
Chinese General Practice ›› 2026, Vol. 29 ›› Issue (25): 3686-3693.DOI: 10.12114/j.issn.1007-9572.2025.0545
• Original Research·Focus on Multimodal Insomnia Therapies • Previous Articles Next Articles
Received:2026-02-15
Revised:2026-06-05
Published:2026-09-05
Online:2026-08-11
Contact:
CHEN Yujie
通讯作者:
陈宇洁
作者简介:作者贡献:
王怡提出主要研究目标,负责研究的构思与设计,撰写论文及负责论文修订;王怡、李瑶、杨凌麟、李勇、何沁泽负责项目的实施;杨凌麟、袁泉进行数据的收集与整理,统计学处理;陈宇洁负责文章的质量控制与审查,对文章整体负责,监督管理。
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URL: https://www.chinagp.net/EN/10.12114/j.issn.1007-9572.2025.0545
| 项目 | 试验组(n=43) | 对照组(n=40) | t(χ2)值 | P值 |
|---|---|---|---|---|
| 性别(男/女) | 31/12 | 29/11 | 0.002a | 0.967 |
| 年龄( | 58.3±6.0 | 58.5±5.4 | 0.185 | 0.854 |
| 身高( | 169.8±6.3 | 169.5±6.0 | 0.232 | 0.818 |
| 体质量( | 78.2±13.7 | 80.8±12.6 | 0.786 | 0.435 |
| BMI( | 27.6±3.9 | 28.1±4.0 | 1.081 | 0.284 |
| PSQI评分( | 13.4±3.7 | 13.9±3.4 | 0.628 | 0.532 |
| SRSS评分( | 32.5±5.8 | 32.3±5.9 | 0.143 | 0.887 |
| ESS评分( | 13.5±5.1 | 13.7±4.8 | 0.115 | 0.909 |
| AHI( | 50.2±24.1 | 49.4±21.4 | 0.144 | 0.886 |
| 总睡眠时间( | 311.2±44.7 | 316.6±45.3 | 0.477 | 0.635 |
| 睡眠效率( | 70.8±7.0 | 71.5±6.6 | 1.064 | 0.292 |
| 入睡潜伏期( | 33.9±12.1 | 37.5±11.8 | 1.975 | 0.053 |
| N1%( | 20.8±6.3 | 21.2±5.9 | 0.289 | 0.773 |
| N2%( | 52.7±11.4 | 45.0±12.3 | 2.711 | 0.407 |
| N3%( | 9.5±9.8 | 13.1±10.2 | 2.980 | 0.112 |
| REM%( | 14.8±6.6 | 14.9±6.0 | 0.119 | 0.906 |
| LSaO2( | 69.8±12.2 | 69.8±12.5 | 0.008 | 0.994 |
| 长期吸烟史[例(%)] | 21(48.8) | 19(47.5) | 0.015a | 0.903 |
| 长期饮酒史[例(%)] | 14(32.6) | 16(40.0) | 0.497a | 0.481 |
| 合并基础疾病 | ||||
| 高血压[例(%)] | 27(62.8) | 21(52.5) | 0.900a | 0.343 |
| 糖尿病[例(%)] | 14(32.6) | 16(40.0) | 0.497a | 0.481 |
| 冠心病[例(%)] | 10(23.3) | 11(27.5) | 0.198a | 0.657 |
| 高脂血症[例(%)] | 20(46.5) | 15(37.5) | 0.690a | 0.406 |
| 心律失常[例(%)] | 5(11.6) | 4(10.0) | 0.057a | 0.812 |
| 鼻炎[例(%)] | 15(34.9) | 14(35.0) | 0.000a | 0.991 |
| 咽炎[例(%)] | 10(23.3) | 11(27.5) | 0.198a | 0.657 |
Table 1 Comparison of baseline data between experimental and control groups
| 项目 | 试验组(n=43) | 对照组(n=40) | t(χ2)值 | P值 |
|---|---|---|---|---|
| 性别(男/女) | 31/12 | 29/11 | 0.002a | 0.967 |
| 年龄( | 58.3±6.0 | 58.5±5.4 | 0.185 | 0.854 |
| 身高( | 169.8±6.3 | 169.5±6.0 | 0.232 | 0.818 |
