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罗匹尼罗作为帕金森病辅助治疗的多中心试验。罗匹尼罗研究组。

A multicenter trial of ropinirole as adjunct treatment for Parkinson's disease. Ropinirole Study Group.

作者信息

Lieberman A, Olanow C W, Sethi K, Swanson P, Waters C H, Fahn S, Hurtig H, Yahr M

机构信息

Barrow Neurological Institute, Phoenix, AZ 85013-4496, USA.

出版信息

Neurology. 1998 Oct;51(4):1057-62. doi: 10.1212/wnl.51.4.1057.

DOI:10.1212/wnl.51.4.1057
PMID:9781529
Abstract

OBJECTIVE

To evaluate the nonergot dopamine agonist ropinirole as an adjunct to L-dopa in a randomized, double-blind trial in PD patients with motor fluctuations.

BACKGROUND

L-dopa in the treatment of PD is associated with motor fluctuations, dyskinesia, and other adverse effects. The use of dopamine agonists in the treatment of PD delays recourse to L-dopa and thus delays the possibility of adverse effect onset.

METHODS

Ropinirole (n = 95) or placebo (n = 54) was added to L-dopa, and L-dopa was then reduced in a planned manner during the 6-month trial.

RESULTS

A significantly greater number of ropinirole patients were able to achieve a 20% or greater reduction in both L-dopa dose and in percent time spent "off" compared with placebo (35.0% versus 13.0%; p = 0.003). The mean daily L-dopa dose was reduced significantly with ropinirole treatment (242 mg versus 51 mg; p < 0.001) as was the percent awake time spent "off" (11.7% versus 5.1%; p = 0.039). There was no difference in the percent of patients who withdrew because of adverse effects (15.8% on ropinirole versus 16.7% on placebo).

CONCLUSIONS

Ropinirole permits a reduction in L-dopa dose with enhanced clinical benefit for PD patients with motor fluctuations.

摘要

目的

在一项针对有运动波动的帕金森病患者的随机双盲试验中,评估非麦角多巴胺激动剂罗匹尼罗作为左旋多巴辅助药物的效果。

背景

左旋多巴用于治疗帕金森病会引发运动波动、异动症及其他不良反应。使用多巴胺激动剂治疗帕金森病可延迟使用左旋多巴,从而延缓不良反应的发生。

方法

在左旋多巴治疗基础上加用罗匹尼罗(n = 95)或安慰剂(n = 54),然后在为期6个月的试验中按计划减少左旋多巴用量。

结果

与安慰剂组相比,罗匹尼罗组有更多患者能够使左旋多巴剂量及“关”期时间百分比降低20%或更多(35.0%对13.0%;p = 0.003)。罗匹尼罗治疗使平均每日左旋多巴剂量显著降低(242毫克对51毫克;p < 0.001),“关”期清醒时间百分比也显著降低(11.7%对5.1%;p = 0.039)。因不良反应退出的患者百分比无差异(罗匹尼罗组为15.8%,安慰剂组为16.7%)。

结论

对于有运动波动的帕金森病患者,罗匹尼罗可降低左旋多巴剂量并增强临床疗效。

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