摘要
早期循证医学所倡导的证据分类和分级体系多基于不同研究设计类型针对干预效力的评价。这些体系给临床研究,给医学实践带来了巨大影响。随着时间推移,这些体系的应用逐渐出现了弊端。特别是在引入到现今真实世界研究和中药上市后安全性评价研究领域时,遇到了许多无法兼容的问题。国内外有关上市后药品安全性证据分级和分类研究尚不多见,研究者们发现系统地收集和评价有关上市后药品安全性证据有重要意义。借鉴循证医学有效性证据分类、分级的成功经验,探索对上市后中药安全性证据评价、分类和分级标准并形成安全性证据评价的基本框架,从点、线、面等多个角度出发,综合不同证据源,构建上市后中药安全性评价证据体,为今后该领域证据体系的研究提供方向和技术支持。
The traditional evidence evaluating hierarchy developed at the early stage in evidence- based medicine （EBM）, founded on an efficacy evaluation model of intervention, is generalized to whole medical research and clinical practice. However, such a hierarchy system were increasingly abused and misunderstood, which has become an obstacle for clinical decision making process. The hierarchical model is valid for limited questions of efficacy and inadequate for the evaluation of interventions in real world, especially safety evidence for postmarketing Chinese medicines. There are very few studies re- porting the evidence grading and classification of postmarketing herbs＇ safety at home and abroad. There- fore, systematical collection and evaluation of evidence of postmarketing herbs＇ safety are of important significance. By referring to successful experiences in evidence grading and classification of drug effec- tiveness in EBM, authors studied the establishment of standards for evaluation, classification and grad- ing of safety evidence of postmarketing Chinese herbs, and the formation of basic frameworks of safety evidence evaluation, and comprehensively analyzed different sources of evidence from the perspectives of point, line, and surface, thus establishing the evidence body for safety evaluation of postmarketing Chinese herbs, and providing methodology and technical supports for future studies on evidence system in this field.
出处
《中国中西医结合杂志》
CAS
CSCD
北大核心
2017年第1期109-114,共6页
Chinese Journal of Integrated Traditional and Western Medicine
基金
国家自然科学基金青年基金资助项目(No.81202776)
中国中医科学院客座研究员联合创新研究项目(No.ZZ070817)
第九批中国中医科学院自主选题研究项目课题(No.Z0406)
2014年第七批博士后特别资助项目(No.2017T70202)
关键词
上市后中药再评价
安全性
证据评价
循证医学
postmarketing re-evaluation of Chinese herbs
safety
evidence evaluation
evidence-based medicine
