The effects of hydroxycarbamide and magnesium on haemoglobin SC disease: results of the multi-centre CHAMPS trial
The effects of hydroxycarbamide and magnesium on haemoglobin SC disease: results of the multi-centre CHAMPS trial
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DOI：
10.1111/j.1365-2141.2010.08523.x
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发表时间：
2011-03-01
影响因子：
6.5
通讯作者：
Kesler, Karen
中科院分区：
文献类型：
--
作者：
Wang, Winfred;Brugnara, Carlo;Kesler, Karen
在一项II期多中心双盲试验中，我们评估了口服羟基脲（HC）和镁（Mg）对5-53岁HbSC患者血液学的影响。受试者被随机分配至HC +安慰剂组、Mg +安慰剂组、HC + Mg组或安慰剂+安慰剂组。主要终点是8周后高密度红细胞的比例。36例受试者可评价，但由于入组缓慢，研究提前终止。在合并HC组中，平均细胞体积和HbF增加，但在高密度红细胞或血管闭塞事件中未观察到差异。Mg没有影响。有必要进一步研究羟基脲作为HbSC疾病的单药治疗。
P>In a phase-II multi-centre double-blinded trial, we evaluated haematological effects of oral hydroxycarbamide (HC) and magnesium (Mg) in patients with HbSC, aged 5-53 years old. Subjects were randomized to HC + placebo, Mg + placebo, HC + Mg, or placebo + placebo. The primary endpoint was the proportion of hyperdense red blood cells after 8 weeks. Thirty-six subjects were evaluable, but the study was terminated early because of slow enrollment. In the combined HC groups, mean cell volume and HbF were increased, but differences were not seen in hyperdense red cells or vaso-occlusive events. Mg had no effects. Further investigation of hydroxycarbamide as monotherapy in HbSC disease is warranted.