罗沙司他治疗慢性肾脏病合并肾性贫血的临床观察
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篇名: 罗沙司他治疗慢性肾脏病合并肾性贫血的临床观察
TITLE: Clinical Observation of Roxadustat in the Treatment of Chronic Kidney Disease Combined with Renal Anemia
摘要: 目的:观察罗沙司他治疗慢性肾脏病(CKD)合并肾性贫血的疗效与安全性。方法:回顾性分析2019年11月-2020年12月于安徽理工大学第一附属医院肾内科治疗的80例CKD合并肾性贫血住院患者的资料。按治疗方案的不同分为观察组(40例)和对照组(40例)。对照组患者皮下注射注射用人促红素,每周100~150IU/kg,分3次给予。观察组患者口服罗沙司他胶囊,体质量45~<60kg的透析患者每次100mg,非透析患者每次70mg,每周3次;体质量≥60kg的透析患者每次120mg,非透析患者每次100mg,每周3次。两组患者均于用药4周后,根据血红蛋白(Hb)水平调整用药剂量。两组患者的疗程均为12周。检测两组患者治疗前和治疗12周时贫血指标[Hb、血细胞计数(RBC)、血细胞比容(Hct)]、铁代谢指标[血清铁(Fe)、铁蛋白(Fer)、总铁结合力(TIBC)、转铁蛋白饱和度(TSAT)]、脂代谢指标[总胆固醇(TC)、三酰甘油(TG)、高密度脂蛋白(HDL)、低密度脂蛋白(LDL)]、炎症指标[C反应蛋白(CRP)]水平,并观察按CRP水平分为高CRP亚组和低CRP亚组患者的Hb水平,同时记录两组患者治疗期间的不良反应发生情况。结果:治疗前,两组患者的贫血指标、铁代谢指标、脂代谢指标、炎症指标水平比较,差异均无统计学意义(P>0.05)。治疗后,两组患者的Hb、RBC、Hct以及观察组患者的TIBC、HDL水平均显著高于同组治疗前,两组患者的Fe、Fer水平和TSAT以及观察组患者的TC、LDL水平均显著低于同组治疗前,且观察组Hb、RBC、Hct、TIBC、HDL水平均显著高于同期对照组,TC水平显著低于同期对照组(P<0.05)。观察组患者的高反应发生率显著高于对照组,低反应发生率显著低于对照组(P<0.05)。两组患者治疗前后CRP水平比较,差异无统计学意义(P>0.05)。亚组比较结果显示,治疗前,两组高CRP亚组、低CRP亚组患者的Hb水平比较差异均无统计学意义(P>0.05);治疗后,观察组高CRP亚组患者的Hb水平显著高于对照组高CRP亚组(P<0.05)。观察组患者的不良反应总发生率显著低于对照组(P<0.05),且两组均未见严重的不良反应发生。结论:罗沙司他可有效改善CKD合并肾性贫血患者的贫血症状,疗效受炎症状态的影响较小,且短期安全性较好。
ABSTRACT: OBJECTIVE:To observe the efficacy and safet y of roxadustat in the treatment of chronic kidney disease (CKD) combined with renal anemia. METHODS :The data of 80 inpatients with CKD combined with renal anemia treated in the nephrology department of the First Affiliated Hospital of Anhui University of Science and Technology during Nov. 2019 to Dec. 2020 were analyzed retrospectively. They were divided into observation group (40 case)and control group (40 case)according to different treatment methods. Control group was given Human erythropoieti n for injection subcutaneously ,100-150 IU/kg every week,3 times a week. Observation group were given Roxadu- stat capsules orally ,100 mg each time for dialysis patients with a bodyweight of 45-<60 kg,70 mg each time for non- 717060193@qq.com dialysis patients ,3 times a week ;120 mg each time for dialysis patients with bodyweight ≥60 kg and 100 mg each time for non-dialysis patients ,3 times a week. After 4 weeks of treatment ,the dosage of the two groups w as adjusted according to the level of hemoglobin (Hb). Treatment course of 2 groups were 12 weeks. The levels of anemia indexes (Hb,red blood cell count (RBC),hematocrit(Hct)),iron metabolism indexes (serum iron (Fe),ferritin(Fer),total iron-binding capacity (TIBC),tranfeerrin saturation (TSAT)),lipid metabolism indexes (total cholesterol (TC),triglycerides(TG),high-density lipoprotein (HDL),low-density lipoprotein (LDL))and inflammation index(C-reactive protein (CRP))were detected in 2 groups before treatment and after 12 weeks of treatment. The levels of Hb were observed in high-level CRP subgroup and low-level CRP subgroup ;the occurrence of ADR was recorded in 2 groups during treatment. RESULTS :Before treatment ,there was no statistical significance in the anemia indexes ,iron metabolism indexes ,lipid metabolism indexes or inflammation index between 2 groups(P>0.05). After treatment ,the levels of Hb ,RBC and Hct in 2 groups and the levels of TIBC and HDL in observation group were significantly higher than before treatment. The levels of Fe ,Fer and TSAT in 2 groups and the levels of TC and LDL in observation group were significantly lower than before treatment ;the levels of Hb ,RBC,Hct,TIBC and HDL in observation group were significantly higher than before control group ,while the level of TC was significantly lower than control group (P<0.05). The incidence of high reactivity in observation group was significantly higher than control group ,while the incidence of low reactivity was significantly lower than control group (P<0.05). There was no statistical significance in the levels of CRP between 2 groups before and after treatment (P>0.05). Subgroup comparison results showed that there was no statistical significance in the level of Hb between high-level CRP subgroup and low-level CRP subgroup of 2 groups before treatment (P>0.05). After treatment ,the level of Hb in high-level CRP subgroup of observation group was significantly higher than that of high-level CRP subgroup of control group (P<0.05). The total incidence of ADR in observation group was significantly lower than control group (P<0.05),and no severe ADR was observed in 2 groups. CONCLUSIONS : Roxadustat can effectively improve anemia in CKD patients with renal anemia ,and curative effect is less affected by inflammatory state,and it has good short-term safety.
期刊: 2021年第32卷第22期
作者: 田晶晶,张圣雨,刘智,张华,张弦,陈旭,王晓娟
AUTHORS: TIAN Jingjing ,ZHANG Shengyu ,LIU Zhi,ZHANG Hua,ZHANG Xian,CHEN Xu,WANG Xiaojuan
关键字: 罗沙司他;慢性肾脏病;肾性贫血;疗效;安全性;炎症状态
KEYWORDS: Roxadustat;Chronic kidn ey disease ;Renal anemia ;Efficacy;Safety;Inflammation state
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