盐酸安非他酮缓释片治疗抑郁症的Ⅱ期临床研究

目的评价盐酸安非他酮缓释片治疗抑郁症的临床疗效和安全性。方法对58例抑郁症患者进行盐酸安非他酮缓释片和氟西汀片的对照研究，其中盐酸安非他酮缓释片组29例（300mg／d），氟西汀组29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，不良事件量表评定安全性。结果经6周治疗后，盐酸安非他酮缓释片治疗总有效率为86．2％，氟西汀组为69．0％，两组比较差异无显著性（P〉0．05）。两组不良反应的发生率无显著性差异（P〉0．05），常见的不良反应有恶心、口干、头昏、出汗、食欲减退等。结论盐酸安非他酮缓释片是一种安全有效的抗抑郁药物。

The second phase clinical trials of bupropion SR for the treatment of the major depressive disorder

Objective The study was to determine the efficacy and safety of bupropion SR for treating depressive patients.Methods A control study was carried out between 58 patients . The 29 of total patients were treated with bupropion SR(300mg/d)and the others were treated with fluoxetine (20mg/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 Adverse Event scale.Results After six weeks treatment, the improvement rates of bupropion SR group and fluoxetine group were 86.2% and 69.0%, respectively (P>0.05).The main adverse events of two groups were nausea,dry mouth, dizziness, diaphoresis and anorexia.There were no significant differences in improvement rate and incidence of adverse events between bupropion SR group and fluoxetine group.Conclusion Bupropion SR is an effective and safe antidepressant.