Department of Biomathematics, University of Thessaly School of Medicine, Larissa, Greece.
Clin Ther. 2010 Feb;32(2):221-37. doi: 10.1016/j.clinthera.2010.01.028.
The use of dopamine agonists (DAs) for the treatment of restless legs syndrome (RLS) has been assessed in numerous randomized clinical trials (RCTs).
The aims of this study were to assess the reporting quality of published RCTs according to the Consolidated Standards of Reporting Trials (CONSORT) statement and to synthesize the study results in terms of efficacy and tolerability to inform the clinical management of RLS.
PubMed and Cochrane Controlled Trials Register were searched for English-language RCTs that assessed the effects of DAs in RLS. Quality of reporting was measured using the proportion of 17 CONSORT checklist items included in each study. The 2 primary outcomes were pooled mean change from baseline in International RLS (IRLS) Study Group rating scale score (Deltamu) (95% CI) and relative risk (RR) (95% CI) of response based on the Clinical Global Impression-Improvement (CGI-I) scale score. The pooled proportions of adverse events (PAEs) (95% CI) were also estimated.
Eighteen RCTs (N = 2848 patients) were included. Two of the 17 CONSORT checklist items were reported in 7 studies (39%) and 9 of the 17 items were reported in all 18 studies (100%). The differences in the IRLS scores and RR for CGI-I were significantly greater with pramipexole, ropinirole, rotigotine, and cabergoline compared with placebo. Results for heterogeneity were nonsignificant. The difference in Deltamu (95% CI) was significant with pramipexole (-6.63 [-9.15 to -4.10]) versus ropinirole (-3.64 [-4.76 to 2.51]) (P = 0.04). The difference between pramipexole and rotigotine was nonsignificant. The pooled PAEs (95% CI) for pramipexole, ropinirole, and rotigotine were 4.8% (2.0% to 8.7%), 10.2% (2.6% to 22.1%), and 7.6% (1.3% to 18.5%), respectively. In the trial of sumanirole, the PAE value was 2% (0% to 5.4%).
Based on the findings from the meta-analysis, DAs were significantly more efficacious in the treatment of RLS compared with placebo.
多巴胺激动剂（DAs）已在大量随机临床试验（RCTs）中被评估用于治疗不宁腿综合征（RLS）。
本研究旨在根据 CONSORT 声明评估已发表的 RCT 的报告质量，并综合评估疗效和耐受性方面的研究结果，为 RLS 的临床管理提供信息。
检索了英文语言的 RCTs，以评估 DAs 在 RLS 中的作用。使用纳入的每个研究的 17 项 CONSORT 清单项目的比例来衡量报告质量。主要结局为国际 RLS（IRLS）研究组评分量表（Deltamu）（95%CI）和基于临床总体印象-改善（CGI-I）量表评分的反应的相对风险（RR）（95%CI）的基线平均变化。还估计了不良事件（PAEs）（95%CI）的合并比例。
纳入了 18 项 RCT（N = 2848 名患者）。有 2 项 CONSORT 清单项目在 7 项研究中（39%），9 项 CONSORT 清单项目在所有 18 项研究中（100%）被报道。与安慰剂相比，普拉克索、罗匹尼罗、罗替高汀和卡麦角林在 IRLS 评分和 CGI-I 的 RR 方面的差异显著更大。结果无显著异质性。普拉克索（95%CI）的 Deltamu（95%CI）差异显著（-6.63 [-9.15 至-4.10]）与罗匹尼罗（-3.64 [-4.76 至 2.51]）（P = 0.04）。普拉克索和罗替高汀之间的差异无统计学意义。普拉克索、罗匹尼罗和罗替高汀的合并 PAEs（95%CI）分别为 4.8%（2.0%至 8.7%）、10.2%（2.6%至 22.1%）和 7.6%（1.3%至 18.5%）。在 sumanirole 的试验中，PAE 值为 2%（0%至 5.4%）。
基于荟萃分析的结果，DAs 治疗 RLS 的疗效明显优于安慰剂。
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