吉西他滨治疗胆管细胞癌的超说明书用药循证评价

Off-label drug use of gemcitabinein treatment of cholangiocarcinoma:an evidence-based review

目的:系统评价吉西他滨治疗胆管细胞癌超说明书用药的合理性。方法:查询国内外网站吉西他滨的最新版药品说明书、权威指南和诊疗规范,收集吉西他滨的全部适应证。计算机检索PubMed、EMbase、Cochrane、Clinicaltrials、CBM、CNKI、VIP和万方数据库等,检索时限为从建库至2016年1月。收集吉西他滨治疗胆管细胞癌超说明书用药研究文献,采用AGREE工具和GRADE系统进行方法质量和研究质量评价。结果:国内外最新版的说明书均未找到吉西他滨治疗胆管细胞癌的适应证,有4篇指南包含吉西他滨治疗胆管细胞癌的内容,包括:2015年日本千叶大学发布的《Clinical practice guidelines for the management of biliary tract cancers 2015:the 2nd English edition》;2014年英国伦敦大学癌症研究所发布《Guidelinesfor the diagnosis and management of intrahepatic cholangiocarcinoma》;2011年德国慕尼黑技术大学发布的《Biliary cancer:ESMO Clinical Practice Guidelines for diagnosis,treatment and follow-up》;2010年意大利帕多瓦大学发布的《Cholangiocarcinoma:A position paper by the Italian Society of Gastroenterology(SIGE),the Italian Association of Hospital Gastroenterology(AIGO),the Italian Association of Medical Oncology(AIOM)and the Italian Association of Oncological Radiotherapy(AIRO)》。同时找到1篇系统评价《Efficacy and safety of gemcitabine-based chemotherapies in biliary tract cancer:A meta-analysis》。结论:依据纳入的临床指南和系统评价的质量,认为有关吉西他滨治疗胆管细胞癌的推荐证据等级较低,相关指南质量不高,疗效不确定,因此胆管细胞癌患者应谨慎选择吉西他滨化疗。

OBJECTIVE To systematically review rationality of off-label drug use of gemcitabine in treatment of cholangiocarcinoma.METHODS The latest edition of medicine instruction,clinical practice guideline databases and rules for clinical medical textbooks were retrieved,to collect all indications of gemcitabine.And PubMed,EMbase,Cochrane,Clinicaltrials,CBM,CNKI,VIP and Wanfang database were searched from inception to January 2016 to collect articles focused on gemcitabine in treatment of cholangiocarcinoma.And then methodological quality and quality of evidence of these studies were evaluated using AGREE tool and GRADE system.RESULTS No instruction indicated that the gemcitabine could be used to treat cholangiocarcinoma.However,four clinical guidelines recommending gemcitabine in treatment of cholangiocarcinoma were found out,including：（1）＂Clinical practice guidelines for the management of biliary tract cancers 2015：the 2nd English edition,＂published by Journal of Hepato-Biliary-Pancreatic Sciences;（2）＂Guidelinesfor the diagnosis and management of intrahepatic cholangiocarcinoma＂,published by Journal of Hepatology;（3）＂Biliary cancer：ESMO Clinical Practice Guidelines for diagnosis,treatment and follow-up＂,published by Annals of Oncology Official Journal of the European Society for Medical Oncology;（4）＂Cholangiocarcinoma：A position paper by the Italian Society of Gastroenterology（SIGE）＂,conducted by Italian Association of Hospital Gastroenterology（AIGO）,Italian Association of Medical Oncology（AIOM）and the Italian Association of Oncological Radiotherapy（AIRO）.At the same time,a Meta-analysis was researched,which was titled ＂Efficacy and safety of gemcitabine-based chemotherapies in biliary tract cancer：A Meta-analysis＂.CONCLUSION According to the evaluation of the included clinical guidelines and systematic review,quality of evidence is low for gemcitabine in treatment of cholangiocarcinoma,and the quality is poor for guidelines recommending gemcitabine in treatment of cholangiocarcinoma,which indicates it is not sure if gemcitabine is effective for cholangiocarcinoma.Therefore,gemcitabine for cholangiocarcinoma should be selected cautious in clinical practice.