异甘草酸镁治疗抗肿瘤药物引起的急性药物性肝损伤的Ⅲ期临床试验

Magnesium isoglycyrrhizinate used in the treatment of chemotherapeutic drugs-induced acute liver dysfunction: A phase Ⅲ clinical trial

目的:本研究旨在评价异甘草酸镁治疗抗肿瘤药物引起的急性药物性肝损伤的有效性和安全性。方法:这是一项多中心、随机、双盲、阳性药物平行的Ⅲ期临床试验。将55例合格受试者按2:1的比例随机分入异甘草酸镁组(35例,甘草酸镁200mg/d,连续2周)和硫普罗宁组(20例,硫普罗宁200mg/d,连续2周)。观察2组的肝功能恢复情况和不良反应。结果:治疗1周时,异甘草酸镁组的总有效率达91.43%,硫普罗宁组的总有效率达65.00%,差异有统计学意义(P<0.05);治疗2周时,异甘草酸镁组血清谷丙转氨酶(alanine amino transferase,ALT)和谷草转氨酶(aspartate transaminase)复常率(74.19%和70.97%)均明显优于硫普罗宁组(42.11%和37.50%),差异有统计学意义(P<0.05)。2组的不良反应发生率差异无统计学意义(P>0.05)。结论:异甘草酸镁治疗抗肿瘤药物引起的急性药物性肝损伤的疗效较好,可缩短肝损伤病程,不良反应较轻。

Objective： This study was designed to evaluate the efficacy and safety of magnesium isoglycyrrhizinate in the treatment of chemotherapeutic drugs-induced acute liver dysfunction. Methods： This was a multi-center, randomized, double-blind and positive-controlled phase Ⅲ clinical trial. Fifty-five eligible subjects were randomly divided in the ratio of 2：1 to receive magnesium isoglycyrrhizinate （n = 35; 200 mg/d for two weeks） or tiopronin （n = 20; 200 mg/d for two weeks）. The change of liver function after treatment and the adverse effects were evaluated. Results： The overall response of the magnesium isoglycyrrhizinate-treated group after treatment for one week was 91.43%, which was much higher than that of the tiopronin-treated group （65.00%, P 〈 0.05）. After two weeks of the treatment, the normalized rates of serum alanine amino transferase （ALT） and aspartate transaminase （AST） levels in the magnesium isoglycyrrhizinate-treated group （74.19% and 70.97%） were also significantly higher than those in the tiopronin-treated group （42.11% and 37.50%） （P 〈 0.05）. The rates of adverse reactions between the two groups had no significant differences （P 〉 0.05）. Conclusion： Magnesium isoglycyrrhizinate exerts its desirable effect on chemotherapeutic drugs-induced acute liver dysfunction, with a shortening course of liver damage and fewer side effects.