Pillai Vivek, Roth Thomas, Roehrs Timothy, Moss Kenneth, Peterson Edward L, Drake Christopher L
Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, MI.
Biostatistics and Research Epidemiology, Henry Ford Hospital, Detroit, MI.
Sleep. 2017 Feb 1;40(2). doi: 10.1093/sleep/zsw044.
To examine the real-world effectiveness of benzodiazepine receptor agonists (BzRAs) by quantifying response and remission rates in a clinical sample receiving chronic BzRA treatment for insomnia.
Participants were outpatients (N = 193; 72% female; 55.2 ± 11.1 year) who had an insomnia diagnosis per medical records, and who were taking a therapeutic dose of BzRA for their insomnia. Endpoints were nocturnal sleep disturbance and Insomnia Severity Index (ISI) scores. A reduction meeting the criterion for the minimally important difference in ISI scores (change ≥ 6) constituted "response"; "remission" was inferred when symptoms fell below the clinical cutoff (ISI < 11).
Most participants (71%) used BzRAs at least 5 nights per week. Mean ISI scores were significantly lower (t = 22.31; p < .01) while on BzRAs than when untreated, but remained in the clinical range (mean = 11.0; standard deviation = 5.7). Although 76.7% responded to treatment, only 47.7% remitted. The majority (68.9%) of participants had a sleep-onset latency > 30 minutes and/or wake-time after sleep onset > 60 minutes while on BzRAs. After controlling for gender and insomnia severity when untreated, odds of insomnia persistence despite BzRA use were 2 times higher in patients with comorbid medical [odds ratio (OR) = 2.39; 95% confidence interval (CI) = 1.20% to 4.77%; p < .05] and psychiatric disorders (OR = 2.24; 95% CI = 1.21% to 4.13%; p < .05).
This is the first study to distinguish between response and remission in insomnia patients taking BzRAs. Findings suggest that while many insomnia patients respond to chronic BzRA treatment, most do not remit. Remission rates are particularly low for comorbid insomnia, the most prevalent phenotype of the disorder.
通过量化接受慢性苯二氮䓬受体激动剂(BzRAs)治疗失眠的临床样本中的反应率和缓解率,来检验BzRAs在现实世界中的有效性。
参与者为门诊患者(N = 193;72%为女性;年龄55.2±11.1岁),根据病历诊断为失眠,且正在服用治疗剂量的BzRAs治疗失眠。终点指标为夜间睡眠障碍和失眠严重程度指数(ISI)评分。ISI评分降低达到最小重要差异标准(变化≥6)构成“反应”;当症状低于临床临界值(ISI<11)时推断为“缓解”。
大多数参与者(71%)每周至少5晚使用BzRAs。服用BzRAs时的平均ISI评分显著低于未治疗时(t = 22.31;p<.01),但仍处于临床范围内(平均值 = 11.0;标准差 = 5.7)。虽然76.7%的患者对治疗有反应,但只有47.7%的患者缓解。大多数(68.9%)参与者在服用BzRAs时入睡潜伏期>30分钟和/或睡眠后觉醒时间>60分钟。在控制性别和未治疗时的失眠严重程度后,使用BzRAs后仍持续失眠的几率在合并内科疾病的患者中高出2倍[比值比(OR) = 2.39;95%置信区间(CI) = 1.20%至4.77%;p<.05],在合并精神疾病的患者中高出2倍(OR = 2.24;95%CI = 1.21%至4.13%;p<.05)。
这是第一项区分服用BzRAs的失眠患者的反应和缓解情况的研究。研究结果表明,虽然许多失眠患者对慢性BzRA治疗有反应,但大多数并未缓解。对于合并失眠这一最常见的疾病表型,缓解率尤其低。