Corticosteroid plus glycyrrhizin therapy for chronic drug- or herb-induced liver injury achieves biochemical and histological improvements: A randomised open-label trial

Wang, Jia-Bo1,2; Huang, Ang1; Wang, Yijin3,4; Ji, Dong1; Liang, Qing-Sheng1; Zhao, Jun1; Zhou, Guangde4; Liu, Shuhong4; Niu, Ming2; Sun, Ying1; Tian, Hui1; Teng, Guang-Ju1; Chang, Bin-Xia1; Bi, Jing-Feng5; Peng, Xiao-Xia6; Xin, Shaojie1; Xie, Huan1; Ma, Xiong7; Mao, Yi-Min7; Liangpunsakul, Suthat8; Saxena, Romil9; Aithal, Guruprasad P.10,11; Xiao, Xiao-He12; Zhao, Jingmin4; Zou, Zhengsheng1

2022-03-01

10.1111/apt.16902

ALIMENTARY PHARMACOLOGY & THERAPEUTICS   影响因子和分区

0269-2813

1365-2036

["Background Treatment of chronic drug-induced liver injury (DILI) or herb-induced liver injury(HILI) is an important and unresolved challenge. There is no consensus regarding the indications for corticosteroids for chronic DILI/HILI.","Aims To investigate the efficacy and safety of corticosteroid plus glycyrrhizin for patients with chronic DILI/HILI.","Methods This was a randomised open-label trial. Eligible patients with causality assessment using the updated RUCAM were randomly assigned (1:1) either to the steroid treatment group (48-week stepwise dose reduction of methylprednisolone plus glycyrrhizin) or control group (glycyrrhizin alone). Liver biopsies were performed at baseline and at the end of the 48-week treatment period. The primary outcome was the proportion of patients with sustained biochemical response (SBR). The secondary outcomes were improvement in liver histology, time to biochemical normalisation and safety.","Results Of 80 participants, 70 (87.5%) completed the trial. The patients were predominantly female (77.5%), aged >40 years (77.5%) and had a hepatocellular injury pattern of DILI (71.2%). Compared to the control group, the treatment group showed a higher proportion of SBR (94.3% vs. 71.4%, p = 0.023), shorter biochemical normalisation time and histological improvements in both histological activity and fibrosis. The DILI and HILI subgroups, as well as the autoimmune hepatitis (AIH)-like DILI and non-AIH-like subgroups, showed comparable responses. No severe adverse events were observed during the trial.","Conclusion This study provides the first clinical evidence that corticosteroid plus glycyrrhizin therapy for chronic DILI with or without AIH-like features can achieve both biochemical response and histological improvements with good safety. (, NCT 02651350)."]

drug-induced liver disease glycyrrhizin liver biopsy herb-induced liver injury methylprednisolone randomised controlled trial updated Roussel Uclaf causality assessment method (RUCAM)

SCI

英语

其他

302 Hospital Foundation[YNKTZ2018001] ; National Natural Science Foundation of China[81670527,81630100,81721002,81930110,81600453,82074112] ; Beijing Nova Program[Z171100001117114] ; Capital Characteristic Clinic Project of the Beijing Municipal Science and Technology Commission[Z181100001718034]

Gastroenterology & Hepatology ; Pharmacology & Pharmacy

Gastroenterology & Hepatology ; Pharmacology & Pharmacy

WOS:000776439600001

WILEY

PHARMACOLOGY & TOXICOLOGY

Web of Science

1.Peoples Liberat Army Gen Hosp, Med Ctr 5, Senior Dept Hepatol, Beijing, Peoples R China
2.Capital Med Univ, Sch Tradit Chinese Med, Beijing, Peoples R China
3.Southern Univ Sci & Technol SUSTech, Sch Med, Shenzhen, Guangdong, Peoples R China
4.Peoples Liberat Army Gen Hosp, Med Ctr 5, Dept Pathol & Hepatol, Beijing, Peoples R China
5.Peoples Liberat Army Gen Hosp, Med Ctr 5, Epidemiol Dept, Beijing, Peoples R China
6.Capital Med Univ, Natl Ctr Childrens Hlth, Beijing Childrens Hosp, Ctr Clin Epidemiol & Evidence Based Med, Beijing, Peoples R China
7.Shanghai Jiao Tong Univ, Renji Hosp, Div Gastroenterol & Hepatol, Shanghai, Peoples R China
8.Indiana Univ Sch Med, Div Gastroenterol & Hepatol, Dept Med, Indianapolis, IN 46202 USA
9.Indiana Univ Sch Med, Dept Pathol & Lab Med, Indianapolis, IN 46202 USA
10.Nottingham Univ Hosp NHS Trust, NIHR Nottingham Biomed Res Ctr, Nottingham, England
11.Univ Nottingham, Nottingham, England
12.Peoples Liberat Army Gen Hosp, Med Ctr 5, China Mil Inst Chinese Med, Beijing, Peoples R China

Wang, Jia-Bo,Huang, Ang,Wang, Yijin,et al. Corticosteroid plus glycyrrhizin therapy for chronic drug- or herb-induced liver injury achieves biochemical and histological improvements: A randomised open-label trial[J]. ALIMENTARY PHARMACOLOGY & THERAPEUTICS,2022.

Wang, Jia-Bo.,Huang, Ang.,Wang, Yijin.,Ji, Dong.,Liang, Qing-Sheng.,...&Zou, Zhengsheng.(2022).Corticosteroid plus glycyrrhizin therapy for chronic drug- or herb-induced liver injury achieves biochemical and histological improvements: A randomised open-label trial.ALIMENTARY PHARMACOLOGY & THERAPEUTICS.

Wang, Jia-Bo,et al."Corticosteroid plus glycyrrhizin therapy for chronic drug- or herb-induced liver injury achieves biochemical and histological improvements: A randomised open-label trial".ALIMENTARY PHARMACOLOGY & THERAPEUTICS (2022).