Kim Ju Hee, Cha Hye Ryeong, Ha Eun Kyo, Kwak Ji Hee, Kim Hakjun, Shin Jeewon, Jee Hye Mi, Han Man Yong
Department of Pediatrics, Kyung Hee University Medical Center, Seoul 02447, Republic of Korea.
Department of Computer Science and Engineering, Sungkyunkwan University, Suwon 16419, Republic of Korea.
Pharmaceuticals (Basel). 2023 Jul 28;16(8):1073. doi: 10.3390/ph16081073.
Cardiotoxicity from first-generation H1-antihistamines has been debated since the 1990s. However, large-scale studies on this topic in a general pediatric population are lacking. This study aimed to assess the association between first-generation H1-antihistamine use and cardiovascular events in a nationwide pediatric population. In this case-crossover study, the main cohort included children with cardiovascular events from the National Health Insurance Service database (2008-2012 births in Korea) until 2018. The second cohort excluded children with specific birth histories or underlying cardiovascular diseases from the main cohort. Cardiovascular events of interest included cardiac arrhythmia and ischemic heart disease. Odds ratios (ORs) of cardiovascular events were estimated using conditional logistic regression models, comparing first-generation H1-antihistamine use during 0-15 days before cardiovascular events (hazard period) with use during 45-60 and 75-90 days before events (control periods). Among the participants, 1194 (59.9%) were aged 24 months to 6 years, and 1010 (50.7%) were male. Cardiovascular event risk was increased among users of first-generation H1-antihistamines (adjusted OR [aOR], 1.201; 95% confidence interval, 1.13-1.27). Significant odds of cardiovascular events persisted within 10 and 5 days (aOR, 1.25 and 1.25). In the second cohort, the association was comparable with that in the main cohort. Our findings indicate that cardiovascular event risk is increased in children who are administered first-generation H1-antihistamines.
自20世纪90年代以来,第一代H1抗组胺药的心脏毒性一直存在争议。然而,在普通儿科人群中缺乏关于这一主题的大规模研究。本研究旨在评估在全国儿科人群中使用第一代H1抗组胺药与心血管事件之间的关联。在这项病例交叉研究中,主要队列包括来自韩国国民健康保险服务数据库(2008 - 2012年出生)直至2018年发生心血管事件的儿童。第二个队列排除了主要队列中有特定出生史或潜在心血管疾病的儿童。感兴趣的心血管事件包括心律失常和缺血性心脏病。使用条件逻辑回归模型估计心血管事件的比值比(OR),将心血管事件发生前0 - 15天(危险期)使用第一代H1抗组胺药的情况与事件发生前45 - 60天和75 - 90天(对照期)使用的情况进行比较。参与者中,1194名(59.9%)年龄在24个月至6岁之间,1010名(50.7%)为男性。第一代H1抗组胺药使用者的心血管事件风险增加(调整后的OR [aOR],1.201;95%置信区间,1.13 - 1.27)。在10天和5天内心血管事件的显著比值比持续存在(aOR,1.25和1.25)。在第二个队列中,这种关联与主要队列中的情况相当。我们的研究结果表明,使用第一代H1抗组胺药的儿童心血管事件风险增加。