Golbe L I, Lieberman A N, Muenter M D, Ahlskog J E, Gopinathan G, Neophytides A N, Foo S H, Duvoisin R C
Department of Neurology, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick 08903.
Clin Neuropharmacol. 1988 Feb;11(1):45-55. doi: 10.1097/00002826-198802000-00004.
Deprenyl, a selective inhibitor of monoamine oxidase, type B, which is free of the "tyramine effect," may ameliorate symptom fluctuations in advanced Parkinson's disease (PD). We randomized 96 patients with marked symptom fluctuations at three centers to receive either deprenyl 5 mg b.i.d. or placebo in parallel fashion in addition to a previously optimized levodopa/carbidopa (Sinemet) regimen. Disability was recorded hourly at home by patients 3 days weekly during the 2-week baseline and the 6-week treatment period. Disability during the "on" state was assessed each week by examination. Mean hourly self-assessment of gait improved in 28 of 50 patients (56%) receiving deprenyl (mean degree of improvement 0.25 points on a 0-2 scale) and in 14 of 46 (30.4%) taking placebo (mean 0.15). Mean hourly overall symptom control improved in 29 (58%) taking deprenyl (mean 0.34) and in 12 (26.1%) taking placebo (mean 0.15) (p less than 0.01 for each parameter). No significant improvement occurred in the objective quality of the "on" state with deprenyl. Mean daily Sinemet dosage decreases were 17% in the deprenyl group and 7% in the placebo group. Adverse effects included nausea, light-headedness, dyskinesias, and hallucinations, all of which abated after the Sinemet dose was reduced. We conclude that deprenyl is of moderate benefit in a majority of patients with symptom fluctuations complicating PD and is generally well tolerated.
司来吉兰是一种对B型单胺氧化酶有选择性抑制作用且无“酪胺效应”的药物,它可能会改善晚期帕金森病(PD)患者的症状波动。我们将96例在三个中心症状波动明显的患者随机分组,除了之前优化的左旋多巴/卡比多巴(息宁)治疗方案外,一组患者每日两次服用5毫克司来吉兰,另一组服用安慰剂,两组平行对照。在为期2周的基线期和6周的治疗期内,患者每周有3天在家中每小时记录一次残疾情况。每周通过检查评估“开”状态下的残疾情况。在接受司来吉兰治疗的50例患者中,有28例(56%)每小时自我评估的步态得到改善(在0至2分的量表上平均改善程度为0.25分),而在服用安慰剂的46例患者中有14例(30.4%)得到改善(平均0.15分)。在服用司来吉兰的患者中,有29例(58%)每小时总体症状控制得到改善(平均0.34分),服用安慰剂的患者中有12例(26.1%)得到改善(平均0.15分)(每个参数的p值均小于0.01)。司来吉兰对“开”状态的客观质量没有显著改善。司来吉兰组的息宁日均剂量降低了17%,安慰剂组降低了7%。不良反应包括恶心、头晕、运动障碍和幻觉,在减少息宁剂量后所有这些不良反应均减轻。我们得出结论,司来吉兰对大多数伴有症状波动的帕金森病患者有中度益处,且总体耐受性良好。