异甘草酸镁预防FOLFOX4方案一线化疗致胃癌患者药物性肝损害的前瞻性随机对照研究

A prospective randomized controlled trial on the prevention of Magnesium isoglycyrrhizinate on drug-induced liver injury by FOLFOX4 in patients with gastric cancer

[目的]探讨异甘草酸镁预防FOLFOX4方案一线化疗致胃癌患者药物性肝损害的疗效。[方法]97例胃癌患者前瞻性随机分为对照组48例,观察组49例。患者均予以FOLFOX4方案一线化疗,对照组于治疗后每日常规静脉滴注50%葡萄糖溶液60ml+10%葡萄糖溶液500ml+10%氯化钾15ml+胰岛素12U,观察组治疗后每日常规静脉滴注100mg异甘草酸镁+250ml 10%葡萄糖溶液。分析比较2组患者的肝功能、肝损害及不良反应。[结果]与治疗前比较,2组血清ALT、AST、ALP、GGT、TBIL水平均明显上升,差异有统计学意义(t=12.13、13.40、9.45、11.67、13.67、10.98、14.56、13.78,P<0.05);治疗后观察组ALT、AST、ALP、GGT、TBIL水平均低于对照组,差异有统计学意义(t=12.34、11.45、11.46、13.65,P<0.05)。对照组1~2级肝损伤例数12例,2~3级肝损伤例数3例;观察组1~2级肝损伤例数5例,2~3级肝损伤例数2例,观察组损伤发生率明显低于对照组,差异有统计学意义(χ~2=15.14,P<0.05)。对照组不良事件例数6例,不良反应例数2例;观察组不良事件例数5例,不良反应例数1例,观察组不良事件及不良反应发生率略低于对照组,但差异无统计学意义(χ~2=0.58、0.96,P>0.05)。[结论]异甘草酸镁预防FOLFOX4方案一线化疗致胃癌患者药物性肝损害疗效显著,能改善其药物性肝损伤预后,值得在临床上推广应用。

[Objective]To investigate the prevention effect of Magnesium isoglycyrrhizinate on drug-induced liver injury by FOLFOX4 regimen of first-line chemotherapy in patients with gastric cancer.[Methods]97 patients with gastric cancer were randomly divided into control group（n=48）and observation group（n=49）.All patients were treated FOLFOX4 regimen of first-line chemotherapy.Patients in the control group after treatment were given with intravenous infusion of 50% glucose solution 60 ml＋10% glucose solution 500 ml＋10% potassium chloride 15 ml＋insulin 12 U.Patients in the observation group after treatment were given intravenous infusion of 100 mg magnesium isoglycyrrhizinate＋250 ml 10% glucose solution.The Liver function,liver damage and adverse reactions were compared between the two groups.[Results]Compared with those before treatment,the serum ALT,AST,ALP,GGT and TBIL levels in two groups were increased significantly（t=12.13,13.40,9.45,11.67,13.67,10.98,14.56,13.78,P0.05）.After treatment,the ALT,AST,ALP,GGT and TBIL levels in the observation group were lower thanthose in the control group（t=12.34,11.45,11.46,13.65,P0.05）.There were 12 cases with grade 1-2 liver injury and 3 cases with grade 2-3 liver injury in the control group.There were 5 cases with grade 1-2 of liver injury and 2 cases with grade 2-3 of liver injury in the observation group.The incidence rate of liver injury in the observation group was significantly lower than that in the control group（χ2=15.14,P0.05）.There were 6 cases with adverse events and 2 cases with adverse reactions in the control group.There were 5 cases with adverse events and 1 cases with adverse reaction in observation group.the incidence of adverse events and adverse reaction were lower than those in the control group,but the difference was not statistically significant（χ~2=0.58,0.96,P0.05）.[Conclusion]Magnesium isoglycyrrhizinate in the prevention of drug-induced liver injury in patients with gastric cancer by FOLFOX4 regimen of firstline chemotherapy can get good clinical efficacy and improve the prognosis of drug-induced liver injury.It is worthy of clinical application.