异甘草酸镁治疗慢性肝病：一项随机、双盲、多剂量、活性药物对照、多中心研究

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

作者信息

Mao Yi-min, Zeng Min-de, Chen Yong, Chen Cheng-wei, Fu Qing-chun, Cai Xiong, Wu Shan-ming, Chen Ya-gang, Sun Ying, Li Jun, Sui Yan-hua, Zhao Wei, Lu Lun-gen, Cao Ai-ping, Chen Hong-zhuan

机构信息

Department of Gastroenterology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200001, China.

出版信息

Zhonghua Gan Zang Bing Za Zhi. 2009 Nov;17(11):847-51.

PMID:19958646

Abstract

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).

CONCLUSION

Magnesium isoglycyrrhizinate is an effective and safe treatment for chronic liver diseases.

摘要

目的

评价异甘草酸镁治疗慢性肝病的有效性和安全性。

方法

这是一项随机、双盲、多剂量、活性药物对照、多中心研究。480例合适的患者被随机分为A组（180例）、B组（180例）或C组（120例）。A组患者接受异甘草酸镁100mg，每日1次。B组患者接受异甘草酸镁150mg，每日1次。C组患者接受复方甘草酸苷120mg，每日1次。疗程为4周。治疗后2周对患者进行随访。患者每2周就诊1次。在治疗前、第2周、第4周和治疗后2周对所有患者评估临床症状、ALT、AST。在治疗前和第4周进行其他肝功能检查。

结果

412例患者按方案完成研究，A组152例，B组160例，C组100例。在第2周和第4周时，所有组的ALT和AST水平均显著降低（P<0.05）。在第2周时，B组ALT降低程度大于C组（P<0.01）。在第4周时，三组间ALT降低程度差异无统计学意义（P>0.05）。A组、B组、C组在第4周时ALT改善率分别为92.59%、91.76%、88.29%（P>0.05）。A组、B组、C组在第4周时症状改善率分别为90.41%、89.86%、86.46%，以及72.22%、73.53%、68.47%（P>0.05）。治疗后三组均未发现复发。三组不良事件发生率相似（P>0.05）。