并提取文献主要信息，包括试验分组、患者性别、年龄、KPS 评分、临床分期及结局指标。比较同步放化疗（同步组）和序贯放化疗（序贯组）治疗直肠癌患者总生存率、无进展生存率、总有效率、完全缓解率和毒副作用发生率的差异。结果共纳入12篇文献，1191例患者。Meta 分析结果显示，同步组和序贯组1年总生存率比较，差异无统计学意义〔 OR ＝1.47，95％ CI（0.96，2.26），P ﹥0.05〕。同步组2年总生存率〔OR ＝2.04，95％ CI（1.26，3.30），P ﹤0.05〕、3年总生存率〔OR ＝2.04，95％ CI（1.50，2.78），P ﹤0.05〕高于序贯组，差异有统计学意义。两组5年总生存率比较，差异无统计学意义〔OR ＝1.30，95％ CI（0.73，2.33），P ﹥0.05〕。同步组1年无进展生存率〔 OR ＝2.68，95％ CI （1.76，4.07），P ﹤0.001〕、2年无进展生存率〔OR ＝2.66，95％ CI（1.19，5.95），P ＝0.02〕、3年无进展生存率〔OR ＝1.70，95％ CI（1.18，2.45），P ＝0.004〕及总有效率〔OR ＝2.49，95％ CI（1.25，4.97），P ＝0.01〕高于序贯组，差异有统计学意义；两组完全缓解率比较，差异无统计学意义（P ﹥0.05）。同步组腹泻发生率高于序贯组，差异有统计学意义〔OR ＝2.94，95％ CI（1.88，4.60），P ﹤0.001〕。两组恶心呕吐、白细胞计数下降、血小板计数下降、神经毒性、腹痛和皮肤黏膜反应发生率比较，差异无统计学意义（ P ﹥0.05）。同步组重度腹泻发生率高于序贯组，差异有统计学意义〔OR ＝2.39，95％ CI（1.31，4.38），P ＝0.005〕。两组重度恶心呕吐、重度白细胞计数下降和重度神经毒性发生率比较，差异无统计学意义（P ﹥0.05）。结论与序贯放化疗相比，同步放化疗可提高直肠癌患者总生存率和无进展生存率，但腹泻的发生风险增加，不同时序放化疗方式各有利弊。%Objective To systematically review the efficacy and safety of different schedules of radiotherapy and chemotherapy for rectal cancer,and to provide references for clinical practice and research. Methods We made computer -based retrieval in foreign databases such as Cochrane Library,PubMed,EMBase,Web of Science and Chinese ones including CBM,CNKI,VIP and Wanfang to collect relevant literatures. Then we made further literature screening to extract primary information including grouping method,gender,age,KPS score,clinical staging and outcome indicators. We compared the differences of overall survival rate,progression - free survival rate,total effective rate,complete remission rate and the incidence of adverse reactions between concurrent radiochemotherapy and sequential radiochemotherapy for patients with rectal cancer. Results Twelve literatures were selected with 1 191 patients included. The results of meta - analysis showed there was no statistically significant difference in 1 - year overall survival rate between the two groups〔 OR = 1. 47,95% CI(0. 96, 2. 26),P ﹥ 0. 05〕. The 2 - year overall survival rate〔OR = 2. 04,95% CI(1. 26,3. 30),P ﹤ 0. 05〕and 3 - year overall survival rate〔OR = 2. 04,95% CI(1. 50,2. 78),P ﹤ 0. 05〕of concurrent schedule group were higher than sequential schedule group. There was no statistically significant difference in 5 - year overall survival rate between the two groups〔OR =1. 30,95% CI(0. 73,2. 33),P ﹥ 0. 05〕. The 1 - year progression - free survival rate〔 OR = 2. 68,95% CI(1. 76, 4. 07),P ﹤ 0. 001〕,2 - year progression - free survival rate〔 OR = 2. 66,95% CI(1. 19,5. 95),P = 0. 02〕,3 - year progression - free survival rate〔OR = 1. 70,95% CI(1. 18,2. 45),P = 0. 004〕and total effective rate〔OR = 2. 49,95%CI(1. 25,4. 97 ),P = 0. 01 〕of concurrent schedule group were higher than sequential schedule group. There was no statistically significant difference in complete remission rate between the two groups(P ﹥ 0. 05). The incidence of diarrhea in concurrent schedule group was higher than sequential schedule group〔 OR = 2. 94,95% CI(1. 88,4. 60),P ﹤ 0. 001〕. There were no statistically significant differences between two groups in the incidence rates of nausea and vomiting,severe decrease of leucocyte and platelets,neurotoxicity,abdominal pain and reaction of skin and mucous membrane(P ﹥ 0. 05). The incidence of acute diarrhea in concurrent schedule group was higher than sequential schedule group〔 OR = 2. 39,95% CI (1. 31,4. 38),P = 0. 005〕. There were no statistically significant differences between two groups in the incidence rates of severe nausea and vomiting,severe decrease of leucocyte and severe neurotoxicity(P ﹥ 0. 05). Conclusion Compared with the sequential radiochemotherapy,concurrent radiochemotherapy can improve overall survival rate and progression - free survival rate of patients with rectal cancer;however,the concurrent scheme has a higher incidence of adverse reactions,especially diarrhea. The two schedules of radiochemotherapy have both advantages and disadvantages.
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