放射性125Ⅰ粒子支架与普通支架在中晚期食管癌治疗中有效性与安全性的Meta分析

Efficacy and safety of stents loaded with 125I seeds for patients with advanced esophageal cancer ： a meta-analysis

目的 系统评价 125Ⅰ覆膜粒子支架治疗中晚期食管癌的有效性与安全性。方法 电子检索PubMed、Embase、The Cochrane Library、和CBM、CNKI、万方数据库，文献检索起止时间均从建库至2016年11月，同时检索纳入文献的参考文献。2位研究者参照纳入与排除标准独立进行文献筛选、资料提取和质量评价后，采用RevMan 5.3软件进行Meta分析。结果 共纳入5篇随机对照研究（RCT）和14篇临床对照研究（CCT），1 211例患者。Meta结果分析显示，125Ⅰ覆膜粒子支架与普通支架比较，两组患者平均生存期的均数差为4.11（95%CI2.16~6.07，P〈0.001），差异具有统计学意义。两组患者术后3个月再狭窄发生率差异同样具有统计学意义（RR=0.23，95%CI0.12~0.62，P=0.002）。此外，两组患者术后出血、术后疼痛、术后支架移位的不良反应发生率差异均无统计学意义（RR=0.80，95%CI0.52~1.23，P=0.30；RR=1.06，95%CI0.88~1.27，P=0.55）；0.53（95%CI0.27~1.05，P=0.07）。结论 综合现有资料，125Ⅰ粒子支架是一种治疗中晚期食管癌安全且有效的治疗策略。但是，目前所纳入研究的证据级别较低，仍有待进一步开展高质量的临床研究。

Objective To evaluate the clinical effectiveness and safety of stents loaded with 125Ⅰ seeds compared to conventional stents. Methods Literatures were searched in PubMed, EMbase, Cochrane Library, CBM, CNKI, Wanfang Data and other electronic databases from inception to November 2016. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted data and assessed quality of the included studies independently. Meta-analyses were performed using RevMan 5.3. Results A total of five RCTs and 14 CCTs involving 1 211 patients were included. The mean survival time of the 125Ⅰ stent group was significantly higher than that of the control group[mean difference=4.11, 95% CI （2.16-6.07）P 〈0.001]. The incidence of restenosis after 3：The available data showed that the incidence of re-staging of 125Ⅰ stent in the treatment group was lower than that of the normal stent group[RR=0.23, 95%CI（0.12-0.62）, P=0.002]. Postoperative bleeding[RR=0.80, 95%CI （0.52-1.23）, P=0.30]; Postoperative pain[RR=1.06,95%CI（90.88-1.27）,P=0.55]; postoperative stent shift [RR=0.53,95%CI（0.27-1.05）, P=0.07]. The difference of incidence of complications was not statistically significant.There was no difference in the incidence of complications between the two groups. Conclusions The available data suggest that 125Ⅰ stent is superior to common stent in the treatment of advanced esophageal cancer. There are no differences found in the incidence of complications between 125Ⅰ stent and conventional stent. However, due to the limited quality of the included studies,more high-quality and multicenter-based studies are needed to verify the above conclusion.