安非他酮与阿米替林治疗抑郁障碍的双盲对照研究  

The double-blind controlled trial of bupropion and amitriptyline in the treatment of depressive disorders

作　　者：王传跃[1] 翟屹民[1] 翁永振[1] 张鸿雁[2] 高成阁[3] 翁正[4] 张秀平[4] 曹毅[5] 

机构地区：[1]首都医科大学附属北京安定医院四科,100088 [2]北京大学精神卫生研究所普通精神病科 [3]西安交通大学第一医院精神科 [4]山东省精神卫生中心普通精神病科 [5]天津市安定医院普通精神病科

出　　处：《中华精神科杂志》2006年第3期169-173,共5页Chinese Journal of Psychiatry

摘　　要：目的评价国产安非他酮片治疗抑郁障碍的疗效及安全性。方法229例符合中国精神障碍分类与诊断标准第3版的各型抑郁发作患者,随机分为安非他酮组(300mg/d或450mg/d) 115例,阿米替林组(100mg/d或150mg/d)114例,疗程均为6周。以汉密尔顿抑郁量表(HAMD)、汉密尔顿焦虑量表(HAMA)及临床大体印象量表进行疗效评估。以治疗中需处理的不良反应量表(TESS)、血常规、尿常规、血生化、心电图及生命体征等进行安全性评估。结果安非他酮组的有效率为74%(67/91),阿米替林组为92%(83/90),差异有统计学意义(P＜0.05)。安非他酮组HAND分数下降[(-16±8)分]少于阿米替林[(-20±7)分],P＜0.01。安非他酮组HAMD的焦虑/躯体化和睡眠障碍及HAMA的精神性焦虑等靶症状的疗效不如阿米替林组(P＜0.01)。安非他酮组的与药物相关的不良事件发生率为65.2%、阿米替林组为88.6%。安非他酮组的思睡、口干、心动过速及体质量增加较阿米替林组少见(P＜0.05)。结论国产安非他酮片治疗抑郁障碍有效,不良反应少于阿米替林,但疗效尤其是抗焦虑等作用不如阿米替林。Objective To evaluate the efficacy and safety of domestic hydrochloric bupropion tablet in the treatment of depressive disorders. Methods All 229 outpatients or inpatients who met criteria for depressive episode in Chinese Classification and Diagnostic Criteria of Mental Disorders, 3rd ed. were randomly assigned to bupropion （ n =115 ） or amitriptyline treatment （ n = 114 ） for six weeks. The efficacy was evaluated with the Hamilton Depression Scale （HAMD） , Hamilton Anxiety Scale （HAMA） and Clinical Global Impression Scale （ CGI ）. The Safety and tolerability were assessed with the Treatment Emergent Symptom Scale （TESS）, hematology, clinical chemistry, urinalysis, electrocardiogram and vital sign. Results The response rates were 74% （67/91） in bupropion and 92% （83/90） in amitriptyline group. The HAMD scores in bupropion group decreased less than that in amitriptyline group （ - 16 ±8 ） vs. （ -20 ± 7 ）, P 〈 0.01. Bupropion was not as good as amitriptyline in treating anxiety/somatization and sleep disorders in HAMD and psychical anxiety in HAMA （ P 〈0. 01 ）. Incidence of adverse events was 65.2% in bupropion and 88.6% in amitriptyline. There were less drowsiness, dry mouth, tachycardia and weight gain in bupropion than that in amitriptyline （ P 〈 0. 05 ）. Conclusion The results suggest that it is effective of bupropion in treating depression, with fewer side effects and less anxiolytic effects in comparison with amitriptyline.

关 键 词：安非他酮 阿米替林 抑郁障碍 

分 类 号：R749.4[医药卫生—神经病学与精神病学] R971.43[医药卫生—临床医学]