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重组人促红细胞生成素作为大需血量(≥5单位)择期手术中自体输血的辅助治疗:一项随机研究。

Recombinant human erythropoietin as adjuvant treatment for autologous blood donation in elective surgery with large blood needs (> or = 5 units): a randomized study.

作者信息

de Pree C, Mermillod B, Hoffmeyer P, Beris P

机构信息

Department of Medicine, Cantonal University Hospital, Geneva, Switzerland.

出版信息

Transfusion. 1997 Jul;37(7):708-14. doi: 10.1046/j.1537-2995.1997.37797369446.x.

Abstract

BACKGROUND

Autologous blood transfusion presents no infectious or immunologic side effects. The aim of this randomized study was to determine the impact of recombinant human erythropoietin (rHuEPO) on the donation of 5 units of autologous blood by nonanemic patients who were candidates for elective surgery with transfusion requirements of > or = 5 units.

STUDY DESIGN AND METHODS

Starting on Day -35, 420 mL of blood was taken weekly. All patients received 200 mg of iron saccharose complex intravenously at each visit and six subcutaneous injections of rHuEPO (141 U/kg) or placebo between Days -21 and -7.

RESULTS

Of 50 patients, 45 completed the study (placebo, 21; rHuEPO, 24). Total red cell production was higher in the rHuEPO group (p = 0.001). Donation of 5 units was possible for 67 percent (placebo group) and 79 percent (rHuEPO group) of patients (p = 0.5). The mean number of blood units donated was 4.6 (placebo group) and 4.7 (rHuEPO group). More patients in the placebo group received allogeneic blood (9/21 [43%] vs. 6/23 [26%]), although the difference did not reach significance (p = 0.34).

CONCLUSION

In nonanemic patients donating 5 units of blood, rHuEPO associated with intravenous iron increased total red cell production. However, no difference was found between the rHuEPO and placebo groups with regard to the number of units of autologous blood donated of the number of patients receiving allogeneic blood transfusion.

摘要

背景

自体输血无感染或免疫方面的副作用。本随机研究的目的是确定重组人促红细胞生成素(rHuEPO)对有输血需求且预计输血≥5单位的择期手术患者(非贫血)捐献5单位自体血的影响。

研究设计与方法

从第-35天开始,每周采血420 mL。所有患者每次就诊时静脉注射200 mg蔗糖铁复合物,并在第-21天至-7天期间皮下注射6次rHuEPO(141 U/kg)或安慰剂。

结果

50例患者中,45例完成研究(安慰剂组21例;rHuEPO组24例)。rHuEPO组的总红细胞生成量更高(p = 0.001)。67%(安慰剂组)和79%(rHuEPO组)的患者能够捐献5单位血液(p = 0.5)。安慰剂组平均献血单位数为4.6,rHuEPO组为4.7。安慰剂组更多患者接受了异体血(9/21 [43%]对6/23 [26%]),尽管差异无统计学意义(p = 0.34)。

结论

对于捐献5单位血液的非贫血患者,rHuEPO联合静脉补铁可增加总红细胞生成量。然而,在自体血捐献单位数或接受异体输血的患者数量方面,rHuEPO组与安慰剂组之间未发现差异。

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