Cairo M S, Agosti J, Ellis R, Laver J J, Puppala B, deLemos R, Givner L, Nesin M, Wheeler J G, Seth T, van de Ven C, Fanaroff A
Georgetown University and Lombardi Cancer Center, Washington, DC 20007, USA.
J Pediatr. 1999 Jan;134(1):64-70. doi: 10.1016/s0022-3476(99)70373-2.
We carried out a randomized placebo-controlled trial in very low birth weight neonates (VLBWNs), comparing the incidence of nosocomial infections after the prophylactic use of recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) versus placebo in VLBWNs.
VLBWNs (n = 264), weighing 501 to 1000 g, </=72 hours of age were randomly assigned to receive rhu GM-CSF (8 microg/kg/d), administered intravenously (n = 134) over 2 hours daily x 7 days and every other day for 21 days, or placebo (n = 130). The safety, incidence of nosocomial infections, days of absolute neutrophil count >/=4000/mm,3 peripheral blood progenitor studies, and 24-hour polymorphonuclear leukocyte C3bi receptor expression were compared between the 2 treatment groups.
No (grade III/IV) toxicity or adverse events were associated with rhu GM-CSF. The absolute neutrophil count and absolute eosinophil count were significantly elevated in the rhu GM-CSF group on days 7 (P =.001), 14 (P =.001), and 21 (P =.007) and on days 7 and 28 (P =.012 and P =.001, respectively). However, there was no difference in the incidence of confirmed nosocomial infections between the 2 treatment groups in this trial (40% vs 39%, rhu GM-CSF vs placebo; P = NS).
In a large randomized placebo-controlled trial, prophylactic administration of rhu GM-CSF in VLBWNs does not appear to decrease the incidence of nosocomial infections.
我们在极低出生体重儿（VLBWNs）中开展了一项随机安慰剂对照试验，比较预防性使用重组人粒细胞巨噬细胞集落刺激因子（rhu GM-CSF）与安慰剂后极低出生体重儿医院感染的发生率。
264例出生体重501至1000g、年龄≤72小时的极低出生体重儿被随机分配接受rhu GM-CSF（8μg/kg/d），静脉注射（n = 134），每日2小时，共7天，之后隔日注射，共21天，或接受安慰剂（n = 130）。比较两个治疗组之间的安全性、医院感染发生率、绝对中性粒细胞计数≥4000/mm³的天数、外周血祖细胞研究以及24小时多形核白细胞C3bi受体表达。
rhu GM-CSF未出现（III/IV级）毒性或不良事件。rhu GM-CSF组在第7天（P = 0.001）、14天（P = 0.001）和21天（P = 0.007）以及第7天和28天（分别为P = 0.012和P = 0.001）时绝对中性粒细胞计数和绝对嗜酸性粒细胞计数显著升高。然而，在该试验中两个治疗组之间确诊的医院感染发生率没有差异（rhu GM-CSF组与安慰剂组分别为40%对39%；P = 无显著性差异）。
在一项大型随机安慰剂对照试验中，预防性给予极低出生体重儿rhu GM-CSF似乎并未降低医院感染的发生率。
