柴桂温胆定志汤联合帕罗西汀治疗抑郁症疗效和安全性评价

Efficacy and Safety of Chaigui Wendan Dingzhi Decoction Combined with Paroxetine in the Treatment of Depression

目的探讨柴桂温胆定志汤联合帕罗西汀治疗抑郁症的疗效和安全性。方法将93例抑郁症患者随机分为对照组(单用帕罗西汀,46例)和研究组(联用柴桂温胆定志汤和帕罗西汀,47例),疗程均为4周。采用副反应量表(TESS)评定临床疗效和不良反应。结果研究组帕罗西汀用量、住院周期均明显优于对照组(P<0.05);研究组临床总有效率为97.87%,明显高于对照组的86.96%(P<0.05);重复测量方差分析显示,汉密尔顿抑郁量表(HAMD)、汉密尔顿焦虑量表(HAMA)评分时间与分组之间均存在交互作用(F=12.406,10.564,P=0.000),治疗2,3,4周末,观察组HAMD和HAMA评分均明显低于对照组(P<0.05);两组治疗第1,2,3,4周末TESS评分均无显著性差异(P>0.05),不良反应除恶心发生率对照组高于研究组外(P<0.05),其余均无明显差异(P>0.05)。结论柴桂温胆定志汤联合帕罗西汀治疗抑郁症起效时间及疗效均优于单用帕罗西汀,不良反应相当。

Objective To investigate the efficacy and safety of Chaigui Wendan Dingzhi Decoction combined with paroxetine in the treatment of depression.Methods Totally 93 patients with depression were randomly divided into the control group(treated with paroxetine,46 cases)and the study group(Chaigui Wendan Dingzhi Decoction combined with paroxetine,47 cases).The course of treatment was 4 weeks.The clinical efficacy and adverse reactions were assessed by Treatment Emergent Symptom Scale(TESS).Results The dosages of paroxetine and hospitalization duration in the study group were significantly better than those in the control group(P<0.05).The total effective rate of the study group was 97.87%,which was significantly higher than 86.96%of the control group(P<0.05).Repeated measures analysis of variance showed that there was interaction between time and group in Hamilton Depression Scale(HAMD)score and Hamilton Anxiety Scale(HAMA)score(F=12.406,10.564,P=0.000).After 2,3,4 weeks of treatment,the HAMD scores and HAMA score in the study group were significantly lower than those in the control group(P<0.05).After 1,2,3,4 weeks of treatment,there was no significant difference in TESS scores between the two groups(P>0.05).Except for the incidence of nausea in the control group was higher than that in the study group(P<0.05),there was no significant difference in the other adverse reactions between the two groups(P>0.05).Conclusion The initial effect time and efficacy of Chaigui Wendan Dingzhi Decoction combined with paroxetine in the treatment of depression were better than those of single-use paroxetine,and the adverse reactions of both are similar.