Kanagaratnam Lukshe, Taam Malak Abou, Heng Marie, De Boissieu Paul, Roux Marie-Paule, Trenque Thierry
Centre Régional de Pharmacovigilance et de Pharmacoépidémiologie de Champagne-Ardenne, Centre Hospitalier Universitaire de Reims, Reims, France.
Centre Régional de Pharmacovigilance et de Pharmacoépidémiologie de Champagne-Ardenne, Centre Hospitalier Universitaire de Reims, Reims, France.
Therapie. 2015 Sep-Oct;70(5):477-84. doi: 10.2515/therapie/2015029.
To describe the serious adverse drug reactions (ADR) in elderly subjects aged over 65 years and assess their preventability.
A retrospective study was conducted at the Regional Pharmacovigilance Center of Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65 years who presented a serious ADR notified to the Regional Pharmacovigilance Center were included in the study.
Over the study period, 100 subjects were included in the study. The sex ratio was 0.96. Twenty seven percent of serious ADR were preventable. Off-label use accounted for 20% and non-compliance for 5%. Bleeding events were the most common serious ADR (36%). The drugs most frequently involved in serious ADR were antithrombotic agents (31.4%).
More than a quarter of serious ADR were preventable. Off-label use and non-compliance are the main causes identified in the occurrence of preventable serious ADR.
描述65岁以上老年患者的严重药物不良反应（ADR）并评估其可预防性。
于2013年1月至5月在香槟-阿登大区药物警戒中心（法国东北部）进行了一项回顾性研究。纳入了向该地区药物警戒中心报告严重ADR的65岁以上患者。
在研究期间，100名受试者被纳入研究。性别比为0.96。27%的严重ADR是可预防的。超说明书用药占20%，用药依从性差占5%。出血事件是最常见的严重ADR（36%）。严重ADR中最常涉及的药物是抗血栓药物（31.4%）。
超过四分之一的严重ADR是可预防的。超说明书用药和用药依从性差是可预防严重ADR发生的主要原因。
