[Magnesium isoglycyrrhizinate in the treatment of chronic liver diseases: a randomized, double-blind, multi-doses, active drug controlled, multi-center study].
OBJECTIVE
To evaluate the efficacy and safety of Magnesium isoglycyrrhizinate in treatment of chronic liver diseases.


METHODS
It is a randomized, double-blind, multi-doses, active drug controlled, multi-center study. 480 proper patients were randomly divided into group A (180 patients), group B (180 patients) or group C (120 patients). Patients in group A received magnesium isoglycyrrhizinate 100 mg once daily. Patients in group B received magnesium isoglycyrrhizinate 150 mg once daily. Patients in group C received compound glycyrrhizin 120 mg once daily. The treatment course was 4 weeks. Patients were followed up 2 weeks after the treatment. Patients visited once every 2 weeks. Clinical symptoms, ALT, AST were evaluated in all the patients before treatment, at week 2, at week 4 and at 2 weeks later after treatment. The other liver function test was done before treatment and at week 4.


RESULTS
412 patients completed the study according to the protocol,152 in group A, 160 in group B and 100 in group C. ALT and AST level were significantly decreased in all groups at week 2 and week 4 (P < 0.05). The degree of ALT decrease is greater in group B than in group C at week 2 (P < 0.01). The degree of ALT decrease was not significant different among three groups at week 4 (P > 0.05). The rates of ALT improvement at week 4 in group A, B, C were 92.59%, 91.76%, 88.29%, respectively (P > 0.05). The rates of symptoms improvement at week 4 in group A, B, C were 90.41%, 89.86%, 86.46% and 72.22%, 73.53%, 68.47%, respectively (P > 0.05). No relapse were found in all three groups after treatment. The rate of adverse event in three groups was similar (P > 0.05).


CONCLUSIONS
Magnesium isoglycyrrhizinate is an effective and safe treatment for chronic liver diseases.
Mao
Yi-min
YM
Department of Gastroenterology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200001, China. mym11968@yahoo.com.cn
Zeng
Min-de
MD
Chen
Yong
Y
Chen
Cheng-wei
CW
Fu
Qing-chun
QC
Cai
Xiong
X
Wu
Shan-ming
SM
Chen
Ya-gang
YG
Sun
Ying
Y
Li
Jun
J
Sui
Yan-hua
YH
Zhao
Wei
W
Lu
Lun-gen
LG
Cao
Ai-ping
AP
Chen
Hong-zhuan
HZ
D000410:Alanine Transaminase / Q000097:blood*; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D002908:Chronic Disease; D004311:Double-Blind Method; D005234:Fatty Liver / Q000097:blood / Q000188:drug therapy; D005260:Female; D019695:Glycyrrhizic Acid / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007275:Injections, Intravenous; D008099:Liver / Q000187:drug effects / Q000473:pathology; D008107:Liver Diseases / Q000097:blood / Q000188:drug therapy*; D008108:Liver Diseases, Alcoholic / Q000097:blood / Q000188:drug therapy; D008297:Male; D012503:Saponins / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D014315:Triterpenes / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*
C521270:18alpha,20beta-hydroxy-11-oxo-norolean-12-en-3beta-yl-2-O-beta-D-glucopyranurosyl-alpha-D-glucopyranosiduronate magnesium tetrahydrate; D000893:Anti-Inflammatory Agents; D012503:Saponins; D014315:Triterpenes; D019695:Glycyrrhizic Acid; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase