舍曲林联合舒肝解郁胶囊治疗复发性抑郁障碍对照研究

A control study of sertraline plus Shugan Jieyu capsule in the treatment of recurrent depressive disorder

目的探讨舍曲林联合舒肝解郁胶囊治疗复发性抑郁障碍患者的临床疗效和安全性。方法将100例复发性抑郁障碍患者按照就诊顺序随机分为两组，每组50例，两组均口服舍曲林治疗，研究组联合舒肝解郁胶囊治疗，观察8周。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1周末起两组汉密顿抑郁量表评分均较治疗前显著性下降（P〈0．01），研究组治疗第2周、4周、6周、8周末汉密顿抑郁量表评分均显著低于对照组（P〈0．01）；治疗8周末研究组总有效率为84．0％，对照组为64．0％，研究组总有效率显著高于对照组（χ2=5．20，P〈o．05）。研究组不良反应发生率为38．0％，对照组为34．0％，两组比较差异无显著性（χ2=0．17，P〉O．05）。结论舍曲林联合疏肝解郁胶囊治疗复发性抑郁障碍起效快，疗效显著，不增加不良反应，安全性高，优于单用舍曲林治疗。

Objective To explore the efficacy and safety of sertraline plus Shugan Jieyu capsule in the treatment of recurrent depressive disorder （RDD）. Methods A total of 100 RDD patients were randomly assigned to two groups of 50 ones each according to visiting order, both groups took orally sertraline, and research group was plus Shugan Jieyu capsu｜e for 8 weeks. Efficacies were assessed with the Hamilton De- pression Scale （HAMD） and adverse reactions with the Treatment Emergent Symptom Scale （TESS）. Re- sults Since the end of the 1st week treatment the HAMD scores of both groups lowered more significantly compared with pretreatment （P〈0.01）, those were significantly lower in research than in control group at the end of the 2nd, 4th, 6th and 8th week （P〈0.01） ; at the end of the 8th week total effective rate was signif- icantly higher in research than in control group（84.0% vs. 64.0%, χ2=5.20,P〈O. 05）. The incidence was respectively 38.0% in research and 34.0% in control group, which showed no significant group differ- ence （χ2=0.17,P〈0.05）. Conclusion Sertraline plus Shugan Jieyu capsule takes effect more rapidly, has an evident effect and higher safety, and doesn＇t increase adverse reactions compares with single sertra- line in the treatment of recurrent depressive disorder.