温阳疏肝汤治疗阳虚肝郁型失眠的临床研究

发布时间：2018-05-09 09:19

本文选题：失眠 + 阳虚肝郁型　；参考：《东南大学》2016年硕士论文

【摘要】：背景睡眠约占据了人生三分之一的时间,良好的睡眠是保证健康的重要条件。以往研究显示,10%-15%的成年人患有慢性失眠,另外25%-35%偶尔失眠或有短暂性失眠。近年来关于失眠的流行病学调查表明,失眠的患病率在增加,正成为困扰人们生活、学习、工作、健康的一个棘手的问题。现代医学针对失眠的治疗主要为药物治疗和认知行为治疗,但效果并不令人满意,且西药自身的副作用也成为其治疗失眠的一大障碍。而中医药对失眠的治疗有着悠久的历史,不但取得了一定的疗效且副作用较少,越来越受到失眠患者的重视。但是,中医药治疗失眠,因缺乏严格的临床试验设计,限制了其推广使用。虽然目前中医对失眠的辨证分型较多,但缺少阳虚肝郁型失眠的报道,而临床中确实存在不少阳虚肝郁型失眠的患者。由于对此证型普遍认识不足,导致此部分患者不能及时得到中医药的有效治疗。因此,我们在临床上开展了温阳疏肝汤治疗阳虚肝郁型失眠的研究。目的研究温阳疏肝汤治疗阳虚肝郁型失眠的临床疗效,评价温阳疏肝汤的有效性。方法采用随机、双盲、安慰剂平行对照的试验设计,将32例阳虚肝郁型失眠患者随机分成两组,经1周洗脱期后,试验组给予温阳疏肝汤治疗2周,对照组给予温阳疏肝汤安慰剂治疗2周。分别在治疗前和治疗2周后各进行一次PSQI、GAD-7、PHQ-9及中医症候量表评定。以PSQI减分率的结果作为主要疗效指标,中医症候量表减分率的结果及GAD-7、PHQ-9的减分作为次要疗效指标。结果①共有29例患者完成试验,试验组15例,对照组14例。②以PSQI减分率为主要疗效指标,温阳疏肝汤组的总有效率为80%；与治疗前相比,PSQI的减分为5.40±2.72,P0.001,95%CI为3.89-6.90,其对日间功能障碍、睡眠效率和睡眠质量的治疗作用最为明显。安慰剂组总有效率为28.57%;PSQI的减分为3.00±1.96,P0.001,95%CI为1.87-4.13,其对日间功能障碍、睡眠效率的影响最大。两组之间PSQI的疗效比较,P=0.0080.05。③以中医症候减分率为次要疗效指标,温阳疏肝汤组的总有效率为86.67%,安慰剂组为35.71%。两组之间中医症候疗效比较,P=0.0040.05。④同时还发现,温阳疏肝汤能降低GAD-7、PHQ-9的总积分,与治疗前相比,有统计学差异(P0.05);虽然安慰剂也能降低GAD-7、PHQ-9的总积分,但与治疗前相比,没有统计学差异(P0.05)。结论①无论PSQI疗效评定还是中医症候评价,温阳疏肝汤均能有效治疗阳虚肝郁型失眠,其治疗作用并非是安慰剂效应。②对失眠伴有的焦虑、抑郁症状,以GAD-7、PHQ-9量表评定,温阳疏肝汤治疗后,对失眠伴有的焦虑、抑郁有一定的缓解作用。
[Abstract]:Background Sleep accounts for about 1/3 of life time, good sleep is an important condition to ensure health. Previous studies have shown that 10 to 15 percent of adults suffer from chronic insomnia, and 25-35 percent have occasional or transient insomnia. The epidemiological survey on insomnia in recent years shows that the prevalence of insomnia is increasing, which is becoming a thorny problem that puzzles people's life, study, work and health. The treatment of insomnia in modern medicine is mainly drug treatment and cognitive behavior treatment, but the effect is not satisfactory, and the side effects of western medicine itself become a major obstacle to insomnia treatment. Traditional Chinese medicine (TCM) has a long history in the treatment of insomnia, which has not only achieved certain curative effect and less side effects, but also has been paid more and more attention to by patients with insomnia. However, traditional Chinese medicine treatment of insomnia, due to the lack of strict clinical trial design, limited its use. Although there are many types of insomnia in TCM at present, there is a lack of reports of insomnia with Yang deficiency and liver depression, and there are many patients with insomnia due to yang deficiency and liver depression in clinic. Due to the lack of general understanding of this syndrome, this part of patients can not get the effective treatment of traditional Chinese medicine in time. Therefore, we carried out a clinical study of warming Yang Shugan decoction for insomnia with yang deficiency and liver depression. Objective to study the clinical efficacy of Wenyang Shugan decoction (WYSD) in treating insomnia with yang deficiency and liver depression. Methods A randomized, double-blind, placebo-controlled trial was conducted. 32 patients with insomnia with Yang deficiency and liver depression were randomly divided into two groups. After one week of elution, the experimental group was treated with Wenyang Shugan decoction for 2 weeks. The control group was treated with placebo for 2 weeks. PSQI GAD-7 PHQ-9 and TCM symptom scale were evaluated before and 2 weeks after treatment respectively. The results of PSQI score reduction, TCM symptom scale and GAD-7 PHQ-9 were taken as the main therapeutic index. Results 1A total of 29 patients completed the test, 15 patients in the trial group and 14 patients in the control group took PSQI reduction rate as the main therapeutic index, the total effective rate of Wenyang Shugan decoction group was 80, and the decrease of PSQI was 5.40 卤2.72g P0.001P0.001C5.95 CI was 3.89-6.90, and the total effective rate of Wenyang Shugan decoction group was 80, compared with that before treatment, the CI was 3.89-6.90. The therapeutic effects of sleep efficiency and sleep quality were most obvious. In the placebo group, the total effective rate was 28.57 and the decrease of PSQI was 3.00 卤1.96, P 0.001 and 95 CI was 1.87-4.13, which had the greatest effect on daytime dysfunction and sleep efficiency. Comparison of the efficacy of PSQI between the two groups: the reduction rate of TCM symptoms was taken as the secondary curative effect index, the total effective rate of WYSDG group was 86.67 and that of placebo group was 35.71. Comparison of traditional Chinese Medicine Syndrome Therapeutic effects between the two groups (P0. 0040.05.4) at the same time, it was also found that Wenyang Shugan decoction could reduce the total score of GAD-7 and PHQ-9, which was significantly different from that before treatment, although placebo could also reduce the total score of GAD-7 and PHQ-9, but compared with that before treatment, There was no statistical difference (P 0.05). Conclusion (1) Wanyang Shugan decoction can effectively treat insomnia with deficiency of Yang and liver depression, regardless of the evaluation of PSQI efficacy or TCM symptoms. The therapeutic effect is not placebo effect .2 on anxiety and depression associated with insomnia. GAD-7PH-PHQ-9 scale is used to evaluate the effect of Wenyang Shugan decoction on insomnia. Wenyang Shugan decoction can relieve insomnia with anxiety and depression.
【学位授予单位】：东南大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R256.23

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