探索异甘草酸镁治疗ALT升高慢性肝炎安全、有效剂量的多中心、随机、双盲、安慰剂平行对照临床研究

目的探索不同剂量异甘草酸镁注射液治疗ALT升高的慢性肝病的临床疗效和安全性。方法多中心、随机、双盲、安慰剂平行对照的试验设计,180例患者按1∶1∶1比例随机进入安慰剂对照组（A组）、异甘草酸镁100mg/d剂量组（B组）和200mg/d剂量组（C组）。A组：空白异甘草酸镁注射液加入到10%葡萄糖注射液250ml中静脉滴注,1次/d;B组：异甘草酸镁注射液100mg加入到10%葡萄糖注射液250ml中静脉滴注,1次/d;C组：异甘草酸镁注射液200mg加入到10%葡萄糖注射液250ml中静脉滴注,1次/d。疗程为4周。治疗前、治疗后每周分别观察ALT;治疗前、治疗第2周、4周分别观察其他肝功能。结果165例患者按方案完成研究,A组56例,B组53例,C组56例。从治疗1周起至疗程结束,B组和C组均较A组能更显著地降低ALT水平（P均〈0.05）。至第4周,B组、C组ALT复常率和总有效率分别为60.71%和83.93%、82.46%和96.49%,B组和C组的总有效率均显著分别高于A组（P值均〈0.05）,C组的总有效率显著高于B组（P=0.0255）。仅B组1例发生不良反应,三组不良反应发生率无显著差异（P〉0.05）。结论100mg/d和200mg/d剂量的异甘草酸镁可以安全、有效地治疗ALT升高慢性肝炎。

Magnesium isoglycyrrhizinate in the treatment of chronic liver diseases with high ALT level: A randomized, double-blind,placebo controlled, multi-center,dose-finding study

Objective To evaluate the efficacy and safety of different dose of Magnesium isoglycyrrhizinate in the treatment of chronic liver diseases with high ALT level. Methods It is a randomized,double-blind,placebo controlled,multi-center,dose-finding study. One hundred and eighty proper patients were randomized to enter either placebo group （group A）,100 mg/d Magnesium isoglycyrrhizinate group （group B） or 200 mg/d Magnesium isoglycyrrhizinate group （group C） in a 1∶1∶1 ratio. Patients in study group A received placebo of Magnesium isoglycyrrhizinate once daily. Patients in study group B received Magnesium isoglycyrrhizinate 100 mg once daily. Patients in group C received Magnesium isoglycyrrhizinate 200 mg once daily. The course is 4 weeks. ALT was evaluated in all patients before treatment and every week after treatment. The other liver function test was evaluated before treatment,at week 2 and at week 4. Results One hundred and sixty-five patients completed the study according to the protocol,56 in group A,53 in group B and 56 in group C. After one week treatment to the study end point,ALT level significantly decreased in group B and group C compare with group A（P〈0.05）.The rate of ALT normalization and total effective rate in group B,group C are 60.71% and 83.93%,82.46% and 96.49%,respectively. Total effective rate in group B and group C are significantly higher than group A,respectively（P〈0.05）. Total effective rate in group C are significantly higher than group B（P=0.025 5）.Only one patient in group B was found occurring adverse event.The rate of adverse event in three groups is similar（P〉0.05）. Conclusion Magnesium isoglycyrrhizinate in dose 100 mg/d and 200 mg/d are effective and safe in treatment of chronic liver diseases with high ALT level.