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司来吉兰作为帕金森病的主要治疗方法——一项长期双盲研究。

Selegiline as the primary treatment of Parkinson's disease--a long-term double-blind study.

作者信息

Myllylä V V, Sotaniemi K A, Hakulinen P, Mäki-Ikola O, Heinonen E H

机构信息

Department of Neurology, Oulu University Hospital, Finland.

出版信息

Acta Neurol Scand. 1997 Apr;95(4):211-8. doi: 10.1111/j.1600-0404.1997.tb00101.x.

DOI:10.1111/j.1600-0404.1997.tb00101.x
PMID:9150811
Abstract

INTRODUCTION

To assess the therapeutic efficacy of selegiline combined with levodopa in the long-term treatment of Parkinson's disease (PD).

MATERIAL AND METHODS

A randomized, prospective, double-blind study on 44 patients with PD needing levodopa therapy after the initial double-blind treatment with placebo or selegiline was carried out. The patients were followed-up for 5 years under combination therapy.

RESULTS

Selegiline induced a significant (P < 0.001) slowing in the need to increase the daily levodopa dose in order to compensate for the progression of the disease. After 5 years of combination therapy the mean dose of levodopa was on average 320 mg lower in the selegiline group (405 +/- 59 mg vs 725 +/- 78 mg). The difference in the levodopa doses between the two groups increased along with follow-up time, as also the ratio of the levodopa doses (placebo/selegiline group). The number of daily levodopa doses needed to compensate for the occurrence of motor fluctuations was significantly lower in the selegiline group. The parkinsonian disability did not differ between the two groups because the clinical condition was kept as optimal as possible by adjusting the levodopa dosage. Nine patients in the placebo group needed initiation of additional dopaminergic therapy in comparison to one in the selegiline group (P = 0.004). During the 5-year follow-up period 11 patients were withdrawn from the selegiline group, 7 due to adverse events. There was no difference in mortality between the two groups.

CONCLUSIONS

Selegiline therapy offers beneficial long-term effets in the treatment of PD.

摘要

引言

评估司来吉兰联合左旋多巴在帕金森病(PD)长期治疗中的疗效。

材料与方法

对44例在初始接受安慰剂或司来吉兰双盲治疗后需要左旋多巴治疗的PD患者进行了一项随机、前瞻性、双盲研究。患者在联合治疗下随访5年。

结果

司来吉兰显著(P < 0.001)延缓了为补偿疾病进展而增加每日左旋多巴剂量的需求。联合治疗5年后,司来吉兰组的左旋多巴平均剂量平均比另一组低320mg(405±59mg对725±78mg)。两组之间左旋多巴剂量的差异随随访时间增加,左旋多巴剂量之比(安慰剂/司来吉兰组)也是如此。司来吉兰组为补偿运动波动发生所需的每日左旋多巴剂量数显著更低。两组之间帕金森病残疾情况无差异,因为通过调整左旋多巴剂量使临床状况尽可能保持最佳。与司来吉兰组的1例患者相比,安慰剂组有9例患者需要开始额外的多巴胺能治疗(P = 0.004)。在5年随访期内,司来吉兰组有11例患者退出,7例因不良事件退出。两组之间死亡率无差异。

结论

司来吉兰治疗在PD治疗中具有有益的长期效果。

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