Zhang Jingyu, Liu Bin, Zheng Yonghui, Chu Tingting, Yang Zichao
Department of Neurology, Fourth Affiliated Hospital of Harbin Medical University, Harbin 150081, China.
Department of Neurology, Fourth Affiliated Hospital of Harbin Medical University, Harbin 150081, China.
Sleep Med. 2015 Jan;16(1):181-5. doi: 10.1016/j.sleep.2014.09.015. Epub 2014 Nov 28.
Restless legs syndrome (RLS) often responds to agents that enhance dopamine neurotransmission. The present 12-week study aimed to evaluate the efficacy and adverse events of pramipexole (PPX) for the treatment of adult, Chinese people with primary RLS.
A total of 204 Chinese people with RLS were randomly assigned to receive either the placebo or PPX (flexibly titrated from 0.25 mg to 0.75 mg), 2 h to 3 h before bedtime for 12 weeks. The primary measuring outcomes were the International RLS Study Group Rating Scale (IRLS) and the Clinical Global Impressions-Improvement (CGI-I) scale. The secondary outcome was adverse events.
One hundred and ninety participants completed the study. At 12 weeks, the adjusted mean (SE) change from baseline was greater for PPX (vs placebo) for the IRLS score (-13.2 ± 0.7 vs -9.4 ± 0.6; p <0.01), and (-12.1 ± 0.6 vs -8.3 ± 0.6; p <0.01) at the end of one month follow-up after treatment. The CGI-I rating of "very much improved" or "much improved" in the percentage of participants (61.8% vs 34.3%; p <0.01), and (51.0% vs 26.5%; p <0.01) after week 12, and one month follow-up of treatment, respectively. The proportion of adverse events was 60.8% in the PPX group and 45.1% in the placebo group. No deaths related to PPX treatment were recorded.
In summary, the present study showed that PPX is efficacious and well tolerated in Chinese people with primary RLS.
不安腿综合征（RLS）通常对增强多巴胺神经传递的药物有反应。本为期12周的研究旨在评估普拉克索（PPX）治疗成年中国原发性RLS患者的疗效和不良事件。
总共204名患有RLS的中国人被随机分配接受安慰剂或PPX（从0.25毫克灵活滴定至0.75毫克），在睡前2至3小时服用，持续12周。主要测量结果是国际RLS研究组评分量表（IRLS）和临床总体印象改善量表（CGI-I）。次要结果是不良事件。
190名参与者完成了研究。在12周时，PPX组（与安慰剂组相比）的IRLS评分从基线的调整后平均（SE）变化更大（-13.2±0.7对-9.4±0.6；p<0.01），在治疗后1个月随访结束时也是如此（-12.1±0.6对-8.3±0.6；p<0.01）。在第12周和治疗后1个月随访时，参与者中“非常改善”或“明显改善”的CGI-I评分百分比分别为61.8%对34.3%；p<0.01）和（51.0%对26.5%；p<0.01）。PPX组不良事件发生率为60.8%，安慰剂组为45.1%。未记录到与PPX治疗相关的死亡病例。
总之，本研究表明PPX对中国原发性RLS患者有效且耐受性良好。
