Montastruc François, Duguet Cannelle, Rousseau Vanessa, Bagheri Haleh, Montastruc Jean-Louis
Laboratoire de Pharmacologie Médicale et Clinique, Equipe de Pharmacoépidémiologie de l'UMR INSERM 1027, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Centre Hospitalier Universitaire et Faculté de Médecine de l'Université de Toulouse, 37 allées Jules-Guesde, 31000, Toulouse, France.
Eur J Clin Pharmacol. 2014 Sep;70(9):1123-7. doi: 10.1007/s00228-014-1707-9. Epub 2014 Jun 14.
Lists of potentially inappropriate medications (PIM) in the elderly were developed in order to identify patients and/or drugs at risk of adverse drug reactions (ADRs) or inefficacy. However, the relationship between PIMs and ADRs remains discussed. We hypothesized that PIM use is associated with more ADRs than other prescriptions.
All ADRs registered by the Midi-Pyrénées PharmacoVigilance Center between the 1st January and the 30th June 2012 in patients ≥75 years were included. Data on patients (age, gender, Charlson comorbidity index), drugs (number, ATC classification, Laroche PIM classification) and ADRs (type, seriousness, mechanisms) were analyzed.
Among the 923 ADRs recorded, 272 (29.5%) were in patients ≥75 years. Mean age was 83.5 ± 5.5 years. Most of them (59%) were females. Mean Charlson index was 5.6 ± 2.0 by ADR report. These 272 prescriptions involved 1,775 drugs [mean value, 6.5 (±3.4) drugs by ADR report] with 129 (7.3%) PIM. Main PIM classes were nervous (n = 98, 76.0%) and cardiovascular (17.8%) drugs, including 32 atropinics (23.4%). ADR-associated drugs were mainly antithrombotics, antibacterials, and analgesics for non-PIM drugs whereas PIM-associated ADRs were mainly observed with digoxine, psycholeptics, and psychoanaleptics. ADRs were mainly found with non-PIM drugs (89.3%). Associated factors were the number of drugs for PIMs and the number of PIMs for PIM-induced ADRs.
Out of the ADR reports registered in the Midi-Pyrénées PharmacoVigilance Database for patients ≥75 years, 1 drug out of 12 is potentially inappropriate (mainly benzodiazepines, imipraminic antidepressants, and atropinic drugs). PIM use is not associated with more ADRs' reports than other prescriptions.
为识别有药物不良反应（ADR）或治疗无效风险的患者和/或药物，制定了老年人潜在不适当用药（PIM）清单。然而，PIM与ADR之间的关系仍存在争议。我们假设使用PIM比使用其他处方会引发更多的ADR。
纳入了2012年1月1日至6月30日期间由南比利牛斯药物警戒中心登记的所有≥75岁患者的ADR。分析了患者数据（年龄、性别、查尔森合并症指数）、药物数据（数量、解剖治疗化学分类系统分类、拉罗什PIM分类）和ADR数据（类型、严重程度、机制）。
在记录的923例ADR中，272例（29.5%）发生在≥75岁的患者中。平均年龄为83.5±5.5岁。其中大多数（59%）为女性。根据ADR报告，查尔森指数平均值为5.6±2.0。这272张处方涉及1775种药物[平均值，每份ADR报告6.5（±3.4）种药物]，其中129种（7.3%）为PIM。主要的PIM类别为神经类药物（n = 98，76.0%）和心血管类药物（17.8%），包括32种阿托品类药物（23.4%）。与ADR相关的非PIM药物主要是抗血栓药、抗菌药和镇痛药，而与PIM相关的ADR主要见于地高辛、抗精神病药和精神兴奋药。ADR主要发生在非PIM药物中（89.3%）。相关因素是PIM的药物数量以及PIM诱发ADR的PIM数量。
在南比利牛斯药物警戒数据库登记的≥75岁患者的ADR报告中，每12种药物中有1种可能是不适当的（主要是苯二氮䓬类、丙咪嗪类抗抑郁药和阿托品类药物）。使用PIM引发的ADR报告并不比其他处方多。
