From the Department of Psychiatry, University of Iowa Carver College of Medicine, Iowa City; McLean Hospital, Harvard Medical School, Belmont, Mass.; and the Department of Psychiatry, University of Minnesota Medical Center, Fairview, Minneapolis.
Am J Psychiatry. 2014 Nov 1;171(11):1174-82. doi: 10.1176/appi.ajp.2014.13101348.
The authors compared the efficacy and tolerability of low and moderate dosages of extended-release quetiapine in adults with borderline personality disorder.
Ninety-five participants with DSM-IV borderline personality disorder were randomly assigned to receive 150 mg/day of quetiapine (the low-dosage group; N=33), 300 mg/day of quetiapine (the moderate-dosage group; N=33), or placebo (N=29). Total score over time on the clinician-rated Zanarini Rating Scale for Borderline Personality Disorder ("Zanarini scale") was analyzed in a mixed-effects model accounting for informative dropout.
Participants in the low-dosage quetiapine group had significant improvement on the Zanarini scale compared with those in the placebo group. Time to response (defined as a reduction of 50% or more on the Zanarini scale total score) was significantly shorter for both the low-dosage quetiapine group (hazard ratio=2.54, p=0.007) and the moderate-dosage quetiapine group (hazard ratio=2.37, p=0.011) than for the placebo group. Among participants who completed the study, 82% in the low-dosage quetiapine group were rated as "responders," compared with 74% in the moderate-dosage group and 48% in the placebo group. Treatment-emergent adverse events included sedation, change in appetite, and dry mouth. The overall completion rate for the 8-week double-blind treatment phase was 67% (67% for the low-dosage quetiapine group, 58% for the moderate-dosage quetiapine group, and 79% for the placebo group). Participants who experienced sedation were more likely to drop out.
Participants treated with 150 mg/day of quetiapine had a significant reduction in the severity of borderline personality disorder symptoms compared with those who received placebo. Adverse events were more likely in participants taking 300 mg/day of quetiapine.
作者比较了低剂量和中剂量的延长释放喹硫平在伴有边缘型人格障碍的成人中的疗效和耐受性。
95 名符合 DSM-IV 边缘型人格障碍标准的参与者被随机分配接受喹硫平 150mg/天(低剂量组,n=33)、喹硫平 300mg/天(中剂量组,n=33)或安慰剂(n=29)。采用混合效应模型分析了经过时间的临床医生评定的边缘型人格障碍 Zanarini 评定量表(“Zanarini 量表”)总分,该模型考虑了信息性脱落。
与安慰剂组相比,低剂量喹硫平组的 Zanarini 量表评分有显著改善。低剂量喹硫平组(危险比=2.54,p=0.007)和中剂量喹硫平组(危险比=2.37,p=0.011)的反应时间(定义为 Zanarini 量表总分降低 50%或更多)均显著短于安慰剂组。完成研究的参与者中,低剂量喹硫平组有 82%被评为“应答者”,中剂量组为 74%,安慰剂组为 48%。治疗中出现的不良事件包括镇静、食欲改变和口干。8 周双盲治疗阶段的总体完成率为 67%(低剂量喹硫平组为 67%,中剂量喹硫平组为 58%,安慰剂组为 79%)。出现镇静的参与者更有可能脱落。
与安慰剂组相比,接受 150mg/天喹硫平治疗的患者边缘型人格障碍症状严重程度有显著降低。接受 300mg/天喹硫平治疗的患者发生不良事件的可能性更高。