罗沙司他胶囊治疗慢性肾衰竭肾性贫血老年患者的临床研究

Clinical trial of roxadustat capsules in the treatment of elderly patients with renal anemia combined with chronic renal failure

目的观察罗沙司他胶囊治疗慢性肾衰竭肾性贫血老年患者的临床疗效及安全性。方法将129例慢性肾衰竭肾性贫血老年患者随机分为对照组65例和试验组64例。对照组给予蔗糖铁注射液200 mg,每周2~3次,于透析2 h后从透析器静脉端注入,达到预计总补铁量后改为每月200 mg+重组人促红素注射液每次3 000 U,每周1次,皮下注射;试验组给予罗沙司他胶囊每次1~2mg·kg^(-1),每周2~3次,口服。2组患者均持续治疗3个月。比较2组患者的临床疗效、血清血红蛋白(Hb)、铁蛋白(SF)、C反应蛋白(CRP)水平,以及药物不良反应的发生情况。结果试验过程中脱落7例。治疗后,试验组和对照组的总有效率分别为93.55%(58例/62例)和80.00%(48例/60例),差异有统计学意义(P <0.05)。治疗后,试验组和对照组的血清Hb分别为(139.52±16.35)和(122.65±11.86) g·L^(-1),SF分别为(258.69±46.71)和(210.36±34.57)μg·L^(-1),CRP分别为(5.79±1.33)和(9.16±2.65) mg·L^(-1),差异均有统计学意义(均P <0.05)。试验组的药物不良反应主要有恶心呕吐、食欲缺乏和皮疹,对照组的药物不良反应主要有恶心呕吐和皮疹。试验组和对照组的总药物不良反应发生率分别为8.06%和6.67%,差异无统计学意义(P> 0.05)。结论罗沙司他胶囊治疗慢性肾衰竭肾性贫血老年患者的临床疗效显著,其能显著地改善微炎症状态和铁代谢,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of roxadustat capsule on elderly patients with renal anemia of chronic renal failure.Methods A total of 129 elderly patients with renal anemia of chronic renal failure were randomly divided into control group(n=65 cases) and treatment groups(n=64 cases).The control group was treated with iron sucrose injection 200 mg,2-3 times a week,which was injected through the dialyzer vein 2 h after dialysis,and changed to200 mg per month after reaching the expected total amount of iron supplement+recombinant human erythropoietin injection 3 000 U per time,once a week,subcutaneously.The treatment group was given roxadustat capsules 1-2 mg·kg^(-1) per time,2-3 times a week,orally.Two groups were treated for 3 months.The clinical efficacy,levels of serum hemoglobin(Hb),ferritin(SF) and C-reactive protein(CRP),and adverse reactions were compared between two groups.Results There were 7 cases of shedding during the trial.After treatment,the total effective rates of treatment and control groups were 93.55%(58 cases/62 cases) and 80.00%(48 cases/60 cases) with significant difference(P <0.05).After treatment,the levels of serum Hb of treatment and control groups were(139.52±16.35) and(122.65±11.86) g·L^(-1),SF were(258.69±46.71) and(210.36±34.57)μg·L^(-1),CRP were(5.79±1.33)and(9.16±2.65) mg·L^(-1),the differences were statistically significant(all P <0.05).The adverse drug reactions of treatment group were nausea,vomiting,appetite deficiency and rash,which in the control group were nausea,vomiting and rash.The total incidences of adverse drug reactions in the treatment and control groups were 8.06% and6.67% without significant difference(P>0.05).Conclusion Roxadustat capsules have a definitive clinical efficacy in the treatment of elderly patients with renal anemia of chronic renal failure,which can significantly improve the micro inflammatory state and iron metabolism,without increasing the incidence of adverse drug reactions.