Oestreicher M K, Desmeules J, Giostra E, Gross B, Hadengue A, Dayer P
Division de pharmacologie clinique, Hôpital Cantonal Universitaire de Genève.
Schweiz Med Wochenschr. 1996 Nov 30;126(48):2094-6.
A retrospective study over the last 5 years on drug-induced liver injury was performed in the Internal Medicine Department of the University Hospital of Geneva. According to WHO and Council for International Organizations of Medical Sciences (CIOMS) criteria for drug-induced liver adverse events, 142 cases were identified, with 255 drugs fulfilling causality criteria of certain, probable or possible. 63 patients (44%) suffered severe consequences of liver injury, including 9 deaths. Drugs reported belonged to the therapeutic classes of antibiotics (43%), cardiovascular (20%), analgesics (10%), gastrointestinal (9%), psychotropic (7%), and others (11%). Despite bias inherent to the retrospective methodology, only 10% of the side effects were spontaneously reported to the pharmaco-vigilance board. This is in accordance with the known reporting rate. It can be concluded that spontaneous reports are to be regarded only as signals.
日内瓦大学医院内科对过去5年药物性肝损伤进行了一项回顾性研究。根据世界卫生组织和国际医学科学组织理事会（CIOMS）关于药物性肝不良事件的标准，确定了142例病例，有255种药物符合肯定、很可能或可能的因果关系标准。63例患者（44%）出现肝损伤的严重后果，包括9例死亡。报告的药物属于抗生素（43%）、心血管药物（20%）、镇痛药（10%）、胃肠道药物（9%）、精神药物（7%）和其他药物（11%）治疗类别。尽管回顾性研究方法存在固有偏差，但只有10%的副作用被自发报告给药物警戒委员会。这与已知的报告率一致。可以得出结论，自发报告仅应被视为信号。
