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保肝草药的临床试验及未来前景的当代综述

Contemporary overview on clinical trials and future prospects of hepato-protective herbal medicines.

作者信息

Alvari Amene, Mehrnaz S Ohadi R, Ahmad Farhan J, Abdin M Z

机构信息

Department of Biotechnology, Jamia Hamdard University, New Delhi, India.

出版信息

Rev Recent Clin Trials. 2012 Aug;7(3):214-23. doi: 10.2174/157488712802281240.

Abstract

Till date the synthetic hepato-protective agents used in clinical practices are therapeutically non-promising and may itself lead to hepatotoxicity. Herbal medicines and their bioactives are considered to be relatively safe and have been used in the treatment of liver diseases for a long time. The 21st century has seen a paradigm shift towards therapeutic standardization of herbal drugs in hepatic disorders by evidence-based randomized controlled clinical trials to support their clinical efficacy. Even so, the specific hepato-protective clinical trial protocols for herbal medicines are not established till now. So, the efficacy of herbal medicines needs to be evaluated through rigorously designed multicentre clinical studies. In this review, we have enlightened the clinically evaluated hepatoprotective herbals and herbal formulations with respect to their status in different trial stages. Moreover, the problems and their strategic solutions during the development of clinical trial protocol for hepatoprotective herbal medicine are also addressed.

摘要

迄今为止,临床实践中使用的合成肝保护剂在治疗上并无前景,而且其本身可能导致肝毒性。草药及其生物活性成分被认为相对安全,并且长期以来一直用于治疗肝脏疾病。21世纪见证了一种范式转变,即通过基于证据的随机对照临床试验来支持草药在肝脏疾病治疗中的临床疗效,从而实现草药治疗的标准化。即便如此,目前尚未建立针对草药的具体肝保护临床试验方案。因此,需要通过精心设计的多中心临床研究来评估草药的疗效。在这篇综述中,我们阐述了经过临床评估的具有肝保护作用的草药和草药制剂在不同试验阶段的情况。此外,还讨论了肝保护草药临床试验方案制定过程中存在的问题及其战略解决方案。

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