【摘要】 目的系统评价氟尿嘧啶缓释剂治疗结直肠癌的疗效及安全性,为临床用药提供循证医学依据。方法通过计算机检索CNKI、CBM、VIP、WanFang Data、PubMed和EMbase(1990~2013),收集所有氟尿嘧啶缓释剂治疗结直肠癌的随机对照试验(RCT)。按照纳入和排除标准选择文献、提取资料,并在评价纳入研究的方法学质量后,采用RevMan5.0软件进行Meta分析。结果共纳入13个RCT,867例患者,根据是否植入氟尿嘧啶缓释剂分为治疗组443例,对照组424例。Meta分析结果显示:疗效Meta分析,治疗组术后2年的局部复发率(OR=0.34,95%CI:0.21~0.54,P<0.00001)和死亡率(OR=0.29,95%CI:0.16~0.52,P<0.0001)均低于对照组,而两组术后2年的远处转移率差异无显著性(OR=0.61,95%CI:0.22~1.70,P=0.34)。安全性Meta分析:两组的切口感染率、腹膜炎发生率、吻合口瘘发生率以及肠梗阻发生率的差异无显著性(P值均>0.05)。结论术中植入氟尿嘧啶缓释剂能较好地降低患者术后2年的局部复发率和死亡率,而无法阻止患者远处转移发生的概率,但并不增加患者术后并发症的发生率,其长期疗效和更全面的安全性尚需开展更多大样本、高质量的RCT加以验证。更多还原

【Abstract】 【Objective】To evaluate the clinical efficacy and safety of intraoperative implant of sustained-release Fluorouracil for colorectal cancer(CRC), and to provide evidence-based medicine for drug using in clinic.【Methods】The following databases as CNKI, CBM, VIP, WanFang Data, PubMed and EMbase from 1990 to 2013 were searched electronically, and traced related references. All randomized controlled trials(RCTs) on intraoperative implant of sustained-release Fluorouracil for colorectal cancer were collected. The literature was screened according to inclusive criteria,data were extracted and the quality of included studies were assessed, and the meta-analysis was conducted using RevMan 5.0 software. 【Results】A total of 13 RCTs with 867 patients were included. According to whether intraoperative implant of sustained-release Fluorouracil or not during operation, they were randomly divided into two group, the treatment group and the control group(443, 424 patients respectively). Meta-analysis showed that compared with the control group, The treatment group was low in 2-year local recurrence rate(OR=0.34, 95%CI: 0.21~0.54,P <0.00001) and 2-year mortality rate(OR=0.29, 95%CI: 0.16~0.52,P <0.0001), but had no difference in 2-year distant metastasis rate(OR=0.61, 95%CI: 0.22~1.70, P =0.34). More than, there were no significant difference in postoperative complications, such as wound infection, peritonitis, anastomotic leakage and intestinal obstruction(P >0.05). 【Conclusions】Compared with the control group, intraoperative implant of sustained-release Fluorouracil during operation could decrease 2-year local recurrence rate and 2-year mortality rate, but could not prevent 2-year distant metastasis rate, without increasing its postoperative complications. But its’ long-term curative effect and more comprehensive safety still needs to be further verified by more large sample and high quality RCTs.更多还原