雷替曲塞联合伊立替康治疗晚期结直肠癌的超说明书用药循证评价

Evidence-based Evaluation on Off-label Drug Use of Rituximab Combined with Irinotecan in the Treatment of Advanced Colorectal Cancer

关键词:  雷替曲塞  伊立替康  晚期结直肠癌  超药品说明书  循证评价

Key words:  rituximab  irinotecan  advanced colorectal cancer  off-label drug use  evidence-based evaluation

摘要:

目的 系统评价雷替曲塞联合伊立替康治疗晚期结直肠癌的超说明书用药合理性。方法 查询国内外网站雷替曲塞、伊立替康的最新版药品说明书、权威指南和诊疗规范，收集雷替曲塞、伊立替康的全部适应证。计算机检索PubMed、EMbase、Cochrane library、Epistemonikos、CBM、CNKI、VIP和万方数据库，检索时限为从建库至2016年10月，收集雷替曲塞联合伊立替康治疗晚期结直肠癌的超说明书用药研究文献，对该方案治疗晚期结直肠癌的有效性和安全性进行系统性评价。结果 伊立替康用于治疗晚期结直肠癌在CFDA说明书中属于超说明书用药；国内外未有指南推荐雷替曲塞联合伊立替康治疗晚期结直肠癌，只有2014年发表的系统评价1篇，包括2个随机试验和10个前瞻性队列研究，样本量为735，AMSTAR评分为6分，该研究认为雷替曲塞联合奥沙利铂和雷替曲塞联合伊立替康治疗晚期结直肠癌在有效率、总体生存时间、疾病无进展生存时间方面无统计学差异。结论 目前有关雷替曲塞联合伊立替康治疗晚期结直肠癌的推荐证据等级较低，需大样本的随机对照试验证实联合治疗的有效性，且该方案在治疗过程中存在潜在的安全性问题。

Abstract:

OBJECTIVE To systematic evaluate the rationality of off-label drug use of rituximab combined with irinotecan in the treatment of advanced colorectal cancer. METHODS To search the latest edition of the drug instructions, authoritative guidelines and diagnosis and treatment specifications of the domestic and foreign websites of retictx and irinotecan, collected all indications of reticetrexed and irinotecan. PubMed, EMbase, Cochrane library, Epistemonikos, CBM, CNKI, VIP and Wanfang database were searched from database foundation to October 2016, collection of rituximab combined with irinotecan in the treatment of advanced colorectal cancer off label drug use research literatures, a systematic evaluation of the efficacy and safety of the drug in the treatment of advanced colorectal cancer. RESULTS The edition of irinotecan medicine instructions were not found about treatment of advanced colorectal cancer in the CFDA drug instruction. There was no guide recommended raltitrexed combined with irinotecan for the treatment of advanced colorectal cancer. Only one systematic review published in 2014, including 12 randomized trials and 10 prospective cohort studies with a sample size of 735 and an AMSTAR score of 6. The study found that raltitrexed combined with oxaliplatin and raltitrexed combined with irinotecan in the treatment of advanced colorectal cancer had no significant difference in the effective, overall survival time, disease progression-free survival time. CONCLUSION At present, there is a low level of evidence for rituximab combined with irinotecan treatment in advanced colorectal cancer. It still needs to carry out a large sample of randomized controlled trials to confirm the effectiveness and potential serious safety problems of rituximab combined with irinotecan, it is suggested that advanced colorectal cancer shall be avoided using.