PDF(Pubmed)
Abstract：
Real-world evidence on the association between natural medicinal products and the recurrence of sleep disorders is currently limited, particularly when compared to the evidence reported for prescription hypnotics. In a retrospective cohort analysis, we investigated patients with sleep disorders prescribed either the natural medicinal product Neurexan (Nx4), benzodiazepines, or nonbenzodiazepines (Z-drugs) using the IQVIA Disease Analyzer database, which encompasses electronic medical records nationwide in Germany. A 1:1 matching procedure based on age, sex, prevalent depression, anxiety or adjustment disorder, and the number of medical consultations in the past 12 months resulted in four cohorts: patients prescribed Nx4 were matched with those prescribed Z-drugs (two cohorts with 8594 matched patients each), and another cohort of patients prescribed Nx4 were matched with those prescribed benzodiazepines (7779 matched pairs). Results from multivariable-adjusted Cox regression models demonstrated that Nx4 was associated with a significantly lower risk of recurrent sleep disorder diagnosis within 30-365 days after prescription compared to both Z-drugs (HR = 0.65, 95%CI = 0.60-0.70, p < 0.001) and benzodiazepines (HR = 0.85, 95%CI = 0.79-0.93, p < 0.001). Additionally, Nx4 was associated with a lower prevalence of depression compared to Z-drugs (HR = 0.90, 95%CI = 0.83-0.98, p = 0.020) and benzodiazepines (HR = 0.89, 95%CI = 0.82-0.97, p = 0.009). These findings suggest an association between Nx4 and improved sleep and mental health outcomes. However, due to inherent limitations in the study design, the causality of this relationship cannot be stated.
摘要：
目前，关于天然药物与睡眠障碍复发之间关联的现实证据有限，特别是与处方催眠药的证据相比。在回顾性队列分析中，我们调查了患有睡眠障碍的患者服用天然药物Neurexan（Nx4），苯二氮卓类药物,或使用IQVIA疾病分析仪数据库的非苯二氮卓类药物（Z-药物），其中包括德国全国的电子病历。基于年龄的1:1匹配程序，性别,普遍的抑郁症，焦虑或适应障碍，在过去的12个月中，医疗咨询的数量导致了四个队列：处方Nx4的患者与处方Z药物相匹配（两个队列，每个队列有8594个匹配的患者），另一批Nx4处方患者与苯二氮卓处方患者相匹配(7779对匹配).多变量校正Cox回归模型的结果表明，与两种Z药物（HR=0.65，95CI=0.60-0.70，p<0.001）和苯二氮卓类药物（HR=0.85，95CI=0.79-0.93，p<0.001）相比，Nx4与处方后30-365天内复发性睡眠障碍诊断风险显着降低相关。此外,与Z类药物（HR=0.90，95CI=0.83-0.98，p=0.020）和苯二氮卓类药物（HR=0.89，95CI=0.82-0.97，p=0.009）相比，Nx4与抑郁症的患病率较低相关。这些发现表明Nx4与改善睡眠和心理健康结果之间存在关联。然而,由于研究设计的固有局限性，这种关系的因果关系无法说明。
