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一项关于舍曲林预防烧伤儿童创伤后应激障碍的随机对照试验。

A randomized controlled trial of sertraline to prevent posttraumatic stress disorder in burned children.

作者信息

Stoddard Frederick J, Luthra Rohini, Sorrentino Erica A, Saxe Glenn N, Drake Jennifer, Chang Yuchiao, Levine John B, Chedekel David S, Sheridan Robert L

机构信息

Shriners Hospitals for Children and Harvard Medical School at Massachusetts General Hospital, Boston, Massachusetts 02114, USA.

出版信息

J Child Adolesc Psychopharmacol. 2011 Oct;21(5):469-77. doi: 10.1089/cap.2010.0133.

DOI:10.1089/cap.2010.0133
PMID:22040192
Abstract

BACKGROUND

This study evaluated the potential benefits of a centrally acting selective serotonin reuptake inhibitor, sertraline, versus placebo for prevention of symptoms of posttraumatic stress disorder (PTSD) and depression in burned children. This is the first controlled investigation based on our review of the early use of a medication to prevent PTSD in children.

METHODS

Twenty-six children aged 6-20 were assessed in a 24-week double-blind placebo-controlled design. Each child received either flexibly dosed sertraline between 25-150 mg/day or placebo. At each reassessment, information was collected in compliance with the study medication, parental assessment of the child's symptomatology and functioning, and the child's self-report of symptomatology. The protocol was approved by the Human Studies Committees of Massachusetts General Hospital and Shriners Hospitals for Children.

RESULTS

The final sample was 17 subjects who received sertraline versus 9 placebo control subjects matched for age, severity of injury, and type of hospitalization. There was no significant difference in change from baseline with child-reported symptoms; however, the sertraline group demonstrated a greater decrease in parent-reported symptoms over 8 weeks (-4.1 vs. -0.5, p=0.005), over 12 weeks (-4.4 vs. -1.2, p=.008), and over 24 weeks (-4.0 vs. -0.2, p=0.017).

CONCLUSIONS

Sertraline was a safe drug, and it was somewhat more effective in preventing PTSD symptoms than placebo according to parent report but not child report. Based on this study, sertraline may prevent the emergence of PTSD symptoms in children.

摘要

背景

本研究评估了一种中枢作用的选择性5-羟色胺再摄取抑制剂舍曲林与安慰剂相比,在预防烧伤儿童创伤后应激障碍(PTSD)和抑郁症状方面的潜在益处。这是我们对早期使用药物预防儿童PTSD进行综述后开展的第一项对照研究。

方法

26名6-20岁儿童参与了一项为期24周的双盲安慰剂对照设计研究。每个儿童接受每日25-150毫克灵活剂量的舍曲林或安慰剂。每次重新评估时,收集与研究药物、家长对孩子症状和功能的评估以及孩子症状自我报告相关的信息。该方案已获得马萨诸塞州总医院和施莱宁儿童医院人类研究委员会的批准。

结果

最终样本包括17名接受舍曲林治疗的受试者和9名在年龄、损伤严重程度和住院类型方面相匹配的安慰剂对照受试者。儿童报告的症状与基线相比没有显著差异;然而,舍曲林组在8周(-4.1对-0.5,p=0.005)、12周(-4.4对-1.2,p=0.008)和24周(-4.0对-0.2,p=0.017)时家长报告的症状下降幅度更大。

结论

舍曲林是一种安全的药物,根据家长报告,它在预防PTSD症状方面比安慰剂更有效,但根据儿童报告则不然。基于本研究,舍曲林可能预防儿童PTSD症状的出现。

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