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天然健康产品与药物的相互作用:临床试验的系统评价

Natural health product-drug interactions: a systematic review of clinical trials.

作者信息

Mills Edward, Wu Ping, Johnston Bradley C, Gallicano Keith, Clarke Mike, Guyatt Gordon

机构信息

Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.

出版信息

Ther Drug Monit. 2005 Oct;27(5):549-57. doi: 10.1097/01.ftd.0000170880.95267.90.

Abstract

Interactions between natural health products (NHP) and prescription medications are of increasing concern. This paper aims to identify all clinical trials of NHP-drug interactions. To determine the prevalence and outcomes of clinical investigations of NHP-drug pharmacokinetic interactions, electronic databases were searched from inception through March 2004, as well as reference lists from published reports and experts in the field for unpublished studies. Eligible studies were clinical investigations of the interaction between a NHP and the metabolism of a regulated medication in humans. Studies were excluded that only investigated the metabolism of an NHP or examined food-drug or NHP-NHP interactions. Two reviewers selected studies for inclusion and independently extracted data. Forty-seven trials were identified, studying an average of 14 participants/study (95% confidence interval [CI] 11-18), examined drug interactions with 19 different herbal preparations. All trials were pharmacokinetic studies, 41 of healthy volunteers and 6 of patients. Ten different herbal medicines as well as 5 different traditional herbal concoctions were studied. Potentially clinically significant drug interactions were observed with St. John wort (16/24 studies), garlic (2/5 studies), and American ginseng (1 study). Research on NHP-drug interactions is limited in number and scope. With the exception of St. John wort, clinicians and the public do not have information that permits strong inferences about interactions between NHPs and conventional medications.

摘要

天然健康产品(NHP)与处方药之间的相互作用日益受到关注。本文旨在识别所有关于NHP与药物相互作用的临床试验。为了确定NHP与药物药代动力学相互作用临床研究的患病率和结果,检索了从数据库建立至2004年3月的电子数据库,以及已发表报告的参考文献列表,并咨询了该领域专家以获取未发表的研究。符合条件的研究是关于NHP与人类中一种受管制药物代谢之间相互作用的临床研究。仅研究NHP代谢或研究食物-药物或NHP-NHP相互作用的研究被排除。两名评审员选择纳入研究并独立提取数据。共识别出47项试验,平均每项研究有14名参与者(95%置信区间[CI]为11 - 18),研究了与19种不同草药制剂的药物相互作用。所有试验均为药代动力学研究,其中41项针对健康志愿者,6项针对患者。研究了10种不同的草药以及5种不同的传统草药配方。观察到与圣约翰草(16/24项研究)、大蒜(2/5项研究)和西洋参(1项研究)存在潜在具有临床意义的药物相互作用。关于NHP与药物相互作用的研究在数量和范围上都很有限。除了圣约翰草之外,临床医生和公众没有足够信息来有力推断NHP与传统药物之间的相互作用。

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