缺血性卒中药物临床前研究的挑战及其对策

发布时间：2018-08-01 09:01

【摘要】：目前缺血性卒中临床前研究所面临的最大挑战是临床转化困难,造成转化困难的原因主要有:动物模型无法复制人类所发生的缺血性卒中;实验设计没有遵循盲法、随机原则;没有预先设定纳入/排除标准;样本量设置不合理;终点指标的选择和评价方法不科学;实验数据的统计缺陷、发表偏倚或不完全等。为此世界各卒中研究学会为临床前研究的实验设计和数据报道制订了相关的准则与指南,包括:改进动物模型和动物实验设计;使用新技术方法对终点指标进行检测;发表阴性结果;建立临床前研究的事先注册与过程监督机制;开展多中心的随机对照临床前实验;采用meta-分析的方法对临床前研究结果进行分析和评价;除以神经保护为靶点外,关注神经血管单元和卒中病理生理级联反应。
[Abstract]:At present, the biggest challenge in the pre-clinical research of ischemic stroke is the difficulty of clinical transformation, which is mainly caused by the following reasons: the animal model can not replicate the ischemic stroke occurring in humans, the experimental design does not follow the blind method, the principle of randomness; No pre-set inclusion / exclusion criteria; unreasonable sample size setting; unscientific selection and evaluation methods of endpoint indicators; statistical defects of experimental data publication bias or incomplete etc. To this end, the World Stroke Research Society has developed relevant guidelines and guidelines for experimental design and data reporting in preclinical studies, including: improving animal models and animal experimental design; using new techniques to detect end-point indicators; To publish negative results; to establish the mechanism of registration and process supervision of preclinical studies; to carry out multi-center randomized controlled preclinical trials; to analyze and evaluate the results of preclinical studies by meta-analysis; In addition to neuroprotection, neurovascular units and stroke pathophysiological cascades are concerned.
【作者单位】：中国医学科学院北京协和医学院药物研究所;美国哈佛医学院附属麻省总医院;首都医科大学附属北京天坛医院;
【基金】：国家自然科学基金资助项目(81473200) 国家“重大新药创制”科技重大专项(2012ZX09301002-004,2014ZX09507003-001) 新药作用机制研究与药效评价北京市重点实验室(BZ0150)
【分类号】：R743.3

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