Dowd Sheila M, Zalta Alyson K, Burgess Helen J, Adkins Elizabeth C, Valdespino-Hayden Zerbrina, Pollack Mark H
Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL 60601, United States.
Department of Psychological Science, University of California Irvine, Irvine, CA 92697, United States.
World J Psychiatry. 2020 Mar 19;10(3):21-28. doi: 10.5498/wjp.v10.i3.21.
Sleep disturbance is a core feature of post-traumatic stress disorder (PTSD). Given the relationship between sleep disturbance and PTSD, there has been a relative paucity of studies examining the potential therapeutic impact of using pharmacotherapy to target sleep disturbance in patients with PTSD. Eszopiclone (ESZ) is a non-benzodiazepine y-aminobutyric acid-A receptor agonist indicated for the treatment of sleep and may affect sleep in patients with PTSD.
To evaluate the efficacy of ESZ placebo (PBO) for patients with PTSD and insomnia.
The study was a 12-wk, double blind, randomized controlled trial with 3 mg of ESZ ( = 13) or PBO ( = 12).
Patients in both arms experienced significant improvement in PTSD symptoms as assessed by the Clinician-Administered PTSD Scale for DSM-IV (CAPS): ESZ (t11 = -3.12, = 0.005) and PBO (t11 = -3.5, = 0.002) and by self-report with the Short PTSD Rating Interview (ESZ t11 = -3.38, = 0.003 and PBO t11 = -4.48, = 0.0005). There were no significant differences between treatments on the CAPS (t22 = -0.13, = 0.70) or the Short PTSD Rating Interview (t22 = -0.58, = 0.56). Similarly, both treated groups improved on sleep measures as assessed by the Pittsburgh Sleep Quality Index with PTSD Addendum (PSQI) and on total sleep time (TST) and sleep latency assessed by actigraphy with no significant differences between groups (PSQI t22 = -0.24, = 0.81; total sleep time t10 = 0.13, = 0.90 and sleep latency t10 = 0.68, = 0.50). There was a significant correlation between improvement in sleep and overall improvement in PTSD as measured by change scores on the PSQI and CAPS, r(8) = 0.79, = 0.01 for ESZ treated subjects, but not for those treated with PBO r(9) = 0.16, = 0.69. Adverse events of ESZ were consistent with the known profile of the medication including dysgeusia (30%, mild), sedation (20%, mild) and headache (20%, moderate to severe).
Results do not support the hypothesis of a specific positive effect of ESZ compared to PBO for measures of PTSD and associated sleep disturbance.
睡眠障碍是创伤后应激障碍（PTSD）的核心特征。鉴于睡眠障碍与PTSD之间的关系，针对使用药物疗法治疗PTSD患者睡眠障碍的潜在治疗效果的研究相对较少。右佐匹克隆（ESZ）是一种非苯二氮䓬类γ-氨基丁酸-A受体激动剂，用于治疗睡眠，可能会影响PTSD患者的睡眠。
评估ESZ与安慰剂（PBO）治疗PTSD合并失眠患者的疗效。
该研究为一项为期12周的双盲随机对照试验，使用3毫克ESZ（n = 13）或PBO（n = 12）。
通过《精神障碍诊断与统计手册第四版临床医生用PTSD量表》（CAPS）评估，两组患者的PTSD症状均有显著改善：ESZ组（t11 = -3.12，p = 0.005）和PBO组（t11 = -3.5，p = 0.002）；通过《PTSD简短评定访谈》自评也有改善（ESZ组t11 = -3.38，p = 0.003；PBO组t11 = -4.48，p = 0.0005）。在CAPS量表（t22 = -0.13，p = 0.70）或《PTSD简短评定访谈》（t22 = -0.58，p = 0.56）上，治疗组之间无显著差异。同样，通过《匹兹堡睡眠质量指数PTSD附录》（PSQI）评估的睡眠指标、通过活动记录仪评估的总睡眠时间（TST）和睡眠潜伏期方面，两组治疗组均有改善，组间无显著差异（PSQI t22 = -0.24，p = 0.81；总睡眠时间t10 = 0.13，p = 0.90；睡眠潜伏期t10 = 0.68，p = 0.50）。通过PSQI和CAPS的变化分数测量，ESZ治疗的受试者睡眠改善与PTSD总体改善之间存在显著相关性，r(8) = 0.79，p = 0.01，但PBO治疗的受试者则无此相关性，r(9) = 0.16，p = 0.69。ESZ的不良事件与该药物已知的情况一致，包括味觉障碍（30%，轻度）、镇静（20%，轻度）和头痛（20%，中度至重度）。
结果不支持与PBO相比，ESZ对PTSD及相关睡眠障碍测量指标有特定积极作用的假设。
