异甘草酸镁注射液治疗ALT升高的慢性肝病的疗效和安全性研究

Clinical efficacy and safety of magnesium isoglycyrrhizinate injection in the treatment of chronic liver disease with elevated ALT

目的分析异甘草酸镁注射液治疗丙氨酸氨基转移酶(ALT)升高的慢性肝病的临床疗效和安全性。方法采用前瞻随机研究方法,选择2016年4月至2017年7月我院收诊的血清ALT升高的慢性肝病患者150例,按随机数字表分成2组。对照组采用复方甘草酸苷注射液方案,观察组则采用异甘草酸镁注射液方案,治疗4周后评价疗效。治疗期间对比组间血清ALT水平,并密切观察治疗期间的药物不良反应。结果观察组的显效率、总有效率高于对照组(69.33%vs.58.67%,96.00%vs.81.33%,P <0.05)。治疗2、4周后,两组血清ALT水平降低(P <0.05),且观察组的下降幅度大于对照组(P <0.05)。两组不良反应程度均较轻,不影响患者正常治疗进度,停药后均逐渐消退,两组不良反应发生率比较差异无统计学意义(P> 0.05)。结论异甘草酸镁注射液治疗ALT升高的慢性肝病患者的效果较好,且不会增加不良反应。

Objective To analyze the clinical efficacy and safety of magnesium isoglycyrrhizinate injection in the treatment of chronic liver disease with elevated alanine aminotransferase （ALT）. Methods Totally 150 patients with chronic liver disease with elevated serum ALT admitted to our hospital from April 2016 to July 2017 were enrolled in the prospective randomized study. All the patients were divided into two groups according to the random number table. Patients in control group were treated with compound glycyrrhizin injection, and patients in observation group were given magnesium isoglycyrrhizinate injection. The efficacy was assessed after 4 weeks. The serum ALT levels were compared, and the adverse drug reactions during treatment were closely observed. Results The effective rate and total effect rate of observation group were higher than those of control group（69. 33% vs. 58.67% ,96. 00% vs. 81.33% , P 〈 0. 05 ）. After 2 and 4 weeks of treatment, the serum ALT levels decreased significantly in both groups（P 〈 0. 05 ）, and the decrease degree in observation group was higher（P 〈 0. 05 ）. Both groups had mild adverse reactions, which did not affect the treatment progress and gradually subsided after withdrawal. There was no significant difference in the rate of adverse reactions between the two groups（P 〉 0. 05 ）. Conclusion The effect of magnesium isoglycyrrhizinate injection on chronic liver disease with elevated ALT is good, which does not increase the adverse reactions.