接受血液透析和促红细胞生成素治疗的心脏病患者中，正常血细胞比容值与低血细胞比容值的影响比较

The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin.

作者信息

Besarab A, Bolton W K, Browne J K, Egrie J C, Nissenson A R, Okamoto D M, Schwab S J, Goodkin D A

机构信息

Division of Nephrology and Hypertension, Henry Ford Hospital, Detroit, USA.

出版信息

N Engl J Med. 1998 Aug 27;339(9):584-90. doi: 10.1056/NEJM199808273390903.

DOI:10.1056/NEJM199808273390903

PMID:9718377

Abstract

BACKGROUND

In patients with end-stage renal disease, anemia develops as a result of erythropoietin deficiency, and recombinant human erythropoietin (epoetin) is prescribed to correct the anemia partially. We examined the risks and benefits of normalizing the hematocrit in patients with cardiac disease who were undergoing hemodialysis.

METHODS

We studied 1233 patients with clinical evidence of congestive heart failure or ischemic heart disease who were undergoing hemodialysis: 618 patients were assigned to receive increasing doses of epoetin to achieve and maintain a hematocrit of 42 percent, and 615 were assigned to receive doses of epoetin sufficient to maintain a hematocrit of 30 percent throughout the study. The median duration of treatment was 14 months. The primary end point was the length of time to death or a first nonfatal myocardial infarction.

RESULTS

After 29 months, there were 183 deaths and 19 first nonfatal myocardial infarctions among the patients in the normal-hematocrit group and 150 deaths and 14 nonfatal myocardial infarctions among those in the low-hematocrit group (risk ratio for the normal-hematocrit group as compared with the low-hematocrit group, 1.3; 95 percent confidence interval, 0.9 to 1.9). Although the difference in event-free survival between the two groups did not reach the prespecified statistical stopping boundary, the study was halted. The causes of death in the two groups were similar. The mortality rates decreased with increasing hematocrit values in both groups. The patients in the normal-hematocrit group had a decline in the adequacy of dialysis and received intravenous iron dextran more often than those in the low-hematocrit group.

CONCLUSIONS

In patients with clinically evident congestive heart failure or ischemic heart disease who are receiving hemodialysis, administration of epoetin to raise their hematocrit to 42 percent is not recommended.

摘要

背景

在终末期肾病患者中，贫血是由于促红细胞生成素缺乏所致，通常会使用重组人促红细胞生成素（依泊汀）来部分纠正贫血。我们研究了接受血液透析的心脏病患者将血细胞比容恢复正常的风险和益处。

方法

我们研究了1233例有充血性心力衰竭或缺血性心脏病临床证据且正在接受血液透析的患者：618例患者被分配接受递增剂量的依泊汀以达到并维持血细胞比容为42%，615例患者被分配接受足以在整个研究过程中维持血细胞比容为30%的依泊汀剂量。治疗的中位持续时间为14个月。主要终点是死亡或首次非致命性心肌梗死的时间长度。

结果

29个月后，正常血细胞比容组有183例死亡和19例首次非致命性心肌梗死，低血细胞比容组有150例死亡和14例非致命性心肌梗死（正常血细胞比容组与低血细胞比容组相比的风险比为1.3；95%置信区间为0.9至1.9）。尽管两组间无事件生存差异未达到预先设定的统计停止界限，但该研究仍被终止。两组的死亡原因相似。两组的死亡率均随血细胞比容值升高而降低。正常血细胞比容组患者的透析充分性下降，且比低血细胞比容组患者更频繁地接受静脉注射右旋糖酐铁。