氟西汀(奥麦伦)治疗1981例抑郁性障碍患者的Ⅲ期临床试验  

A phase Ⅲ clinical trial of fluoxetine in treatment of 1981 cases of depressive disorders.

作　　者：方贻儒[1] 王祖承[2] 盛建华[2] 邱宏[2] 

机构地区：[1]上海第二医科大学精神医学教研室,200030 [2]上海市精神卫生中心

出　　处：《上海精神医学》1999年第2期75-80,共6页Shanghai Archives of Psychiatry

摘　　要：目的 验证国产氟西汀大范围、大样本治疗抑郁性障碍的有效性与安全性。 方法 采用多中心协作、开放、非对照研究,入组病例符合CCMD—2—R抑郁发作的诊断标准,入组后予氟西汀20mg/日,可酌情增减剂量,疗程分6周、3月、6月三组。结果 全国50家医院参加本次验证,完成试验病例1937例,结果显示盐酸氟西汀能显著降低HAMD总分及各因子分,在治疗后4周已有显著疗效。不良反应常见有口干、便秘、失眠、食欲减退、恶心呕吐、心动过速、出汗等。结论 国产氟西汀对各类抑郁障碍疗效理想,不良反应轻,服用方便。Objective: To verify the efficacy and safety of domestic fluoxetine in treatment of depressive disorders. Method: Subjects were qualified for a CCMD-2-R diagnosis of depressive episode, and they took fluoxetine 20 mg daily initially and flexibly afterwards for at least 6 weeks. Results: Totally 1937 patients from 50 hospitals nationawide completed the trial. Total and sub-scale scores in HAMD were significantly decreased after treatment of fluoxetine and significant responses occurred in 4th week. Common side effects included dry mouth, constipation, insomnia, lowered appetite, nausea, vomiting, tachycardia and perspiration. Conclusion: Domestic fluoxetine was effective in treatment of depressive disorders, had less side effects and could be used simply.

关 键 词：氟西汀 抗抑郁剂 抑郁障碍 多中心研究 抑郁症 药物治疗 

分 类 号：R749.41[医药卫生—神经病学与精神病学]