125I粒子支架置入治疗中晚期食管癌效果和安全性meta分析

I seed stent implantation for the treatment of advanced esophageal cancer: a meta analysis of its efficacy and safety

目的系统评价125I粒子支架置入在中晚期食管癌姑息治疗中的疗效与安全性。方法计算机检索PubMed、Cochrane Library、EMbase、CNKI、CBM、万方数据库建库至2019年4月有关125I粒子支架置入姑息治疗中晚期食管癌相关研究文献。2名研究者筛选文献、提取资料并独立评价质量,采用Stata12.0、RevMan 5.3软件进行meta分析。结果纳入11项随机对照试验(RCT)研究文献共862例患者,其中试验组418例(置入125I粒子支架),对照组444例(置入普通支架)。Meta分析结果显示,相比于普通支架,125I粒子支架显著提高术后3个月生存率(RR=1.38,95%CI=1.17~1.62,P<0.001),延长术后平均生存时间(WMD=4.20,95%CI=3.76~4.64,P=0.001),改善术后2个月(WMD=8.45,95%CI=5.14~11.77,P<0.001)、3个月(WMD=6.92,95%CI=2.71~11.13,P<0.001)Karnofsky行为状态(KPS)评分,降低死亡风险47%(HR=0.53,95%CI=0.35~0.80,P=0.003)、降低6个月支架内再狭窄发生率(RR=0.53,95%CI=0.34~0.83,P=0.005);两组术后6个月生存率(RR=2.26,95%CI=0.96~5.34,P=0.060)、生存期支架内再狭窄发生率(RR=0.95,95%CI=0.69~1.31,P=0.750)、术后3个月吞咽功能评分及术后并发症发125I粒子支架置入治疗中晚期食管癌伴吞咽困难患者安全有效。

Objective To systemically evaluate the efficacy and safety of125I seed stent implantation in palliative treatment of advanced esophageal cancer.Method Computer retrieval of PubMed,Cochrane Library,EMbase,CNKI,CBM and Wan Fang data pool was conducted to collect the eligible clinical research documents concerning the125I seed stent implantation for palliative treatment of advanced esophageal cancer.The retrieval time period was from the establishment of data bases to April 2019.Two independent researchers strictly screened the documents,extracted the valuable data,and evaluated the quality of documents.Stata 12.0 software and RevMan 5.3 software were used to make meta analysis.Results A total of 11 randomized controlled trials(RCTs)with 862 patients,including 418 patients in study group(receiving125I seed stent implantation)and 444 patients in control group(receiving conventional stent implantation),were enrolled in this study.Meta analysis showed that compared with conventional stent implantation,125I seed stent implantation could significantly improve the postoperative 3-month survival rate(RR=1.38,95%CI=1.17-1.62,P<0.001),prolong the mean postoperative survival time(WMD=4.20,95%CI=3.76-4.64,P=0.001),improve Karnofsky performance status(KPS)score at 2 months(WMD=8.45,95%CI=5.14-11.77,P<0.001)as well as at 3 months(WMD=6.92,95%CI=2.71-11.13,P<0.001)after125I stent implantation.The death risk was remarkably decreased by 47%(HR=0.53,95%CI=0.35-0.80,P<0.003),the 6-month incidence of instent restenosis was reduced(RR=0.53,95%CI=0.34-0.83,P<0.005).No statistically significant differences in the 6-month survival rate(RR=2.26,95%CI=0.96-5.34,P=0.060),the in-stent restenosis rate during survival time(RR=0.95,95%CI=0.69-1.31,P=0.750),the 3-month swallowing function score and the incidence of postoperative complications existed between the two groups.Conclusion For the treatment of patients with advanced esophageal cancer complicated by dysphagia,125I seed stent implantation is clinically safe and effective.