Pierantozzi Mariangela, Placidi Fabio, Liguori Claudio, Albanese Maria, Imbriani Paola, Marciani Maria Grazia, Mercuri Nicola Biagio, Stanzione Paolo, Stefani Alessandro
Movement Disorders Centre, Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy.
Sleep Disorders Centre, Neurophysiopathology Unit, Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy.
Sleep Med. 2016 May;21:140-4. doi: 10.1016/j.sleep.2016.01.016. Epub 2016 Feb 17.
BACKGROUND/OBJECTIVES: Growing evidence demonstrates that in Parkinson's Disease (PD) sleep disturbances are frequent and difficult to treat. Since the efficacy of rotigotine on sleep is corroborated by studies lacking polysomnography (PSG), this study explores the possible rotigotine-mediated impact on PSG parameters in PD patients.
This is a randomized, double-blind, placebo-controlled, parallel-group study to determine the efficacy of rotigotine vs placebo on PSG parameters in moderately advanced PD patients. An unusual protocol was utilized, since patches were maintained from 18:00 h to awakening, minimizing the possible diurnal impact on motor symptoms. All participants underwent sleep PSG recordings, subjective sleep questionnaires (Parkinson Disease Sleep Scale [PDSS], Pittsburgh Sleep Quality Index [PSQI]), and the assessment of early-morning motor disability.
We evaluated 42 PD patients (Hoehn & Yahr stages 2 and 3) with sleep impairment randomly assigned to active branch (N =21) or placebo (N = 21). Rotigotine significantly increased sleep efficiency and reduced both wakefulness after sleep onset and sleep latency compared to placebo. Moreover, the mean change in REM sleep quantity was significantly higher in the rotigotine than placebo group. The improvement of PSG parameters corresponded to the amelioration of PDSS and PSQI scores together with the improvement of patient morning motor symptoms.
This study demonstrated the significant effect of rotigotine on sleep quality and continuity in PD patients by promoting sleep stability and increasing REM. The effectiveness of rotigotine on sleep may be ascribed to its pharmacokinetic/pharmacodynamic profile directly on both D1 and D2 receptors.
背景/目的：越来越多的证据表明，帕金森病（PD）患者经常出现睡眠障碍且难以治疗。由于缺乏多导睡眠图（PSG）的研究证实了罗替戈汀对睡眠的疗效，本研究探讨了罗替戈汀对PD患者PSG参数可能产生的影响。
这是一项随机、双盲、安慰剂对照、平行组研究，旨在确定罗替戈汀与安慰剂对中度晚期PD患者PSG参数的疗效。采用了一种不同寻常的方案，因为贴片从18:00开始持续到醒来，以尽量减少对运动症状可能产生的日间影响。所有参与者均接受睡眠PSG记录、主观睡眠问卷（帕金森病睡眠量表[PDSS]、匹兹堡睡眠质量指数[PSQI]）以及清晨运动功能障碍评估。
我们评估了42例有睡眠障碍的PD患者（Hoehn & Yahr分期为2期和3期），他们被随机分配至活性药物组（N = 21）或安慰剂组（N = 21）。与安慰剂相比，罗替戈汀显著提高了睡眠效率，减少了睡眠起始后的觉醒时间和睡眠潜伏期。此外，罗替戈汀组快速眼动（REM）睡眠量的平均变化显著高于安慰剂组。PSG参数的改善与PDSS和PSQI评分的改善以及患者清晨运动症状的改善相对应。
本研究表明，罗替戈汀通过促进睡眠稳定性和增加REM睡眠，对PD患者的睡眠质量和连续性有显著影响。罗替戈汀对睡眠的有效性可能归因于其直接作用于D1和D2受体的药代动力学/药效学特性。
