罗沙司他胶囊与红细胞生成刺激剂治疗慢性维持性血液透析合并肾性贫血的临床观察

Clinical observation of Rosalastat capsule and erythrocytes-stimulating agents in the treatment of adult chronic maintenance hemodialysis patients with renal anemia

目的观察口服罗沙司他胶囊与红细胞生成刺激剂(ESAs)对成人慢性维持性血液透析(MHD)合并肾性贫血(RA)患者的临床治疗效果和安全性。方法纳入2023年6月至2024年6月河北唐山982医院和北京京信医院收治的40例MHD合并RA患者,随机分为观察组(n=20)和对照组(n=20)。观察组给予罗沙司他胶囊口服,对照组给予重组人促红素(huEPO)联合静脉铁剂,治疗时长均为12周。比较两组患者总有效率,血液学指标如血红蛋白(Hb)、红细胞计数(RBC)、血细胞比容(HCT),铁代谢指标如血清铁蛋白(SF)、转铁蛋白饱和度(TAST)及不良反应发生率的变化。结果与对照组相比,观察组在治疗12周后的总有效率显著提高(95%比70%,P<0.05);观察组患者的Hb[(104.76±11.73)g/L比(87.58±6.71)g/L]、Hct[(29.37±3.83)%比(25.88±1.96)%]、RBC[(3.36±0.15)×10^(12)L比(2.93±0.24)×10^(12)/L]、SF[(265.45±21.97)Hg/L比(210.59±11.90)Hg/L]、TSAT[(32.66±3.87)%比(28.27±2.27)%]水平均高于对照组,差异有统计学意义(P均<0.05);不良反应发生率无显著差异(15%比20%,P>0.05)。结论口服罗沙司他胶囊较静注huEPO联合静脉铁剂治疗MH合并RA患者疗效更加显著,能有效提高患者的RBC、Hb、HCT、SF、TSAT等指标水平,改善贫血指标,纠正铁代谢紊乱,减少不良反应的发生。

Objective To observe the clinical efficacy and safety of Rosalastat capsules and erythropoiesis-stimulating agents(ESAs)in patients with maintenance hemodialysis(MHD)and renal anemia(RA).Methods Forty patients with MHD and RA treated at the 982 Hospital in Tangshan,and the Beijing Jingxin Hospital from June 2023 to June 2024 were enrolled and randomly divided into the observation group(n=20)and the control group(n=20).The observation group received rosuvastatin capsules orally,and the control group received treatment with recombinant human erythropoietin(huEPO)combined with intravenous iron.The treatment duration for both groups was 12 weeks.The study compared the changes in overall efficacy,hemoglobin(Hb),red blood cell count(RBC),hematocrit(HCT),serum ferritin(SF),and transferrin saturation(TSAT)between the two groups,as well as the incidence of adverse events.Results Compared with the control group,the overall efficacy rate of the observation group was significantly increased after 12 weeks of treatment(95%vs 70%,P<0.05).The levels of Hb[(104.76±11.73)g/L vs(87.58±6.71)g/L],Hct[(29.37±3.83)%vs(25.88±1.96)%],RBC[(3.36±0.15)×10^(12)/L vs(2.93±0.24)×10^(12)/L],SF[(265.45±21.97)Hg/L vs(210.59±11.90)Hg/L],and TSAT[(32.66±3.87)%vs(28.27±2.27)%]were significantly elevated in the observation group compared to the control group(all P<0.05).No statistically significant difference was observed in the incidence of adverse drug reactions between the two groups(15%vs 20%,P>0.05).Conclusion Oral rosuvastatin capsules are more effective than intravenous huEPO combined with intravenous iron therapy in the treatment of patients with MHD and RA,and can effectively improve the levels of RBC,Hb,HCT,SF,and TSAT in patients,improve anemia indicators,correct iron metabolism disorders,and reduce the incidence of adverse reactions.