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围手术期重组人促红细胞生成素在择期髋关节置换术中的有效性。加拿大骨科围手术期促红细胞生成素研究组。

Effectiveness of perioperative recombinant human erythropoietin in elective hip replacement. Canadian Orthopedic Perioperative Erythropoietin Study Group.

出版信息

Lancet. 1993 May 15;341(8855):1227-32.

PMID:8098389
Abstract

Concern about the risk of transmission of viral infection has led to attempts to reduce transfusion requirements in patients undergoing surgery. To determine whether recombinant human erythropoietin decreases blood transfusion requirements in patients undergoing elective hip arthroplasty, a multicentre double-blind, randomised, placebo-controlled trial was conducted. 208 patients undergoing elective primary or revision hip arthroplasty were randomised to 3 groups. All received daily subcutaneous injections of either erythropoietin or placebo starting 10 days before surgery. Group 1 (78 patients) received 14 days of placebo, group 2 (77 patients) received 14 days of erythropoietin (300 units/kg to a maximum of 30,000 units), and group 3 (53 patients) received placebo for days 10 to 6 before surgery and erythropoietin for the next 9 days. A primary outcome event (any transfusion or a haemoglobin concentration < 80 g/L) occurred in 46% of patients in group 1, 23% in group 2, and 32% in group 3 (p = 0.003). The mean number of transfusions was 1.14 in group 1, 0.52 in group 2, 0.70 in group 3. The mean reticulocyte count the day before surgery was 72 x 10(9)/L in group 1, 327 in group 2, and 170 in group 3. Deep venous thrombi were detected in 5 patients in group 1, 8 patients in group 2, and 8 patients in group 3. Patients who had a haemoglobin concentration before randomisation of < 135 g/L benefited most from erythropoietin. Thus erythropoietin given for 14 days perioperatively decreases the need for transfusion in patients undergoing elective hip arthroplasty.

摘要

对病毒感染传播风险的担忧促使人们尝试减少手术患者的输血需求。为了确定重组人促红细胞生成素是否能降低择期髋关节置换术患者的输血需求,进行了一项多中心双盲、随机、安慰剂对照试验。208例接受择期初次或翻修髋关节置换术的患者被随机分为3组。所有患者均在手术前10天开始每日皮下注射促红细胞生成素或安慰剂。第1组(78例患者)接受14天的安慰剂治疗,第2组(77例患者)接受14天的促红细胞生成素治疗(300单位/千克,最大剂量为30,000单位),第3组(53例患者)在手术前第10天至第6天接受安慰剂治疗,接下来的9天接受促红细胞生成素治疗。第1组46%的患者发生了主要结局事件(任何输血或血红蛋白浓度<80 g/L),第2组为23%,第3组为32%(p = 0.003)。第1组的平均输血量为1.14,第2组为0.52,第3组为0.70。手术前一天的平均网织红细胞计数第1组为72×10⁹/L,第2组为327,第3组为170。第1组有5例患者检测到深静脉血栓,第2组有8例,第3组有8例。随机分组前血红蛋白浓度<135 g/L的患者从促红细胞生成素中获益最大。因此,围手术期给予14天的促红细胞生成素可减少择期髋关节置换术患者的输血需求。

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Effectiveness of perioperative recombinant human erythropoietin in elective hip replacement. Canadian Orthopedic Perioperative Erythropoietin Study Group.围手术期重组人促红细胞生成素在择期髋关节置换术中的有效性。加拿大骨科围手术期促红细胞生成素研究组。
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