| 体质量( | 78.2±13.7 | 80.8±12.6 | 0.786 | 0.435 |
| BMI( | 27.6±3.9 | 28.1±4.0 | 1.081 | 0.284 |
| PSQI评分( | 13.4±3.7 | 13.9±3.4 | 0.628 | 0.532 |
| SRSS评分( | 32.5±5.8 | 32.3±5.9 | 0.143 | 0.887 |
| ESS评分( | 13.5±5.1 | 13.7±4.8 | 0.115 | 0.909 |
| AHI( | 50.2±24.1 | 49.4±21.4 | 0.144 | 0.886 |
| 总睡眠时间( | 311.2±44.7 | 316.6±45.3 | 0.477 | 0.635 |
| 睡眠效率( | 70.8±7.0 | 71.5±6.6 | 1.064 | 0.292 |
| 入睡潜伏期( | 33.9±12.1 | 37.5±11.8 | 1.975 | 0.053 |
| N1%( | 20.8±6.3 | 21.2±5.9 | 0.289 | 0.773 |
| N2%( | 52.7±11.4 | 45.0±12.3 | 2.711 | 0.407 |
| N3%( | 9.5±9.8 | 13.1±10.2 | 2.980 | 0.112 |
| REM%( | 14.8±6.6 | 14.9±6.0 | 0.119 | 0.906 |
| LSaO2( | 69.8±12.2 | 69.8±12.5 | 0.008 | 0.994 |
| 长期吸烟史[例(%)] | 21(48.8) | 19(47.5) | 0.015a | 0.903 |
| 长期饮酒史[例(%)] | 14(32.6) | 16(40.0) | 0.497a | 0.481 |
| 合并基础疾病 | ||||
| 高血压[例(%)] | 27(62.8) | 21(52.5) | 0.900a | 0.343 |
| 糖尿病[例(%)] | 14(32.6) | 16(40.0) | 0.497a | 0.481 |
| 冠心病[例(%)] | 10(23.3) | 11(27.5) | 0.198a | 0.657 |
| 高脂血症[例(%)] | 20(46.5) | 15(37.5) | 0.690a | 0.406 |
| 心律失常[例(%)] | 5(11.6) | 4(10.0) | 0.057a | 0.812 |
| 鼻炎[例(%)] | 15(34.9) | 14(35.0) | 0.000a | 0.991 |
| 咽炎[例(%)] | 10(23.3) | 11(27.5) | 0.198a | 0.657 |
| 组别 | 例数 | NPPV使用(h/晚) | 使用天数占总天数的比例(%) | ||||
|---|---|---|---|---|---|---|---|
| 1周 | 1个月 | 3个月 | 1周 | 1个月 | 3个月 | ||
| 对照组 | 40 | 5.5±1.4 | 5.4±1.6 | 5.2±1.5 | 75.1±16.9 | 75.9±10.8 | 73.6±11.2 |
| 试验组 | 43 | 6.9±1.3 | 6.8±1.1 | 6.8±0.9 | 80.3±15.7 | 81.9±9.3 | 80.2±8.3 |
| F值 | F组间=101.103,F时间=47.932,F交互=51.164 | F组间=5.864,F时间=3.340,F交互=2.453 | |||||
| P值 | P组间<0.001,P时间=0.019,P交互=0.045 | P组间=0.018,P时间=0.042,P交互=0.122 | |||||
| 组别 | 使用天数≥4 h的比例(%) | 95%压力(cmH2O) | |||||
| 1周 | 1个月 | 3个月 | 1周 | 1个月 | 3个月 | ||
| 对照组 | 80.1±6.6 | 76.9±6.5 | 80.2±7.2 | 10.6±2.6 | 11.8±2.5 | 10.9±2.3 | |
| 试验组 | 84.6±11.3 | 81.9±11.0 | 83.5±9.4 | 10.2±2.6 | 11.0±2.3 | 11.3±2.0 | |
| F值 | F组间=13.235,F时间=10.390,F交互=15.061 | F组间=1.068,F时间=3.161,F交互=1.706 | |||||
| P值 | P组间<0.001,P时间=0.002,P交互=0.035 | P组间=0.206,P时间=0.080,P交互=0.633 | |||||
| 组别 | 治疗后AHI(次/h) | 漏气量(L/min) | |||||
| 1周 | 1个月 | 3个月 | 1周 | 1个月 | 3个月 | ||
| 对照组 | 6.9±3.9 | 6.8±1.6 | 7.0±3.2 | 19.4±5.7 | 21.2±5.9 | 19.7±5.8 | |
