Robb Adelaide S, Cueva Jeanette E, Sporn Jonathan, Yang Ruoyong, Vanderburg Douglas G
Department of Psychiatry and Behavioral Sciences, Children’s National Medical Center, 111 Michigan Ave., N.W., Washington, DC 20010, USA.
J Child Adolesc Psychopharmacol. 2010 Dec;20(6):463-71. doi: 10.1089/cap.2009.0115.
The aim of this study was to evaluate the safety and efficacy of sertraline in children and adolescents who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for posttraumatic stress disorder (PTSD).
Children and adolescents (6-17 years old) meeting DSM-IV criteria for PTSD were randomized to 10 weeks of double-blind treatment with sertraline (50-200 mg/day) or placebo. The primary efficacy measure was the University of California, Los Angeles Post-Traumatic Stress Disorder Index for DSM-IV (UCLA PTSD-I).
A total of 131 patients met entry criteria and were randomized to sertraline (n = 67; female, 59.7%; mean age, 10.8; mean UCLA PTSD-I score, 43.8 ± 8.5) or placebo (n = 62; female, 61.3%; mean age, 11.2; mean UCLA PTSD-I score, 42.1 ± 8.8). There was no difference between sertraline and placebo in least squares (LS) mean change in the UCLA PTSD-I score, either on a completer analysis (-20.4 ± 2.1 vs. -22.8 ± 2.1; p = 0.373) or on an last observation carried forward (LOCF) end point analysis (-17.7 ± 1.9 vs. -20.8 ± 2.1; p = 0.201). Attrition was higher on sertraline (29.9%) compared to placebo (17.7%). Discontinuation due to adverse events occurred in a 7.5% treated with sertraline and 3.2% treated with placebo.
Sertraline was a generally safe treatment in children and adolescents with PTSD, but did not demonstrate efficacy when compared to placebo during 10 weeks of treatment. ClinicalTrials.gov Identifier: NCT00150306.
本研究旨在评估舍曲林对符合《精神疾病诊断与统计手册》第4版（DSM-IV）创伤后应激障碍（PTSD）标准的儿童及青少年的安全性和有效性。
符合DSM-IV创伤后应激障碍标准的儿童及青少年（6至17岁）被随机分为两组，接受为期10周的双盲治疗，一组服用舍曲林（50 - 200毫克/天），另一组服用安慰剂。主要疗效指标是加州大学洛杉矶分校DSM-IV创伤后应激障碍指数（UCLA PTSD-I）。
共有131名患者符合入选标准并被随机分组，其中服用舍曲林组（n = 67；女性占59.7%；平均年龄10.8岁；UCLA PTSD-I平均得分43.8 ± 8.5），服用安慰剂组（n = 62；女性占61.3%；平均年龄11.2岁；UCLA PTSD-I平均得分42.1 ± 8.8）。在完成分析中，舍曲林组和安慰剂组在UCLA PTSD-I得分的最小二乘（LS）均值变化上无差异（-20.4 ± 2.1对-22.8 ± 2.1；p = 0.373）；在末次观察结转（LOCF）终点分析中也无差异（-17.7 ± 1.9对-20.8 ± 2.1；p = 0.201）。与安慰剂组（17.7%）相比，舍曲林组的脱落率更高（29.9%）。因不良事件停药的比例在舍曲林治疗组为7.5%，在安慰剂治疗组为3.2%。
舍曲林对患有创伤后应激障碍的儿童及青少年总体上是一种安全的治疗方法，但在10周的治疗期间与安慰剂相比未显示出疗效。ClinicalTrials.gov标识符：NCT00150306。
