Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Clin Pharmacol Ther. 2010 Sep;88(3):347-53. doi: 10.1038/clpt.2010.90. Epub 2010 Jul 14.
We sought to estimate the risk of seizure-related events associated with refilling prescriptions for antiepileptic drugs (AEDs) and to estimate the effect of switching between brand-name and generic drugs or between two generic versions of the same drug. We conducted a case-crossover study using health-care databases from British Columbia, Canada, among AED users who had an emergency room visit or hospitalization for seizure (index seizure-related event), defined using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9) codes 345.xx (epilepsy and recurrent seizures) and 780.3x (convulsions), between 1997 and 2005. AED prescription refilling itself was associated with 2.3-fold elevated odds of seizure-related events when the refill occurred within 21 days before the index event (odds ratio (OR) 2.31; 95% confidence interval (CI) 1.56-3.44). The OR was 2.75 (95% CI 0.88-8.64) for refills that involved switching, yielding a refill-adjusted OR for switching of 1.19 (95% CI 0.35-3.99). Refilling the same AED prescription was associated with an elevated risk of seizure-related events whether or not the refill involved switching from a brand-name to a generic product.
我们旨在评估与抗癫痫药物(AED)处方再配药相关的癫痫发作相关事件的风险,并评估在品牌药和仿制药之间或同一药物的两种仿制药之间转换的效果。我们使用来自加拿大不列颠哥伦比亚省的医疗保健数据库,对 1997 年至 2005 年间因癫痫发作(以 ICD-9 代码 345.xx(癫痫和反复性发作)和 780.3x(抽搐)定义的急诊室就诊或住院的 AED 使用者进行了病例交叉研究。AED 处方再配药本身与癫痫发作相关事件的发生几率增加了 2.3 倍,当再配药发生在索引事件前 21 天内时(比值比(OR)2.31;95%置信区间(CI)1.56-3.44)。涉及转换的再配药的 OR 为 2.75(95% CI 0.88-8.64),转换的再配药调整后的 OR 为 1.19(95% CI 0.35-3.99)。无论再配药是否涉及从品牌药转换为仿制药,使用相同的 AED 处方再配药都与癫痫发作相关事件的风险增加有关。