舒肝解郁胶囊联合氟伏沙明治疗抑郁症的疗效及对睡眠影响研究

Clinical efficacy of the Shugan Jieyu capsule plus Fluvoxamine on depression and sleep

目的:观察中药舒肝解郁胶囊联合氟伏沙明治疗抑郁症的临床疗效及对睡眠质量的影响。方法:研究2013年10月-2015年3月期间在门诊就诊的符合DSM-IV重性抑郁发作的患者82例,根据就诊先后顺序,采用随机数字表法将其分为研究组和对照组,每组41例。研究组接受可变剂量的氟伏沙明联合固定剂量(2粒,2次/d)的舒肝解郁胶囊治疗,对照组仅接受可变剂量的氟伏沙明治疗,观察6周。采用汉密尔顿抑郁量表(HAMD),汉密尔顿焦虑量表(HAMA),治疗中出现的副作用量表(TESS)和匹兹堡睡眠质量指数量表(PSQI)评定两组患者治疗前、治疗第6周末的症状严重程度、不良反应和睡眠质量,并统计治疗前后的变化和组间差异。结果:治疗前,两组患者HAMD、HAMA评分组间比较,P>0.05。两组患者治疗6周后HAMD、HAMA评分均较其治疗前明显下降,P均<0.01,且研究组降分程度更高,但两组间比较无统计学差异,P>0.05;两组间有效率和痊愈率比较,P均>0.05;研究组氟伏沙明平均剂量为(108.5±35.7)mg/d,对照组为(131.7±42.8)mg/d,P<0.05;睡眠质量方面,研究组的PSQI睡眠效率、睡眠时间、睡眠质量及日间功能因子评分较治疗前明显下降(P<0.05),对照组的PSQI睡眠时间及日间功能因子评分亦较治疗前明显下降(P<0.05)。研究组恶心、口干、食欲减退的发生率明显低于对照组,P<0.05。结论:舒肝解郁胶囊联合氟伏沙明治疗抑郁症可减少氟伏沙明的使用剂量,可更好地改善睡眠质量,并且不良反应更少,是值得推荐的一种治疗抑郁症的中西药结合方式。

Objective: To investigate clinical efficacy of the Shugan Jieyu capsule plus Fluvoxamine on depression and sleep quality.Methods: 82 cases with major depressive disorder were randomly divided into the study group (41 cases) and control group (41 cases).All patients took flexible dose of Fluvoxamine, for 6 weeks. The study group also took the Shugan Jieyu capsule (2 capsules once, twice a day),for 6 weeks. The severity of depression, adverse reaction and quality of sleep before and in the end of 6 weeks were evaluated by HAMD,HAMA, TESS and PSQI. Results: Before treatment, the HAMD, HAMA between two groups were not different (P>0.05). In 6 weeks, the HAMD, HAMA total scores were decreased significantly (P<0.01); The reduction in the study group was greater than that in the control group, with no significant difference (P>0.05). The efficiency and response rate between two groups were no significantly difference (P>0.05). The average dose of fluvoxamine in study group was (108.5±35.7) mg/d, and significantly lower than (131.7±42.8) mg/d in the control group (P<0.05). In the study group, the sleep duration, daytime function, sleep efficiency and sleep quality of PSQI were significantly decreased (P<0.05); and sleep duration, daytime function were also significantly decreased in control group (P<0.05). The occurrence rates of nausea, dry mouth and decreased appetite in the study group were significantly lower than those in the control group (P<0.05). Conclusion: The Shugan Jieyu capsule plus Fluvoxamine on major depressive disorder can less dose of Fluvoxamine, improve quality of sleep, reduce the adverse reactions, and is worthy of recommendation.