【摘要】 目的:比较艾司西酞普兰20mg/d天和帕罗西汀40mg/d治疗惊恐障碍12周的疗效及安全性。方法:随机、双盲双模拟、活性药平行对照的多中心临床研究。入组共有173例符合DSM-IV惊恐障碍诊断标准且筛选成功的患者进入为期12周的随机治疗,分别在随机后第2周末、第4周末、第8周末、第12周末评估疗效和安全性。主要疗效指标为惊恐相关症状量表(Panic Associated Symptom Scale,PASS)总分变化,次要疗效指标包括Marks Sheehan恐怖量表(Marks Sheehan Phobia Scale,MSPS)、Sheehan残疾量表(Sheehan Disability Scale,SDS)、17项汉密尔顿抑郁量表(Hamilton rating scale for depression,HAMD17)、汉密尔顿焦虑量表(Hamilton Rating Scale for Anxiety,HAMA)、临床总体印象量表(Clinical Global ImpressionScale,CGI)和病人总体评价(Patient Global Evaluation,PGE)。安全性评价包括治疗前后生命体征、体格检查、实验室检查和心电图检查的改变。结果:治疗终点研究组和对照组的PASS总分分别为(2.1±2.7)和(2.0±2.7),减分分别为(9.1±3.5)和(9.7±4.3),两组比较差异无统计学意义(P=0.244)。治疗终点研究组和对照组的有效率分别为94%和91%,痊愈率分别为87%和80%,两组比较差异无统计学意义(P=0.217)。研究组的不良事件发生率为36%(31/86),对照组为35%(30/86)。最常见的不良反应是恶心、嗜睡和头痛。结论:艾司西酞普兰20毫克/天治疗伴有或不伴有广场恐怖的惊恐障碍安全有效。更多还原

【Abstract】 Objective:To investigate the efficacy and safety of escitalopram in outpatients diagnosed with panic disorder compared with paroxetine.Methods:This was a multi-center,randomized,double-blind double-dummy,active-controlled,fixed-dosage study.A total of 173 outpatients with panic disorder with or without agoraphobia were randomized to 20 mg daily escitalopram or 40 mg daily paroxetine for 12 weeks.Changes in scores of the Panic Associated Symptom Scale(PASS)were used as the primary outcome indexes.The secondary measure tools included panic attack frenquence and the Mark Sheehan Phobia Questionnaire,Sheehan Disability Scale,17-items Hamilton Rating Scale for Depression(HAMD17),Hamilton Rating Scale for Anxiety(HAMA),Clinical Global Impressions Scale(CGI),and Patient Global Evaluation(PGE).Results:At the endpoint,escitalopram and paroxetine were associated with equivalent levels of improvement on the PASS total score,as well as on all secondary outcome measures.The response rate was 94%.in the patients taking escitalopram and 91% in those taking paroxetine.The zero panic attack remession rate were 87% ~80% in the two groups.The rate of adverse events was 36% and 35% respectively.The common adverse reaction symptoms were nausea,somnolence and headache.Conclusion:Escitalopram is effective and well tolerated in the treatment of panic disorder.更多还原