Biraben A, De Toffol B, Semah F, Rouaud T
CHU de Rennes, service de Neurologie, Hôpital Pontchaillou, Rennes.
Rev Neurol (Paris). 2007 Apr;163(4):455-61. doi: 10.1016/s0035-3787(07)90421-x.
The use of generic substitution for antiepileptic drugs is more and more frequent but remains controversial.
This survey aimed to assess physicians' feelings towards effectiveness, tolerability and clinical impact of generic substitution of antiepileptic drugs on their patients. A questionnaire was sent to all French private neurologists and hospital specialists in epilepsy. Their responses were recorded from December 2005 to March 2006.
A total of 312 neurologists responded. A few prescribed generic antiepileptic drugs; but a few as well indicated not to switch their prescription. Most of them felt discomfort by generic substitution. One third reported breakthrough seizures or new adverse events after generic substitution and 70p.cent extra phone consultation.
Neurologists' reluctance with prescribing generic AEDs may be explained by several different facts: no controlled study about the safety and efficacy of generic AEDs as compared with brand name drugs, substitutions by pharmacists without their agreement, lack of medical information about generic AEDs, symbolic dimension of the treatment, and, most of all, the fear of breakthrough seizures in patients good controlled.
A prospective controlled evaluation of the safety and efficacy of generic substitution in epilepsy needs to be performed.
抗癫痫药物的通用名替代使用越来越频繁，但仍存在争议。
本次调查旨在评估医生对于抗癫痫药物通用名替代对患者有效性、耐受性及临床影响的看法。向所有法国私立神经科医生及癫痫专科住院医生发放了问卷。于2005年12月至2006年3月记录他们的回复。
共有312名神经科医生回复。少数人开具通用名抗癫痫药物；但也有少数人表示不会更换他们的处方。他们中的大多数人对通用名替代感到不适。三分之一的人报告在通用名替代后出现突破性癫痫发作或新的不良事件，70%的人额外进行了电话咨询。
神经科医生不愿开具通用名抗癫痫药物可能由几个不同的因素解释：与品牌名药物相比，缺乏关于通用名抗癫痫药物安全性和有效性的对照研究，药剂师未经他们同意进行替代，缺乏关于通用名抗癫痫药物的医学信息，治疗的象征意义，以及最重要的是，担心病情得到良好控制的患者出现突破性癫痫发作。
需要对癫痫中通用名替代的安全性和有效性进行前瞻性对照评估。
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