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Efficacy and safety of magnesium isoglycyrrhizinate injection in patients with acute drug-induced liver injury: A phase II trial.

Authors
  • Wang, Yongfeng1
  • Wang, Zhenghua1
  • Gao, Mengqiu2
  • Zhong, Haijun3
  • Chen, Chengwei4
  • Yao, Yang5
  • Zhang, Zhongshun6
  • Zhang, Xia7
  • Li, Fujian8
  • Zhang, Jianzhong9
  • Gu, Hong-Mei10
  • Chen, Yingxuan1
  • Tang, Jieting1
  • Zhong, Wei1
  • Zeng, Minde1
  • Mao, Yimin1
  • 1 Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. , (China)
  • 2 Division of Tuberculosis, Beijing Chest Hospital, Beijing, China. , (China)
  • 3 Division of Tumor, Zhejiang Provincial Tumor Hospital, Hangzhou, China. , (China)
  • 4 Liver Disease Center of Naval 905 Hospital, Shanghai, China. , (China)
  • 5 Division of Tumor, Shanghai Sixth People's Hospital, Shanghai, China. , (China)
  • 6 Division of Tuberculosis, Shanghai Pulmonary Hospital, Shanghai, China. , (China)
  • 7 Division of Tuberculosis, Nanjing Chest Hospital, Nanjing, China. , (China)
  • 8 Division of Tuberculosis, Zhejiang Hospital of Integrated Traditional Chinese and Western Medicine, Hangzhou, China. , (China)
  • 9 Unimed Scientific Inc., Wuxi, China. , (China)
  • 10 Chia Tai Tianqing Pharmaceutical Group Co., Ltd, Nanjing, China. , (China)
Type
Published Article
Journal
Liver international : official journal of the International Association for the Study of the Liver
Publication Date
Nov 01, 2019
Volume
39
Issue
11
Pages
2102–2111
Identifiers
DOI: 10.1111/liv.14204
PMID: 31379118
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Drug-induced liver injury (DILI) is the most common reason for a drug to be withdrawn from the market. Apart from stopping the offending drug, no regimens are available for treating idiosyncratic DILI in clinical practice. We carried out a randomized, double-blind, multidoses, active drug controlled, multicentre phase II trial to assess the safety and efficacy of the study drug, magnesium isoglycyrrhizinate (MgIG), as compared to tiopronin, a standard therapy for DILI in China. The primary outcome was the proportion of alanine aminotransferase (ALT) normalization at week 4 after study drug administration. Logistic regression was used to examine the odds of ALT normalization between low dose (Group A) and high dose (Group B) vs active control (Group C). One hundred and seventy-four eligible subjects were randomized and enrolled into three groups: 59 in group A, 56 in group B and 59 in group C. It was shown that group A and group B lowered ALT level even at early stage of study drug administration; when compared with Group C (61.02%), the proportions of ALT normalization at week 4 were significantly greater in Group A (84.75%, P = .0029) and Group B (85.71%, P = .0037) respectively. The results from the univariate logistic model showed that the odds of ALT normalized among subjects in Group A were about 3.6 times greater (OR = 3.55, 95% CI: 1.47-8.57, P = .0049) than subjects in Group C. Similar effect was observed among subjects in Group B (OR = 3.83, 95% CI: 1.54-9.55, P = .0039). This trial provided preliminary evidence that MgIG is an effective and safe treatment for patients with acute DILI. © 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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