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【文摘发布】一语惊人：改善CKD患者贫血，目标
Anemia in patients with chronic kidney disease: defining the optimal hemoglobin target
慢性肾脏疾病患者贫血：确定最佳的血红蛋白靶目标
Laura M Dember
Boston University Medical Center, Renal Section, EBRC 504, 650 Albany Street, Boston, MA 02118, USA
Email ldember@bu.edu
波士顿大学医学中心，肾脏科，EBRC 504, 650奥尔巴尼街 波士顿, 马萨诸塞州， 02118, 美国
Nature Clinical Practice Nephrology (2007) 3, 244-245
自然临床诊疗肾病学(2007) 3, 244-245
Practice point
诊疗要点
Full correction of anemia with recombinant erythropoietin is not warranted in patients with chronic kidney disease, and might be harmful; the optimal hemoglobin range remains unknown
对于慢性肾病（CKD）病人，贫血与重组人红细胞生成素之间的相关并不确定，并且可能是有害的；最佳血红蛋白范围还不清楚。
Background
背景
There are no definitive data to indicate the optimal hemoglobin level in patients with anemia caused by chronic kidney disease (CKD).
还没有确实的资料表明CKD所致贫血的病人中血红蛋白最佳范围。
Objective
目的
To establish whether correction of anemia to a hemoglobin level of 135 g/l (13.5 g/dl) lowers the risk of adverse cardiovascular outcomes and death in patients with CKD, compared with correction to 113 g/l (11.3 g/dl).
为了确定与113 g/l (11.3 g/dl)相比血红蛋白水平在135 g/l (13.5 g/dl)的贫血是否使CKD病人发生不利于心血管病预后和死亡的危险因素减少。
Design
设计
The open-label, randomized, multicenter US CHOIR (Correction of Hemoglobin and Outcomes in Renal Insufficiency) study recruited adults with anemia (hemoglobin level <110 g/l [<11.0 g/dl]) and CKD (glomerular filtration rate 15–50 ml/min/1.73 m2, as estimated by the modification of diet in renal disease equation). Individuals with iron overload, active gastrointestinal bleeding, or uncontrolled hypertension were among those excluded.
非盲、随机、多中心US CHOIR（血红蛋白与肾功能不全相关性）研究入选标准为同时患有贫血（血红蛋白低于110g/L）和慢性肾脏病(肾小球滤过率15-50ml/min/1.73m2通过肾脏病膳食改良试验 (MDRD)公式估计),有铁过载、活动性胃肠道出血、或不能控制的高血压的个体被排除。
Intervention
Participants received sufficient subcutaneous epoetin alfa to achieve a randomly assigned target hemoglobin level of either 135 g/l or 113 g/l. Maintenance doses were administered fortnightly. For patients who did not experience an end point, follow-up was censored at completion of, or withdrawal from, the study.
干预
参与试验者皮下注射足量重组促红细胞生成素α以达到任意一种指定的目标血红蛋白水平135g/L或113g/L，每两周注射一次维持剂量。未到达实验终点的患者在研究结束或中途退出时随访被删除。
Outcome measures
A composite of death, myocardial infarction, stroke, and hospital admission for congestive heart failure (not involving renal replacement therapy) was the primary end point. Quality of life (QOL) was a secondary end point.
结果测量
死亡，心肌梗死，中风，因充血性心力衰竭住院治疗（不包括换肾治疗）为主要观察终点。生活质量为次要观察终点。
Results
结果
Of the 1,432 patients enrolled, 715 were assigned to the high hemoglobin target and 717 were assigned to the low hemoglobin target. The study was terminated early because interim analysis indicated that it was unlikely that a beneficial effect of the higher target would be found. Overall median follow-up was 16 months. A total of 222 patients (15.5%) experienced a primary end point. Of the remaining 1,210 patients, 661 (46.2%) completed 36 months of follow-up and 549 (38.3%) withdrew from the study early. Reasons for early withdrawal did not differ significantly between the hemoglobin target groups. The groups also had largely similar baseline demographic and clinical characteristics. Mean hemoglobin levels during the study were 113 g/l in the low-target group and 126 g/l (12.6 g/dl) in the high-target group. In the intention-to-treat analysis, there was a significantly higher rate of primary end point events in the patients assigned the high target than in those assigned the low target (17.5% [125/715] vs 13.5% [97/717]; hazard ratio 1.34, 95% CI 1.03–1.74; P = 0.03). The end points included 65 deaths (29.3%), 101 hospital admissions for congestive heart failure (45.5%), 25 myocardial infarctions (11.3%) and 23 strokes (10.4%)Improvement in QOL, as evaluated by the LASA, KDQ and SF-36 instruments, was generally similar in both groups. The rate of serious adverse events was significantly higher in the high-hemoglobin group than in the low-hemoglobin group (54.8% [376/686] vs (29.3%)48.5% [334/688]; P = 0.02).
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作者:admin@医学,生命科学 2010-10-12 17:11
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