罗替戈汀治疗原发性不宁腿综合征的Meta分析  

Meta-analysis of rotigotine in the treatment of primary restless legs syndrome

作　　者：丁君 罗利俊[1] 范威[2] DING Jun;LUO Li-jun;FAN Wei(Department of Neurology,Wuhan No.1 Hospital,Wuhan 430022,China)

机构地区：[1]武汉市第一医院神经内科,430022 [2]湖北省肿瘤医院乳腺科

出　　处：《临床神经病学杂志》2021年第3期181-186,共6页Journal of Clinical Neurology

摘　　要：目的研究罗替戈汀治疗原发性不宁腿综合征(RLS)的疗效和安全性。方法检索Pub Med、EMBASE和Cochrane数据库中关于罗替戈汀治疗RLS的随机对照临床试验,评估罗替戈汀在RLS中的作用。以罗替戈汀组和安慰剂组在国际不宁腿研究组评分量表(IRIS)评分变化方面的加权均数差(WMD)和罗替戈汀组相对于安慰剂组在临床疗效总评量表(CGI-I)方面疗效显著率的OR值作为主要终点事件进行疗效评价;以其在不良事件方面的OR值为指标进行安全性评价。结果总共纳入7项随机对照临床试验。本篇Meta分析的结果显示,与安慰剂组相比,罗替戈汀组IRLS评分的总体平均变化更为显著(MD=-4.64,95%CI:-5.72~-3.57;P<0.00001);罗替戈汀组CGI-I评估疗效显著率更加明显(OR=2.18,95%CI:1.85~2.57;P<0.00001)。最常见的不良反应为应用部位反应、恶心、头痛和疲劳。总体而言,罗替戈汀在原发性RLS患者中耐受性良好。结论罗替戈汀治疗RLS是安全且有效的。然而,需要长期的研究和更多的证据来比较罗替戈汀和其他多巴胺激动剂的疗效与安全性。Objective To study the efficacy and safety of rotigotine in treatment for primary restless legs syndrome(RLS).Methods Randomized controlled clinical trials of rotigotine in the treatment of primary RLS was searched in Pub Med,EMBASE and Cochrane databases to evaluate the role of rotigotine in RLS.The two primary outcomes were the weighted mean difference(WMD)between the rotigotine group and the placebo group in the international restless legs study group scoring scale(IRIS)and the OR value of rotigotine group compared to the placebo group in the overall clinical efficacy evaluation of clinical global impression-improvement(CGI-I).The OR value of adverse events was used as the index to evaluate the safety.Results Seven randomized clinical trials were included.The Meta-analysis showed that compared with the rotigotine group,the average changes of IRIS score in placebo group were significantly pronounced(MD=-4.64,95%CI:-5.72--3.57;P<0.00001);(OR=2.18,95%CI:1.85-2.57;P<0.00001).The most common adverse events were application site reactions,nausea,headache and fatigue.In general,rotigotine was well-tolerated in patients with primary RLS.Conclusions Rotigotine is safe and effective in the treatment of RLS.However,long-term studies and more evidence are needed to compare the efficacy and safety of rotigotine with other dopamine agonists.

关 键 词：不宁腿综合征 罗替戈汀 多巴胺激动剂 

分 类 号：R597[医药卫生—内科学]