目的: 系统评价结直肠癌术中植入5-氟尿嘧啶(5-FU)缓释剂的疗效和安全性,为临床提供循证参考。方法: 计算机检索中国期刊全文数据库、中文科技期刊数据库、中国生物医学文献数据库、万方数据库、PubMed、Web of Science和EMBase,收集结直肠癌术中植入5-FU缓释剂的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取,并采用改良后的Jadad量表进行质量评价后,采用STATA 12.0 统计软件进行Meta分析。结果:共纳入23项RCT,合计2 089例患者。Meta分析结果显示,结直肠癌术中植入5-FU缓释剂可显著降低患者术后2年局部复发率[OR=0.32,95%CI(0.21,0.48),P<0.001]、远处转移率[OR=0.16,95%CI(0.05,0.50),P=0.002]和2年病死率[OR=0.38,95%CI(0.22,0.65),P<0.001],差异均有统计学意义,但对患者术后并发症发生率无显著影响 [OR=1.06,95%CI(0.81,1.39),P=0.662]。结论:结直肠癌患者术中植入5-FU缓释剂能较好地降低患者术后2年局部复发率、远处转移率和2年病死率,对并发症的发生无明显影响。
Abstract
OBJECTIVE: To systematically review the efficacy and safety of implanting sustained-release 5-fluorouracil in colorectal cancer surgery, and provide evidence-based reference for clinic. METHODS: Retrieved from CJFD, VIP,CBM, Wanfang Database, PubMed, Web of Science and EMBase, randomized controlled trials (RCT) about sustained-release 5-fluorouracil in the treatment of colorectal cancer were collected. Meta-analysis was performed by using STATA 12.0 software after data extraction and quality evaluation by modified Jadad scale. RESULTS: Totally 23 RCTs were enrolled, involving 2 089 patients. Results of Meta-analysis showed, implanting sustained-release 5-fluorouracil in colorectal cancer surgery can significantly reduce postoperative 2-year local recurrence rate [OR=0.32,95%CI(0.21,0.48),P<0.001], distant metastasis rate [OR=0.16,95%CI(0.05,0.50),P=0.002] and mortality rate within 2-year [OR=0.38,95%CI(0.22,0.65),P<0.001], with statistical significance, while had no significant difference in the incidence of postoperative complications [OR=1.06,95%CI(0.81,1.39),P=0.662]. CONCLUSIONS: Implanting sustained-release 5-fluorouracil in colorectal cancer surgery can reduce postoperative 2-year local recurrence rate, distant metastasis rate and mortality rate within 2-year, and has no obvious effect on the incidence of complications.