From the Clinical Trial Center, Hallym University Sacred Hospital, Anyang, Gyeonggi-do.
Department of Pharmacy, College of Pharmacy, Kyung Hee University, Seoul.
J Patient Saf. 2020 Dec;16(4):e215-e224. doi: 10.1097/PTS.0000000000000742.
The objectives of this study were to describe the prevalence and seriousness of analgesic-induced adverse events (AEs) and to identify factors associated with serious analgesic-related AEs in Korea.
Voluntarily reported analgesic-induced AEs to the Korea Adverse Event Reporting System from 2007 to 2016 were retrospectively reviewed. Analgesic medications were classified into nonopioids and opioids based on the Anatomical Therapeutic Chemical classification system. All AEs were grouped using System Organ Classes according to the World Health Organization-Adverse Reaction Terminology. Logistic regression was performed to identify factors associated with serious AEs.
Overall, 194,566 AEs (32.2% for nonopioids, 67.8% for opioids) were included in this analysis. The most common causative nonopioid and opioid analgesics was ketorolac (n = 10,789) and tramadol (n = 53,727), respectively. The most frequent AEs were skin and appendage disorders for nonopioids (31.8%) and gastrointestinal disorders (59.5%) for opioids. Serious AEs occurred in 6102 (9.7%) and 3326 (2.5%) cases of the nonopioid and opioid groups, respectively. The most common serious AEs were skin and appendage disorders (33.2%) for nonopioids and neurologic disorders (19.3%) for opioids. Serious AEs were significantly associated with male (odds ratio [OR] = 1.423), advanced age (OR = 1.570), certain causality (OR = 2.304), nonopioid analgesics (OR = 4.182), and polypharmacy (OR = 1.009; P <0.001 for all).
In Korea, analgesic-induced AEs are prevalent with opioids more commonly implicated. Tramadol is the most common etiologic medication. Serious AEs are more frequently caused by nonopioids with skin and appendage disorders most common.
本研究旨在描述阿片类药物引起的不良反应（AE）的发生率和严重程度，并确定与韩国严重阿片类药物相关 AE 相关的因素。
回顾性分析了 2007 年至 2016 年自愿向韩国不良事件报告系统报告的阿片类药物引起的 AE。根据解剖治疗化学分类系统将阿片类药物分为非甾体类和阿片类。根据世界卫生组织不良反应术语，所有 AE 均按系统器官类别进行分组。采用 logistic 回归分析确定与严重 AE 相关的因素。
本研究共纳入 194566 例 AE（非甾体类占 32.2%，阿片类占 67.8%）。最常见的致病因非甾体类和阿片类镇痛药分别为酮咯酸（n=10789）和曲马多（n=53727）。最常见的 AE 是非甾体类的皮肤和附属器疾病（31.8%）和阿片类的胃肠道疾病（59.5%）。非甾体类和阿片类严重 AE 发生率分别为 6102 例（9.7%）和 3326 例（2.5%）。最常见的严重 AE 是非甾体类的皮肤和附属器疾病（33.2%）和阿片类的神经系统疾病（19.3%）。严重 AE 与男性（比值比[OR] = 1.423）、高龄（OR = 1.570）、一定的因果关系（OR = 2.304）、非甾体类镇痛药（OR = 4.182）和多药治疗（OR = 1.009；所有 P<0.001）显著相关。
在韩国，阿片类药物引起的 AE 较为常见，阿片类药物更为常见。曲马多是最常见的病因药物。非甾体类药物引起的严重 AE 更为常见，以皮肤和附属器疾病最为常见。
