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针刺治疗缺血性中风后失眠:一项评估者和参与者双盲、随机对照试验。

Acupuncture for insomnia after ischemic stroke: an assessor-participant blinded, randomized controlled trial.

机构信息

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

出版信息

Acupunct Med. 2022 Oct;40(5):443-452. doi: 10.1177/09645284221077106. Epub 2022 Mar 22.

DOI:10.1177/09645284221077106
PMID:35317665
Abstract

BACKGROUND

To date, there has been little focus on research into acupuncture for insomnia after ischemic stroke. Insomnia is one of the most common sequelae after ischemic stroke, and it is the most unrecognized modifiable risk factor.

OBJECTIVE

To evaluate the efficacy and safety of acupuncture for insomnia after ischemic stroke.

METHODS

In this assessor-participant blinded, randomized, controlled trial, 144 ischemic stroke patients with insomnia meeting (fifth edition, -5) criteria were assigned to verum or sham acupuncture treatment (n = 72 per group) for three sessions per week over 4 weeks. The outcomes were the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), stroke-specific quality of life (SSQoL), and Hospital Anxiety and Depression Scale (HADS) scores. Multiple objective sleep variables were recorded using actigraphy. Assessment was conducted at baseline, and thereafter once biweekly for the 4-week treatment and at 4 weeks of follow-up.

RESULTS

The verum acupuncture group had significantly greater improvements than the sham acupuncture group in sleep quality from 2 weeks into treatment throughout the follow-up, indicated by ISI scores and actigraphic variable SE (sleep efficiency). This greater improvement was also observed in the PSQI after 4 weeks of treatment throughout follow-up, as well as actigraphic variable TST (total sleep time), SSQoL and HADS scores at the end of treatment, and SSQoL and depression scores at follow-up. There was no significant difference between groups in the actigraphic variable SA (sleep awakenings). Adverse events were mild in severity, and their incidence was not significantly different between the two groups.

CONCLUSION

Acupuncture appears to be efficacious, in terms of improving insomnia, related quality of life, and affective symptoms, for patients with ischemic stroke.

TRIAL REGISTRATION NUMBER

ChiCTR-IIC-16008382 (Chinese Clinical Trial Registry).

摘要

背景

迄今为止,针对缺血性中风后失眠的针灸研究关注甚少。失眠是缺血性中风后最常见的后遗症之一,也是最未被认识的可改变的危险因素。

目的

评价针灸治疗缺血性中风后失眠的疗效和安全性。

方法

在这项评估者参与、随机、对照试验中,纳入了 144 名符合(第五版)标准的缺血性中风伴失眠患者,将其按 1:1 比例随机分为真针刺组和假针刺组(每组 72 例),每周接受 3 次治疗,共 4 周。结局指标包括匹兹堡睡眠质量指数(PSQI)、失眠严重程度指数(ISI)、中风特异性生存质量量表(SSQoL)和医院焦虑抑郁量表(HADS)评分。使用活动记录仪记录多项客观睡眠变量。在基线、治疗 2 周后、治疗 4 周后及随访 4 周时进行评估。

结果

与假针刺组相比,真针刺组在睡眠质量方面的改善更为显著,从治疗 2 周开始,一直持续到随访期,ISI 评分和活动记录仪变量 SE(睡眠效率)均有改善。这种改善在治疗 4 周后及随访期内的 PSQI 中也得到了体现,同时还体现在治疗结束时的活动记录仪变量 TST(总睡眠时间)、SSQoL 和 HADS 评分以及随访时的 SSQoL 和抑郁评分上。两组间的活动记录仪变量 SA(睡眠觉醒次数)无显著差异。不良事件的严重程度较轻,且两组间的发生率无显著差异。

结论

针灸治疗缺血性中风后失眠在改善睡眠、相关生活质量和情绪症状方面具有一定疗效。

试验注册号

ChiCTR-IIC-16008382(中国临床试验注册中心)。

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