文档介绍：Methodology Chin J Evid-based Med 2011, 11(12): 1464-1467
药品标示外使用的循证医学评价方法探讨
易湛苗刘芳翟所迪
北京大学第三医院药剂科(北京 100191)
摘要目的介绍国内外药品标示外使用的循证医学评价情况,探讨药品标示外使用的循证医学评价方法。
方法综合国内外相关文献,从证据来源、证据分级及推荐强度三个方面探讨药品标示外使用的循证医学评价方
法。结果药品标示外使用的证据来源包括临床药理学、药品咨询系统(DRUGDEX® System)、肿瘤药典及手工检
索补充的证据;证据分级及推荐强度可参考 2009 年牛津证据分级与推荐意见强度(治疗部分)和药品咨询系统的
推荐强度和证据强度。结论本研究初步建立了一种系统的药品标示外使用的循证医学评价方法。
关键词药品标示外使用;循证医学;评价
Method of Evidence-Based Evaluation on Off-label Uses
YI Zhan-miao, LIU Fang, ZHAI Suo-di
Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China
Abstract Objective To introduce the evidence-based evaluation on off-label uses at home and abroad, so as to in-
vestigate a systematic method of evidence-based evaluation on off-label uses. Methods bination with the domes-
tic and international research literature, a systematic method of evidence-based evaluation on off-label uses was discussed
from the following three aspects: sources of evidence, levels of evidence, and mendation strength. Results Sources
of evidence included Clinical Pharmacology, DRUGDEX® System, Drugs & pendium and hand-
searched literature. Levels of evidence and mendation strength could refer to the 2009 grade system of Oxford
Centre for Evidence-Based Medicine, and the strength of mendations and scientific support of DRUGDEX® System.
Conclusion A systematic method of evidence-base