目的 分析阿托伐他汀致肝损伤不良反应的发生规律及特点，并进行相关性因素分析，为其安全使用提供参考。方法 对福州市长乐区医院2010—2021年74例阿托伐他汀致肝损伤不良反应报告病例进行回顾性分析，统计分析患者的一般情况、临床症状、临床分型、严重程度和转归情况等临床资料。结果 收集到的74例阿托伐他汀致肝损伤患者，男女比例1.74∶1；患者年龄33～93岁；原患疾病主要是心脑血管疾病（93.24%），发生时间平均为用药后（42.78±75.98）d，临床表现主要为乏力、纳差、皮肤巩膜黄染、腹部不适，53例患者无症状；临床分型中肝细胞损伤型比例最高为29例（39.19%）、混合型次之为27例（36.49%），胆汁瘀积型最少为18例（24.32%），RUCAM量表评分均在3分以上，14例（18.92%）≥6分；3种临床分型之间的丙氨酸氨基转移酶（ALT）、碱性磷酸酶（ALP）、γ-谷氨酰转肽酶（GGT）水平比较差异具有统计学意义（P＜0.05）；严重程度分级中轻度肝损伤63例（85.13%），中度肝损伤9例（12.17%），重度肝损伤2例（2.70%）；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 临床医师应重视阿托伐他汀所致的肝损伤，应加强干预和肝功能生化指标监测，避免严重药物性肝损伤的发生。

Objective To analyze the occurrence regularity and characteristics of adverse reactions of liver injury caused by atorvastatin, and to analyze the correlation factors, so as to provide reference for its safe use. Methods A total of 74 reported cases of adverse reactions of liver injury caused by atorvastatin in Fuzhou Changle District Hospital from 2010 to 2021 were retrospectively analyzed. The general condition, clinical symptoms, clinical classification, severity, and outcome of the patients were statistically analyzed. Results A total of 74 patients with atorvastatin-induced liver injury were collected, with a male to female ratio of 1.74:1, The age of the patients was 33 to 93 years old, the primary disease was cardiovascular and cerebrovascular disease (93.24%), and the average occurrence time was (42.78 ±75.98) days. The main clinical manifestations were fatigue, anorexia, yellowing of skin and sclera, abdominal discomfort, and 53 patients were asymptomatic. In the clinical classification, the highest proportion of hepatocyte injury type was 29 cases (39.19%), mixed type was 27 cases (36.49%), the least cholestasis type was 18 cases (24.32%), the RUCAM scale scores were all above 3 points, and 14 cases (18.92%) were more than 6 points. There were statistically significant differences in the levels of ALT, ALP, and GGT (P < 0.05). There were 63 cases (85.13%) of mild liver injury in severity classification, 9 cases (12.17%) of moderate liver injury, 2 cases of severe liver injury (2.70%). After drug withdrawal/reduction and liver protection and symptomatic treatment, the clinical outcome was good. Conclusion Clinicians should pay attention to the liver injury caused by atorvastatin, and should strengthen the intervention and monitoring of biochemical indicators of liver function to avoid the occurrence of serious drug-induced liver injury.

R972

中国毒理学会临床毒理课题(CST2021CT101)