Ding Jun, Fan Wei, Chen Hong-Hui, Yan Peng, Sun Sheng-Gang, Zheng Jin
Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
Department of Breast Surgery, Hubei Cancer Hospital, Wuhan, 430079, China.
J Huazhong Univ Sci Technolog Med Sci. 2015 Apr;35(2):169-175. doi: 10.1007/s11596-015-1406-5. Epub 2015 Apr 16.
The aim of this study was to summarize the efficacy and tolerability of rotigotine in the treatment of primary restless legs syndrome (RLS). PubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for English-language randomized controlled trials (RCTs) that assessed the effectiveness of rotigotine for RLS. The pooled mean change from baseline in International RLS (IRLS) Study Group Rating Scalescore and relative risk (RR) of response based on the Clinical Global Impression-Improvement (CGI-I) scale score were applied to evaluate the outcomes. The pooled proportions of adverse events (AEs) were also estimated. Six RCTs were included. The meta-analysis showed a favorable effectiveness of rotigotine versus placebo on RLS [mean change on IRLS score: mean difference (MD)=-4.80; 95% confidence interval (CI): -5.90 to -3.70; P<0.00001 and RR of response on CGI-I was 2.19; 95% CI: 1.86 to 2.58, P<0.00001]. The most common AEs were application site reactions, nausea, headache and fatigue. In general, rotigotine was well-tolerated in patients with primary RLS. Based on the findings from the meta-analysis, rotigotine was more significantly efficacious in the treatment of RLS than placebo. Nevertheless, long-term studies and more evidence of comparisons of rotigotine with other dopamine agonists are needed.
本研究的目的是总结罗替戈汀治疗原发性不宁腿综合征（RLS）的疗效和耐受性。检索了PubMed、EMBASE和Cochrane对照试验中央注册库（CENTRAL），以查找评估罗替戈汀治疗RLS有效性的英文随机对照试验（RCT）。采用国际不宁腿综合征（IRLS）研究组评分量表得分相对于基线的合并平均变化以及基于临床总体印象改善（CGI-I）量表得分的反应相对风险（RR）来评估结果。还估计了不良事件（AE）的合并比例。纳入了六项RCT。荟萃分析显示，与安慰剂相比，罗替戈汀治疗RLS具有良好的有效性[IRLS评分的平均变化：平均差（MD）=-4.80；95%置信区间（CI）：-5.90至-3.70；P<0.00001，CGI-I上反应的RR为2.19；95%CI：1.86至2.58，P<0.00001]。最常见的AE是应用部位反应、恶心、头痛和疲劳。总体而言，原发性RLS患者对罗替戈汀耐受性良好。基于荟萃分析的结果，罗替戈汀治疗RLS比安慰剂更有效。然而，需要进行长期研究以及更多罗替戈汀与其他多巴胺激动剂比较的证据。
