疏肝健脾法治疗阈下抑郁肝郁脾虚证随机对照双盲研究

A randomized controlled double-blind study of soothing the liver and invigorating the spleen in the treatment of subthreshold depression of liver depression and spleen deficiency

目的观察疏肝健脾法治疗阈下抑郁肝郁脾虚证的临床疗效。方法采用随机、对照、双盲的研究方法,将100例阈下抑郁肝郁脾虚证患者随机分为对照组和治疗组,每组各50例,剔除脱落病例后,对照组47例、治疗组48例。治疗组患者服用解忧开郁方,对照组患者服用安慰剂,治疗12周,随访1年,观察临床疗效、汉密尔顿17项抑郁量表(17-item Hamilton depression scale, HAMD-17)和中医证候量表的评分,并进行安全性评估。结果治疗12周,HAMD-17评定结果示:对照组47例中,临床控制2例、显著进步4例、进步12例、无效29例,总有效18例,总有效率为38.30%;治疗组48例中,临床控制12例、显著进步11例、进步15例、无效10例,总有效38例,总有效率为79.16%。经广义估计方程分析,Wald χ^(2)=18.383,P<0.001,说明治疗组临床疗效优于对照组。治疗12周,中医证候量表评定结果示:对照组47例中,临床控制0例、显著进步4例、进步10例、无效33例,总有效14例,总有效率为29.79%;治疗组48例中,临床控制20例、显著进步14例、进步10例、无效4例,总有效44例,总有效率为91.67%。经广义估计方程分析,Wald χ^(2)=44.861,P<0.001,说明治疗组中医证候疗效优于对照组。治疗后12个月随访,对照组12例转化为抑郁症,转化率为25.53%,治疗组6例转化为抑郁症,转化率为12.50%。治疗期间未发生严重不良反应。结论疏肝健脾法对阈下抑郁肝郁脾虚证具有较好的临床疗效,并且可防止其向抑郁症的发展。

Objective To observe the clinical efficacy of soothing the liver and invigorating the spleen in the treatment of subthreshold depression of liver depression and spleen deficiency. Methods The method of random, controlled and double-blind was conducted. 100 cases of subthreshold depression with liver depression and spleen deficiency syndrome were randomly divided into control group and treatment group, 50 cases in each group. After excluding the falling off cases, 47 cases were in the control group and 48 cases were in the treatment group. The patients in the treatment group were treated with Jie-you-kai-yu recipe, while the patients in the control group were given placebos. After 12 weeks of treatment and 1 year of follow-up, the clinical efficacy, Hamilton Depression Scale and TCM Syndrome Scale were observed, and the safety was evaluated.Results After 12 weeks of treatment, the results of Hamilton Depression Scale showed that: in the control group, 2 cases were clinically controlled, 4 cases had significant progress, 12 cases had progress, 29 cases were ineffective, 18 cases were effective, and the total effective rate was 38.30%;in the treatment group, 12 cases were clinically controlled, 11 cases were significant progress, 15 cases were progress, 10 cases were ineffective, 38 cases were effective, and the total effective rate was 79.16%. Generalized linear analysis, Wald chi square =18.383, P<0.001, showed that the clinical efficacy of the treatment group was better than that of the control group. After 12 weeks of treatment, TCM syndrome scale evaluation results showed that: in the control group, there was 0 case which were clinically controlled, 4 cases of significant progress, 10 cases of progress, 33 cases of ineffective, 14 cases of effective, and the total effective rate was 29.79%;in the treatment group of 48 cases, 20 cases of clinical control, 14 cases of significant progress, 10 cases of progress, 4 cases of no effect, the total effective rate was 91.67%. According to the generalized linear analysis, Wald chi square = 44.861, P<0.001, indicating that the therapeutic effect of the treatment group was better than that of the control group. After 12 months of follow-up, 12 cases in the control group were transformed into depression, with the conversion rate of 25.53%, and 6 cases in the treatment group were transformed into depression, with the conversion rate of 12.50%. No serious adverse reactions occurred during the treatment.Conclusions The method of soothing the liver and invigorating the spleen has a definite effect on subthreshold depression of liver depression and spleen deficiency, and can prevent it from developing into depression.