异甘草酸镁治疗ALT升高的慢性肝病的多中心、随机、双盲、多剂量、阳性药物平行对照临床研究

目的 通过与阳性药物复方甘草酸苷比较,观察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、多剂量、阳性药物平行对照的试验设计,480例患者随机进入异甘草酸镁100 mg/d剂量组(A组,180例)、150 mg/d剂量组(B组,180例)和阳性药复方甘草酸苷对照组(C组,120例).试验A组:异甘草酸镁注射液100nag加入到10%葡萄糖注射液250ml中静脉滴注,1次/d;试验B组:异甘草酸镁注射液150mg加入到1%葡萄糖注射液250ml中静脉滴注,1次/d;对照组:复方甘草酸苷注射液120 mg加入到10%葡萄糖注射液250ml中静脉滴注,1次/d.疗程为4周,停药2周后随访.治疗前,治疗第2周、第4周和停药后2周观察症状、体征及ALT,AST变化情况;治疗前、治疗第4周观察其他肝功能指标.采用t检验分析计量资料,Fisher确切概率法分析计数资料,Wilcoxon秩和检验分析等级资料.组内疗效指标比较采用非参数的符号秩和检验方法,组间疗效指标比较采用中心效应的方差分析法或CMH方法.结果 412例患者按方案完成研究,其中A组152例,B组160例,C组100例.治疗2周和4周后,三组患者ALT、AST水平均明显下降(P值均<0.05);治疗2周时的ALT下降幅度,B组明显大于C组(P<0.01),治疗4周时ALT下降幅度三组间差异无统计学意义(P>0.05).治疗4周后,A,B、C组ALT改善的总有效率分别为92.59%、91.76%、88.29%,差异无统计学意义(P>0.05).4周后,A、B、C组的临床总有效率和总体疗效的总有效率分别为90.41%、89.86%、86.46%和72.22%,73.53%、68.47%,三组间差异均无统计学意义(P值均>0.05).停药后,三组患者均无明显反跳.三组患者的不良反应发生率差异无统计学意义(P>0.05).结论 异甘草酸镁注射液可以安全、有效地治疗ALT升高的慢性肝病.

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 intreatment of chronic liver diseases. Methods It is a randomized, double-blind, multi-doses, active drug controlled, multi-center study. 480 proper patients were randomlly devided 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 150rag once daily. Patients in group C received compound glycyrthizin 120rag 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 treatmenti￠at week 2, at week 4 and at 2weeks 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.