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超微化棕榈酸乙醇酰胺对腕管综合征患者睡眠-觉醒节律和神经病理性疼痛表型的影响:一项开放标签、随机对照研究。

Ultra-micronized Palmitoylethanolamide Effects on Sleep-wake Rhythm and Neuropathic Pain Phenotypes in Patients with Carpal Tunnel Syndrome: An Open-label, Randomized Controlled Study.

机构信息

Department of Emergency, Institute of Anesthesia, Resuscitation and Pain Medicine, Catholic University of Sacred Heart, Italy.

Orthopaedics Institute Clinic, Catholic University of Sacred Heart, Columbus Hospital, Rome, Italy.

出版信息

CNS Neurol Disord Drug Targets. 2018;17(4):291-298. doi: 10.2174/1871527317666180420143830.

Abstract

BACKGROUND

Patients with carpal tunnel syndrome often suffer from fragmentary sleep. This study was designed to assess the effectiveness of treatment with ultramicronized palmitoylethanolamide in reducing pain intensity and improving quality of sleep in patients with neuropathic pain due to carpal tunnel syndrome.

METHODS

An open, controlled study was conducted on 42 patients awaiting carpal tunnel syndrome surgery, suffering from sleep disorders and painful symptoms and randomized into two groups. One group received ultramicronized palmitoylethanolamide (600 mg twice daily) during the pre- and postsurgery periods, while the other group did not receive any treatment except surgical therapy. The primary outcome measure was sleep quality assessment by the Pittsburgh Sleep Quality Index, with secondary outcome as painful symptomatology intensity evaluated by the Numeric Rating Scale.

RESULTS

At the end of the pre-surgery period (T1) there was a highly significant improvement (p<0.0001) in overall sleep quality with an increase of continuous sleep time and a reduction of sleep latency and disturbances as well as a significant mitigation (p<0.0001) of painful symptoms in favor of the treated group.

CONCLUSION

Disturbed sleep patterns are very common in patients suffering from neuropathic pain due to carpal tunnel syndrome. Our results, albeit preliminary, suggest that ultramicronized palmitoylethanolamide administration favors a clear improvement of sleep quality, confirming a correlation between sleep disorders and pain intensity.

摘要

背景

腕管综合征患者常伴有睡眠片段化。本研究旨在评估超微化棕榈酸乙酯酰胺治疗腕管综合征神经病理性疼痛患者减轻疼痛强度和改善睡眠质量的效果。

方法

对 42 例腕管综合征手术患者进行了一项开放、对照研究,这些患者存在睡眠障碍和疼痛症状,并随机分为两组。一组在术前和术后期间接受超微化棕榈酸乙酯酰胺(600mg,每日两次)治疗,另一组除手术治疗外不接受任何治疗。主要观察指标是匹兹堡睡眠质量指数评估睡眠质量,次要观察指标是数字评分量表评估疼痛症状严重程度。

结果

在术前(T1)期间,所有患者的睡眠质量均有显著改善(p<0.0001),表现为连续睡眠时间增加,睡眠潜伏期和障碍减少,疼痛症状明显减轻(p<0.0001),且这些改善均有利于治疗组。

结论

患有腕管综合征神经病理性疼痛的患者常伴有睡眠模式紊乱。我们的初步结果表明,超微化棕榈酸乙酯酰胺的应用有利于改善睡眠质量,证实了睡眠障碍与疼痛强度之间存在相关性。

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