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右美沙芬。安全问题概述。

Dextromethorphan. An overview of safety issues.

作者信息

Bem J L, Peck R

机构信息

Pharma Division, F. Hoffmann-LaRoche Ltd, Basel, Switzerland.

出版信息

Drug Saf. 1992 May-Jun;7(3):190-9. doi: 10.2165/00002018-199207030-00004.

Abstract

Dextromethorphan is a highly effective and widely used nonopioid antitussive drug. As it has been in use for more than 30 years, a large body of clinical experience has been used to formulate a safety profile. An anthology of adverse drug events has been analysed, drawn both from published case records and a data base recording dextromethorphan-related adverse events spontaneously reported by physicians or pharmacists. The resulting safety profile indicates that adverse drug reactions are infrequent and usually not severe. The predominant symptoms are usually dose related and include neurological, cardiovascular and gastrointestinal disturbances. Particular safety concerns arise when monoamine oxidase inhibiting (MAOI) drugs and dextromethorphan are coadministered. In addition to adverse drug reactions, the safety profile of dextromethorphan is affected by episodic and sporadic abuse. In fact, abuse appeared to be the most significant hazard identified by analysis of spontaneous adverse event reporting. No evidence could be found that the well documented pharmacokinetic polymorphism observed with dextromethorphan is correlated with any clinically significant safety risk if it is used for short term treatment. In summary, the safety profile of dextromethorphan is reassuring, particularly relating to overdose in adults and children.

摘要

右美沙芬是一种高效且广泛使用的非阿片类镇咳药。由于其已使用超过30年,大量临床经验已被用于制定其安全性概况。已对一系列药物不良事件进行了分析,这些不良事件来自已发表的病例记录以及一个记录医生或药剂师自发报告的与右美沙芬相关不良事件的数据库。由此得出的安全性概况表明,药物不良反应并不常见,且通常不严重。主要症状通常与剂量相关,包括神经、心血管和胃肠道紊乱。当单胺氧化酶抑制(MAOI)药物与右美沙芬合用时,会出现特殊的安全问题。除了药物不良反应外,右美沙芬的安全性概况还受到偶发性和散发性滥用的影响。事实上,滥用似乎是通过对自发不良事件报告的分析确定的最重大危害。未发现有证据表明右美沙芬存在的已充分记录的药代动力学多态性与短期治疗时的任何临床显著安全风险相关。总之,右美沙芬的安全性概况令人放心,尤其是在成人和儿童过量用药方面。

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