Chinese Journal of Pharmacovigilance ›› 2015, Vol. 12 ›› Issue (6): 347-351.

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Analysis of 60 Cases of Acute Hepatic Injury Induced by Intravenous Infusion of Amiodarone

MAO Min1,XU Xiao-hua1,ZHAO Jia-shu1,2,MAO Jian-sheng3,DU Jin-hang3, LU Jin1   

  1. 1Department of Pharmacy, China-Japan Friendship Hospital, Beijing 100029, China;
    2Department of Pharmacy, Puren Hospital, Beijing 100062, China;
    3Integrative Medicine Cardiology, China-Japan Friendship Hospital, Beijing 100062, China
  • Received:2014-07-30 Online:2015-06-08 Published:2015-07-27

Abstract: Objective To conclude intravenous infusion of amiodarone-induced acute hepatic injury cases, to analyze the causal factors and mechanisms of acute hepatic injury induced by intravenous infusion of amiodarone, and to find the way of prevention and treatment of acute hepatic injury. Methods The clinical feature, primary disease, indications and Methods of using amiodarone, characteristics of hepatic injury and functions of other organs, concomitant medicines and prognosis of patients were analyzed in 60 cases. One of the cases was the inpatient of our hospital in 2011, and the others were collected from foreign and domestic medical journals between 1988 to 2012. Results The dosage of intravenous amiodarone was 193.2~4 310(1 345.7±550.6)mg, the duration of administration was 6~29(34.0±17.9)h. The peak of AST was 122.3~17 471(3 798±3 982)U?L-1 and ALT was 225~12 426(3 206±1 788)U?L-1. After discontinuation of intravenous amiodarone and conventional liver adjuvant therapy, 52 cases of liver enzymes returned to normal, the average time was 21.6 ± 13.24 d, 4 cases died of acute renal failure or multi-organ failure, one case died of hepatic encephalopathy, three cases died of cardiogenic shock. The liver function of 15 cases who adopted oral amiodarone after stopping intravenous amiodarone continued to improve. Conclusion The relationship between incidence of acute liver injury induced by intravenous amiodarone and the total does of amiodarone, and the treatment time is unclear. However,the high concentration of cosolvent polysorbate 80 is the most critical factors to lead to acute liver injury. The patient with both acute liver injury and other organs damage would have poor prognosis. Intravenous infusion of amiodarone could be safely replaced by oral amiodarone when acute hepatic injury happened. Acute hepatic injury with acute renal failure induced high mortality, CBP is conducive to treatment as soon as possible.

Key words: amiodarone, acute hepatotoxicity, intravenous administration, adverse reactions

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