以证据为基础的超药品说明书用药指导规范的制订  

Guideline Formulation of the Off-label Use of Drugs Based on Evidences

作　　者：赵靖 顾国煜[2] 陈耀龙[3] 邵蓉[4] 翟晓梅[5] 张幸国[2] 赵青威[2] 羊红玉[2] 王融溶[2] 柳琳[2] 楼燕[2] 洪东升[2] 饶跃峰[2] 吴佳莹[2] 李菌[2] 姜赛平[2] 俞慧群 赵昕 叶云 

机构地区：[1]国家卫生计生委医疗管理服务指导中心,北京100044 [2]浙江大学附属第一医院药学研究中心,杭州310003 [3]兰州大学循证医学中心/GRADE中国中心,兰州730000 [4]中国药科大学国家药物政策与医药产业经济研究中心,南京211198 [5]北京协和医学院人文和社会科学学院,北京100032 [6]宁波市北仑区人民医院药剂科,浙江宁波315800

出　　处：《中国药房》2017年第16期2167-2170,共4页China Pharmacy

摘　　要：目的:探讨如何应用循证医学方法学制订我国超药品说明书用药指导规范的方法和流程。方法:确定制订指导规范的7个步骤,即组建"规范"制订工作组;调查和遴选超药品说明书使用现状;确定临床问题;检索、评价和综合证据;应用GRADE进行证据质量分级;形成推荐意见并达成共识;同行评审和结果发布。据此步骤最终形成指导规范,并以风湿免疫学科为例进行示范研究。结果与结论:利用循证评价体系并依据7个步骤制订了一套综合行政、法律、临床医学、药学等多学科共同参与的风湿免疫学科超药品说明书用药相关指导规范的方法和流程。以证据为基础的超药品说明书用药指导规范的制订,充分体现了工作组的多学科性、流程的先进性、证据的全面性、分级的严谨性及共识的规范性,为进一步建立起一整套覆盖临床各专科病种超药品说明书用药的评价和管理体系提供了方法学借鉴,从而促进我国超药品说明书用药管理的规范化、法制化。OBJECTIVE： To explore an effective method to formulate management-related strategies for off-lable use of drugs by the evidence-based medicine. METHODS： The process of guideline formulation included seven procedures, i.g. establishment of ＂guidelies＂ formulation workgroup; investigation and selection of the status quo on off-label drug use; identification of the clinical problems; retrieval and evaluation and comprehensing of evidence; applification of GRADE in evidence quality grading; formation of the recommendations consensus; peer review and result publication. And eventually guidelines were formed based on the steps. This study took off-label use of rheumatoid immtmoprotective subjects as a case to explore. RESULTS ＆ CONCLUSIONS： Based on the evidence evaluation system and above 7 steps, the methods and process of guideline formulation on off-label use of rheuma- toid immunoprotective subjects that integrated administration, law, clinical medicine, pharmacy subjects were made .The process of guideline formulation fully reflects multidisciplinary characteristics of the workgroup, the advanced nature of the process, the comprehensiveness of evidence , the rigor of evidence quality grading, and the normalization of consensus. It provides reference in methodology for establishing a comprehensive evidence-based evaluation and management system of off-label use of drugs for all clinical specialist disease. Therefore, this scientific research results may promote the standardization and legalization of the off-labeluse of drugs management in China.

关 键 词：循证 超药品说明书用药 指导规范 制订 

分 类 号：R95[医药卫生—药学]