Bénard-Laribière Anne, Miremont-Salamé Ghada, Pérault-Pochat Marie-Christine, Noize Pernelle, Haramburu Françoise
CHU Bordeaux, Service de pharmacologie, F-33000, Bordeaux, France.
Fundam Clin Pharmacol. 2015 Feb;29(1):106-11. doi: 10.1111/fcp.12088. Epub 2014 Sep 25.
To assess the incidence of hospital admissions related to adverse drug reactions (ADRs) in France and the frequency of preventable ADRs in France, a prospective study was conducted among a representative randomly selected sample of medical wards in public hospitals between December 2006 and June 2007; all patients admitted during a 2-week period were included. An ADR-related hospitalization case was defined as a hospital admission because of an ADR, and an independent committee reviewed and validated all potential cases. Preventability was assessed using the French ADR preventability scale. Data were extrapolated to the population of France. Among 2692 admissions, 97 were related to an ADR (incidence 3.6%, 95% confidence interval, CI [2.8-4.4]). Patients admitted for an ADR were significantly older than those admitted for other reasons (P < 0.001). A third (32.0%) of ADR-related hospitalizations were 'preventable', 16.5% 'potentially preventable'. Drug interactions accounted for 29.9% of ADR-related hospitalizations. The most frequent causes of ADR-related hospitalizations were vascular disorders (20.6%), mainly bleeding complications, central nervous system disorders (11.3%), gastrointestinal disorders, and general disorders (9.3%). Antithrombotic and antineoplastic agents were the most frequently involved (12.6% each), followed by diuretics and analgesics (9.0% each). Vitamin-K-antagonists (VKAs) were the most common drugs associated with admission. The estimated annual number of ADR-related hospitalizations in France was 143 915 (95% CI [112 063-175 766]). ADRs were a significant cause of hospital admission in 2006-2007, in particular those due to VKAs. As new oral anticoagulants (NOACs) have been marketed, more attention needs to be paid to ensure a safe use of antithrombotic agents.
为评估法国与药物不良反应（ADR）相关的住院发生率以及法国可预防ADR的发生频率，于2006年12月至2007年6月期间，在公立医院具有代表性的随机抽取的内科病房样本中开展了一项前瞻性研究；纳入了所有在为期2周的时间段内入院的患者。与ADR相关的住院病例定义为因ADR而入院，一个独立委员会对所有潜在病例进行了审查和确认。使用法国ADR可预防性量表评估可预防性。数据外推至法国人口。在2692例入院病例中，97例与ADR相关（发生率3.6%，95%置信区间，CI[2.8 - 4.4]）。因ADR入院的患者明显比因其他原因入院的患者年龄大（P<0.001）。三分之一（32.0%）与ADR相关的住院是“可预防的”，16.5%是“可能可预防的”。药物相互作用占与ADR相关住院的29.9%。与ADR相关住院最常见的原因是血管疾病（20.6%），主要是出血并发症、中枢神经系统疾病（11.3%）、胃肠道疾病和全身性疾病（9.3%）。抗血栓药和抗肿瘤药是最常涉及的药物（各占12.6%），其次是利尿剂和镇痛药（各占9.0%）。维生素K拮抗剂（VKA）是与入院相关最常见的药物。法国每年与ADR相关的住院估计数为143915例（95%CI[112063 - 175766]）。在2006 - 2007年，ADR是住院的一个重要原因，特别是那些由VKA引起的。随着新型口服抗凝药（NOAC）上市，需要更加关注以确保抗血栓药物的安全使用。
