开郁安神胶囊治疗轻中度抑郁症的Ⅱ期临床研究

The second phase clinical trials of Kaiyu Anshen capsule for the treatment of mild to moderate depressive disorders

目的评价开郁安神胶囊治疗轻、中度抑郁症的临床疗效和安全性。方法对符合CCMD-3抑郁症诊断标准的60例抑郁症患者进行开郁安神胶囊与氟西汀片的对照研究,其中开郁安神胶囊组30例(1.44g/d),氟西汀组30例(20mg/d),共治疗6周。采用汉密尔顿抑郁量表(HAMD)、汉密尔顿焦虑量表(HAMA)、临床总体评定量表(CGI)评定临床疗效,不良反应量表(TESS)评定不良反应。结果经6周治疗后,开郁安神胶囊组治疗总有效率为53.57%,氟西汀组为50.00%,两组比较无显著性差异(P>0.05);两组的HAMD,HAMA评分治疗前后有极显著性差异(P<0.01)。两组常见的不良反应有恶心呕吐、腹泻、口干、头昏、食欲减退和厌食等,发生率无显著性差异(P>0.05)。结论开郁安神胶囊治疗轻、中度抑郁症疗效好,且不良反应少而轻,适合临床应用。

Objective The aim of this study was to determine the efficacy and safety of Kaiyu Ansheng capsule to the patients with mild to moderate depressive disorders. Methods A controlled study was carried out between 60 patients who met the CCMD - 3 criteria of major depression and depressed episode. The 30 of total patients were treated with Kaiyu Ansheng capsule（1.44g/d） and the others were treated with fluoxetine （20rag/d） for 6 weeks. The efficacy were assessed by Hamilton depression rating scale （ HAMD）, Hamilton anxiety scale （ HAMA）, clinical global impression （CGI） and the safety was assessed by treatment emergent symptom scale （TESS）. Results After six weeks treatment,the improvement rate of Kaiyu Ansheng capsule group and fluoxetine group were 53.57% and 50. 00%, respectively （P 〉 0. 05 ）. The scores of HAMD and HAMA in two groups were statistical difference before and after treatment （P 〈 0. 01 ）. The main adverse events of two groups were retching, vomiting, diarrhea, dry mouth, dizziness, anorexia, et al. There was no significant difference in incidence of adverse events between Kaiyu Ansheng capsule group and fluoxetine group. Conclusion Kaiyu Ansheng capsule is an effective antidepressants,with less side effects,better safety,suiting for clinical use.