A randomized controlled trial of haemoglobin normalization with epoetin alfa in pre-dialysis and dialysis patients
A randomized controlled trial of haemoglobin normalization with epoetin alfa in pre-dialysis and dialysis patients
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DOI：
10.1093/ndt/18.2.353
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发表时间：
2003-02-01
影响因子：
6.1
通讯作者：
Danielson, BG
中科院分区：
文献类型：
--
作者：
Furuland, H;Linde, T;Danielson, BG
背景。使用促红细胞生成素部分纠正肾性贫血可提高生活质量 (QoL)。我们的目的是检查在透析前和透析患者中使用阿法依泊汀使血红蛋白正常化是否可以进一步改善生活质量并且是安全的。方法。 416 名斯堪的纳维亚肾性贫血患者 [透析前、血液透析 (HD) 和腹膜透析患者] 被随机分为 135-160 g/l (n = 216) 的正常血红蛋白或 90-120 g/l (n = 200) 的低于正常血红蛋白，使用或不使用阿法依泊汀。研究持续时间为48-76周。使用肾脏疾病调查问卷对 253 名瑞典透析患者的生活质量进行了测量。对所有患者进行了安全性检查。结果。当血红蛋白正常化时，瑞典透析患者的身体症状（P = 0.02）、疲劳（P = 0.05）、抑郁（P = 0.01）和沮丧（P = 0.05）减少，生活质量得到改善。在透析前患者中，48周后，正常组的舒张压高于血红蛋白正常组。然而，慢性肾衰竭的进展率相当。在血红蛋白正常组 (N-Hb) 中，51% 的人至少发生过一种严重不良事件，而血红蛋白异常组 (S-Hb) 中这一比例为 49% (P = 0.32)。 HD 患者的血栓血管事件和血管通路血栓形成的发生率没有差异。 N-Hb 组的死亡率为 13.4%，S-Hb 组的死亡率为 13.5%（P = 0.98）。两组的死亡率均随着平均血红蛋白的增加而降低。结论。血红蛋白正常化可以改善透析患者亚组的生活质量，似乎是安全的，并且可以在许多患有终末期肾病的患者中考虑。
Background. Partial correction of renal anaemia with erythropoietin improves quality of life (QoL). We aimed to examine if normalization of haemoglobin with epoetin alfa in pre-dialysis and dialysis patients further improves QoL and is safe.Methods. 416 Scandinavian patients with renal anaemia [pre-dialysis, haemodialysis (HD) and peritoneal dialysis patients] were randomized to reach a normal haemoglobin of 135-160 g/l (n = 216) or a subnormal haemoglobin of 90-120 g/l (n = 200) with or without epoetin alfa. Study duration was 48-76 weeks. QoL was measured using Kidney Disease Questionnaires in 253 Swedish dialysis patients. Safety was examined in all patients.Results. QoL improved, measured as a decrease in physical symptoms (P = 0.02), fatigue (P = 0.05), depression (P = 0.01) and frustration (P = 0.05) in the Swedish dialysis patients when haemoglobin was normalized. In pre-dialysis patients, diastolic blood pressure was higher in the normal compared with the subnormal haemoglobin group after 48 weeks. However, the progression rate of chronic renal failure was comparable. In the normal haemoglobin group (N-Hb), 51% had at least one serious adverse event compared with 49% in the subnormal haemoglobin group (S-Hb) (P = 0.32). The incidence of thrombovascular events and vascular access thrombosis in HD patients did not differ. The mortality rate was 13.4% in the N-Hb group and 13.5% in the S-Hb group (P = 0.98). Mortality decreased with increasing mean haemoglobin in both groups.Conclusions. Normalization of haemoglobin improved QoL in the subgroup of dialysis patients, appears to be safe and can be considered in many patients with end-stage renal disease.