中国医院用药评价与分析2025，Vol.25Issue(5)：595-597,603,4.DOI:10.14009/j.issn.1672-2124.2025.05.017
基于循证医学方法评价注射用雷替曲塞超适应证用药情况
Evaluation on Off-Label Use of Raltitrexed for Injection Based on Evidence-Based Medicine Method
摘要
Abstract
OBJECTIVE:Based on evidence-based medicine method,to evaluate the off-label use of raltitrexed for injection,to probe into the methods of rationality evaluation on the off-label use of raltitrexed for injection.METHODS:Domestic and foreign websites were retrieved to obtain the latest version of drug instructions of raltitrexed for injection,review the current authoritative guidelines and clinical practice standards,analyze all the drug instructions of raltitrexed for injection,investigate the indication and usage.Database including PubMed,Ovid,Embase,Web of Science,the Cochrane Library,CNKI and Wanfang Data were retrieved to collect studies on off-label use of raltitrexed for injection,the retrieval time was from database establishment to Jul.1st,2024,the effects of raltitrexed for injection on the therapeutic effects and safety in patients with malignant tumor were analyzed.RESULTS:A total of 1 325 studies or guidelines were preliminary enrolled,1 guideline and 10 systematic reviews were obtained from preliminary screening,and 1 qualified systematic review was finally enrolled according to the inclusion and exclusion criteria.Drug instructions in the United States and China both mentioned the specific usage of raltitrexed for injection in advanced colorectal cancer.In addition,drug instructions in the United States also mentioned that raltitrexed for injection could be used in patients with advanced gastric cancer,cholangiocarcinoma,liver cancer and pancreatic cancer.The enrolled 1 systematic review was published in 2017,including 8 studies,with 6 prospective cohort studies and 2 randomized trials,with a total sample size of 741 cases,and the score of AMSTAR evaluation tool was 6 points.CONCLUSIONS:Through evidence-based medicine evaluation,the off-label use of raltitrexed for injection in advanced colorectal cancer,advanced gastric cancer and cholangiocarcinoma is rational,while the other off-label drug use is irrational.关键词
循证方法/雷替曲塞/抗肿瘤/超适应证用药/安全性Key words
Evidence-based method/Raltitrexed/Anti-tumor/Off-label drug use/Safety分类
医药卫生引用本文复制引用
陈培杰,张珊珊,熊乘风..基于循证医学方法评价注射用雷替曲塞超适应证用药情况[J].中国医院用药评价与分析,2025,25(5):595-597,603,4.基金项目
安徽高校自然科学研究项目(No.KJ2020A0188) （No.KJ2020A0188）
安徽医科大学校科研基金项目(No.2023xkj045) （No.2023xkj045）
