Liu Jinfeng, Tan Junyi, Xiao Qinli, Bai Yingtao, Chang En, Su Chun, Wei Yuxun, Zhong Hu, Wei Wei
Department of Pharmacy, People's Hospital of Zhongjiang County, Deyang, Sichuan, China.
Department of Rehabilitation, People's Hospital of Zhongjiang County, Deyang, Sichuan, China.
Front Pharmacol. 2025 Jun 26;16:1532461. doi: 10.3389/fphar.2025.1532461. eCollection 2025.
Drug-associated hearing impairment has a serious impact on children's quality of life and poses a significant public health burden. However, there is a lack of large-scale population-based studies of medication-associated hearing impairment in children. The aim of this study was to hypothesize about medications through data mining in order to assess the potential risk of these medications increasing hearing impairment in children.
We extracted and analyzed reports on drugs linked to hearing impairment in children from the FDA Adverse Event Reporting System (FAERS). To assess the relationship between drugs and hearing impairment in children, we performed a disproportionality study utilizing the proportional reporting ratio (PRR) and reporting odds ratio (ROR). Concurrently, we conducted comparisons with medicine labels to identify medications that, although not now indicating hearing impairment in their labels, may possibly pose risks of hearing impairment in children.
In the FAERS database, there are 1,884 reports of AE related to hearing impairment in children. The top three medications with the highest ROR were vinblastin [N = 6 cases, ROR = 86.72 (34.15-220.19)], risedronate [N = 3 cases, ROR = 73.59 (20.24-267.63)], and amikacin [N = 11 cases, ROR = 71.31 (36.40-139.72)]. The top 3 drugs with the highest number of reports were carboplatin [N = 125 cases, ROR = 18.41 (15.27-22.21)], cisplatin [N = 78 cases, ROR = 31.24 (24.59-39.70)], and vincristine [N = 56 cases, ROR = 6.32 (4.83-8.27)]. Based on drug labeling, 48% drugs (27/56) were classified as potentially ototoxic.
Our findings suggest that nearly half of the 56 drugs linked to hearing impairment signals in children are not currently labeled with ototoxicity warnings. Consequently, further research is required to evaluate the association of these medicines with this risk.
药物相关性听力障碍对儿童生活质量有严重影响，并构成重大公共卫生负担。然而，缺乏基于大规模人群的儿童药物相关性听力障碍研究。本研究的目的是通过数据挖掘对药物进行假设，以评估这些药物增加儿童听力障碍的潜在风险。
我们从美国食品药品监督管理局不良事件报告系统（FAERS）中提取并分析了与儿童听力障碍相关的药物报告。为评估药物与儿童听力障碍之间的关系，我们利用比例报告比（PRR）和报告比值比（ROR）进行了不成比例性研究。同时，我们与药品标签进行比较，以识别那些尽管目前在标签中未表明有听力障碍，但可能对儿童构成听力障碍风险的药物。
在FAERS数据库中，有1884份与儿童听力障碍相关的不良事件报告。ROR最高的前三种药物是长春碱[N = 6例，ROR = 86.72（34.15 - 220.19）]、利塞膦酸盐[N = 3例，ROR = 73.59（20.24 - 267.63）]和阿米卡星[N = 11例，ROR = 71.31（36.40 - 139.72）]。报告数量最多的前三种药物是卡铂[N = 125例，ROR = 18.41（15.27 - 22.21）]、顺铂[N = 78例，ROR = 31.24（24.59 - 39.70）]和长春新碱[N = 56例，ROR = 6.32（4.83 - 8.27）]。根据药品标签，48%的药物（27/56）被归类为潜在耳毒性药物。
我们的研究结果表明，与儿童听力障碍信号相关的56种药物中，近一半目前未标注耳毒性警告。因此，需要进一步研究来评估这些药物与这种风险的关联。
