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轻中度抑郁症的临床疗效和安全性。方法 对符合《CCMD》勘抑郁症诊断标准的66例抑郁症患者进行盐酸安非他酮缓释片和氟西汀的对照研究，其中盐酸安非他酮缓释片组34例（300mg／d），氟西汀组32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，副反应量表（Tess）评定不良反应。结果经6w治疗后，盐酸安非他酮缓释片治疗总有效率为76．47％，氟西汀组为75．00％，两组比较。差异无显著性（P〉0．05）。两组的HAMD，HAMA评分治疗前后相比较差异有高度显著性（P〈0．01）。不良反应分析，两组药物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、失眠、出汗、食欲减退、便秘等。结论 盐酸安非他酮缓释片治疗抑郁症安全有效。

clinical trials of bupropion SR for the treatment of the major depression

Objective The aim of this study was to determine the efficacy and safety of bupropion SR for the depressive patients.Methods A controlled study was carried out between 66 patients who met the CCMD-3 criteria of major depression and depressed episode.34 of total patients were treated with bupropion SR(300 mg/d),and the others were treated with fluoxetine(20 mg/d)for 6 weeks.The efficacy were assessed by Hamilton Depression Rating Scale(HAMD),Hamilton Anxiety Scale(HAMA),and Clinical Global Impression(CGI),and the safety was assessed by Treatment Emergent Symptom Scale(TESS).Results After six weeks treatment,the improvement rate of bupropion SR group and fluoxetine group were 76.47% and 75.00% respectively(P>0.05).The scores of HAMD and HAMA in two groups were statistically different before and after treatment(P<0.01).The main adverse events of two groups were nausea,dry mouth,dizziness,insomnia,diaphoresis,anorexia,and constipation.There was no significant difference in incidence of adverse events between bupropion SR group and fluoxetine group.Conclusions Bupropion SR is an effective and safe antidepressant.