Maier Rolf F, Obladen Michael, Müller-Hansen Ingo, Kattner Evelyn, Merz Ulrich, Arlettaz Romaine, Groneck Peter, Hammer Hannes, Kössel Hans, Verellen Gaston, Stock Gerd-Jürgen, Lacaze-Masmonteil Thierry, Claris Olivier, Wagner Martin, Matis Jacqueline, Gilberg Frank
J Pediatr. 2002 Jul;141(1):8-15. doi: 10.1067/mpd.2002.124309.
To investigate whether recombinant erythropoietin (rhEPO) reduces the need for transfusion in extremely low birth weight (ELBW) infants (birth weight 500-999 g) and to determine the optimal time for treatment.
In a blinded multicenter trial, 219 ELBW infants were randomized on day 3 to one of 3 groups: early rhEPO group (rhEPO from the first week for 9 weeks, n = 74), late rhEPO group (rhEPO from the fourth week for 6 weeks, n = 74), or control group (no rhEPO, n = 71). All infants received enteral iron (3-9 mg/kg/day) from the first week. The rhEPO beta dose was 750 IU/kg/week. Success was defined as no transfusion and hematocrit levels never below 30%.
Success rate was 13% in the early rhEPO group, 11% in the late rhEPO group, and 4% in the control group (P =.026 for early rhEPO versus control group). Median transfusion volume was 0.4 versus 0.5 versus 0.7 mL/kg/day (P =.02) and median donor exposure was 1.0 versus 1.0 versus 2.0 (P =.05) in the early rhEPO group, the late rhEPO group, and the control group, respectively. Infection risk was not increased and weight gain was not delayed with rhEPO beta.
Early rhEPO beta treatment effectively reduces the need for transfusion in ELBW infants.
研究重组促红细胞生成素(rhEPO)是否能减少极低出生体重(ELBW)婴儿(出生体重500 - 999克)的输血需求,并确定最佳治疗时间。
在一项双盲多中心试验中,219名ELBW婴儿在第3天被随机分为3组之一:早期rhEPO组(从第一周开始使用rhEPO,持续9周,n = 74)、晚期rhEPO组(从第四周开始使用rhEPO,持续6周,n = 74)或对照组(不使用rhEPO,n = 71)。所有婴儿从第一周开始接受肠内铁剂(3 - 9毫克/千克/天)。rhEPOβ剂量为750国际单位/千克/周。成功定义为未输血且血细胞比容水平从未低于30%。
早期rhEPO组的成功率为13%,晚期rhEPO组为11%,对照组为4%(早期rhEPO组与对照组相比,P = 0.026)。早期rhEPO组、晚期rhEPO组和对照组的中位输血量分别为0.4毫升/千克/天、0.5毫升/千克/天和0.7毫升/千克/天(P = 0.02),中位供血者暴露次数分别为1.0、1.0和2.0(P = 0.05)。使用rhEPOβ未增加感染风险,也未延迟体重增加。
早期使用rhEPOβ治疗可有效减少ELBW婴儿的输血需求。