| 试验组 | 5.1±3.5 | 5.2±3.1 | 5.6±3.0 | 15.5±4.5 | 18.4±4.2 | 16.2±4.5 | |
| F值 | F组间=37.226,F时间=56.759,F交互=82.633 | F组间=51.514,F时间=38.083,F交互=40.319 | |||||
| P值 | P组间=0.009,P时间=0.015,P交互=0.018 | P组间=0.032,P时间=0.176,P交互=0.811 | |||||
Table 2 Comparison of ventilator parameters after NPPV
| 组别 | 例数 | NPPV使用(h/晚) | 使用天数占总天数的比例(%) | ||||
|---|---|---|---|---|---|---|---|
| 1周 | 1个月 | 3个月 | 1周 | 1个月 | 3个月 | ||
| 对照组 | 40 | 5.5±1.4 | 5.4±1.6 | 5.2±1.5 | 75.1±16.9 | 75.9±10.8 | 73.6±11.2 |
| 试验组 | 43 | 6.9±1.3 | 6.8±1.1 | 6.8±0.9 | 80.3±15.7 | 81.9±9.3 | 80.2±8.3 |
| F值 | F组间=101.103,F时间=47.932,F交互=51.164 | F组间=5.864,F时间=3.340,F交互=2.453 | |||||
| P值 | P组间<0.001,P时间=0.019,P交互=0.045 | P组间=0.018,P时间=0.042,P交互=0.122 | |||||
| 组别 | 使用天数≥4 h的比例(%) | 95%压力(cmH2O) | |||||
| 1周 | 1个月 | 3个月 | 1周 | 1个月 | 3个月 | ||
| 对照组 | 80.1±6.6 | 76.9±6.5 | 80.2±7.2 | 10.6±2.6 | 11.8±2.5 | 10.9±2.3 | |
| 试验组 | 84.6±11.3 | 81.9±11.0 | 83.5±9.4 | 10.2±2.6 | 11.0±2.3 | 11.3±2.0 | |
| F值 | F组间=13.235,F时间=10.390,F交互=15.061 | F组间=1.068,F时间=3.161,F交互=1.706 | |||||
| P值 | P组间<0.001,P时间=0.002,P交互=0.035 | P组间=0.206,P时间=0.080,P交互=0.633 | |||||
| 组别 | 治疗后AHI(次/h) | 漏气量(L/min) | |||||
| 1周 | 1个月 | 3个月 | 1周 | 1个月 | 3个月 | ||
| 对照组 | 6.9±3.9 | 6.8±1.6 | 7.0±3.2 | 19.4±5.7 | 21.2±5.9 | 19.7±5.8 | |
| 试验组 | 5.1±3.5 | 5.2±3.1 | 5.6±3.0 | 15.5±4.5 | 18.4±4.2 | 16.2±4.5 | |
| F值 | F组间=37.226,F时间=56.759,F交互=82.633 | F组间=51.514,F时间=38.083,F交互=40.319 | |||||
| P值 | P组间=0.009,P时间=0.015,P交互=0.018 | P组间=0.032,P时间=0.176,P交互=0.811 | |||||
| 组别 | 例数 | PSQI评分 | SRSS评分 | ESS评分 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 基线 | 3个月 | t配对值 | P值 | 基线 | 3个月 | t配对值 | P值 | 基线 | 3个月 | t配对值 | P值 | ||
| 对照组 | 40 | 13.9±3.4 | 12.8±3.0 | 3.713 | 0.001 | 32.3±5.9 | 28.6±4.6 | 6.066 | 0.036 | 13.7±4.8 | 8.4±5.0 | 0.237 | 0.814 |
| 试验组 | 43 | 13.4±3.7 | 6.7±3.2 | 6.816 | 0.022 | 32.5±5.8 | 23.3±7.5 | 5.497 | <0.001 | 13.5±5.1 | 6.6±3.9 | 2.068 | 0.041 |
| t值 | 0.628 | 5.276 | 0.143 | 0.853 | 0.115 | 1.844 | |||||||
| P值 | 0.532 | <0.001 | 0.887 | 0.398 | 0.909 | 0.016 | |||||||
Table 3 Comparison of sleep scale scores before and after treatment
| 组别 | 例数 | PSQI评分 | SRSS评分 | ESS评分 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 基线 | 3个月 | t配对值 | P值 | 基线 | 3个月 | t配对值 | P值 | 基线 | 3个月 | t配对值 | P值 | ||
