纳比隆对帕金森病患者睡眠结局的影响：NMS-Nab研究的事后分析
Effects of Nabilone on Sleep Outcomes in Patients with Parkinson's Disease: A Post-hoc Analysis of NMS-Nab Study.
作者信息
Peball Marina, Seppi Klaus, Krismer Florian, Knaus Hans-Günther, Spielberger Sabine, Heim Beatrice, Ellmerer Philipp, Werkmann Mario, Poewe Werner, Djamshidian Atbin
机构信息
Department of Neurology Medical University of Innsbruck Innsbruck Austria.
Department for Medical Genetics, Molecular, and Clinical Pharmacology Medical University of Innsbruck Innsbruck Austria.
出版信息
Mov Disord Clin Pract. 2022 May 31;9(6):751-758. doi: 10.1002/mdc3.13471. eCollection 2022 Aug.
BACKGROUND
The synthetic tetrahydrocannabinol analogue nabilone improved overall non-motor symptom (NMS) burden in Parkinson's disease (PD) patients in comparison to placebo.
OBJECTIVES
To characterize the effects of nabilone on different sleep outcomes in PD patients.
METHODS
We performed a post-hoc analysis of the controlled, double-blind, enriched enrollment randomized withdrawal NMS-Nab study to assess the effects of nabilone on sleep outcomes in study participants who reported clinically-relevant sleep problems (MDS-UPDRS-1.7 ≥ 2 points).
RESULTS
After open-label nabilone administration, 77.4% reported no relevant sleep problem. In the withdrawal phase of the trial, the MDS-UPDRS-1.7. and the NMS-Scale Domain 2 (i.e., Sleep/Fatigue) significantly worsened only in PD patients in the placebo group, which was mostly driven by a significant worsening of insomnia (question 5 of the NMS-Scale Domain 2).
CONCLUSIONS
This post-hoc analysis of the NMS-Nab trial suggests that nabilone has beneficial effects on sleep outcomes in PD patients experiencing sleep problems at baseline.The original trial was registered with ClinicalTrials.gov (NCT03769896, https://clinicaltrials.gov/ct2/show/NCT03769896) and EudraCT (2017-000192-86).
背景
与安慰剂相比，合成四氢大麻酚类似物纳布隆可改善帕金森病（PD）患者的总体非运动症状（NMS）负担。
目的
描述纳布隆对PD患者不同睡眠结局的影响。
方法
我们对对照、双盲、富集入组随机撤药的NMS-Nab研究进行了事后分析，以评估纳布隆对报告有临床相关睡眠问题（MDS-UPDRS-1.7≥2分）的研究参与者睡眠结局的影响。
结果
在开放标签给予纳布隆后，77.4%的人报告没有相关睡眠问题。在试验的撤药阶段，仅安慰剂组的PD患者中，MDS-UPDRS-1.7和NMS量表第2领域（即睡眠/疲劳）显著恶化，这主要是由失眠（NMS量表第2领域问题5）的显著恶化所致。
结论
NMS-Nab试验的这项事后分析表明，纳布隆对基线时有睡眠问题的PD患者的睡眠结局有有益影响。原始试验已在ClinicalTrials.gov（NCT03769896，https://clinicaltrials.gov/ct2/show/NCT03769896）和EudraCT（2017-000192-86）注册。
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