滋肾调肝和脾安神法治疗失眠的临床研究
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摘要
目的观察滋肾调肝和脾安神法治疗失眠的有效性和安全性。方法采用前瞻性队列研究方法,治疗组予以滋肾调肝和脾安神颗粒剂,2次/日,连服4周,配合睡眠卫生教育,对照组予以睡眠卫生教育。比较两组治疗前后的临床疗效,包括总有效率、匹兹堡睡眠质量指数(PSQI)因子及中医证候,并记录不良反应。结果治疗组总有效率显著优于对照组;治疗组治疗前后五个因子得分(入睡时间,睡眠时间、质量、效率、障碍)差值比较均显著优于对照组(P <0. 001)。两组各因子不同分值(0～3分)患者例次比较,0分和1分较好,治疗组治疗后睡眠质量、效率、障碍为0分的患者例次较基线均显著增加(P <0. 05),治疗组治疗后睡眠质量、效率,入睡时间为0分+1分的患者例次较基线均显著增加(P <0. 05);治疗组治疗后睡眠效率为0分的患者例次显著高于对照组(P <0. 05),治疗组治疗后睡眠质量为0分+1分的患者例次显著高于对照组(P <0. 001);治疗组阴虚火旺证候总有效率显著优于对照组(P <0. 001),治疗组肝脾不和证候总有效率显著优于对照组(P <0. 001),且能改善头晕、乏力、躁热等症状。结论滋肾调肝和脾安神法能改善阴虚火旺肝脾不和型失眠患者的总体睡眠情况及不同睡眠维度,且能改善患者症状,用药安全,患者满意度和接受度较高。
Objective To observe the efficacy and safety of nourishing kidney,harmonizing liver and spleen and tranquilizing mind to treat insomnia. Methods A prospective cohort study method was used to form a cohort. The treatment group was given Chinese medicine of nourishing kidney,harmonizing liver and spleen and tranquilizing mind,2 times per day for 4 weeks,combined with sleep hygiene education,and control group was given sleep hygiene education. The clinical efficacy was compared between two groups,including total effective rate,Pittsburgh Sleep Quality Index( PSQI) factor and traditional Chinese medicine( TCM) syndromes. And adverse reactions were also recorded. Results The total effective rate of treatment group was significantly better than that of control group( P < 0. 001); Five factors of treatment group( sleep latency,sleep quality,sleep duration,sleep efficiency,sleep disturbances) were significantly better than control group( P <0. 001). When treatment had been finished,cases of 0 point were significantly better than baseline( P < 0. 05) by comparing 3 factors( sleep quality,sleep efficiency,sleep disturbances) between these two groups. Cases of 0 point and 1 point were significantly better than baseline( P < 0. 05) in factors( sleep quality,sleep efficiency,sleep latency). Treatment group had a better sleep efficiency and sleep quality than control group. Total effective rate of fire due to yin deficiency syndromein treatment group was significantly better than control group( P < 0. 001). Total effective rate of disharmony between liver and spleen syndrome in treatment group was significantly better than control group( P < 0. 001);( 4) Safety: During treatment,no obvious adverse reactions occurred in two groups. Conclusions The method of nourishing kidney,harmonizing liver and spleen and tranquilizing mind can improve overall sleep condition and different sleep dimensions of insomnia patients with fire due to yin deficiency and disharmony between liver and spleen,it also can improve patient' s symptoms more safely,and has high patient satisfaction and reception.
Objective To observe the efficacy and safety of nourishing kidney,harmonizing liver and spleen and tranquilizing mind to treat insomnia. Methods A prospective cohort study method was used to form a cohort. The treatment group was given Chinese medicine of nourishing kidney,harmonizing liver and spleen and tranquilizing mind,2 times per day for 4 weeks,combined with sleep hygiene education,and control group was given sleep hygiene education. The clinical efficacy was compared between two groups,including total effective rate,Pittsburgh Sleep Quality Index( PSQI) factor and traditional Chinese medicine( TCM) syndromes. And adverse reactions were also recorded. Results The total effective rate of treatment group was significantly better than that of control group( P < 0. 001); Five factors of treatment group( sleep latency,sleep quality,sleep duration,sleep efficiency,sleep disturbances) were significantly better than control group( P <0. 001). When treatment had been finished,cases of 0 point were significantly better than baseline( P < 0. 05) by comparing 3 factors( sleep quality,sleep efficiency,sleep disturbances) between these two groups. Cases of 0 point and 1 point were significantly better than baseline( P < 0. 05) in factors( sleep quality,sleep efficiency,sleep latency). Treatment group had a better sleep efficiency and sleep quality than control group. Total effective rate of fire due to yin deficiency syndromein treatment group was significantly better than control group( P < 0. 001). Total effective rate of disharmony between liver and spleen syndrome in treatment group was significantly better than control group( P < 0. 001);( 4) Safety: During treatment,no obvious adverse reactions occurred in two groups. Conclusions The method of nourishing kidney,harmonizing liver and spleen and tranquilizing mind can improve overall sleep condition and different sleep dimensions of insomnia patients with fire due to yin deficiency and disharmony between liver and spleen,it also can improve patient' s symptoms more safely,and has high patient satisfaction and reception.
