Negishi Akio, Oshima Shinji, Horii Norimitsu, Mutoh Mizue, Inoue Naoko, Numajiri Sachihiko, Ohshima Shigeru, Kobayashi Daisuke
Laboratory of Analytical Pharmaceutics and Informatics, Faculty of Pharmacy and Pharmaceutical Sciences, Josai University, 1-1 Keyakidai, Sakado, Saitama, 350-0295, Japan.
Laboratory of Pharmacy Management, Faculty of Pharmacy and Pharmaceutical Sciences, Josai University, Saitama, Japan.
Drugs Real World Outcomes. 2021 Mar;8(1):49-61. doi: 10.1007/s40801-020-00221-8. Epub 2020 Dec 23.
Pharmacokinetics and pharmacodynamics of drugs in elderly individuals differ from those in younger adults; thus, adverse drug events (ADEs) are common in older patients with polypharmacy because co-existing comorbidities elevate the risk of ADEs occurring. However, ADEs have not yet been characterised based on the elderly patients of Japanese origin and polypharmacy.
The 100 most commonly reported ADEs were grouped into four classes (Class 1-Class 4) based on elderly patients with polypharmacy.
In this study, logistic regression analysis was performed using cases recorded in the Japanese Adverse Drug Event Report (JADER) database.
ADEs in elderly patients treated with polypharmacy-in whom the risk of electrolyte abnormalities, renal and respiratory disorders, and coagulopathy was high-were categorised as 'Class 1 [E(+), P(+)]', while ADEs in elderly patients not treated with polypharmacy-in whom the risk of delirium and fall was high-were categorised as 'Class 2 [E(+), P(-)]'. When there was no association with being elderly, ADEs associated with polypharmacy that carried a high risk of myelosuppression and infection were categorised as 'Class 3 [E(-), P(+)]', and allergic ADEs that were not affected by being elderly or polypharmacy, were categorised as 'Class 4 [E(-), P(-)]'. Class 1 events as well as Class 3 ADEs occurred more frequently in females than in males, whereas Class 3 ADEs (deep vein thrombosis and pulmonary embolism) occurred more frequently in males.
Class 1 and Class 2 ADEs should be investigated in analyses that focus on individual drugs.
老年人药物的药代动力学和药效学与年轻人不同；因此，在患有多种药物治疗的老年患者中，药物不良事件（ADEs）很常见，因为并存的合并症会增加ADEs发生的风险。然而，尚未基于日本老年患者和多种药物治疗对ADEs进行特征描述。
根据患有多种药物治疗的老年患者，将100种最常报告的ADEs分为四类（1类 - 4类）。
在本研究中，使用日本药物不良事件报告（JADER）数据库中记录的病例进行逻辑回归分析。
接受多种药物治疗的老年患者中发生的ADEs（其电解质异常、肾脏和呼吸系统疾病以及凝血病风险较高）被归类为“1类[E(+)，P(+)]”，而未接受多种药物治疗的老年患者中发生的ADEs（其谵妄和跌倒风险较高）被归类为“2类[E(+)，P(-)]”。当与年龄无关时，与多种药物治疗相关且骨髓抑制和感染风险较高的ADEs被归类为“3类[E(-)，P(+)]”，不受年龄或多种药物治疗影响的过敏性ADEs被归类为“4类[E(-)，P(-)]”。1类事件以及3类ADEs在女性中比在男性中更频繁发生，而3类ADEs（深静脉血栓形成和肺栓塞）在男性中更频繁发生。
在关注个别药物的分析中应调查1类和2类ADEs。
