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仿制药真的是劣等药品吗?

Are generic drugs really inferior medicines?

机构信息

Department of Pharmacology, University of Bordeaux, Bordeaux, France.

出版信息

Clin Pharmacol Ther. 2010 Sep;88(3):302-4. doi: 10.1038/clpt.2010.168.

Abstract

In this issue Gagne et al. report an elegant case-crossover study of seizures in patients on antiepileptic drugs. They found that a dispensation episode approximately triples the risk of having a seizure within 21 days, but the risk is not statistically different whether the dispensation was of the same brand-name or generic drug as previously used or a switch from brand-name to a generic or from a generic to a brand name. The cause of the seizure might be a delay in taking medication or late redispensation, among others, but apparently the nature of the product dispensed is not relevant in this study; this may alleviate some of the concerns about generic drugs and epilepsy.

摘要

在本期中,Gagne 等人报告了一项关于抗癫痫药物治疗患者癫痫发作的精心设计的病例交叉研究。他们发现,配药事件使 21 天内发生癫痫的风险大约增加了两倍,但配药与之前使用的品牌名或仿制药相同或从品牌名切换到仿制药或从仿制药切换到品牌名,风险并无统计学差异。癫痫发作的原因可能是延迟服药或重新配药延迟等,但显然在这项研究中,所配药物的性质并不相关;这可能会减轻一些对仿制药和癫痫的担忧。

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