摘要
目的探讨百乐眠胶囊联合自助失眠认知行为疗法（CBTI－SH）对慢性失眠症的疗效。方法经医院伦理委员会批准，选择60例慢性失眠症患者，按随机数字表法随机分为试验组（百乐眠胶囊联合CBTI－SH）和对照组（单纯CBTI－SH）各30例，干预4周；使用睡眠日志、失眠严重程度指数量表（ISI）、焦虑自评量表（SAS）、抑郁自评量表（SDS）、不良反应量表（TESS）分别评价患者的睡眠、情绪及治疗不良反应等，并进行统计学分析。结果试验组临床总有效率显著高于对照组（73.3%比46.7%）（P〈0.05）。试验组治疗后的入睡时间、睡眠效率均显著好于对照组[（27.5±9.8）比（38.3±13.1）min、（80.5±6.6）%比（76.6±5.7）%]（均P〈0.05）；试验组治疗后的入睡时间、总睡眠时间、卧床时间、睡眠效率均显著优于治疗前[（27.5±9.8）比（56.2±19.4）min、（334.4±41.6）比（310.8±31.7）min、（415.6±38.9）比（446.9±39.9）min、（80.5±6.6）%比（69.6±4.9）%]（均P〈0.05）；对照组治疗后的入睡时间、卧床时间、睡眠效率均显著优于治疗前[（38.3±13.1）比（55.2±16.2）min、（430.4±32.6）比（452.4±34.4）min、（76.6±5.7）%比（69.9±5.2）%]（均P〈0.05）。治疗后，试验组SAS、SDS评分均显著低于对照组[（51.5±6.5）比（55.0±5.8）分、（52.0±5.3）比（55.3±4.4）分]（均P〈0.05）；试验组及对照组治疗后SAS、SDS评分均显著低于治疗前[（51.5±6.5）比（61.5±4.8）分、（52.0±5.3）比（60.2±4.5）分，（55.0±5.8）比（62.5±3.7）分、（55.3±4.4）比（62.2±3.7）分] （均P〈0.01）。结论百乐眠胶囊联合CBTI－SH对慢性失眠症具有较好的疗效。
Objective To evaluate the efficacy of Bailemian capsule combined with self-help cognitive behavioral therapy （ CBTI-SH ） in treatment of chronic insomnia. Methods Approved by the Ethics Committee of the hospital, 60 patients with chronic insomnia were randomly divided into two groups, the test group （Bailemian capsule combined with CBTI-SH） and the control group （CBTI-SH alone）. Each group contained 30 cases. After 4 weeks for therapy, the sleep quality, mood and adverse reactions of treatment in patients were evaluated by sleep diary, sleep severity index scale （ ISI ） , self-rating anxiety scale （SAS）, self-rating depression scale （SDS） and treatment emergent symptom scale （TESS） respectively. The data were statistically analyzed. Results The total effective rate in the test group was significantly higher than that of the control group （73.3% vs 46. 7% , P 〈 0. 05 ）. Compared to the control group, the sleep onset latency was significantly shorten [ （38.3 ± 13.1 ） vs （27.5 ± 9.8） min, P 〈 0. 051, while the sleep efficiency were increased markedly [ （76. 6 ± 5.7 ） % vs （ 80. 5 ± 6. 6） %, P 〈 0. 051 in the test group. In the test group, the sleep onset latency, the total sleep time, the time in bed and sleep efficiency both improved significantly after treatment [（27. 5 ± 9.8） vs （56. 2 ±19.4） min, （334. 4 ± 41.6） vs （310.8±31.7） rain, （415.6±38.9） vs （446.9±39.9） min, （80.5±6.6）% vs （69.6± 4. 9） % , all P 〈 0. 05 1, while in the control group, the sleep onset latency, the time in bed and sleep efficiency also improved significantly after therapy [ （ 38. 3 ± 13.1 ） vs （ 55.2 ± 16. 2 ） min, （ 430.4 ± 32. 6 ）vs （452.4 ± 34.4） min, （76. 6 ± 5.7） % vs （69. 9 ± 5.2） %, all P 〈 0. 05 ]. After combined treatment, theSASandSDS scores [（51.5 ±6.5） vs （55.0±5.8）, （52.0±5.3） vs （55.3 ±4.4）, both P〈 0. 05 ] both decreased significantly than those of the control group, at the same time, the SAS and SDS scores decreased significantly after treatment in both the test group and the control group [ （51.5 ± 6. 5 ） vs （61.5±4.8）, （52.0 ±5.3） vs （60.2±4.5）, （55.0 ±5.8） vs （62.5±3.7）, （55.3 ±4.4） vs （62.2 ± 3.7 ） , all P 〈 0.011. Conclusion The efficacy of Bailemian capsule combined with CBTI-SH in the treatment of chronic insomnia is more effective.
出处
《中华医学杂志》
CAS
CSCD
北大核心
2016年第36期2893-2897,共5页
National Medical Journal of China
关键词
入睡和睡眠障碍
百乐眠胶囊
自助认知行为治疗
治疗结果
Sleep initiation and maintenance disorders
Bailemian capsule
Self-help cognitive behavioral therapy for insomnia
Treatment outcome
