罗沙司他在ESAs低反应性肾性贫血中的疗效和安全性分析  

Efficacy and safety analysis on roxadustat in treating renal anemia of patients lowly response to ESAs

作　　者：王金宝[1] 张卫东[1] 黄琳 Wang Jinbao;Zhang Weidong;Huang lin(Blood Purification Center,the First Affiliated Hospital of Wannan Medical College,Wuhu,Anhui 241001,China)

机构地区：[1]皖南医学院附属第一医院血液净化中心,安徽芜湖241001

出　　处：《齐齐哈尔医学院学报》2023年第14期1322-1326,共5页Journal of Qiqihar Medical University

基　　金：2014年度皖南医学院中青年科研基金自然科学类项目(WK2014F35)。

摘　　要：目的 探讨罗沙司他对红细胞生成刺激剂(ESAs)低反应性维持性血液透析(MHD)肾性贫血患者的临床疗效和安全性分析。方法 回顾性自身对照分析2021年9月—2022年12月本院收治的ESAs低反应性MHD肾性贫血患者40例临床资料,比较换用罗沙司他治疗后血红蛋白(Hb)、铁代谢、血脂等相关指标变化与不良反应。结果 40例患者Hb基线值(81.21±9.23)g/L,平均ESAs剂量[(12375.17±1804.06) IU/W],换用罗沙司他使用后4、8、12、24周,Hb较基线值均明显增加,基线值在(86.95±13.21)g/L以上者获益更明显(P<0.05)。第12周血红蛋白达标率最高达62.5%,Hb平均增加(15.87±12.81)g/L(P<0.05)。换用罗沙司他第12~24周观察铁代谢指标发现血清铁蛋白(SF)较基线值下降、总铁结合力(TIBC)较基线值升高(P<0.05)而血清铁(SI)、转铁蛋白饱和度(TSAT)仅较基线值轻度增加,差异无统计学意义(P>0.05)。其他指标如C-反应蛋白(CRP)、TC、TG、LDL值等较基线值下降(P>0.05);不同炎症水平(以CRP≥5 mg/L分界)不同时间节点Hb、 SI、SF、TSAT、TIBC值比较亦均无差异(P>0.05),所有患者无严重不良反应。结论 罗沙司他对ESAs低反应肾性贫血患者仅部分有效,且不受体内炎症指标的影响,无严重不良反应,临床安全有效。Objective To explore the clinical efficacy and safety of roxadustat in treating erythropoiesis-stimulating agents(ESAs)hyporeactive renal anemia among patients receiving maintenance hemodialysis(MHD).Methods The clinical data of forty patients receiving MHD with ESAs-hyporeactive anemia who were admitted to our hospital during September 2021 and December 2022 were retrospectively analyzed.The changes of hemoglobin,iron metabolism,blood lipids and other related indexes and adverse reactions were compared.Results The baseline Hb of 40 the patients was(81.21±9.23)g/L,and the mean ESAs dose was[(12375.17±1804.06)IU/w].The Hb of all patients were significantly increased at 4,8,12 and 24 weeks after administration of roxadustat,the patients whose baseline value was above(86.95±13.21)g/L obtained more significant benefit(P<0.05).At the 12th week,the rate of reaching the standard of hemoglobin was 62.5%,and the mean increase of Hb was(15.87±12.81)g/L(P<0.05).During the 12th~24th week of roxadustat replace treatment,serum ferritin(SF)decreased,total iron binding capacity(TIBC)increased(P<0.05);while serum iron(SI)and transferrin saturation(TSAT)increased slightly,there was no significant difference(P>0.05).Other indexes such as CRP,TC,TG,LDL decreased from baseline(P>0.05);different levels of inflammation(defined by CRP≥5 mg/L)at different time points,there was no significant difference in Hb,SI,SF,TSAT and TIBC(P>0.05),and no serious adverse reaction was found in all patients.Conclusions Roxadustat was only partially effective in patients with ESAs-hyporeactive renal anemia,and was not influenced by in vivo inflammatory markers.It was clinically safe and effective without severe adverse reactions.

关 键 词：肾性贫血 罗沙司他 红细胞生成刺激剂 

分 类 号：R459.9[医药卫生—治疗学]