术中植入缓释氟尿嘧啶治疗胃癌有效性及安全性的系统评价

Effectiveness and Safety of Sustained-Release Fluorouracil for Gastric Cancer:A Systematic Review

目的系统评价植入用缓释氟尿嘧啶治疗胃癌的有效性及安全性。方法计算机检索PubMed、EMbase、e Cochrane Library(2012年第6期)、CNKI、VIP和WanFang Data,收集术中植入缓释氟尿嘧啶治疗胃癌的随机或半随机对照试验,检索时限均为从建库至2012年6月。由2位评价者按照纳入与排除标准独立筛选文献、提取资料并评价质量后,采用RevMan 5.1软件进行Meta分析。结果最终纳入7个研究,共742例患者。Meta分析结果显示:植入组术后并发症发生率与对照组无明显差异[OR=0.93,95%CI(0.54,1.59),P=0.79],但术后随访1～3年复发率明显低于对照组,其差异有统计学意义[术后随访1年:OR=0.32,95%CI(0.15,0.65),P=0.002;术后随访2年:OR=0.19,95%CI(0.08,0.42),P<0.001;术后随访3年:OR=0.40,95%CI(0.24,0.67),P=0.004]。植入组术后随访1年生存率与对照组无明显差异[OR=1.98,95%CI(0.92,4.25),P=0.08],但术后随访2年和3年生存率则明显高于对照组[术后随访2年:OR=2.63,95%CI(1.17,5.91),P=0.02;术后随访3年:OR=2.42,95%CI(1.53,3.83),P=0.002]。植入组的不良反应发生率低于对照组,但其差异无统计学意义[OR=1.22,95%C(I0.49,3.07),P=0.67]。结论术中植入缓释氟尿嘧啶治疗胃癌可降低术后1、2年复发率,且提高术后随访2、3年生存率,且并不增加手术并发症及药物不良反应的发生率。受纳入研究数量及质量限制,上述结论尚需更多高质量、大样本、多中心的随机对照试验加以验证。

Objective To evaluate the effectiveness and safety of implanted sustained-release fluorouracil in gastric cancer surgery.Methods Literature search was conducted in the following databases：PubMed,EMbase,The Cochrane Library（Issue 6,2012）,CNKI,VIP and WanFang Data from inception to June,2012.Randomized controlled trials（RCTs） or quasi-randomized controlled trials on implanted sustained-release fluorouracil for gastric cancer were included.Two reviewers independently identified the literature according to the inclusion and exclusion criteria,and then extracted the data and assessed the quality of the included studies.Then,meta-analysis was conducted using RevMan 5.1 software.Results A total of 7 studies involving 742 patients were included.The results of meta-analysis showed no significant difference in the rate of postoperative complications between the two groups（OR=0.93,95%CI 0.54 to 1.59,P=0.79）,while a significant reduction was found in the recurrence rate in the sustained-release fluorouracil group during 1 to 3 year follow-up（1 year after surgery：OR=0.32,95%CI 0.22 to 0.46,P=0.02;2 years after surgery：OR=0.19,95%CI 0.08 to 0.42,P0.001;3 years after surgery：OR=0.40,95%CI 0.24 to 0.67,P=0.004）.As for the survival rate,no significant difference was found between the two groups 1 year after surgery（OR=1.98,95%CI 0.92 to 4.25,P=0.08）,while it was significantly higher in the sustained-release fluorouracil group than in the control group 2 to 3 years after surgery（2 years after surgery：OR=2.63,95%CI 1.17 to 5.91,P=0.02;3 years after surgery：OR=2.42,95%CI 1.53 to 3.83,P=0.002）.Adverse reaction rates in the sustained-release fluorouracil group were lower than those in the control group,but without significantly differences between the two groups（OR=1.22,95%CI 0.49 to 3.07,P=0.67）.Conclusion Compared with the control group,implanted sustained-release fluorouracil for gastric cancer can significantly reduce the recurrence rate 1 to 2 years after surgery and improve the overall survival rate 2 to 3 years after surgery without increasing the incidences of the postoperative complications and adverse reaction.However,due to the limitation of quantity and quality of the included studies,this conclusion should be further confirmed by more high quality,larger sample and multi-center RCTs.