草酸依地普仑治疗抑郁症的Ⅱ期临床研究

目的评价国产草酸依地普仑片治疗抑郁症的疗效和安全性.方法对符合《DSM-Ⅳ》重性抑郁发作诊断标准的56例抑郁症患者进行国产草酸依地普仑片（10～20mg/d）和进口草酸艾司西酞普兰片（10～20mg/d）的双盲对照研究,其中国产草酸依地普仑组28例,进口草酸艾司西酞普兰组28例,共治疗6周.采用汉密尔顿抑郁量表（HAMD）,汉密尔顿焦虑量表（HAMD）,临床疗效总评量表（CG）I评定临床疗效,采用实验室检查和临床观察评定不良反应.结果经6周治疗,两组的HAMD、HAMA评分治疗前后相比较差异有统计学意义（P〈0.01）,两组的HAMD、HAMA评分之间差异性比较无统计学意义（P〉0.05）.不良反应分析,两组不良反应的发生率无统计学意义（P〉0.05）,常见的不良反应为恶心、食欲减退、乏力等.结论国产草酸依地普仑片治疗抑郁症疗效好,不良反应少而轻,适合临床应用.

The Phase Ⅱ Clinical Trials for Escitalopram Oxalate to Treat Major Depressive Disorder

Objective To determine the efficacy and safety of escitalopram oxalate to treat the depressive patients.Methods A double-blind controlled study was carried out in 56 patients who meet the DSM-Ⅳ diagnostic criteria of major depression and depressed episode.The 28 cases of total patients were treated with escitalopram oxalate made in china and the others were treated with escitalopram oxalate made in Lundbeck for 6 weeks.The clinical efficacy was assessed with Hamilton Depressin Rating Scale（HAMD）,Hamilton Anxiety Rating Scale（HAMA） and Clinical Global Impression（CGI）,The safety was assessed with laboratory tests and clinical observation.Results After 6 weeks treatment,the scores of HAMD and HAMA in two groups had statistical difference between before and after treatment（P〈0.01）;however,there was no significant difference between the two groups.The main adverse events of two group were anorexia,reching and voming etc.There was no significant difference in incidence of adverse events between the two groups.Conclusion Escitalopram oxalate made in china is a safe and effective antidepressants with few side effects,and fits in clinical use.