引文
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[19]曾智力,黄柳向,王行宽.王行宽滋肾清肝润燥法治疗干燥综合征经验[J].中医杂志,2018,59(2):104-107.
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[2]McReynolds JR,Holloway-Erickson CM,Parmar TU,et al. Corticosterone-induced enhancement of memory and synaptic Arc protein in the medial prefrontal cortex[J]. Neurobiol Learn Mem,2014(112):148-157.
[3]Dai XJ,Peng DC,Gong HH,et al. Altered intrinsic regional brain spontaneous activity and subjective sleep quality in patients with chronic primary insomnia:a resting-state f MRI study[J]. Neuropsychiatr Dis Treat,2014(10):2163-2175.
[4]Walker MP. The role of sleep in cognition and emotion[J]. Ann NY Acad Sci,2009,1156(1):168-197.
[5]Zhou QH,Wang HL,Zhou XL,et al. Efficacy and safety of suanzaoren decoction for chronic insomnia disorder in adults:study protocol for randomised,double-blind,double-dummy,placebo-controlled trial[J]. BMJ Open,2017,7(4):e014 280.
[6]Luyster FS,Strollo PJ,Zee PC,et al. Sleep:a health imperative[J].Sleep,2012,35(6):727-734.
[7]中华医学会神经科分会.中国精神障碍分类与诊断标准[M]. 3版.济南:山东科学技术出版社,2011:103-412.
[8]国家中医药管理局.中医病证诊断疗效标准(中华人民共和国中医药行业标准)[M]. 2012版.北京:中国医药科技出版社,2012:31-32.
[9]刘贤臣,唐茂芹,胡蕾,等.匹兹堡睡眠质量指数的信度和效度研究[J].中华精神科杂志,1996,29(2):103-107.
[10]王斌,张谈,裘磊,等.基于仲景柴胡方证理论运用柴胡加龙骨牡蛎汤治疗失眠的临床研究[J].中华中医药学刊,2016,34(6):1430-1433.
[11]Xiang YT,Ma X,Cai ZJ,et al. The prevalence of insomnia,its sociodemographic and clinical correlates,and treatment in rural and urban regions of Beijing,China:a general population-based survey[J]. Sleep,2008,31(12):1655-1662.
[12]中华医学会神经病学分会睡眠障碍学组.中国成人失眠诊断与治疗指南[J].中华神经科杂志,2012,45(7):534-540.
[13]Vgontzas AN,Liao D,Bixler EO,et al. Insomnia with objective short sleep duration is associated with a high risk for hypertension[J].Sleep,2009,32(4):491-497.
[14]Ohayon MM. Epidemiology of insomnia:what we know and what we still need to learn[J]. Sleep Med Rev,2002,6(2):97-111.
[15]程国良,钱彦方,李静,等.失眠机制研究进展[J].世界睡眠医学杂志,2016,3(3):174-179.
[16]叶天士.临证指南医案[M].北京:北京科学技术出版社,2014:227.
[17]袁拯忠,叶人,项祖闯,等. 913例失眠患者中医证型分布规律[J].中华中医药学刊,2011,29(7):1508-1510.
[18]袁拯忠,戴春秀,叶人,等. 913例失眠患者中医证型分布的影响因素分析[J].中华中医药杂志,2011,26(7):1587-1590.
[19]曾智力,黄柳向,王行宽.王行宽滋肾清肝润燥法治疗干燥综合征经验[J].中医杂志,2018,59(2):104-107.
[20]Zhang Y,Li M,Kang RX,et al. NHBA isolated from Gastrodia elata exerts sedative and hypnotic effects in sodium pentobarbital-treated mice[J]. Pharmacol Biochem Behav,2012,102(3):450-457.
[21]Hoffmann KM,Herbrechter R,Ziemba PM,et al. Kampo Medicine:Evaluation of the Pharmacological Activity of 121 Herbal Drugs on GABAA and 5-HT3A Receptors[J]. Front Pharmacol,2016(7):219.