Abstract：
OBJECTIVE: Several medications are associated with delirium; however, studies with adequate statistical power are limited, and it is difficult to determine the effects of the various concomitant medications used in clinical practice. Therefore, in this study, we aimed to comprehensively evaluate the safety signals of delirium-associated drugs using a spontaneous adverse event reporting system.
METHODS: The JAPIC AERS (Food and Drug Administration Adverse Event Reporting System pre-processed by the Japan Pharmaceutical Information Center) was used for the analysis in this pharmacovigilance study. The reporting odds ratio (ROR) for delirium was adjusted for using multivariate logistic regression analysis with sex, age, indication, and melatonin receptor agonist use, and 22 drug categories were targeted as covariates.
RESULTS: After excluding patients with missing information, 7,527,568 patients were included in the study. Delirium signals were detected even after adjusting for covariates in 17 drug categories, including benzodiazepines (adjusted ROR, 1.76; 95% confidence interval [CI], 1.64-1.89), opioids (adjusted ROR, 4.42; 95% CI, 4.21-4.64), and tricyclic antidepressants (adjusted ROR, 2.44; 95% CI, 2.20-2.71).
CONCLUSIONS: These findings suggest that many drug classes, such as benzodiazepines, are independent risk factors for delirium and strengthen the evidence of an association between delirium and medications.
METHODS: The JAPIC AERS (Food and Drug Administration Adverse Event Reporting System pre-processed by the Japan Pharmaceutical Information Center) was used for the analysis in this pharmacovigilance study. The reporting odds ratio (ROR) for delirium was adjusted for using multivariate logistic regression analysis with sex, age, indication, and melatonin receptor agonist use, and 22 drug categories were targeted as covariates.
RESULTS: After excluding patients with missing information, 7,527,568 patients were included in the study. Delirium signals were detected even after adjusting for covariates in 17 drug categories, including benzodiazepines (adjusted ROR, 1.76; 95% confidence interval [CI], 1.64-1.89), opioids (adjusted ROR, 4.42; 95% CI, 4.21-4.64), and tricyclic antidepressants (adjusted ROR, 2.44; 95% CI, 2.20-2.71).
CONCLUSIONS: These findings suggest that many drug classes, such as benzodiazepines, are independent risk factors for delirium and strengthen the evidence of an association between delirium and medications.
摘要：
目的：几种药物与谵妄有关；然而，具有足够统计能力的研究是有限的，并且很难确定临床实践中使用的各种伴随药物的效果。因此,在这项研究中，我们旨在使用自发性不良事件报告系统全面评估谵妄相关药物的安全性.
方法：JAPICAERS（由日本药物信息中心预处理的食品和药物管理局不良事件报告系统）用于本药物警戒研究的分析。谵妄的报告比值比（ROR）使用多变量逻辑回归分析与性别，年龄,指示,和褪黑激素受体激动剂的使用，和22个药物类别作为协变量的目标。
结果：排除信息缺失的患者后，该研究包括7,527,568名患者。即使在调整了17种药物类别的协变量后，也能检测到谵妄信号，包括苯二氮卓类药物(调整后的ROR，1.76；95%置信区间[CI]，1.64-1.89),阿片类药物(调整后的ROR，4.42；95%CI，4.21-4.64），和三环抗抑郁药(调整的ROR，2.44；95%CI，2.20-2.71）。
结论：这些研究结果表明，许多药物类别，例如苯二氮卓类药物，是谵妄的独立危险因素，并加强了谵妄与药物之间关联的证据。
方法：JAPICAERS（由日本药物信息中心预处理的食品和药物管理局不良事件报告系统）用于本药物警戒研究的分析。谵妄的报告比值比（ROR）使用多变量逻辑回归分析与性别，年龄,指示,和褪黑激素受体激动剂的使用，和22个药物类别作为协变量的目标。
结果：排除信息缺失的患者后，该研究包括7,527,568名患者。即使在调整了17种药物类别的协变量后，也能检测到谵妄信号，包括苯二氮卓类药物(调整后的ROR，1.76；95%置信区间[CI]，1.64-1.89),阿片类药物(调整后的ROR，4.42；95%CI，4.21-4.64），和三环抗抑郁药(调整的ROR，2.44；95%CI，2.20-2.71）。
结论：这些研究结果表明，许多药物类别，例如苯二氮卓类药物，是谵妄的独立危险因素，并加强了谵妄与药物之间关联的证据。
