Foley Robert N
Chronic Disease Research Group and Department of Medicine, University of Minnesota, Minneapolis, MN 55404, USA.
Clin J Am Soc Nephrol. 2006 Jul;1(4):678-84. doi: 10.2215/CJN.01731105. Epub 2006 Jun 8.
The major objectives of this article are to review hemoglobin outcome studies, focusing on the utility of purely observational approaches; the design limitations of hemoglobin target randomized trials; what is known from the trials that have been performed to date; and whether confident recommendations for target ranges can be made. The commonly observed association among lower hemoglobin levels, left ventricular hypertrophy, and higher mortality also has been seen within randomized trials when assigned hemoglobin targets were ignored; critically, however, corresponding relationships were absent when intention-to-treat principles were used, strongly suggesting noncausal associations and the need for randomized designs. This being said, hemoglobin typical target trials often have undesirable features, including inadequate blinding and the use of imbalanced, nonstandardized, nonblinded co-interventions. The trials published to date, spanning hemoglobin levels of approximately 7 to 13 g/dl, suggest that higher treatment targets enhance quality of life but at the price of higher BP, thrombotic events, and reduced dialysis adequacy in hemodialysis patients. To date, there is no convincing evidence that targets that approach the physiologic range (versus intermediate targets) have an effect on left ventricular size or survival. Therefore, depending on the outcome examined, higher hemoglobin levels may have beneficial effects, harmful effects, or no effect, leading to the unsatisfactory situation of having to make opinion-based tradeoff decisions. Whereas the available evidence suggests that 11 g/dl is a reasonable lower bound for the hemoglobin target range, the upper bound remains to be defined and targets above 13 g/dl cannot be routinely recommended.
本文的主要目的是回顾血红蛋白结局研究,重点关注纯观察性方法的实用性;血红蛋白目标随机试验的设计局限性;迄今为止已开展试验的已知情况;以及是否能够对目标范围给出有把握的建议。在随机试验中,当忽略分配的血红蛋白目标时,也常观察到较低血红蛋白水平、左心室肥厚和较高死亡率之间的关联;然而,关键的是,当采用意向性治疗原则时,相应的关系并不存在,这强烈表明这些是非因果关联,且需要随机设计。话虽如此,血红蛋白典型目标试验往往存在不良特征,包括盲法不足以及使用不均衡、未标准化、非盲法的联合干预措施。迄今为止发表的试验涵盖了大约7至13g/dl的血红蛋白水平,表明较高的治疗目标可提高生活质量,但代价是血液透析患者的血压升高、血栓形成事件增加以及透析充分性降低。迄今为止,没有令人信服的证据表明接近生理范围的目标(相对于中等目标)对左心室大小或生存率有影响。因此,根据所研究的结局,较高的血红蛋白水平可能有有益影响、有害影响或无影响,导致不得不基于观点进行权衡决策这种不尽人意的情况。虽然现有证据表明11g/dl是血红蛋白目标范围的合理下限,但上限仍有待确定,不能常规推荐高于13g/dl的目标。