摘要
目的通过循证医学方法评价羟氯喹超适应证用药的合理性,并提出分级管理建议。方法回顾性抽取2019年1月至2022年4月本院羟氯喹门诊处方,按照最新版药品说明书筛选超适应证用药处方。依据循证医学证据等级制定的超适应证循证医学评价流程,检索循证医学证据,并进行质量评价和Thomson分级,最后提出分级管理建议。结果羟氯喹超适应证用药涉及15种诊断。依据权威医学专著和指南,判定口腔扁平苔藓、皮肌炎、玫瑰痤疮(酒糟鼻)有循证证据,建议A级管理(同意使用);依据Micromedex数据库收载及系统性评价/Meta分析,判定免疫性血小板减少症、慢性荨麻疹、妊娠期抗磷脂综合征、干燥综合征有循证证据,建议C级管理(特殊使用);其余诊断均无循证证据,建议D级管理(禁止使用)。结论羟氯喹临床实践中存在超适应证使用情况,建议严格分级管理,以促进羟氯喹的合理、有效、安全使用。
AIM To evaluate the off-label use of hydroxychloroquine through evidence-based medicine,and provide a recommendations for hierarchical management.METHODS The outpatient prescriptions of hydroxychloroquine in our hospital from January 2019 to April 2022 were retrospectively selected,and the off-label prescriptions were screened according to the latest version of medication package insert.The off-label evidence-based medicine evaluation process was developed according to the evidence level of evidence-based medicine,the evidence was searched and quality evaluation and Thomson grading was conducted,and finally the graded management suggestions were put forward.RESULTS There were 15 kinds of diagnosis involved in the off-label use of hydroxychloroquine.According to authoritative medical monographs and guidelines,there were evidences for oral lichen planus,dermatomyositis,and rosacea(acne rosacea),and A-level management(agree to use)was recommended.According to the collection of Micromedex database and systematic evaluation/meta analysis,there were evidences for immune thrombocytopenia,chronic urticaria,antiphospholipid syndrome during pregnancy,and Sjogren's syndrome,and C-level management(special use)was recommended.There was no evidence found for other diagnoses,and D-level management is recommended(prohibited use)was recommended.CONCLUSION The off-label use of hydroxychloroquine exists in clinical practice.It is suggested that strict grading management be carried out to promote the rational,effective and safe use of hydroxychloroquine.
作者
曹迪
CAO Di(Department of Pharmacy,the Third People's Hospital of Bengbu,Bengbu ANHUI 233000,China)
出处
《中国新药与临床杂志》
CSCD
北大核心
2023年第12期825-831,共7页
Chinese Journal of New Drugs and Clinical Remedies
关键词
羟氯喹
药品标示外使用
合理用药
循证医学
hydroxychloroquine
off-label use
rational use of drug
evidence-based medicine
作者简介
曹迪,男,副主任药师,学士,主要从事临床药学工作,E-mail:94006719@qq.com。
