Meier Yvonne, Cavallaro Marzia, Roos Malgorzata, Pauli-Magnus Christiane, Folkers Gerd, Meier Peter J, Fattinger Karin
Division of Clinical Pharmacology and Toxicology, Department of Medicine, University Hospital Zurich, CH-8091, Zürich, Switzerland.
Eur J Clin Pharmacol. 2005 Apr;61(2):135-43. doi: 10.1007/s00228-004-0888-z. Epub 2005 Feb 23.
Drug-induced liver injury (DILI) is a common concern. However, data on DILI epidemiology in inpatients are sparse.
To investigate the incidence of DILI, we screened all patients in the pharmacoepidemiological inpatient database according to the CIOMS (Council for International Organisation of Medical Science) criteria, which consist of the evaluation of some clinical chemistry laboratory liver parameters (CIOMS laboratory criteria) and the exclusion of any disease-related causes for the liver injury. Thus, only cases with probable or certain causality according to the World Health Organization criteria were included.
Among a total of 6383 patients, liver parameters were determined in 4610, and 489 among them fulfilled the CIOMS laboratory criteria. However, 401 patients had to be excluded because of disease-related liver injury and, thus, the study cohort consisted of 4209 patients at risk for DILI. Among a total of 88 DILI cases, 31 had no documented normal baseline liver parameters and, thus, represented prevalent cases. The remaining 57 represented incident DILI cases. Thus, the incidence of DILI was 1.4% (95% CI 1.0, 1.7). The drug classes most frequently causing DILI were heparins, antibacterials, tuberculostatics and antineoplastic agents. Among those, antineoplastic agents and tuberculostatics showed the highest incidence. Liver injury was not mentioned among the diagnoses or in the physician's discharge letter in about 52-68% of all cases.
Approximately 1 in 100 patients develops DILI during hospitalisation in a department of medicine. Incidences of DILI were highest for antineoplastic agents and tuberculostatics. DILI is frequently missed and, therefore, DILI detection by diagnoses will result in misleadingly low incidence rates.
药物性肝损伤（DILI）是一个普遍关注的问题。然而，关于住院患者中DILI流行病学的数据却很稀少。
为了调查DILI的发病率，我们根据国际医学科学组织理事会（CIOMS）标准，对药物流行病学住院患者数据库中的所有患者进行了筛查，该标准包括对一些临床化学实验室肝脏参数的评估（CIOMS实验室标准）以及排除任何与疾病相关的肝损伤原因。因此，仅纳入了根据世界卫生组织标准具有可能或肯定因果关系的病例。
在总共6383例患者中，4610例进行了肝脏参数测定，其中489例符合CIOMS实验室标准。然而，401例患者因与疾病相关的肝损伤而被排除，因此，研究队列由4209例有DILI风险的患者组成。在总共88例DILI病例中，31例没有记录正常的基线肝脏参数，因此为现患病例。其余57例为新发DILI病例。因此，DILI的发病率为1.4%（95%可信区间1.0，1.7）。最常引起DILI的药物类别是肝素、抗菌药物、抗结核药物和抗肿瘤药物。其中，抗肿瘤药物和抗结核药物的发病率最高。在所有病例中，约52% - 68%的诊断或医生出院小结中未提及肝损伤。
在医学科住院期间，约每100名患者中有1例发生DILI。抗肿瘤药物和抗结核药物的DILI发病率最高。DILI经常被漏诊，因此，通过诊断检测到的DILI发病率会低得具有误导性。
