Incidence of drug-induced liver injury in medical inpatients
Incidence of drug-induced liver injury in medical inpatients
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DOI：
10.1007/s00228-004-0888-z
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发表时间：
2005-04-01
影响因子：
2.9
通讯作者：
Fattinger, K
中科院分区：
文献类型：
--
作者：
Meier, Y;Cavallaro, M;Fattinger, K
目的：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 DILI 流行病学的数据很少。 方法：为了调查 DILI 的发生率，我们根据 CIOMS（国际医学科学组织理事会）标准对药物流行病学住院患者数据库中的所有患者进行筛查，其中包括评估一些临床化学实验室肝脏参数（CIOMS 实验室标准）并排除任何与疾病相关的原因。 肝损伤。因此，仅纳入根据世界卫生组织标准具有可能或确定因果关系的病例。 结果：在总共6383名患者中，4610名患者进行了肝脏参数测定，其中489名患者符合CIOMS实验室标准。然而，由于与疾病相关的肝损伤，必须排除 401 名患者，因此，研究队列由 4209 名有 DILI 风险的患者组成。在总共 88 例 DILI 病例中，有 31 例没有记录正常基线肝脏参数，因此代表了流行病例。其余 57 起是 DILI 事件。因此，DILI 的发生率为 1.4%（95% CI 1.0，1.7）。最常引起 DILI 的药物类别是肝素、抗菌药物、结核抑制剂和抗肿瘤药物。其中，抗肿瘤药和结核抑制剂的发病率最高。约 52-68% 的病例在诊断或医生出院信中未提及肝损伤。结论：大约百分之一的患者在内科住院期间发生 DILI。抗肿瘤药物和结核抑制剂的药源性肝损伤（DILI）发生率最高。药源性肝损伤 (DILI) 经常被漏诊，因此，通过诊断检测药源性肝损伤 (DILI) 会导致发病率过低，从而产生误导。
Objectives: Drug-induced liver injury (DILI) is a common concern. However, data on DILI epidemiology in inpatients are sparse.Methods: 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.Results: 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.Conclusion: 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.