雷莫芦单抗治疗胃或胃食管结合部腺癌疗效与安全性的Meta分析

Efficacy and Safety of Ramucirumab in the Treatment of Adenocarcinoma in Stomach or Gastroesophageal Junction:A Meta-analysis

目的：系统评价雷莫芦单抗治疗胃或胃食管结合部腺癌的疗效与安全性,为临床提供循证参考。方法：计算机检索万方数据库、中国期刊全文数据库、Pub Med、EBSCO、Medline、Cochrane图书馆和Clinical Trials.gov,检索时限均从各数据库建库起至2015年9月,收集加用雷莫芦单抗（试验组）对比其他抗癌药物（对照组）治疗胃或胃食管结合部腺癌的随机对照试验（RCT）,对符合标准的临床研究进行资料提取,并采用Cochrane系统评价员手册5.1.0进行质量评价,采用Rev Man 5.3统计软件进行Meta分析。结果：共纳入3项RCT,合计1 188例患者,其中试验组652例,对照组536例。Meta分析结果显示,试验组患者的总生存期[HR=0.83,95%CI（0.72,0.95）,P=0.006]和无进展生存期[HR=0.66,95%CI（0.47,0.92）,P=0.01]均显著长于对照组,差异均有统计学意义;但两组患者客观反应率比较,差异无统计学意义[RR=1.31,95%CI（0.81,2.11）,P=0.28]。试验组患者的严重不良反应（不良反应程度：3~4级）发生率显著高于对照组,差异有统计学意义[RR=1.14,95%CI（1.00,1.29）,P=0.04]。结论：雷莫芦单抗可延长胃或胃食管结合部腺癌患者的总生存期和无进展生存期,但在临床使用时应注意严重不良反应的发生。

OBJECTIVE：To systematically review the efficacy and safety of ramucirumab in the treatment of adenocarcinoma in stomach or gastroesophagealjunction,and provide evidence-based reference for clinic. METHODS： Retrieved from Wanfang database,CJFD,Pub Med,EBSCO,Medline and Cochrane Library,randomized controlled trials（RCT）oframucirumab and（or）other medicines or other chemotherapy（test group） versus placebo or and Clinical Trials. gov other antibiotics（control goroup）were collected with time limit from establishment to Sept. 2015. Meta-analysis was performed by using Rev Man 5.3 software after data extraction and quality evaluation by Cochrane systematic review manual 5.1.0. RESULTS：Totally 3 RCTs involving 1 188 patients were enrolled,including 652 patients in the test group and 536 patients incontrol group. Results of Meta-analysis showed,the overall survival[HR=0.83,95%CI（0.72,0.95）,P=0.006] and progression-freesurvival[HR=0.66,95%CI（0.47,0.92）,P=0.01]in test group were significantly longer than control group,the difference was statistically significant;there was no significant difference in the objective response rate[RR=1.31,95%CI（0.81,2.11）,P=0.28]. The incidence of severe adverse reactions（degree level：3-4 grade）in test group was significantly higher than control group,the difference was statistically significant [RR=1.14,95% CI（1.00,1.29）,P=0.04].CONCLUSIONS：Ramucirumab can extend overall survival and progression-free survival of adenocarcinoma in stomach or gastro-oesophageal junction,but the incidence of adverse reactions should be noticed.