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作 者:郭二涛[1] 崔纪丽[1] 武利萍[1] 杨文义[1] 韩大正[1] 王伟兰[2] GUO Er-tao;CUI Ji-li;WU Li-ping;YANG Wen-yi;HAN Da-zheng;WANG Wei-lan(The First Affiliated Hospital of Henan University,Kaifeng 475001,China;Department of Pharmacy,Medical Supplies Center of Chinese PLA General Hospital,Beijing 100853,China)
机构地区:[1]河南大学第一附属医院,河南开封475001 [2]中国人民解放军总医院医疗保障中心药剂科,北京100853
出 处:《中国药物应用与监测》2020年第4期213-217,共5页Chinese Journal of Drug Application and Monitoring
基 金:开封市科技攻关项目(1903099)。
摘 要:目的:系统评价VEGFR-2抑制剂雷莫芦单抗与血栓发生风险的关系,为临床提供循证参考。方法:计算机检索PubMed,ASCO Abstracts,ESMO Abstracts,Embase,Cochrane Library,ClinicalTrials.gov,中国期刊全文数据库以及万方数据库,检索时限均从各数据库建库起至2019年12月,收集雷莫芦单抗的临床随机对照试验,纳入文献经数据提取和质量评价后,采用Revman 5.2软件进行Meta分析。结果:共纳入12篇文献,包含6511例肿瘤患者。荟萃分析结果显示:雷莫芦单抗组发生所有级别和高级别静脉血栓事件的风险均低于对照组,差异有统计学意义(RR:0.79,95%CI:0.63-0.98,P=0.04;RR:0.72,95%CI:0.52-0.99,P=0.03)。雷莫芦单抗组发生所有级别和高级别动脉血栓事件的风险均与对照组相似,差异均无统计学意义(RR:1.04,95%CI:0.72-1.50,P=0.84;RR:1.32,95%CI:0.80-2.15,P=0.27)。结论:VEGFR-2抑制剂雷莫芦单抗没有增加血栓的发生风险,其远期安全性有待更多大样本、高质量、长期随访的随机对照试验加以验证。Objective:To systematically evaluate the correlationship between the vascular endothelial growth factor receptor-2(VEGFR-2)inhibitor ramucirumab and the risk of thrombosis,in order to provide evidence-based references for clinic.Methods:Randomized controlled trials(RCTs)of ramucirumab were retrieved in PubMed,ASCO Abstracts,ESMO Abstracts,Embase,Cochrane Library,ClinicalTrials.gov,CNKI and Wanfang databases from the time of establishment to December 2019.RCTs were analyzed by the software RevMan 5.2 after data extraction and quality evaluation.Results:A total of 12 RCTs,6511 patients were enrolled in this study.Results of meta-analysis showed that ramucirumab group had significantly lower risk of all-grade and high-grade venous thrombosis compared with the control group(RR:0.79,95%CI:0.63-0.98,P=0.04;RR:0.72,95%CI:0.52-0.99,P=0.03).Ramucirumab group and control group had similar risk of all-grade and high-grade arterial thrombosis(RR:1.04,95%CI:0.72-1.50,P=0.84;RR:1.32,95%CI:0.80-2.15,P=0.27).Conclusion:VEGFR-2 inhibitor ramucirumab did not increase the risk of thrombosis.But its long-term safety remained to be confirmed by more RCTs with the high quality,large-sample and long-term follow-ups.
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