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Efficacy and motor complications of original and generic levodopa in Parkinson's disease treatment

机译:左旋多巴和普通左旋多巴在帕金森病治疗中的疗效和运动并发症

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Background: In general, a generic drug is considered interchangeable with the original formulated drug. In Parkinson’s disease (PD), generic drug use remains debated. This study was aimed to investigate whether the generic drug was as effective as the original in improving the symptoms of PD and the prevalence of motor complications. Methods: This study was a multicenter cohort study of patients with PD enrolled from three northeast hospitals in Thailand between February 2013 and February 2014. The patients were categorized into original and generic levodopa groups. The clinical characteristics, efficacy, and motor complications were compared between the groups. Results: There were 400 eligible patients. Of these, 327 patients (81.75%) met the study criteria and were classified as the original levodopa group (200 patients, 61.16%) and the generic levodopa group (127 patients, 38.84%). The average age of all patients with PD was 65 years. The duration of PD and the modified Hoehn–Yahr stages were not different between the groups. The total doses of original and generic levodopa-equivalent doses were significantly different (199.97±127.08 versus 305.58±138.27 mg; P -value 0.999), but the development of motor complications was significantly greater in the original than in the generic group. Conclusion: Generic levodopa was effective in improving the symptoms of PD. The prevalence of motor complications in the original compound group, at a lower dose of levodopa equivalent, was higher than in the generic group.
机译:背景:一般而言,仿制药被认为可与原始配方药物互换。在帕金森氏病(PD)中,仿制药的使用仍存在争议。这项研究旨在调查该仿制药在改善PD症状和运动并发症患病率方面是否与原始药物一样有效。方法:这项研究是一项多中心队列研究,研究对象为2013年2月至2014年2月在泰国三所东北医院招募的PD患者。这些患者分为原始左旋多巴和普通左旋多巴。比较两组之间的临床特征,疗效和运动并发症。结果:有400名合格患者。其中,符合研究标准的327例患者(占81.75%)被划分为原始左旋多巴组(200例患者,占61.16%)和普通左旋多巴组(127例患者,占38.84%)。所有PD患者的平均年龄为65岁。两组之间的PD持续时间和改良的Hoehn-Yahr阶段无差异。左旋多巴等效剂量的原始和总剂量显着不同(199.97±127.08与305.58±138.27 mg; P值0.999),但运动并发症的发生在原始组比在普通组显着更大。结论:通用左旋多巴可有效改善PD的症状。左旋多巴当量剂量较低时,原始化合物组的运动并发症患病率高于普通组。

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