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已发表的苦橙提取物和辛弗林不良事件临床研究病例报告综述。

Review of Published Bitter Orange Extract and -Synephrine Adverse Event Clinical Study Case Reports.

作者信息

Stohs Sidney J, Ray Sidhartha D

机构信息

Creighton University Medical Center, Omaha, NE, USA Kitsto Consulting LLC, Frisco, TX, USA.

Manchester University College of Pharmacy, Ft. Worth, IN, USA.

出版信息

J Diet Suppl. 2020;17(3):355-363. doi: 10.1080/19390211.2019.1577936. Epub 2019 Mar 5.

DOI:10.1080/19390211.2019.1577936
PMID:30835576
Abstract

-Synephrine is the primary active ingredient in bitter orange () extract and is present in other citrus species. This review summarizes all known case reports that have been published regarding adverse events associated with multi-ingredient dietary supplements containing bitter orange extract. A common characteristic of all the case studies was the assumption that if bitter orange extract is listed on the label of the product it is the most likely cause of any adverse effect, although in no case was the presence of -synephrine determined or a direct link demonstrated. No case study reviewed the existing published literature, and all failed to note that numerous clinical studies have not demonstrated adverse effects at commonly used doses. Most studies did not indicate the composition of the product involved, and no study analyzed the product in question. In no case was a direct correlation between the event and -synephrine made. Although -synephrine and ephedrine have some structural similarity, the structural differences result in markedly different pharmacokinetic, physiological, and pharmacological effects, and thus the effects produced by ephedrine cannot be extrapolated to -synephrine.

摘要

辛弗林是苦橙提取物中的主要活性成分,也存在于其他柑橘类植物中。本综述总结了所有已发表的关于含苦橙提取物的多成分膳食补充剂相关不良事件的已知病例报告。所有病例研究的一个共同特点是,假设如果产品标签上列出了苦橙提取物,那么它就是任何不良反应最可能的原因,尽管在任何情况下都未确定辛弗林的存在或证明直接关联。没有病例研究回顾现有的已发表文献,并且所有研究都未注意到大量临床研究表明常用剂量下无不良反应。大多数研究未表明所涉产品的成分,也没有研究对相关产品进行分析。在任何情况下都未建立事件与辛弗林之间的直接关联。尽管辛弗林和麻黄碱在结构上有一些相似之处,但结构差异导致药代动力学、生理学和药理学效应明显不同,因此麻黄碱产生的效应不能外推至辛弗林。

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