| 对照组 | 40 | 13.9±3.4 | 12.8±3.0 | 3.713 | 0.001 | 32.3±5.9 | 28.6±4.6 | 6.066 | 0.036 | 13.7±4.8 | 8.4±5.0 | 0.237 | 0.814 |
| 试验组 | 43 | 13.4±3.7 | 6.7±3.2 | 6.816 | 0.022 | 32.5±5.8 | 23.3±7.5 | 5.497 | <0.001 | 13.5±5.1 | 6.6±3.9 | 2.068 | 0.041 |
| t值 | 0.628 | 5.276 | 0.143 | 0.853 | 0.115 | 1.844 | |||||||
| P值 | 0.532 | <0.001 | 0.887 | 0.398 | 0.909 | 0.016 | |||||||
| 不良事件类型 | 例数 | 发生率(%) | 严重程度 | 发生时间 | 处理措施 | 转归 |
|---|---|---|---|---|---|---|
| 口苦 | 5 | 11.6 | 轻度(4例)、中度(1例) | 服药后次晨 | 嘱多饮水、含服无糖糖果(4例);无须特殊处理(1例) | 2例持续1周后减轻,3例用药期间持续存在但可耐受 |
| 日间困倦 | 2 | 4.7 | 轻度(1例)、中度(1例) | 服药后次日日间 | 调整服药时间至睡前30 min内、避免驾驶等危险活动(2例) | 2例调整后改善 |
| 晨起头晕 | 2 | 4.7 | 轻度 | 晨起时 | 嘱缓慢起床、避免突然站立 | 均于1周内缓解 |
| 恶心 | 1 | 2.3 | 轻度 | 服药后30 min | 与少量食物同服 | 2 d后消失 |
| 口干 | 1 | 2.3 | 轻度 | 夜间及次晨 | 睡前床旁备水 | 用药期间持续存在但可耐受 |
Table 4 Incidence and management of drug-related adverse events in the eszopiclone
| 不良事件类型 | 例数 | 发生率(%) | 严重程度 | 发生时间 | 处理措施 | 转归 |
|---|---|---|---|---|---|---|
| 口苦 | 5 | 11.6 | 轻度(4例)、中度(1例) | 服药后次晨 | 嘱多饮水、含服无糖糖果(4例);无须特殊处理(1例) | 2例持续1周后减轻,3例用药期间持续存在但可耐受 |
| 日间困倦 | 2 | 4.7 | 轻度(1例)、中度(1例) | 服药后次日日间 | 调整服药时间至睡前30 min内、避免驾驶等危险活动(2例) | 2例调整后改善 |
| 晨起头晕 | 2 | 4.7 | 轻度 | 晨起时 | 嘱缓慢起床、避免突然站立 | 均于1周内缓解 |
| 恶心 | 1 | 2.3 | 轻度 | 服药后30 min | 与少量食物同服 | 2 d后消失 |
| 口干 | 1 | 2.3 | 轻度 | 夜间及次晨 | 睡前床旁备水 | 用药期间持续存在但可耐受 |
| 技术问题类型 | 发生次数[n=3 280,次(%)] | 涉及患者例数[n=43,例(%)] | 发生时间 | 处理措施 | 解决率(%) |
|---|---|---|---|---|---|
| 数据上传失败 | 50(1.52) | 12(27.9) | 主要集中在初始使用1周内 | (1)远程指导重启设备(41次) (2)联系设备厂商技术支持(7次) (3)更换SIM卡(2次) | 100.0 |
| 网络连接不稳定 | 42(1.28) | 9(20.9) | 分布于整个随访期 | (1)建议切换网络环境(25次) (2)设备自动重连(17次) | 100.0 |
| 平台数据显示异常 | 8(0.24) | 3(7.0) | 数据解析错误 | 后台人工校正数据;联系工程师修复 | 100.0 |
Table 5 Occurrence and handling of remote management technical issues
| 技术问题类型 | 发生次数[n=3 280,次(%)] | 涉及患者例数[n=43,例(%)] | 发生时间 | 处理措施 | 解决率(%) |
|---|---|---|---|---|---|
| 数据上传失败 | 50(1.52) | 12(27.9) | 主要集中在初始使用1周内 | (1)远程指导重启设备(41次) (2)联系设备厂商技术支持(7次) (3)更换SIM卡(2次) | 100.0 |
| 网络连接不稳定 | 42(1.28) | 9(20.9) | 分布于整个随访期 | (1)建议切换网络环境(25次) (2)设备自动重连(17次) | 100.0 |
| 平台数据显示异常 | 8(0.24) | 3(7.0) | 数据解析错误 | 后台人工校正数据;联系工程师修复 | 100.0 |
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