养心开郁片治疗中、轻度抑郁症90例临床观察

Observation of Efficacy of Yangxin Kaiyu Tablets on 90 Patients with Moderate or mild Depression

目的:观察养心开郁片治疗中-轻度抑郁症的临床疗效及安全性。方法:将135例患者随机分为治疗组90例,对照组45例,治疗组口服养心开郁片4片/次,3次/d;对照组口服氟西汀25mg/d,上午服用;夜间睡前30min2组均给予枣安胶囊2～4粒。于第一次就诊及用药第2和6周末分别以HAMD-17、中医症状量表、SCL-90、SDS、SAS、SERS量表及实验室检查评估疗效与安全性。结果:用药前2组各类量表评分无统计学差异(P>0·05);用药2周后治疗组各类评分均有所改善(P<0·05);6周后治疗组总有效率85·55%,各类评分较用药前有显著差异(P<0·05)。2组间总有效率、各类量表的各时间点评分基本无统计学差异;SAS评分治疗组优于对照组(P<0·05)。治疗组中医症状少寐多梦、心烦心悸改善明显,对照组忧伤郁闷改善明显(P<0·05)。SERS评估、安全性评估均未发现明显不良反应。结论:提示养心开郁片治疗中轻度抑郁症具有较好的疗效,2周即可起效,治疗6周后效果明显,与氟西汀相当,安全性良好。

Objectives：To observe efficacy and safety of Yangxin Kaiyu tablets on moderate or mild depression.Method：135 patients were randomized to the tablet arm （n=90,4 tablets,3 times per day） and Fluoxetine arm （n=45,25mg/day in the morning）;background medication：4 Zaoan capsules 30min before bed.Efficacy and safety parameters include the Hamilton depression rating scale （HAMD-17）,TCMsyndrom scale,Symptom Checklist90 （SCL-90）,self-rating scale for depression （SDS）,self-rating scale for Anxiety （SAS）,Rating Scale for Side Effects（SERS） and related laboratory analysis at WEEK2 and WEEK6.Results：There were no statistical significance of before treatment （P0·05）.At WEEK2 both groups improved on all parameters （P0·05）;At WEEK6 total effective rate for the tablet was 85.55%.The total effective rate and the scores of various rating scale at the set time points were not statistically different between the two groups.The SAS assessment was better with the tablet.Palpitation,insomnia and the symptom of depression improved significantly in the treatment group and the control group respectively （P0·05）.No safety concerns revealed during the study.Conclusion：the Yangxin Kaiyu tablets can treat moderate or mild depression without obvious safety issue.