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金刚烷胺治疗帕金森病运动障碍的随机对照试验。

Amantadine for dyskinesias in Parkinson's disease: a randomized controlled trial.

机构信息

Clinical Research Center, Utano National Hospital, Kyoto City, Japan.

出版信息

PLoS One. 2010 Dec 31;5(12):e15298. doi: 10.1371/journal.pone.0015298.

Abstract

BACKGROUND

Dyskinesias are some of the major motor complications that impair quality of life for patients with Parkinson's disease. The purpose of the present study was to investigate the efficacy of amantadine in Parkinson's disease patients suffering from dyskinesias.

METHODS

In this multi-center, double-blind, randomized, placebo-controlled, cross-over trial, 36 patients with Parkinson's disease and dyskinesias were randomized, and 62 interventions, which included amantadine (300 mg/day) or placebo treatment for 27 days, were analyzed. At 15 days after washout, the treatments were crossed over. The primary outcome measure was the changes in the Rush Dyskinesia Rating Scale (RDRS) during each treatment period. The secondary outcome measures were changes in the Unified Parkinson's Disease Rating Scale part IVa (UPDRS-IVa, dyskinesias), part IVb (motor fluctuations), and part III (motor function).

RESULTS

RDRS improved in 64% and 16% of patients treated with amantadine or placebo, respectively, with significant differences between treatments. The adjusted odds-ratio for improvement by amantadine was 6.7 (95% confidence interval, 1.4 to 31.5). UPDRS-IVa was improved to a significantly greater degree in amantadine-treated patients [mean (SD) of 1.83 (1.56)] compared with placebo-treated patients [0.03 (1.51)]. However, there were no significant effects on UPDRS-IVb or III scores.

CONCLUSIONS

Results from the present study demonstrated that amantadine exhibited efficacious effects against dyskinesias in 60-70% of patients.

TRIAL REGISTRATION

UMIN Clinical Trial Registry UMIN000000780.

摘要

背景

运动障碍是影响帕金森病患者生活质量的主要运动并发症之一。本研究旨在探讨金刚烷胺治疗帕金森病伴运动障碍患者的疗效。

方法

本多中心、双盲、随机、安慰剂对照、交叉试验纳入 36 例帕金森病伴运动障碍患者,随机分为两组,分别接受金刚烷胺(300mg/天)或安慰剂治疗 27 天。洗脱 15 天后交叉治疗。主要结局指标为每个治疗期 Rush 运动障碍评分量表(RDRS)的变化。次要结局指标为统一帕金森病评定量表第四部分 a(UPDRS-IVa,运动障碍)、第四部分 b(运动波动)和第三部分(运动功能)的变化。

结果

分别有 64%和 16%的金刚烷胺或安慰剂治疗患者的 RDRS 改善,治疗之间存在显著差异。金刚烷胺改善的调整优势比为 6.7(95%置信区间,1.4 至 31.5)。与安慰剂治疗患者相比,金刚烷胺治疗患者的 UPDRS-IVa 显著改善[平均(SD)1.83(1.56)]。然而,UPDRS-IVb 或 III 评分无显著影响。

结论

本研究结果表明,金刚烷胺对 60%-70%的患者有效治疗运动障碍。

试验注册

UMIN 临床试验注册 UMIN000000780。

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