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罗替高汀治疗睡眠周期性肢体运动障碍患者的疗效和耐受性:系统评价和荟萃分析。

The efficacy and tolerability of rotigotine on patients with periodic limb movement in sleep: A systematic review and meta-analysis.

机构信息

Department of Neurology, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.

Department of Master's Program in Neurology, Faculty of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.

出版信息

PLoS One. 2018 Apr 18;13(4):e0195473. doi: 10.1371/journal.pone.0195473. eCollection 2018.

DOI:10.1371/journal.pone.0195473
PMID:29668694
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5905969/
Abstract

OBJECTIVE

There is still no consensus on the treatment for periodic limb movement in sleep (PLMS). This study aimed to determine the efficacy and tolerability of rotigotine in patients suffering from PLMS.

METHODS

Publications listed in PubMed, ScienceDirect, The Cochrane Library, and ClinicalTrials.gov were reviewed to assess the efficacy of rotigotine on PLMS. Analyses of PLMS frequency before and after rotigotine treatments (pre- and post-intervention studies) and PLMS frequency between placebo and rotigotine treatments (placebo-controlled trial studies) were included in our study. A systematic review and meta-analysis was conducted.

RESULTS

Five publications involving 197 participants were included in this study. Among these articles, pre- and post-intervention data involving 55 participants were available from three articles, while placebo-controlled trial data from 107 participants receiving rotigotine and 70 participants receiving a placebo were available from an additional three articles. In the pre- and post-intervention studies, the periodic limb movement index was significantly decreased after therapy with rotigotine with a difference in means of -5.866/h (95% CI, -10.570 to -1.162, p = 0.015). In comparison with the placebo, the use of rotigotine significantly lowered the periodic limb movement index, with a difference in means of -32.105/h (95% CI, -42.539 to -21.671, p < 0.001), reduced the PLMS with arousal index, with a difference in means of -7.160/h (95% CI, -9.310 to -5.010, p < 0.001), and increased the withdrawal rate, with an odds ratio of 3.421 (95% CI, 1.230 to 9.512, p = 0.018).

CONCLUSIONS

This meta-analysis revealed the considerable efficacy of rotigotine in alleviating the frequency of PLMS. However, the high withdrawal rate should be taken into account.

摘要

目的

对于睡眠周期性肢体运动(PLMS),目前仍没有一致的治疗方法。本研究旨在确定罗替高汀治疗 PLMS 的疗效和耐受性。

方法

检索 PubMed、ScienceDirect、The Cochrane Library 和 ClinicalTrials.gov 上的出版物,评估罗替高汀治疗 PLMS 的疗效。纳入研究包括罗替高汀治疗前后 PLMS 频率的分析(干预前后研究)和安慰剂与罗替高汀治疗之间 PLMS 频率的分析(安慰剂对照试验研究)。进行了系统评价和荟萃分析。

结果

本研究纳入了 5 项研究,共 197 名参与者。其中 3 项研究提供了 55 名参与者的干预前后数据,另外 3 项研究提供了 107 名接受罗替高汀和 70 名接受安慰剂的参与者的安慰剂对照试验数据。在干预前后的研究中,罗替高汀治疗后周期性肢体运动指数显著降低,平均差值为-5.866/h(95%CI,-10.570 至-1.162,p=0.015)。与安慰剂相比,罗替高汀显著降低了周期性肢体运动指数,平均差值为-32.105/h(95%CI,-42.539 至-21.671,p<0.001),降低了伴有觉醒的周期性肢体运动指数,平均差值为-7.160/h(95%CI,-9.310 至-5.010,p<0.001),并增加了停药率,比值比为 3.421(95%CI,1.230 至 9.512,p=0.018)。

结论

这项荟萃分析显示,罗替高汀在缓解 PLMS 频率方面具有显著疗效。然而,应考虑到较高的停药率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d4e/5905969/b7ee76aaa160/pone.0195473.g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d4e/5905969/3d9bd63a66df/pone.0195473.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d4e/5905969/770af352f1e0/pone.0195473.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d4e/5905969/57e4cc1a2bbd/pone.0195473.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d4e/5905969/c586df0ff9c3/pone.0195473.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d4e/5905969/b7ee76aaa160/pone.0195473.g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d4e/5905969/3d9bd63a66df/pone.0195473.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d4e/5905969/770af352f1e0/pone.0195473.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d4e/5905969/57e4cc1a2bbd/pone.0195473.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d4e/5905969/c586df0ff9c3/pone.0195473.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d4e/5905969/b7ee76aaa160/pone.0195473.g005.jpg

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Pharmacokinetics of rotigotine transdermal system in adolescents with idiopathic restless legs syndrome (Willis-Ekbom disease).罗替高汀透皮贴剂在青少年特发性不安腿综合征(不宁腿综合征)中的药代动力学。
Sleep Med. 2017 Apr;32:48-55. doi: 10.1016/j.sleep.2016.04.012. Epub 2016 Jun 8.
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Associations of Incident Cardiovascular Events With Restless Legs Syndrome and Periodic Leg Movements of Sleep in Older Men, for the Outcomes of Sleep Disorders in Older Men Study (MrOS Sleep Study).
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Sleep. 2017 Apr 1;40(4). doi: 10.1093/sleep/zsx023.
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A method to switch from oral dopamine agonists to rotigotine in patients with restless legs syndrome and mild augmentation.一种用于不安腿综合征伴轻度增敏患者从口服多巴胺激动剂转换为罗替戈汀的方法。
Sleep Med. 2016 Aug;24:18-23. doi: 10.1016/j.sleep.2016.05.004. Epub 2016 Jun 23.
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