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目的:探讨盐酸胺碘酮注射液致急性肝损伤（AHI）的临床特点与危险因素。方法:研究设计为集中监测，监测对象为2018年3月1日至2019年2月28日在山西白求恩医院住院并使用盐酸胺碘酮注射液的所有患者，但在进行该药致AHI临床特点和危险因素分析时，排除患有病毒性肝炎、自身免疫性肝病、原发性肝癌或恶性肿瘤肝转移以及用药前肝功能异常者。对用药后出现肝功能异常并经主诊医师和临床药师共同判定为盐酸胺碘酮注射液所致AHI者，由专人另行建立临床档案，并每个月通过医院信息系统对当月应用该药患者的实验室检查记录进行复核。监测期结束后，检索医院信息系统收集监测对象的电子病历，记录纳入分析患者的基本信息，基础疾病，盐酸胺碘酮注射液用药总剂量，联合用药情况，应用盐酸胺碘酮注射液前后血清丙氨酸转氨酶（ALT）、天冬氨酸转氨酶（AST）、总胆红素（TBil）检测结果，用药至发生AHI的时间，以及AHI的临床表现、治疗和转归情况。将患者分为AHI组和无AHI组，比较2组患者的临床特征，将组间比较n P0.05）；AHI组冠状动脉粥样硬化性心脏病（冠心病）患者占比高于非AHI组[58.8%（20/34）比30.8%（73/237），n χn 2=10.358，n P=0.001]。2组患者应用盐酸胺碘酮注射液前ALT、AST、TBil水平差异均无统计学意义（均n P>0.05）；用药后AHI组患者ALT、AST和TBil水平均明显高于用药前[341（176，1 175）U/L比25（16，31）U/L，n P=0.014；439（167，1 586）U/L比36（24，56）U/L，n P=0.029；36.0（15.31，42.1）μmol/L比18.6（14.8，22.1）μmol/L，n P0.05 for all). The levels of ALT, AST, and TBil in the AHI group were significantly higher than those in the non-AHI group after application of amiodarone hydrochloride injection [341 (176, 1175) U/L n vs. 25 (16, 31) U/L, n P=0.014; 439 (167, 1 586) U/L n vs. 36 (24, 56) U/L, n P=0.029; 36.0 (15.3, 42.1) μmol/L n vs. 18.6 (14.8, 22.1) μmol/L, n P<0.001], and also significantly higher than those in the non-AHI group (n P=0.006, n P=0.026, n P<0.001). Of 34 AHI patients, 19, 14 and 1 patients developed abnormal liver function on day 2, 3 and 5 of medication, respectively, all of them had no obvious clinical signs and symptoms. After being diagnosed as having AHI, 29 patients discontinued the amiodarone hydrochloride injection treatment, 3 changed to lidocaine, and 2 discontinued it after 1 and 3 days of continued medication, respectively. All 34 patients received symptomatic treatments such as liver-protective drugs, in which 32 patients (94.1%) were improved, including 25 patients (78.1%) with liver function within the reference range, 7 patients with ALT and AST levels within 2 times of upper limit of reference range values and their TBil level within the reference range. The other 2 patients (5.9%) developed multi-organ dysfunction syndrome, in which one patient returned with normal liver function after treatment and one died. The results of multivariate regression analysis showed that coronary atherosclerotic heart disease, combined basic diseases ≥3 kinds, and combination drugs ≥3 kinds were the independent risk factors for AHI due to amiodarone hydrochloride injection (n OR=3.209, 95n %CI: 1.537-6.704, n P=0.002; n OR=2.437, 95n %CI: 1.083-5.486, n P=0.031; n OR=3.172, 95n %CI: 1.507-6.677, n P=0.002).n Conclusions:AHI due to amiodarone hydrochloride injection occurred mostly within 3 days of medication, which are acute onset and no obvious clinical signs and symptoms. The AHI′s diagnosis is mainly based on liver function examination. Patients with coronary atherosclerotic heart disease, combined basic diseases ≥3 kinds, and combination drugs ≥3 kinds are independent risk factors for AHI due to amiodarone hydrochloride injection.