滋肾调肝和脾安神法治疗失眠的临床研究

Clinical study on treatment of insomnia with nourishing kidney,harmonizing liver and spleen and tranquilizing mind

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.