中国药房2017，Vol.28Issue(16)：2167-2170,4.DOI:10.6039/j.issn.1001-0408.2017.16.02
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
赵靖 1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 3赵昕 3叶云 3顾国煜 2陈耀龙 4邵蓉 5翟晓梅 6张幸国 2赵青威 2羊红玉 2王融溶2
作者信息
- 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. 宁波市北仑区人民医院药剂科,浙江宁波 315800
- 4. 兰州大学循证医学中心/GRADE中国中心,兰州 730000
- 5. 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
- 6. 北京协和医学院人文和社会科学学院,北京 100032
- 折叠
摘要
Abstract
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 immunoprotective 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-label use of drugs management in China.关键词
循证/超药品说明书用药/指导规范/制订Key words
Evidence-based/Off-label drug use/Guide-lines/Formulation分类
医药卫生引用本文复制引用
赵靖,柳琳,楼燕,洪东升,饶跃峰,吴佳莹,李菌,姜赛平,俞慧群,赵昕,叶云,顾国煜,陈耀龙,邵蓉,翟晓梅,张幸国,赵青威,羊红玉,王融溶..以证据为基础的超药品说明书用药指导规范的制订[J].中国药房,2017,28(16):2167-2170,4.
