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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 efficacy and safety of sustained-release fluorouracil for gastric cancer. Methods PubMed, EMbase, eCochrane Library (2012No.6), CNKI, VIP and WanFang Data were collected. The randomized and quasi-randomized controlled trials of intraoperative transplantation of sustained-release fluorouracil for the treatment of gastric cancer were collected. The search time was from Until June 2012. Two reviewers independently screened the literature according to inclusion and exclusion criteria, extracted data, and assessed quality. Meta-analysis was performed using RevMan 5.1 software. The results eventually included 7 studies, a total of 742 patients. Meta analysis showed that the incidence of postoperative complications in the implantation group was no significant difference compared with the control group [OR = 0.93, 95% CI (0.54, 1.59, P = 0.79], but the recurrence rate was significantly The difference was statistically significant (follow-up 1 year after operation: OR = 0.32, 95% CI 0.15-0.65, P 0.002; Follow-up 2 years after operation: OR = 0.19,95% CI 0.08 , 0.42), P <0.001; Follow-up 3 years: OR = 0.40, 95% CI (0.24, 0.67), P = 0.004]. The 1-year follow-up survival rate in the implantation group was not significantly different from that in the control group [OR = 1.98, 95% CI (0.92, 4.25), P = 0.08] The control group [2 years after follow-up: OR = 2.63, 95% CI 1.17, 5.91, P = 0.02; 3 years after follow-up: OR = 2.42,95% CI 1.53,3.83, P = 0.002]. The incidence of adverse reactions in the implantation group was lower than that in the control group, but the difference was not statistically significant [OR = 1.22,95% C (I0.49,3.07), P = 0.67]. Conclusions Intraoperative implantation of sustained-release fluorouracil for gastric cancer can reduce the recurrence rates at 1 and 2 years after operation and improve the 2-year and 3-year survival rates after operation. The incidence of surgical complications and adverse drug reactions does not increase. Due to the number of studies included and quality limitations, the above conclusion still needs more high-quality, large sample, multicenter randomized controlled trials to be verified.