Objective:To explore the clinical characteristics and risk factors of acute hepatic injury (AHI) due to amiodarone hydrochloride injection.Methods:The study was designed as centralized monitoring. The monitored subjects were patients who were hospitalized in Shanxi Bethune Hospital and received amiodarone hydrochloride injection from March 1, 2018 to February 28, 2019, in which the patients with virus hepatitis, autoimmune liver disease, primary carcinoma of liver or hepatic metastasis of malignant tumor, and abnormal liver function before medication were excluded when analyzing the clinical characteristics and risk factors of AHI due to amiodarone hydrochloride injection. The special clinical records of the patients, who developed abnormal liver function after medication and were adjudged as AHI by attending physician and clinical pharmacist, were established by specially-assigned person. The laboratory tests records of the patients treated with the drug were rechecked through the Hospital Information System every month. After finishing the monitoring, the electronic medical records of monitored subjects were collected by searching the Hospital Information System; the patients′ basic information, basic diseases, the total dose of amiodarone hydrochloride injection, combination drugs, the detection results of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBil) before and after application of amiodarone hydrochloride injection, the time from medication to AHI occurrence, and the clinical manifestations, treatment and outcome of AHI were recorded. The patients were divided into the AHI group and the non-AHI group and the clinical features between the 2 groups were compared. The indices of P<0.2 between groups were analyzed using the multivariable logistic regression model, and odds ratio ( OR) and its 95% confidence interval ( CI) were calculated. Results:A total of 271 patients were enrolled into the study. Of them, 34 patients developed AHI, the incidence of AHI was 12.5%. The differences of sex distribution, age, height, body weight, total dose by intravenous medication, situations of other combination drugs (including antiplatelet drugs, statins, Beta-adrenergic blockers, anticoagulants, hormones, and antineoplastic drugs and etc.) between the AHI group and the non-AHI group (237 patients) were not statistically significant ( P>0.05 for all). The proportion of patients with coronary atherosclerotic heart disease in the AHI group was higher than that in the no-AHI group [58.8% (20/34) vs. 30.8% (73/237), χ 2=10.358, P=0.001]. The differences of ALT, AST and TBil levels between the 2 groups before application of amiodarone hydrochloride injection were not statistically significant ( P>0.05 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 vs. 25 (16, 31) U/L, P=0.014; 439 (167, 1 586) U/L vs. 36 (24, 56) U/L, P=0.029; 36.0 (15.3, 42.1) μmol/L vs. 18.6 (14.8, 22.1) μmol/L, P<0.001], and also significantly higher than those in the non-AHI group ( P=0.006, P=0.026, 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 ( OR=3.209, 95 %CI: 1.537-6.704, P=0.002; OR=2.437, 95 %CI: 1.083-5.486, P=0.031; OR=3.172, 95 %CI: 1.507-6.677, P=0.002). 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.