Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital, One Bowdoin Square, Sixth Floor, Boston, MA 02114, USA.
J Clin Psychiatry. 2011 Jul;72(7):892-7. doi: 10.4088/JCP.09m05607gry. Epub 2011 Feb 22.
The development of novel strategies for the treatment of posttraumatic stress disorder (PTSD) represents a critical public health need. We present the first prospective, randomized, double-blind, placebo-controlled trial of a non-benzodiazepine hypnotic agent for the treatment of PTSD and associated insomnia.
Twenty-four patients with PTSD by DSM-IV criteria and sleep disturbance were treated in a randomized, double-blind, placebo-controlled crossover study of 3 weeks of eszopiclone 3 mg at bedtime compared to placebo. The primary outcome measures were changes in scores on the Short PTSD Rating Interview (SPRINT) and the Pittsburgh Sleep Quality Index (PSQI). The data were collected from April 2006 to June 2008.
Three weeks of eszopiclone pharmacotherapy was associated with significantly greater improvement than placebo on PTSD symptom measures including the SPRINT (P = .032) and the Clinician-Administered PTSD Scale (P = .003), as well as on measures of sleep including the PSQI (P = .011) and sleep latency (P = .044). Greater improvement with eszopiclone on PTSD measures was present even when specific sleep-related items were excluded. Adverse events were consistent with the known profile of the drug.
This study provides initial evidence that pharmacotherapy with eszopiclone may be associated with short-term improvement in overall PTSD severity as well as associated sleep disturbance. Longer, more definitive study of eszopiclone in PTSD is warranted.
clinicaltrials.gov Identifier: NCT00120250.
开发治疗创伤后应激障碍（PTSD）的新策略是公共卫生的迫切需求。我们首次前瞻性、随机、双盲、安慰剂对照研究了一种非苯二氮䓬类催眠药物治疗 PTSD 及其相关失眠的疗效。
24 名符合 DSM-IV 标准且伴有睡眠障碍的 PTSD 患者参与了这项 3 周的随机、双盲、安慰剂对照交叉研究，患者在睡前接受艾司佐匹克隆 3mg 或安慰剂治疗。主要疗效指标为短 PTSD 评定访谈（SPRINT）和匹兹堡睡眠质量指数（PSQI）评分的变化。数据收集时间为 2006 年 4 月至 2008 年 6 月。
3 周的艾司佐匹克隆药物治疗与安慰剂相比，在 PTSD 症状测量上有显著改善，包括 SPRINT（P =.032）和临床医生管理 PTSD 量表（P =.003），以及睡眠测量，包括 PSQI（P =.011）和睡眠潜伏期（P =.044）。即使排除与睡眠相关的特定项目，艾司佐匹克隆对 PTSD 测量值的改善仍然存在。不良反应与该药物的已知特征一致。
这项研究初步证明，艾司佐匹克隆的药物治疗可能与 PTSD 严重程度和相关睡眠障碍的短期改善有关。有必要对 PTSD 中艾司佐匹克隆进行更长、更明确的研究。
clinicaltrials.gov 标识符：NCT00120250。
