品牌药到仿制药的转换 - 一项前瞻性观察研究。
Brand-to-generic oxcarbazepine switch - A prospective observational study.
机构信息
Dept. of Neurology, Jagiellonian University Medical College, Krakow, Poland.
Dept. of Neurology, Jagiellonian University Medical College, Krakow, Poland.
出版信息
Epilepsy Res. 2019 Mar;151:75-77. doi: 10.1016/j.eplepsyres.2019.02.017. Epub 2019 Feb 27.
PURPOSE
To determine the clinical outcomes of brand-to- generic oxcarbazepine (OXC) switch in patients with epilepsy.
METHODS
This prospective observational study included 103 patients treated with OXC in the tertiary outpatient epilepsy clinic. In 2016 the price of the brand-name OXC in Poland increased by 10 times in comparison to the generic products. Assuming that the majority of the patients would be forced to switch to generic drugs due to financial issues we decided to follow them prospectively to evaluate the safety of switching from brand-name to generic OXC.
RESULTS
A quarter of our cohort (26%) decided to continue on brand-name OXC, the majority (74%) switched to generic products. We did not find differences in terms of frequency of seizures and adverse events between patients continuing on brand-name OXC and those switching to generic AED.
CONCLUSION
The switching from brand-name to generic OXC seems to be safe, however, larger prospective studies are required in order to confirm our findings.
目的
确定癫痫患者品牌到仿制药奥卡西平（OXC）转换的临床结果。
方法
这项前瞻性观察性研究包括在三级门诊癫痫诊所接受 OXC 治疗的 103 名患者。2016 年，波兰的品牌 OXC 价格与仿制药相比上涨了 10 倍。由于考虑到大多数患者因经济问题将被迫改用仿制药，我们决定对他们进行前瞻性随访，以评估从品牌 OXC 转换为仿制药 OXC 的安全性。
结果
我们的队列中有四分之一（26%）的患者决定继续使用品牌 OXC，大多数（74%）的患者转为使用仿制药。我们没有发现继续使用品牌 OXC 的患者和转为使用仿制药 AED 的患者在癫痫发作频率和不良事件方面存在差异。
结论
从品牌到仿制药 OXC 的转换似乎是安全的，然而，需要进行更大规模的前瞻性研究来证实我们的发现。
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