九味镇心颗粒合并氟西汀片治疗首发抑郁症伴焦虑的疗效与安全性对照研究

The study of clinical efficacy and safety between Nine town heart particles and combination therapy with Fluoxetine Hydrochloride Tablets in the treatment of first-episode depression

目的:评价九味镇心颗粒合并氟西汀片治疗首发抑郁症伴焦虑患者的临床疗效及安全性。方法:将118例首发抑郁症伴焦虑患者分成氟西汀片合并九味镇心颗粒治疗组(研究组)58例和氟西汀片治疗组(对照组)60例,于治疗前及治疗后第2周、第4周、第6周、第8周末分别采用汉密尔顿抑郁量表(HAMD)、汉密尔顿焦虑量表(HAMA)、治疗中需处理的不良反应症状量表(TESS)进行疗效和不良反应评估。结果:至治疗后第2周、第4周、第6周及第8周末两组患者的治疗效果与治疗前均有显著性差异,有统计学意义(均P<0.01)。在治疗后第6周、第8周末研究组HAMD评分低于对照组,差异有统计学意义(u=4.8055,P<0.01)。在缓解焦虑方面研究组在第2周、第4周、第6周、第8周末评分明显低于对照组,差异有统计学意义(均P<0.01),不良反应二者无明显差异(P>0.05),表现出好的治疗优势。结论:九味镇心颗粒合并氟西汀片对首发抑郁症伴焦虑的治疗可以明显提高抗抑郁疗效,快速缓解焦虑,治疗安全性高。

Objective To evaluate the clinical efficacy and safety of Nine town heart particles combined with Fluoxetine Hydrochloride Tablets in treatment of First-episode depression with anxiety.Method 118 patients with first-episode depression and anxiety were divided into fluoxetine tablet combined with Jiuwei Zhenxin Granule treatment group(study group)58 cases and fluoxetine tablet treatment group(control group)60 cases.All patients were assessed with Hamilton Depression Rating Scale(HAMD),Hamilton Anxiety Scale(HAMA)and Emergent Symptoms Scale(TESS)at the 2 nd,4 th,6 th,8 th weekend to evaluate the efficacy and adverse reaction before and after treatment.Results At the 2 nd,4 th,6 th,8 th weekend after treatment,the scores were significantly different before and after treatment in both groups(P<0.01).At the 6 th,8 th weekend after treatment,the scores of HAMD in the study group were significantly lower than that in the control group(u=4.8055,P<0.01).In terms of relieving anxiety,the study group scored were significantly lower than the control group at the 2 nd,4 th,6 th,8 th weekend(P<0.01).The scores of TESS were no significantly different between the two groups(P>0.05).Showinggood therapeutic advantages.Conclusion Nine town heart particles combined with Fluoxetine Hydrochloride Tablets can significantly improve the effect of antidepressant and rapid relief anxiety for treatment of First-episode depression with anxiety.The safety of treatment is high.