加味柴平汤联合酒石酸唑吡坦片治疗肝郁脾虚夹湿证失眠临床研究

Clinical Study on Modified Chaiping Decoction Combined with Zolpidem Tartrate Tablets for Insomnia with Syndrome of Liver Constraint and Spleen Deficiency Complicated with Dampness

目的:观察加味柴平汤联合酒石酸唑吡坦片治疗肝郁脾虚夹湿证失眠的临床疗效。方法:选取70例肝郁脾虚夹湿证失眠患者为研究对象,按随机数字表法分为观察组与对照组各35例。对照组给予口服酒石酸唑吡坦片治疗,观察组在对照组治疗方案的基础上予加味柴平汤治疗。治疗1个月后评价临床疗效,观察比较治疗前后中医证候评分变化、匹茨堡睡眠质量指数(PSQI)评分变化及失眠严重程度指数(ISI)评分变化。结果:有4例患者因未能完成疗程服用而脱落,最终纳入统计:观察组33例,对照组33例。治疗后,中医证候评分疗效总有效率观察组87.9%,对照组66.7%,2组比较,差异有统计学意义(P<0.05);2组情志抑郁、脘腹胀满、倦怠乏力、恶心呕吐、便溏不爽、食少纳呆、善太息、胸胁胀满、口中黏腻等中医证候评分均较治疗前降低,差异均有统计学意义(P<0.05),且观察组上述中医证候评分均低于对照组,差异均有统计学意义(P<0.05)。治疗后,PSQI疗效观察组总有效率90.9%,对照组81.8%,2组比较,差异有统计学意义(P<0.05);治疗后,2组PSQI总评分均较治疗前降低,且观察组PSQI总评分低于对照组,差异均有统计学意义(P<0.05)。治疗后,2组睡眠质量、入睡时间、睡眠时间、睡眠障碍、日间功能障碍、睡眠效率评分均较治疗前降低,且观察组睡眠时间、日间功能障碍评分均低于对照组,差异均有统计学意义(P<0.05)。治疗后,2组ISI评分均较治疗前降低,且观察组ISI评分低于对照组,差异均有统计学意义(P<0.05)。结论:加味柴平汤联合酒石酸唑吡坦片治疗有利于改善肝郁脾虚夹湿证失眠的临床症状,从而提高睡眠质量,临床疗效良好。

Objective:To observe the clinical effect of modified Chaiping Decoction combined with Zolpidem Tartrate Tablets for insomnia with the syndrome of liver constraint and spleen deficiency complicated with dampness.Methods:A total of 70 cases of patients with insomnia with syndrome of liver constraint and spleen deficiency complicated with dampness were selected as the study subjects and divided into the observation group and the control group according to the random number table method,with 35 cases in each group.The control group was treated with Zolpidem Tartrate Tablets orally,and the observation group was additionally treated with modified Chaiping Decoction based on the treatment of the control group.After a one-month treatment,clinical effects were evaluated.The changes in traditional Chinese medicine syndrome scores and the scores of Pittsburgh Sleep Quality Index(PSQI)and Insomnia Severity Index(ISI)were observed and compared before and after treatment.Results:Four patients dropped out due to failure to complete the treatment course;ultimately,there were 33 patients in the observation group and 33 patients in the control group.After treatment,the total effective rate of traditional Chinese medicine syndrome scores was 87.9%in the observation group and 66.7%in the control group,the difference being significant(P<0.05);traditional Chinese medicine syndrome scores of emotional depression,distention and fullness in the stomach cavity,fatigue and lack of strength,nausea and vomiting,loose stools and incomplete defecation,poor appetite and digestion,frequent sighing,distension in the chest and rib-side,and sticky and greasy in the mouth in the two groups were decreased when compared with those before treatment,differences being significant(P<0.05),and the above traditional Chinese medicine syndrome scores in the observation group were lower than those in the control group,differences being significant(P<0.05).After treatment,the total effective rate of PSQI was 90.9%in the observation group and 81.8%in the control group,the difference being significant(P<0.05);after treatment,PSQI scores in the two groups were declined when compared with those before treatment,and PSQI scores in the observation group were lower than those in the control group,differences being significant(P<0.05).The scores of sleep quality,falling asleep time,sleep duration,sleep disorders,daytime dysfunction,and sleep efficiency in the two groups were reduced when compared with those before treatment,and the scores of sleep duration,daytime dysfunction in the observation group were lower than those in the control group,differences being significant(P<0.05).After treatment,the ISI scores in the two groups were decreased when compared with those before treatment,and the ISI scores in the observation group were lower than those in the control group,differences being significant(P<0.05).Conclusion:The combination of modified Chaiping Decoction and Zolpidem Tartrate Tablets is beneficial for improving the clinical symptoms of insomnia with the syndrome of liver constraint and spleen deficiency complicated with dampness,thereby improving sleep quality with good clinical effects.