Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea.
Department of Biostatistics, Soonchunhyang University Hospital, Seoul, Republic of Korea.
Parkinsonism Relat Disord. 2020 Jun;75:50-54. doi: 10.1016/j.parkreldis.2020.03.029. Epub 2020 May 16.
The present study was a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of prolonged-release melatonin (PRM) in Parkinson's disease (PD) patients with poor sleep quality.
PD patients with a global Pittsburgh Sleep Quality Index (PSQI) score > 5 were included. Patients were assessed using the PSQI, a rapid eye movement sleep behavior disorder screening questionnaire, the Epworth Sleepiness Scale, Non-Motor Symptoms Scale (NMSS), Parkinson's Disease Quality of Life-39 (PDQ-39), and Unified Parkinson's Disease Rating Scale (UPDRS)-III at the beginning of the study and after 4 weeks of treatment with 2 mg of PRM. Partial correlation analysis was performed to investigate the relationship between PSQI score and the other scales.
Thirty-four PD patients with poor sleep quality were enrolled and divided into 2 groups based on medication; PRM (n = 16) and placebo (n = 18). Regarding efficacy, PSQI was significantly improved in the PRM group compared to the control group. Improvement in the NMSS and PDQ-39 summary index were observed in the PRM but not in the placebo group; UPDRS-III score was not significantly changed in either group. PSQI improvement correlated with improvement in NMSS score and PDQ-39 summary index. Regarding safety, all enrolled subjects did not complain of side effects due to PRM.
PRM is an effective and safe treatment option for subjective sleep quality in PD patients and beneficial effects on sleep quality are associated with improved non-motor symptoms and quality of life in PD patients.
本研究为一项随机、双盲、安慰剂对照、多中心试验，旨在评估延长释放褪黑素（PRM）在睡眠质量差的帕金森病（PD）患者中的疗效和安全性。
纳入全球匹兹堡睡眠质量指数（PSQI）评分>5 的 PD 患者。患者在研究开始时和接受 2mg PRM 治疗 4 周后，使用 PSQI、快速眼动睡眠行为障碍筛查问卷、爱泼沃斯嗜睡量表、非运动症状量表（NMSS）、帕金森病生活质量-39 量表（PDQ-39）和统一帕金森病评定量表（UPDRS）-III 进行评估。进行偏相关分析以探讨 PSQI 评分与其他量表之间的关系。
共纳入 34 例睡眠质量差的 PD 患者，并根据用药情况分为 PRM 组（n=16）和安慰剂组（n=18）。关于疗效，与安慰剂组相比，PRM 组 PSQI 显著改善。PRM 组 NMSS 和 PDQ-39 综合指数改善，但安慰剂组未见改善；两组 UPDRS-III 评分均无显著变化。PSQI 的改善与 NMSS 评分和 PDQ-39 综合指数的改善相关。关于安全性，所有入组患者均未因 PRM 出现不良反应。
PRM 是治疗 PD 患者主观睡眠质量的有效且安全的选择，其对睡眠质量的改善与 PD 患者非运动症状和生活质量的改善相关。
