Schmiedl S, Rottenkolber M, Szymanski J, Drewelow B, Siegmund W, Hippius M, Farker K, Guenther I R, Hasford J, Thuermann P A
a Philipp Klee-Institute for Clinical Pharmacology , HELIOS Clinic Wuppertal , Wuppertal , Germany.
b Department of Clinical Pharmacology, School of Medicine, Faculty of Health , Witten/Herdecke University , Witten , Germany.
Expert Opin Drug Saf. 2018 Feb;17(2):125-137. doi: 10.1080/14740338.2018.1415322. Epub 2017 Dec 19.
Studies evaluating the impact of age and potentially inappropriate medication (PIM) on avoidable adverse drug reactions (ADRs) are scarce.
In this prospective, multi-center, long-term (8.5 years) observational study, we analysed ADRs leading to hospitalization in departments of internal medicine. ADRs causality and preventability were assessed using standardised algorithms. PIM was defined based on the PRISCUS-list. Multivariate analyses and estimation of ADR incidence rates were conducted.
Of all 6,427 ADR patients, a preventable ADR was present in 1,253 (19.5%) patients (elderly patients ≥70 years: 828). Risk factors for preventable ADRs in elderly patients were multimorbidity, two to four ADR-causative drugs, and intake of particular compounds (e.g. spironolactone) but not sex, PIM usage, or the total number of drugs. Regarding particular compounds associated with preventable ADRs, highest incidence rates for preventable ADRs were found for patients aged ≥70 years for spironolactone (3.3 per 1,000 exposed persons (95% CI: 1.4-6.6)) and intermediate-acting insulin (3.3 per 1,000 exposed persons (95% CI: 1.6-6.1)).
Avoiding PIM usage seems to be of limited value in increasing safety in elderly patients whereas our results underline the importance of an individualized medication review of the most commonly implicated drugs in preventable ADRs (supported by BfArM FoNr: V-11337/68605/2008-2010).
评估年龄和潜在不适当用药（PIM）对可避免的药物不良反应（ADR）影响的研究较少。
在这项前瞻性、多中心、长期（8.5年）的观察性研究中，我们分析了导致内科住院的ADR。使用标准化算法评估ADR的因果关系和可预防性。PIM根据PRISCUS清单定义。进行了多变量分析和ADR发病率估计。
在所有6427例ADR患者中，1253例（19.5%）患者存在可预防的ADR（≥70岁老年患者：828例）。老年患者可预防ADR的危险因素是多种疾病、两到四种导致ADR的药物以及特定化合物的摄入（如螺内酯），而非性别、PIM使用情况或药物总数。关于与可预防ADR相关的特定化合物，≥70岁患者中，螺内酯导致可预防ADR的发病率最高（每1000名暴露者中3.3例（95%CI：1.4 - 6.6）），中效胰岛素次之（每1000名暴露者中3.3例（95%CI：1.6 - 6.1））。
避免使用PIM在提高老年患者安全性方面似乎价值有限，而我们的结果强调了对可预防ADR中最常涉及药物进行个体化用药审查的重要性（德国联邦药品和医疗器械研究所资助编号：V - 11337/68605/2008 - 2010）。
