摘要
目的系统评价吉西他滨联合替吉奥治疗晚期胰腺癌的有效性和安全性,为临床用药治疗提供科学依据。方法计算机检索Cochrane图书馆临床对照试验资料库、EMBASE、PubMed、中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、维普数据库(VIP)、万方科技等数据库中关于吉西他滨联合替吉奥治疗晚期胰腺癌临床随机对照试验(RCT),检索时间均从各数据库创建至2019年12月。由两名评价员独立评价文献质量、提取资料并交叉核对,并进行方法学质量评价,采用RevMan 5.2的软件进行Meta-分析。结果共纳入23篇RCTs,共1817例患者,其中治疗组920例、对照组897例。Meta-分析结果显示:应用吉西他滨联合替吉奥组总有效率[RR=1.76,95%CI(1.51,2.04),P<0.00001]和临床获益率[RR=1.40,95%CI(1.30,1.50),P<0.00001]与对照组相比有显著性差异;在安全性方面,治疗组不良反应发生危险度高于对照组。结论基于现有临床证据,吉西他滨联合替吉奥在治疗晚期胰腺癌方面均较对照组疗效更为显著,是一种较为理想的用药方案。
Objective To systematically evaluate efficacy and safety of gemcitabine combined with tegafur for advanced pancreatic cancer,for which to provide scientific proofs for clinical decision making.Methods The databases including:The Cochrane Library、EMBASE、PubMed、CNKI、CBM、VIP、Wanfang Data were searched from the inception to Dec 2019 to collect the randomized controlled trials(RCTs)related to the safety and efficacy of gemcitabine combination with tegafur versus monotherapy for the treatment of advanced pancreatic cancer.Quality assessment and data extraction were conducted by two reviewers independently.Disagreement was resolved through discussion.and data analyses were performed with RevMan 5.2 software.Results A total of 23 articles were included,including 1817 patients.There were 920 patients in treatment groups and 897 patients in the control group.The Meta-analysis results showed that,In terms of validity,compared with the control group,the total effective rate and clinical benefit rate were significantly different in gemcitabine combined with tegafur group,the total effective rate[RR=1.76,95%CI(1.51,2.04),P<0.00001]and clinical benefit rate[RR=1.40,95%CI(1.30,1.50),P<0.00001],In terms of safety,The results of toxic side effects were obviously higher than those in gemcitabine monotherapy.Conclusion Based on the present clinical evidence,the meta-analysis results indicate that the treatment efficacy of gemcitabine combined with tegafur group is better than control group on treating advanced pancreatic cancer,which is a standard treatment of advanced pancreatic cancer.
作者
史宁
耿帅
郭宏举
常李荣
SHI Ning;GENG Shuai;GUO Hongju;CHANG Lirong(Department of Pharmacy,Strategic Support Force Characteristic Medical Center,Beijing 100101,China)
出处
《药物评价研究》
CAS
2020年第5期928-934,共7页
Drug Evaluation Research
基金
战略支援部队特色医学中心医药卫生基础研究探索课题(19ZX63,19ZX17)。
关键词
吉西他滨
替吉奥
晚期胰腺癌
系统评价
gemcitabine
tegafur
advanced pancreatic cancer
systematic review