疏肝解郁胶囊联合舒眠胶囊治疗轻中度抑郁症对照研究

A control study of dispersing the stagnated liver-qi capsules plus Shumian capsules in mild to moderate depression

目的探讨疏肝解郁胶囊联合舒眠胶囊治疗轻中度抑郁症的临床疗效和安全性。方法将86例轻中度抑郁症患者随机分为3组，观察I组29例，口服疏肝解郁胶囊治疗，观察Ⅱ组29例，口服疏肝解郁胶囊联合舒眠胶囊治疗，对照组28例，口服文拉法辛缓释片治疗，观察6周。于治疗前及治疗第1周、2周、4周、6周末采用汉密顿抑郁量表评定临床疗效，副反应量表评定不良反应。结果治疗后3组汉密顿抑郁量表评分均较治疗前显著下降（P〈0．01），治疗2周末起观察Ⅱ组较观察I组、对照组下降更显著（P〈0．05或0．01）；治疗6周末，观察Ⅱ组痊愈率及有效率高于观察I组及对照组，不良反应发生率低于观察I组及对照组，睡眠状况优于观察I组及对照组，但差异均无显著性（P〉0．05）。结论疏肝解郁胶囊联合舒眠胶囊治疗轻中度抑郁症患者疗效显著，不良反应轻微，能改善患者的睡眠状况，值得在临床推广应用。

Objective To explore the efficacy and safety of dispersing the stagnated liver-qi （DSLQ） cap- sules plus Shumian capsules in mild to moderate depression. Methods Eighty-six mild to moderate depres- sion patients were randomly divided into three groups, observation group 1 （n=29） took orally DSLQ cap- sules, observation group 2 （n=29） did DSLQ capsules plus Shumian capsules and control group did ven- lafaxine XR for 6 weeks. Efficacies were assessed with the Hamilton Depression Scale （HAMD） and ad- verse reactions with the Treatment Emergent Symptom Scale （TESS） at baseline and at the end of the Ist , 2nd, 4th and 6th week. Results After treatment the HAMD scores of all three groups lowered more signifi- cantly compared with pretreatment （P〈0.01）, since the end of the 2na week so did that in observation group 2 than in 1 and control group （P〈0.05 or 0.01） ; at the end of the 6th week, cure and effective rate were higher, the incidences of adverse reactions lower and sleep condition better in observation group 2 than in 1 and control group, but differences were not significant （P〉0.05）. Conclusion DSLQ capsules plus Shumian capsules have an evident effect and mild adverse reaction in mild to moderate depression, could improve patients＇ sleep quality, deserve to be clinically generalized and utilized.