112例药物性肝损伤的临床关联性评价

Causality assessment of 112 patients with drug-induced liver injury

目的评价10年间对112例药物性肝损伤患者的诊断正确性。方法采用回顾性调查方法和国际共识会议诊断标准,围绕用药与发生肝损伤的时间关系、停药后肝损伤恢复时间过程及排除非药物性相关因素,对112例药物性肝损伤患者进行临床关联性评价。结果在10年间住院的1127例急性肝损伤患者中,药物性肝损伤112例(10%)。其中,60例(53.6%)不符合用药与发生肝损伤的时间关系,20例(17.9%)不符合停药后肝脏生化指标恢复的时间过程,有其他可疑病因者34例(37.5%)。综合分析认为,药物相关性肝损伤26例(23.2%),药物不相关性肝损伤25例(22.3%),未能确定病因的肝损伤61例(54.5%)。结论国际共识会议诊断标准有助于肯定或排除药物性肝损伤,但仍有半数以上病例为疑似状态,现行的临床诊断方法尚有待改进。

Objective To evaluate the diagnostic accuracy of drug-induced liver injury over a 10- year period . Methods The 112 cases of drug-induced liver injury were retrospectively studied. Inter national consensus criteria were applied to assess the causality of suspected drug hepatotoxieity,in which the chronological criteria and elimination of other causes were analysed. Results Among 1127 adult inpatients with acute hepatitis over 10-year period, 112 patients（10%） were recorded as drug-induced liver injury. Based on the causality assessment of 112 cases, either incompatible time to apparent onset of the reaction or incompatible course of the reaction was found in 60 cases（53.6%） and 20 eases（ 17.9%）, respectively. The presence of other possible causes for the reaction was found in 34 patients （37.5%）. Therefore, 26 cases（23. 2%） of liver in）ury were related to the incriminated drug, 25 cases（22. 3%） unrelated,61 （54.5 %） were considered to indeterminate cause. Conclusions The international consensus criteria were helpful to identify drug-related or unrelated liver injury, but more than half of reported hepatic adverse drug reactions are still in suspected condition. The current diagnostic methods for drug- induced liver injury are needed to be revised in clinical practice.