Myllylä V V, Sotaniemi K A, Vuorinen J A, Heinonen E H
Department of Neurology, University of Oulu, Finland.
Acta Neurol Scand Suppl. 1991;136:70-2. doi: 10.1111/j.1600-0404.1991.tb05023.x.
In order to investigate the efficacy of selegiline as a primary treatment in Parkinson's disease (PD), we carried out a placebo controlled, double-blind prospective trial. Fifty-four de novo patients with PD were randomized to receive either selegiline (10 mg/day) or matching placebo. We continued the monotherapy until the initiation of levodopa therapy became necessary. The disability of the patients was evaluated with three different rating scales at baseline, after 3 weeks, 2, 4, 8, and 12 months, and every 4 months thereafter. Fifty-two patients were eligible for the final analysis: 27 in the selegiline group and 25 in the placebo group. The median duration of time without levodopa was 545 +/- 90 days in the selegiline treated patients and 372 +/- 28 days in the placebo treated ones (p = 0.03). The disability of the patients was significantly milder in the selegiline than in the placebo group up to 12 months. More patients showed symptomatic improvement in the selegiline than in the placebo group. However, the symptomatic effect alone did not explain the prolongation of the time without levodopa in the selegiline treated patients. Selegiline was well tolerated and no severe side effects were encountered.
为了研究司来吉兰作为帕金森病（PD）初始治疗药物的疗效，我们进行了一项安慰剂对照、双盲前瞻性试验。54例新发PD患者被随机分为两组，分别接受司来吉兰（10毫克/天）或匹配的安慰剂治疗。我们持续进行单一疗法，直到有必要开始左旋多巴治疗。在基线、3周、2个月、4个月、8个月和12个月时，以及此后每4个月，使用三种不同的评定量表对患者的残疾情况进行评估。52例患者符合最终分析条件：司来吉兰组27例，安慰剂组25例。司来吉兰治疗的患者无左旋多巴治疗的中位时间为545±90天，安慰剂治疗的患者为372±28天（p = 0.03）。在长达12个月的时间里，司来吉兰组患者的残疾程度明显轻于安慰剂组。与安慰剂组相比，司来吉兰组有更多患者出现症状改善。然而，仅症状改善这一效应并不能解释司来吉兰治疗的患者无左旋多巴治疗时间的延长。司来吉兰耐受性良好，未出现严重副作用。
