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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。
Objective To introduce the evidence-based medical evaluation used at home and abroad for drug labeling and to explore the evidence-based medical evaluation method used outside of drug labeling. Methods Based on the relevant literature at home and abroad, this paper discusses the evidence-based medical evaluation methods used in drug labeling from three aspects: the source of evidence, the grading of evidence and the recommended strength. RESULTS Evidence sources used outside of drug labeling included evidence of clinical pharmacology, DRUGDEX® System, oncology pharmacopoeia, and manual retrieval supplementation; evidence grading and recommended strength can be found in the 2009 Oxford Classification of Evidence and Recommendation Strengths (Therapeutic Sections ) And drug counseling system recommended strength and strength of evidence. Conclusion This study initially established a systematic evaluation of evidence-based medicine used outside the labeling of drugs.