Yan Jingwen, Yang Minhui, Li Michael Ke, Huang Yangyu, Tan Ying, Shi Jiayu, Fan Qianqian, Zhu Zhu, Guan Yuzhou, Cui Liying
Department of Neurology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Department of Neurology, Central South University Xiangya School of Medicine Affiliated Haikou Hospital, Haikou, China.
Front Neurol. 2023 Sep 22;14:1266862. doi: 10.3389/fneur.2023.1266862. eCollection 2023.
This study aimed to evaluate the efficacy and safety of non-benzodiazepine hypnotics in the treatment of myasthenia gravis (MG) patients with insomnia.
This is a prospective longitudinal study. Outpatients who met the criteria for stable MG and insomnia diagnosis according to the International Classification of Sleep Disorders (third edition) were included in the study. They took a regular dose of non-benzodiazepine hypnotics (zolpidem 10 mg per night or zopiclone 7.5 mg per night) based on their own preferences. Patients received psychotherapy (including sleep health education) and were followed up for 4-5 weeks. Cases with lung diseases, respiratory disorders, or inappropriate use of hypnotic medications were excluded. The primary outcome is the difference in total Pittsburgh Sleep Quality Index (PSQI) score between baseline and the end of follow-up period. Secondary outcomes include the difference in Myasthenia Gravis Activities of Daily Living (MG-ADL) score, 7-item Generalized Anxiety Disorder Questionnaire (GAD-7), and the Patient Health Questionnaire-9 (PHQ-9) between baseline and the end of follow-up period and the safety of medication.
A total of 75 MG patients with insomnia were included in this study. After 4-5 weeks of treatment, the total PSQI score and MG-ADL score were lower than baseline ( < 0.01). No patients had an increased MG-ADL score. The incidence rate of adverse events was 16.0% (12 cases), including dizziness (6 cases, 8.0%), drowsiness (3 cases, 4.0%), fatigue (2 cases, 2.7%), and nausea (1 case, 1.3%), all of which were mild. No patients had new onset breathing disorders.
Non-benzodiazepine hypnotics are safe and effective for stable MG patients who need insomnia treatment.
本研究旨在评估非苯二氮䓬类催眠药治疗重症肌无力(MG)合并失眠患者的疗效和安全性。
这是一项前瞻性纵向研究。纳入符合《国际睡眠障碍分类(第三版)》中MG病情稳定且失眠诊断标准的门诊患者。他们根据自身偏好服用常规剂量的非苯二氮䓬类催眠药(每晚服用10毫克唑吡坦或每晚服用7.5毫克佐匹克隆)。患者接受心理治疗(包括睡眠健康教育),并随访4 - 5周。排除患有肺部疾病、呼吸障碍或催眠药物使用不当的病例。主要结局是匹兹堡睡眠质量指数(PSQI)总分在基线与随访期末的差异。次要结局包括重症肌无力日常生活活动能力(MG - ADL)评分、7项广泛性焦虑障碍问卷(GAD - 7)以及患者健康问卷 - 9(PHQ - 9)在基线与随访期末的差异和药物安全性。
本研究共纳入75例MG合并失眠患者。治疗4 - 5周后,PSQI总分和MG - ADL评分均低于基线(<0.01)。无患者MG - ADL评分升高。不良事件发生率为16.0%(12例),包括头晕(6例,8.0%)、嗜睡(3例,4.0%)、疲劳(2例,2.7%)和恶心(1例,1.3%),均为轻度。无患者出现新发呼吸障碍。
非苯二氮䓬类催眠药对需要治疗失眠的病情稳定的MG患者安全有效。