罗匹尼罗治疗慢性血液透析患者不安腿综合征：与左旋多巴缓释片对比的开放性随机交叉试验
Ropinirole as a treatment of restless legs syndrome in patients on chronic hemodialysis: an open randomized crossover trial versus levodopa sustained release.
作者信息
Pellecchia Maria Teresa, Vitale Carmine, Sabatini Massimo, Longo Katia, Amboni Marianna, Bonavita Vincenzo, Barone Paolo
机构信息
Department of Neurological Sciences, University Federico II, Naples, Italy.
出版信息
Clin Neuropharmacol. 2004 Jul-Aug;27(4):178-81. doi: 10.1097/01.wnf.0000135480.78529.06.
OBJECTIVE
Restless legs syndrome (RLS) is a common neurologic condition characterized by uncomfortable and unpleasant sensations in the legs, occurring primarily at rest, which are usually worse in the evening and are alleviated by movement. RLS is present in 20-40% of patients with renal failure. This study was a 14-week open, randomized, crossover trial of ropinirole vs. levodopa sustained release (SR) in 11 patients with RLS on chronic hemodialysis.
METHODS
Eleven patients (7 men, 4 women) were enrolled in the study. They received either levodopa SR or ropinirole for 6 weeks, followed by a washout week, then the alternate treatment for 6 weeks. Patients rated the severity of RLS by means of a 6-item questionnaire developed by the International Restless Legs Study Group (6-item IRLS), by the Clinical Global Impression (CGI) scale, and by sleep diaries.
RESULTS
Under treatment with levodopa SR, 1 patient presented severe vomiting, leading to study discontinuation. The 10 patients who completed the study reported a 33.5% improvement (from 16.7 +/- 3.2 to 11.1 +/- 4; P < 0.001) of the 6-item IRLS scores during levodopa SR treatment and a 73.5% improvement (from 16.6 +/- 2.8 to 4.4 +/- 3.8; P < 0.001) during ropinirole treatment. By the end of the study the mean levodopa SR dosage was 190 mg/d and the mean ropinirole dosage was 1.45 mg/d. Ropinirole was superior to levodopa SR in reducing 6-item IRLS scores (P < 0.001) and in increasing sleep time (P < 0.001). The patient CGI scale showed a significant difference favoring ropinirole (P < 0.01). There was no significant carryover or period effect for any outcome measure. Four patients reported a complete reversion of RLS symptoms during ropinirole treatment at doses ranging from 0.25-2 mg/d.
CONCLUSIONS
These results suggest that ropinirole is more effective than levodopa SR in the treatment of RLS in patients on chronic hemodialysis.
目的
不安腿综合征（RLS）是一种常见的神经系统疾病，其特征为腿部出现不适和不愉快的感觉，主要在休息时发生，通常在晚上更严重，活动后可缓解。RLS在20%至40%的肾衰竭患者中存在。本研究是一项为期14周的开放性、随机、交叉试验，比较罗匹尼罗与左旋多巴缓释剂（SR）对11例接受慢性血液透析的RLS患者的疗效。
方法
11例患者（7例男性，4例女性）纳入研究。他们接受左旋多巴SR或罗匹尼罗治疗6周，随后有1周的洗脱期，然后接受另一种治疗6周。患者通过国际不安腿研究组制定的6项问卷（6项IRLS）、临床总体印象（CGI）量表和睡眠日记对RLS的严重程度进行评分。
结果
在左旋多巴SR治疗期间，1例患者出现严重呕吐，导致研究中断。完成研究的10例患者报告，在左旋多巴SR治疗期间，6项IRLS评分改善了33.5%（从16.7±3.2降至11.1±4；P<0.001），在罗匹尼罗治疗期间改善了73.5%（从16.6±2.8降至4.4±3.8；P<0.001）。研究结束时，左旋多巴SR的平均剂量为190mg/d，罗匹尼罗的平均剂量为1.45mg/d。罗匹尼罗在降低6项IRLS评分（P<0.001）和增加睡眠时间（P<0.001）方面优于左旋多巴SR。患者CGI量表显示罗匹尼罗有显著优势（P<0.01）。对于任何结局指标，均无显著的残留效应或周期效应。4例患者报告在罗匹尼罗治疗期间，剂量为0.25 - 2mg/d时RLS症状完全缓解。
结论
这些结果表明，在治疗接受慢性血液透析的RLS患者方面，罗匹尼罗比左旋多巴SR更有效。
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