Davidson Jonathan, Rothbaum Barbara O, Tucker Phebe, Asnis Gregory, Benattia Isma, Musgnung Jeff J
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA.
J Clin Psychopharmacol. 2006 Jun;26(3):259-67. doi: 10.1097/01.jcp.0000222514.71390.c1.
This 12-week, double-blind, multicenter trial evaluated the efficacy of venlafaxine extended release (ER), sertraline, and placebo in adult outpatients (N = 538) with a primary diagnosis of posttraumatic stress disorder (PTSD), as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, symptoms for 6 months or more and 17-item Clinician-administered PTSD Scale (CAPS-SX17) score of 60 or more. Patients were randomly assigned to receive placebo or flexible doses of venlafaxine ER (37.5-300 mg/d) or sertraline (25-200 mg/d) for 12 weeks or less. The primary outcome was the baseline-to-end point change in total CAPS-SX17 score (last observation carried forward). Secondary measures included CAPS-SX17 symptom cluster scores for reexperiencing/intrusion, avoidance/numbing, and hyperarousal; frequency of remission (CAPS-SX17 < or =20); and changes in Davidson Trauma Scale total score and symptom cluster scores for avoidance/numbing, hyperarousal, and reexperiencing/intrusion. Mean changes in CAPS-SX17 scores were -41.8, -39.4, and -33.9 for venlafaxine ER (P < 0.05 vs. placebo), sertraline, and placebo, respectively. Mean changes for venlafaxine ER, sertraline, and placebo in CAPS-SX17 cluster scores were -13.0, -11.7, and -11.0 for reexperiencing; -17.1, -16.8, and -13.7 (P < 0.05 both active treatments vs. placebo) for avoidance/numbing; and -11.8, -10.9, and -9.2 (P < 0.05 venlafaxine vs. placebo) for hyperarousal. Week 12 remission rates were venlafaxine ER 30.2% (P < 0.05 vs. placebo), sertraline 24.3%, and placebo 19.6%. The venlafaxine ER group had significantly better Davidson Trauma Scale total and cluster scores than placebo. Mean maximum daily doses were 225-mg venlafaxine ER and 151-mg sertraline. Both treatments were generally well tolerated. Study results suggest that venlafaxine ER is effective and well tolerated in the short-term treatment of PTSD.
这项为期12周的双盲多中心试验评估了文拉法辛缓释剂（ER）、舍曲林和安慰剂对成年门诊患者（N = 538）的疗效，这些患者的主要诊断为创伤后应激障碍（PTSD），符合《精神障碍诊断与统计手册》第四版的定义，症状持续6个月或更长时间，且17项临床医生评定的PTSD量表（CAPS-SX17）得分在60分或以上。患者被随机分配接受安慰剂或灵活剂量的文拉法辛ER（37.5 - 300毫克/天）或舍曲林（25 - 200毫克/天），治疗时间为12周或更短。主要结局指标是CAPS-SX17总分从基线到终点的变化（末次观察结转）。次要测量指标包括CAPS-SX17症状簇得分，分别为再体验/侵入、回避/麻木和过度警觉；缓解频率（CAPS-SX17≤20）；以及戴维森创伤量表总分和症状簇得分的变化，分别为回避/麻木、过度警觉和再体验/侵入。文拉法辛ER组、舍曲林组和安慰剂组CAPS-SX17得分的平均变化分别为-41.8、-39.4和-33.9（与安慰剂相比，文拉法辛ER组P < 0.05）。文拉法辛ER组、舍曲林组和安慰剂组在CAPS-SX17簇得分方面，再体验症状的平均变化分别为-13.0、-11.7和-11.0；回避/麻木症状的平均变化分别为-17.1、-16.8和-13.7（两种活性治疗与安慰剂相比均P < 0.05）；过度警觉症状的平均变化分别为-11.8、-10.9和-9.2（文拉法辛与安慰剂相比P < 0.05）。第12周的缓解率分别为：文拉法辛ER组30.2%（与安慰剂相比P < 0.05），舍曲林组24.3%，安慰剂组19.6%。文拉法辛ER组的戴维森创伤量表总分和簇得分显著优于安慰剂组。文拉法辛ER的平均最大日剂量为225毫克，舍曲林为151毫克。两种治疗的耐受性总体良好。研究结果表明，文拉法辛ER在PTSD的短期治疗中有效且耐受性良好。
