大剂量重组人促红细胞生成素治疗血透患者肾性贫血的疗效与安全性  

Effects and safety of high-dosed recombinant human erythropoietin on renal anemia in hemodialysis patients: a multicenter clinical investigation

作　　者：顾勇[1] 施雪枫[1] 

机构地区：[1]复旦大学附属华山医院肾病科,上海200040

出　　处：《中国临床药学杂志》2004年第2期69-72,共4页Chinese Journal of Clinical Pharmacy

摘　　要：目的 :观察大剂量重组人促红细胞生成素 (rHuEPO)治疗维持性血透患者肾性贫血的有效性和安全性。方法 :选择2 0 0 2年 2 8月期间在上海市 2 4个血透中心的 2 0 3例 (男 10 4例 ,女 99例 )血透肾性贫血患者 ,予rHuEPO 1万U ,qw ,sc ,当Hb迅速升至 10 0g·L-1时可酌情减量至每 2wk 1次 ,甚至更少 ,观察 2 0～ 2 4wk。共 185例完成验证 ,按初始Hb (Hb0 )分为A组 (5 0g·L-1≤Hb0 <70g·L-1) ,B组 (70g·L-1≤Hb0 <90g·L-1)和C组 (Hb0 ≥ 90g·L-1) ;又按透析龄分为a组 (<3mo) ,b组 (≥ 3mo ,<6 0mo)和c组 (≥ 6 0mo)。结果 :治疗后A ,B和C组的Hb均有增加 ,各组的有效率分别为 6 7.5 % ,85 .7%和 89.8% ,平均有效率为 81.6 % ;各透析龄组的Hb也有增加趋势。 16例患者于wk 4～ 12将rHuEPO减量为每 2wk 1次 ,Hb并无显著降低。验证过程中有 16例患者发生 2 2次药物不良事件 ,主要表现为高血压、头痛等 ,但与rHuEPO相关程度较低。结论 :大剂量rHuE PO可有效纠正血透患者肾性贫血 。AIM:To observe the efficacy and safety of high-dosed recombinant human erythropoietin (rHuEPO) on renal anemia in hemodialysis(HD) patients. METHODS: Two hundred and three HD patients (104 male, 99 female) from 24 dialysis centers were recruited from February to August, 2002, and received 10 000 units of rHuEPO, qw, sc, unless hemoglobin (Hb) increase was so fast that the dose was reduced to 10 000 U every other week or even less. The investigation lasted 20 to 24 wk. One hundred and eighty-five patients accomplished the follow-up, and they were stratified to A (50 to 70 g·L -1),B (70 to 90 g·L -1) and C (≥90 g·L -1)groups on their original Hb level, or a (<3 mo),b (3 to 60 mo) and c (≥60 mo) groups on different dialysis duration. RESULTS: Hb in A, B and C groups increased till the end of the study, and clinical efficiency ratio was 67.5%, 85.7% and 89.8% respectively in the groups, totally averaged to 81.6%. Baseline values of hematological indices among groups with different dialysis spans were comparable (P>0.05). Hb in a, b and c groups also elevated gradually. rHuEPO dose was successively reduced to twice a week in sixteen patients, without any significant decrease of Hb. Twenty-two adverse events with weak relationship in sixteen patients were recorded, mainly as hypertension and headache. CONCLUSION: The use of high-dosed rHuEPO can yield an efficient outcome in improving renal anemia in HD patients, and provide considerable safety.

关 键 词：剂量 重组人促红细胞生成素 治疗 血透患者 肾性贫血 治疗效果 安全性 

分 类 号：R692.5[医药卫生—泌尿科学]