罗沙司他治疗腹膜透析患者贫血的疗效及经济学评价

EEfficacy and economic evaluation of roxadustat in the treatment of anemia in peritoneal dialysis patients

目的观察腹膜透析患者肾性贫血应用罗沙司他治疗的有效性、安全性及经济性。方法收集2020年1月~2021年12月龙岩市第二医院腹膜透析合并肾性贫血的患者,予罗沙司他治疗的为罗沙司他组,共32例,按1:1随机选取32例使用重组人红细胞生成素(recombinant human erythropoietin,rHuEPO)的为红细胞生成素(erythropoietin,EPO)组。观察患者用药前及用药第1、3、6月的血红蛋白、铁代谢指标等的变化及药物的不良反应,对2组进行成本-效果分析及增量分析评估药物治疗的经济性并进行单因素敏感性分析。结果治疗后2组血红蛋白升高,罗沙司他组较EPO组高(1月t=0.025,P=0.616;3月:t=0.286,P=0.136;6月:t=0.417,P=0.045)。治疗后2组铁蛋白(1月t=-0.319,P=0.137;3月:t=-0.254,P=0.096;6月:t=-0.645,P=0.064)、转铁蛋白饱和度(1月t=0.241,P=0.314;3月:t=0.354,P=0.216;6月:t=0.415,P=0.335)、总铁结合力(1月t=6.272,P=0.235;3月:t=2.334,P=0.327;6月:t=2.696,P=0.284)比较差异无统计学意义。2组治疗期间未见严重不良反应。罗沙司他组的成本较EPO组高(t=29.150,P<0.001),增量成本-效果比(incremental cost-effectiveness ratio,ICER)为51049.58,ICER是人均国内生产总值(gross domestic product,GDP)的1~3倍,增加的成本可以接受。以药费下降做单因素敏感性分析,当药价降低25%时,ICER<1倍人均GDP,经济性更好。结论罗沙司他治疗腹膜透析患者肾性贫血效果好且能够改善铁代谢状态,安全性好,罗沙司他成本较高,但增加的成本可以接受,当药价降低25%时经济性更好。

Objectives To observe the efficacy,safety and economy of roxadustat in the treatment of renal anemia in peritoneal dialysis patients.Methods We collected peritoneal dialysis patients with renal anemia in Longyan Second Hospital from January 2020 to December 2021.32 patients treated with roxadustat selected as the roxadustat group,and 32 patients treated with recombinant human erythropoietin(rHuEPO)were randomly selected as the EPO group.The changes of hemoglobin,iron metabolism indexes and adverse reactions of the patients before and at the first,third and sixth months of the treatment were observed.Cost-effectiveness analysis and incremental analysis were used to evaluate the economy of drug treatment and conduct single actor sensitivity analysis.Results The hemoglobin level of the two groups both increased after treatment,but it was higer in roxadustat group than EPO group(the first month:t=0.025,P=0.616;the third month:t=0.286,P=0.136,the sixth month:t=0.417,P=0.045).After treatment,the ferroprotein of the two groups(the first month:t=-0.319,P=0.137;the third month:t=-0.254,P=0.096;the sixth month:t=-0.645,P=0.064)、transferin saturation(the first month::t=0.241,P=0.314;the third month:t=0.354,P=0.216;the sixth month:t=0.415,P=0.335),and the total iron binding capacity(the first month:t=6.272,P=0.235;the third month:t=2.334,P=0.327;the sixth month:t=2.696,P=0.284)were no significant differences between the two groups.Meanwhile,there were no serious adverse reactions in the two groups.The cost of roxadustat group were higher than EPO group(t=29.150,P<0.001).The incremental cost-effectiveness ratio(ICER)is 51049.58,which was 1-3 times of per capita gross domestic product(GDP),so the increased cost was acceptable.Single factor sensitivity analysis based on the decline of drug cost shown that when the drug price decreases by 25%,ICER was less than 1 time of per capita GDP,indicating that its economy was better.Conclusions Roxadustat is effective in the treatment of renal anemia in peritoneal dialysis patients and can improve iron metabolism safety.And roxadustat cost higher but the increased cost is acceptable,with better economy when drug prices decrease by 25%.