Han Yan-Zhong, Guo Yu-Ming, Xiong Peng, Ge Fei-Lin, Jing Jing, Niu Ming, Zhao Xu, Bai Zhao-Fang, Song Hai-Bo, Xiao Xiao-He, Wang Jia-Bo
College of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu, China.
China Military Institute of Chinese Medicine, Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
Front Med (Lausanne). 2022 Mar 17;9:832557. doi: 10.3389/fmed.2022.832557. eCollection 2022.
Aging population is generally considered more sensitive to adverse drug reactions (ADRs). Yet, big data-based quantitative evidence currently does not exist to support this concept. This study aims to investigate age-associated risks of liver-related ADR (L-ADR).
Spontaneous reporting data from 2012 to 2016 were retrieved from the China National ADR Monitoring System. The risk ratio (RR) was used to quantify the relative risk of L-ADR of each age group. The reporting odds ratio (ROR) was used to quantify the correlation with the risk of L-ADR of each drug category or drug in older adults.
Totally, 64,702 L-ADR reports were retrieved, covering ages from 1 to 116, with a median age of 49. The RR values increased exponentially with the increase of age, which indicates that the relative risk of L-ADR increased by 33% for every 10-year increase in age. The age cutoff point for relative high risk of L-ADR was estimated at 52.0 years old (RR = 1). In 17 categories composed of 270 drugs, the top 3 drug categories with a high correlation to the risk of L-ADR in older adults were antiarrhythmic (ROR, 5.75; 95% CI: 4.45-7.42), antilipemic (ROR, 4.77; 95% CI: 4.53-5.02), and antihypertensive (ROR, 2.97; 95% CI: 2.59-3.41).
This research illustrates quantitatively that aging is a potential risk factor for L-ADR, with a 33% increase in relative risk for every 10-year increase in age. Risk management should be addressed for older adults when those drugs with a high correlation to the risk of L-ADR are used.
老龄化人口通常被认为对药物不良反应（ADR）更为敏感。然而，目前尚无基于大数据的定量证据支持这一概念。本研究旨在调查与年龄相关的肝脏相关药物不良反应（L-ADR）风险。
从中国国家药品不良反应监测系统中检索2012年至2016年的自发报告数据。风险比（RR）用于量化各年龄组L-ADR的相对风险。报告比值比（ROR）用于量化老年人中各类药物或每种药物与L-ADR风险的相关性。
共检索到64702份L-ADR报告，年龄范围为1至116岁，中位年龄为49岁。RR值随年龄增长呈指数增加，这表明年龄每增加10岁，L-ADR的相对风险增加33%。L-ADR相对高风险的年龄分界点估计为52.0岁（RR = 1）。在由270种药物组成的17类药物中，与老年人L-ADR风险相关性较高的前3类药物为抗心律失常药（ROR，5.75；95%CI：4.45 - 7.42）、抗血脂药（ROR，4.77；95%CI：4.53 - 5.02）和抗高血压药（ROR，2.97；95%CI：2.59 - 3.41）。
本研究定量表明，老龄化是L-ADR的一个潜在风险因素，年龄每增加10岁，相对风险增加33%。当使用与L-ADR风险相关性较高的药物时，应针对老年人进行风险管理。
