Tolcapone improves motor function and reduces levodopa requirement in patients with Parkinson's disease experiencing motor fluctuations: A multicenter, double-blind, randomized, placebo-controlled trial
Tolcapone improves motor function and reduces levodopa requirement in patients with Parkinson's disease experiencing motor fluctuations: A multicenter, double-blind, randomized, placebo-controlled trial
复制标题
DOI：
10.1212/wnl.48.1.81
复制
发表时间：
1997-01-01
期刊：
影响因子：
9.9
通讯作者：
Magni, G
中科院分区：
文献类型：
--
作者：
Kurth, MC;Adler, CH;Magni, G
托卡朋是一种有效的儿茶酚-O-甲基转移酶抑制剂，可延长左旋多巴的血浆半衰期。这项多中心、双盲、安慰剂对照研究使用了两项10小时的临床评价，以比较三种剂量的托卡朋（50、200和400 mg tid）与安慰剂在经历左旋多巴/卡比多巴运动波动的帕金森病（PD）患者中的疗效和安全性。151例患者完成了研究。在第-1天和第42天使用联合帕金森病评定量表运动子量表和“开/关”进行持续10小时的临床评价，每30分钟进行一次运动障碍评估。与安慰剂治疗相比，在所有剂量水平下，托卡朋显著减少了平均40%的“关闭"时间，并增加了约25%的总”开启“时间。左旋多巴/卡比多巴剂量和频率显著降低。托卡朋耐受性良好，患者经历典型的多巴胺能副作用，可以通过降低左旋多巴/卡比多巴剂量来减少或消除。托卡朋可有效延长左旋多巴的临床获益，并降低运动波动PD患者的总左旋多巴需求量。
Tolcapone is a potent catechol-O-methyltransferase inhibitor that prolongs the plasma half-life of levodopa. This multicenter, double-blind, placebo-controlled study used two 10-hour clinical evaluations to compare the efficacy and safety of three doses of tolcapone (50, 200, and 400 mg tid) with placebo in patients with Parkinson's disease (PD) experiencing motor fluctuations from levodopa/carbidopa. One hundred fifty-one patients completed the study. Clinical evaluations lasting 10 hours were performed on day -1 and day 42 using United Parkinson's Disease Rating Scale motor subscale and ''on/off'' and dyskinesia assessments every 30 minutes. Tolcapone significantly reduced ''off'' time an average of 40% and increased total ''on'' time by about 25% at all dose levels, as compared to placebo treatment. Levodopa/carbidopa dosage and frequency were significantly reduced. Tolcapone was well tolerated, with patients experiencing typical dopaminergic side effects that could be reduced or eliminated by lowering levodopa/carbidopa dosages. Tolcapone was effective at prolonging the clinical benefit of levodopa and reducing total levodopa requirements in PD patients with motor fluctuations.