448例住院患者药物性肝损伤相关不良反应特征分析

doi:10.19803/j.1672-8629.20220648

摘要/Abstract

摘要： 目的分析某院住院患者药物性肝损伤发生及转归情况,为临床合理用药提供依据。方法对2014年1月1日至2022年7月31日某院上报的药物性肝损伤（DILI）住院患者进行回顾性分析,通过设定纳入和排除标准筛选出DILI不良反应病例,对这些病例的年龄、性别、临床分型、RUCAM评分、严重程度、转归及所涉及的药物进行统计分析。结果收集到201 268例住院患者;筛选得到448例DILI不良反应住院患者病例;DILI不良反应的住院患者粗发病率为0.22%;男女比例为1∶0.56;平均年龄（59.24±18.22）岁,男女年龄有显著差（P<0.05）;原患疾病主要是感染性疾病（28.35%）、心脑血管疾病（27.46%）,临床表现多无特异性;临床分型中肝细胞损伤型比例最高为218例（48.46%）、混合型次之为161例（35.93%）,胆汁淤积型最少为69例（15.40%）,RUCAM量表评分均在3分以上,264例（58.93%）≥6分;3种临床分型之间RUCAM评分及严重程度有显著差异;3种临床分型之间的丙氨酸氨基转移酶（ALT）、谷草转氨酶（AST）、碱性磷酸酶（ALP）、γ-谷氨酰转移酶（GGT）、总胆红素（TBIL）、白蛋白（ALB）水平比较差异具有统计学意义;可疑药物种类出现频次排名前3位的依次为心脑血管及血脂调节药、抗生素、解热镇痛药;排名前3位的可疑药物依次为阿托伐他汀、瑞舒伐他汀、莫西沙星;严重程度分级中轻度肝损伤387例（86.38%）;中度肝损伤36例（8.04%）;重度肝损伤25例（5.58%）;停药/减量并给予保肝及对症治疗后,临床转归结果良好。结论提示男性、中老年患者易发生DILI不良反应,主要以轻中度肝损伤为主。临床上使用心脑血管及血脂调节药、抗生素、解热镇痛药时需警惕其引起的DILI不良反应。

关键词: 药物性肝损伤, 药品不良反应, 阿托伐他汀, 瑞舒伐他汀, 莫西沙星

Abstract: Objective To investigate the occurrence and outcomes of drug-induced liver injury in hospitalized patients and provide evidence for rational drug use in the clinic. Methods Drug-induced liver injury (DILI) reported between January 1, 2014 and July 31, 2022 was analyzed retrospectively. Cases of DILI adverse reactions were screened by setting inclusion and exclusion criteria before they were analyzed in terms of age, gender, clinical typing, RUCAM scores severity, regression, and drugs involved. Results A total of 201 268 hospitalizations were collected, and 448 inpatients with DILI adverse reactions were screened. The incidence of DILI adverse reactions was 0.22%. The male-to-female ratio was 1: 0.56. The mean age was (59.24±18.22) years old, and there was a significant difference between males and females in age (P< 0.05). The diseases were mostly infectious diseases (28.35%) and cerebrovascular diseases (27.46%), and the clinical manifestations were primarily non-specific. As for clinical types, the dominating type was hepatocyte injury (218 cases, 48.46%), followed by the mixed type (161 cases, 35.93%), and the cholestasis type (69 cases,15.40%). The RUCAM scale score averaged above 3 points, with 264 cases (58.93%) ≥6 points. There were significant differences in RUCAM scores and severity between the three clinical types. The levels of ALT, AST, ALP, GGT, TBIL and ALB were also significantly different between. The top three suspected types of drugs were cardio-cerebrovascular and lipid-regulating drugs, antibiotics and antipyretic analgesics. The top three suspected drugs were atorvastatin, rosuvastatin and moxifloxacin. There were 387 cases (86.38%) of mild liver injury according to the grading of severity. There were of 36 cases of moderate liver injury (8.04%), compared with 25 cases of severe liver injury (5.58%). The clinical outcomes were generally good after drug withdrawal/reduction and liver-protecting and symptomatic treatment. Conclusion Male, middle-aged and elderly patients are prone to DILI adverse reactions, especially mild to moderate liver injury. Clinical use of cardio-cerebrovascular and lipid-regulating drugs, antibiotics, antipyretic analgesics requires alertness to DILI adverse reactions.

Key words: drug-induced liver injury(DILI), adverse drug reactions, atorvastatin, rosuvastatin, moxifloxacin

中图分类号:

R994.11

陈崇泽, 李婕, 旷煉, 檀学文, 刘敏惠, 刘熙, 郑燕钗, 靳洪涛. 448例住院患者药物性肝损伤相关不良反应特征分析[J]. 中国药物警戒, 2023, 20(6): 697-704.

CHEN Chongze, LI Jie, KUANG Lian, TAN Xuewen, LIU Minhui, LIU Xi, ZHENG Yanchai, JIN Hongtao. Characterization of adverse reactions associated with drug-induced liver injury in 448 inpatients[J]. Chinese Journal of Pharmacovigilance, 2023, 20(6): 697-704.

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