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司来吉兰用于初发帕金森病患者:芬兰的研究。

Selegiline in de novo parkinsonian patients: the Finnish study.

作者信息

Myllylä V V, Sotaniemi K A, Vuorinen J A, Heinonen E H

机构信息

Department of Neurology, University of Oulu, Finland.

出版信息

Mov Disord. 1993;8 Suppl 1:S41-4. doi: 10.1002/mds.870080509.

Abstract

Selegiline (L-deprenyl) has been recommended as an antiparkinsonian drug to be used as an adjunct to therapy with L-dopa, if and when L-dopa starts to lose its effect. However, initial selegiline monotherapy followed by L-dopa may be both effective and safe. A double-blind, placebo-controlled trial was carried out in previously untreated patients with Parkinson's disease randomized to receive selegiline (10 mg/day; 27 patients) or placebo (25 patients) until L-dopa treatment became imperative. Three rating scales were used for assessment. The study design continues to be double-blind even after L-dopa is introduced. L-Dopa was needed after 545 +/- 90 days in the selegiline group. This was significantly later (p = 0.03) than after placebo (372 +/- 28 days). Disability was less severe in the selegiline group, and there were no serious adverse effects. A nearly twofold dose of L-dopa was needed in the placebo group to achieve a sufficient therapeutic effect during long-term treatment. These results show that selegiline is safe and effective as monotherapy in early parkinsonism. It delays the need for L-dopa treatment and reduces the amount of daily L-dopa required. This could be explained by either a symptomatic effect or neuroprotective efficacy or, more likely, a combination of both.

摘要

司来吉兰(L-司来吉兰)已被推荐作为一种抗帕金森病药物,当左旋多巴开始失去疗效时,用作左旋多巴治疗的辅助药物。然而,最初采用司来吉兰单药治疗,随后使用左旋多巴,可能既有效又安全。在未经治疗的帕金森病患者中进行了一项双盲、安慰剂对照试验,将患者随机分为两组,一组接受司来吉兰(10毫克/天;27例患者),另一组接受安慰剂(25例患者),直至必须开始使用左旋多巴治疗。使用三个评定量表进行评估。即使在引入左旋多巴后,研究设计仍保持双盲。司来吉兰组在545±90天后需要使用左旋多巴。这明显晚于安慰剂组(372±28天)(p = 0.03)。司来吉兰组的残疾程度较轻,且无严重不良反应。在长期治疗期间,安慰剂组需要近两倍剂量的左旋多巴才能达到足够的治疗效果。这些结果表明,司来吉兰作为早期帕金森病的单药治疗是安全有效的。它延迟了左旋多巴治疗的需求,并减少了每日所需左旋多巴的用量。这可以通过症状性作用或神经保护作用来解释,或者更可能是两者的结合。

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