普拉克索治疗原发性不宁腿综合征的疗效和安全性观察

Effects and safety of pramipexole on patients with idiopathic restless legs syndrome

目的观察普拉克索对我国原发性不宁腿综合征（RLS）患者的治疗效果以及可能发生的不良反应。方法选择自2009年5月至11月在哈尔滨医科大学第二附属医院神经内科就诊的10例中到重度原发性RLS患者．给予普拉克索0．125～0．75mg／d，每日睡前2～3h顿服，持续治疗6周。利用国际RLS研究小组的RLS严重程度量表（IRLS）、临床总体印象改善量表（COI—I）、患者总体印象量表（PGI）和Epworth嗜睡量表（ESS）对患者治疗前后的RLS症状严重程度和嗜睡程度进行评估，并对结果进行统计学分析，同时记录不良反应。结果（1）治疗后患者的IRLS评分较治疗前平均降低73．7％，比较差异有统计学意义（P〈0．05），9例患者IRLS评分降低在50％以上；（2）治疗结束时，8例患者PGI评估选择“很好”或“非常好”，9例患者CGI-I评估为“明显改善”或“非常明显改善”；（3）患者ESS评分在治疗后较治疗前平均降低3．80±1．75，比较差异有统计学意义衅0．05）；（4）1例患者在治疗末期加量至0．5mg／d时出现轻度恶心，胃区不适，治疗结束停药2d后症状自行消失：（5）1例患者首次用药后双下肢感觉异常和睡眠障碍即有明显改善。结论为期6周的临床实验表明，在每日口服剂量为0．125-0．75mg时，普拉克索对于我国原发性RLS的治疗是安全有效的。

Objective To demonstrate the efficacy and safety ofpramipexole on patients with idiopathic restless legs syndrome （RLS） and explore its possible side effects. Methods Among 10 adults with moderate to severe RLS who were admitted to our hospital from May 2009 to November 2009, pramipexole initiated at 0.125 mg/d was titrated to maximum 0.75 mg/d for a consecutive 6 weeks. Such efficacy evaluations as the international RLS study group rating scale （IRLS）, patient global impression （PGI） scale, clinical global impressions-improvement （CGI-I） scale, and Epworth sleepiness scale （ESS） were performed. The incidence of adverse events was recorded throughout the trial. Results The mean reduction of IRLS score after the treatment was 73.7% as compared with that before the treatment （P〈0.05）; the score reduced by 50% or more was noted in 9 patients. On the PGI scale, 8 patients rated themselves as ＂very much＂ or ＂much＂ better. On CGI-I assessment, 9 patients were considered either ＂very much＂ or ＂much＂ improved. Mean ESS score after the treatment showed a modest but statistically significant reduction of 3.80±1.75 as compared with that before the treatment （P〈0.05）. Mild nausea and stomach discomfort were reported in 1 patient at the end of the trial when the dosage was titrated to 0.50 mg/d, and the symptoms disappeared 2 d after the withdrawal ofpramipexole. First night efficacy was significant in one patient. Conclusion In the present 6-week flexible-dose trial （0.125 mg-0.75 mg） on 10 patients, pramipexole is well tolerated and effective in the treatment of patients with idiopathic RLS.