目的 分析阿托伐他汀致肝損傷不良反應(yīng)的發(fā)生規(guī)律及特點(diǎn)，并進(jìn)行相關(guān)性因素分析，為其安全使用提供參考。方法 對(duì)福州市長(zhǎng)樂(lè)區(qū)醫(yī)院2010—2021年74例阿托伐他汀致肝損傷不良反應(yīng)報(bào)告病例進(jìn)行回顧性分析，統(tǒng)計(jì)分析患者的一般情況、臨床癥狀、臨床分型、嚴(yán)重程度和轉(zhuǎn)歸情況等臨床資料。結(jié)果 收集到的74例阿托伐他汀致肝損傷患者，男女比例1.74∶1；患者年齡33～93歲；原患疾病主要是心腦血管疾?。?3.24%），發(fā)生時(shí)間平均為用藥后（42.78±75.98）d，臨床表現(xiàn)主要為乏力、納差、皮膚鞏膜黃染、腹部不適，53例患者無(wú)癥狀；臨床分型中肝細(xì)胞損傷型比例最高為29例（39.19%）、混合型次之為27例（36.49%），膽汁瘀積型最少為18例（24.32%），RUCAM量表評(píng)分均在3分以上，14例（18.92%）≥6分；3種臨床分型之間的丙氨酸氨基轉(zhuǎn)移酶（ALT）、堿性磷酸酶（ALP）、γ-谷氨酰轉(zhuǎn)肽酶（GGT）水平比較差異具有統(tǒng)計(jì)學(xué)意義（P＜0.05）；嚴(yán)重程度分級(jí)中輕度肝損傷63例（85.13%），中度肝損傷9例（12.17%），重度肝損傷2例（2.70%）；停藥/減量并給予保肝及對(duì)癥治療后，臨床轉(zhuǎn)歸結(jié)果良好。結(jié)論 臨床醫(yī)師應(yīng)重視阿托伐他汀所致的肝損傷，應(yīng)加強(qiáng)干預(yù)和肝功能生化指標(biāo)監(jiān)測(cè)，避免嚴(yán)重藥物性肝損傷的發(fā)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

中國(guó)毒理學(xué)會(huì)臨床毒理課題(CST2021CT101)