他克莫司在成人肾脏病中超适应证用药的循证证据评价与合理性分析  

Evidence Evaluation and Rationality Analysis for Off-label Use of Tacrolimus in the Kidney Diseases in Adults

作　　者：李晓敏[1] 谭心怡 张奥博 张学丽[1] 邵华[1] LI Xiaomin;TAN Xinyi;ZHANG Aobo;ZHANG Xueli;SHAO Hua(Department of Pharmacy,Zhongda Hospital Southeast University,Nanjing 210009,China)

机构地区：[1]东南大学附属中大医院药学部,南京210009

出　　处：《中国现代应用药学》2024年第13期1830-1835,共6页Chinese Journal of Modern Applied Pharmacy

基　　金：南京药学会—常州四药医院药学科研基金项目(2021YX003);国家卫生健康委医院管理研究所医院药学高质量发展研究项目(NIHAYS2314);江苏省药品监督管理局药品监管科学科研计划项目(83)。

摘　　要：目的 评价他克莫司在成人肾脏病中超适应证用药的循证医学证据和临床使用合理性。方法 通过系统查阅他克莫司用于成人肾脏病的国内外不同厂商药品说明书、临床指南、医学文献等,筛选最高级别循证医学证据,建立他克莫司在成人肾脏病中超适应证用药的循证医学证据评价表,并以此为依据,调取东南大学附属中大医院肾内科2021年1月1日—2022年12月31日超适应证使用他克莫司的成人患者病例,评价其使用合理性。结果 共罗列了他克莫司用于成人肾脏病的超说明书适应证19种,并根据每种适应证的循证医学证据类型确定了其使用推荐等级,结果显示大部分临床常见病种的推荐等级较高。调取了东南大学附属中大医院肾内科成人患者他克莫司超适应证用药病例194人次,其中临床使用推荐等级为“强推荐”“中等强推荐”“弱推荐”和“不推荐”的比例分别为67.0%、12.9%、15.0%和5.1%。结论 他克莫司在成人肾脏病中存在广泛的超适应证用药,但大部分常见病种的循证医学证据比较充分,使用合理性较高。OBJECTIVE To evaluate the levels of evidence and analyze the rationality for off-label use of tacrolimus in the kidney diseases in adults.METHODS By systematically reviewing the drug instructions,clinical guidelines and medical literature of tacrolimus in the kidney diseases in adults,screening the highest level of evidence,and an evaluation table based on evidence-based medical for off-label use of tacrolimus in the kidney diseases in adults was established.Based on the evaluation table,collect adult patients from the Department of Nephrology in Zhongda Hospital Southeast University who had a medication history of off-label use of tacrolimus from January 1,2021 to December 31,2022,and evaluated the rationality of application for tacrolimus.RESULTS A total of 19 indications for off-label use of tacrolimus in the kidney diseases in adults were listed,and their recommended levels were determined based on evidence.Among them,the recommended levels for common types of kidney diseases were higher.In addition,194 adult patients with off-label use of tacrolimus were selected from the Department of Nephrology in Zhongda Hospital Southeast University,and their application recommended levels with"strongly recommended""moderately strongly recommended""weakly recommended"and"not recommended",were 67.0%,12.9%,15.0%and 5.1%,respectively.CONCLUSION Tacrolimus has a wide range of indications for off-label use in the kidney diseases in adults,but the evidence for most common types of kidney diseases are relatively sufficient and their use are reasonable.

关 键 词：他克莫司 肾脏病 超适应证用药 循证医学 合理性 

分 类 号：R969.3[医药卫生—药理学]