弥散型左旋多巴-苄丝肼治疗帕金森病204例的多中心研究

目的 :观察弥散型左旋多巴 苄丝肼 (DM )治疗帕金森病的疗效和安全性。方法 :采用全国多中心、开放性试验 ,给原用标准片左旋多巴 苄丝肼的 2 0 4例帕金森病病人 ,根据伴随症状的不同 ,选用不同的弥散型左旋多巴 苄丝肼治疗共 8wk。通过Webster评分、病人日记和实验室检查评价药物疗效和安全性。结果 :由标准片左旋多巴 苄丝肼改用或加用弥散型左旋多巴 苄丝肼后 ,“开”期潜伏期缩短 37min ,“开”期持续时间增加 4 7min ,“关”期减少 11min ,Webster评分改善 2 5% ,P <0 .0 1。不良反应少。结论 :弥散型左旋多巴 苄丝肼是一种快速有效和安全的抗帕金森病药物新剂型 ,尤适用于晨僵、“开”期延迟、午后“关闭”、吞咽困难等帕金森病病人

Dispersible formulation oflevodopa-benserazide in treatment of 204 parkinson disease: a multicenter study

AIM: To study the efficacy and safety of dispersible formulation of levodopa-benserazide on the parkinson disease.　METHODS: The multicenter, open-label, self-controlled trial was conducted at 23 hospitals in 15 cities. Two hundred and four patients with idiopathic parkinson who had received standard levodopa-benserazide previously participated in this study. Dispersible levodopa-benserazide instead of standard levodopa-benserazide for 8 wk as a course. The Webster rating scale and patient diary were applied to assess the efficacy and safety of dispersible levodopa-benserazide.　RESULTS： The medication with dispersible levodopa-benserazide increased “on” time by 47 min, decreased “off” time by 11 min, and speeded the onset of “on” time by 37 min. The Webster score was improved by 25 %. Statistical significant difference was calculated (P<0.01). Slight and few adverse reactions were found.　CONCLUSION: Dispersible formulation of levodopa-benserazide is a powerful anti-parkinsonian drug characterized by oral easy use and rapid reach to therapeutic action after ingestion. This drug is particularly used in the parkinsonian patients with morning akinesia, delayed onset of “on” time, afternoon “off” status and dysphagia.