OPPORTUNITY™: a large-scale randomized clinical trial of growth hormone in hemodialysis patients
OPPORTUNITY™: a large-scale randomized clinical trial of growth hormone in hemodialysis patients
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DOI：
10.1093/ndt/gfr363
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发表时间：
2011-12-01
影响因子：
6.1
通讯作者：
Ikizler, Talat Alp
中科院分区：
文献类型：
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作者：
Kopple, Joel D.;Cheung, Alfred K.;Ikizler, Talat Alp
背景。成人维持性血液透析 (MHD) 患者死亡率和发病率较高，生活质量 (QoL) 较差。蛋白质能量浪费的标志与这些不良结果相关。 OPPORTUNITY (TM) 试验检验了重组人生长激素 (hGH) 是否可以降低低白蛋白 MHD 患者的死亡率。次要终点是对住院次数、心血管事件、去脂体重 (LBM)、血清蛋白、运动能力、生活质量和不良事件的影响。方法。我们进行了一项针对糖尿病状况进行分层的随机、双盲、安慰剂对照、多中心多国试验。临床上，稳定的成年 MHD 患者血清白蛋白
Background. Adult maintenance hemodialysis (MHD) patients experience high mortality and morbidity and poor quality of life (QoL). Markers of protein-energy wasting are associated with these poor outcomes. The OPPORTUNITY (TM) Trial examined whether recombinant human growth hormone (hGH) reduces mortality in hypoalbuminemic MHD patients. Secondary end points were effects on number of hospitalizations, cardiovascular events, lean body mass (LBM), serum proteins, exercise capacity, QoL and adverse events.Methods. We performed a randomized, double-blind, placebo-controlled, multicenter multinational trial stratified for diabetic status. Clinically, stable adult MHD patients with serum albumin