[缺血性脑卒中治疗药物临床前评价的进展与挑战]。

药学学报 Pub Date : 2017-03-01
Ying Feng, Fei Ma, Ting-ting Xu, Shan Wang, Long-jian Huang, Xiao-ying Wang, Yong-jun Wang, Xiao-liang Wang
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引用次数: 0

摘要

在过去的几十年里,将科学进步转化为临床实践是中风研究领域的一个主要挑战。原因有很多:动物模型可能不能准确地捕捉人类临床中风的所有方面,没有严格遵循盲随机设计原则,以前没有建立纳入和排除标准,样本量不足,终点不科学也不盲目评估,数据报告不充分和统计缺陷。为了弥合实验和临床研究之间的差距,国际联盟试图建立标准化的研究设计和数据报告指南,包括优化动物模型和实验设计,使用创新的方法评估终点,提供原始数据和阴性结果,建立优先注册机制,开展多中心临床前随机对照试验(prct),对临床前研究的系统回顾和荟萃分析,将最初对神经保护的关注发展为对神经血管单位和缺血级联作用的更广泛考虑。
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[Advances and challenges in preclinical evaluation of therapeutic drugs for treating ischemic stroke].

Translating of scientific advances into clinical practice is a major challenge in the stroke research field in the past decades. There were many reasons involved: animal models might not accurately capture all aspects of clinical stroke in humans, the blind and randomized design principle was not closely followed, the inclusion and exclusion criteria was not previously established, sample size was inadequate, endpoint was not scientific nor blindly assessed, inadequate reporting of data and statistical flaws. To bridge the gap between experimental and clinical research, international consortia have attempted to establish standardized guidelines for study design and data report, which include optimizing animal models as well as experimental design, using innovative approaches to assess endpoint, making raw data and negative results available, establishing prior registration mechanism, conducting multicenter preclinical randomized controlled trials (pRCTs), systematic reviews and meta-analysis of preclinical studies, evolving the original focus on neuroprotection into a broader consideration of the role of neurovascular unit and ischemic cascade.

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来源期刊
药学学报
药学学报 Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)
CiteScore
1.20
自引率
0.00%
发文量
0
期刊介绍: Acta Pharmaceutica Sinica B (APSB) is a bimonthly English peer-reviewed online journal in ScienceDirect, which publishes significant original research articles, communications and high quality reviews of recent advances. APSB encourages submissions from all areas of pharmaceutical sciences, including pharmacology, pharmaceutics, medicinal chemistry, natural products, pharmacognosy, pharmaceutical analysis and pharmacokinetics. APSB is a part of the series Acta Pharmaceutica Sinica, which was founded in 1953. The journal is co-published by Elsevier B.V., in association with the Institute of MateriaMedica, Chinese Academy of Medical Sciences and Chinese Pharmaceutical Association.
期刊最新文献
[Protection effects of schizandrin B against liver injury induced by clozapine in mice]. [Effect of apigenin on dendritic cells maturation and function in murine splenocytes]. [Advances and challenges in preclinical evaluation of therapeutic drugs for treating ischemic stroke]. [Advances in the study of the rat model of aging induced by D-galactose] [Current status of ion channels as drug targets for diabetic neuropathic pain].
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