Miura E, Procianoy R S, Bittar C, Miura C S, Melo C, Miura M S
Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.
J Pediatr (Rio J). 2000 May-Jun;76(3):193-9. doi: 10.2223/jped.51.
To evaluate the efficacy of the recombinant human granulocyte colony-stimulating factor (rhG-CSF) in the treatment of early-onset neonatal sepsis among premature infants.MATERIALS AND METHODS: A double-blind, randomized, placebo-controlled trial was performed among forty-four preterm neonates who had "clinical diagnosis" of early-onset sepsis. The treatment group (n=22) received 10 micro g/kg/d of rhG-CSF, IV once daily for three consecutive days, and the placebo group (n=22) received the same volume of a visually-indistinguishable vehicle. Prior to the first dose, and prior to the second and third doses, and again 10 days after the first dose, we measured tumor necrosis factor-a, interleukin-6, granulocyte-macrophagocyte colony-stimulating factor, G-CSF, leukocyte count, absolute neutrophil count, immature/total neutrophil ratio, platelet count, and hemoglobin concentration. A bone marrow aspiration was performed seven days after the first dose, and both the neutrophil storage pool (NSP) percent and the NSP/NPP (neutrophil proliferative pool) ratios were tabulated.RESULTS: The treatment and placebo groups were of similar gestational age (29-/+ 3 vs 31-/+ 3 weeks) and birth weight (1376 -/+ 491 vs 1404 -/+ 508 grams). They had similar Apgar scores and 24 hour SNAP scores. No deaths occurred during the first week of life among the treatment group while three deaths occurred in the placebo group. RhG-CSF treatment did not alter the serum concentrations of the cytokines measured (except for G-CSF). Serum G-CSF levels, blood leukocyte counts, absolute neutrophil counts, NSP percentages, and NSP/NPP ratios were higher in the treatment group 24 hours and 72 hours after dosing. The occurrence of a subsequent infection over the two week period following dosing was significantly lower in the treatment group (n=2) than in the placebo group (n=9; p<0.02, RR 0.19 [0.05-0.78]). The overall mortality rate during the entire hospitalization was not different between treatment and placebo groups.CONCLUSIONS: Administration of rhG-CSF to premature neonates with the clinical diagnosis of early-onset sepsis was associated with lower incidence of nosocomial infection over the ensuing three weeks period, but it did not change the overall mortality rate.
评估重组人粒细胞集落刺激因子（rhG-CSF）治疗早产儿早发型新生儿败血症的疗效。
对44例临床诊断为早发型败血症的早产儿进行了一项双盲、随机、安慰剂对照试验。治疗组（n=22）接受10μg/kg/d的rhG-CSF，静脉注射，每日1次，连续3天，安慰剂组（n=22）接受相同体积的外观无法区分的溶媒。在首次给药前、第二次和第三次给药前以及首次给药后10天，我们测量了肿瘤坏死因子-α、白细胞介素-6、粒细胞巨噬细胞集落刺激因子、G-CSF、白细胞计数、绝对中性粒细胞计数、未成熟/总中性粒细胞比率、血小板计数和血红蛋白浓度。首次给药7天后进行骨髓穿刺，并列出中性粒细胞储存池（NSP）百分比和NSP/NPP（中性粒细胞增殖池）比率。
治疗组和安慰剂组的胎龄（29±3周对31±3周）和出生体重（1376±491克对1404±508克）相似。他们的阿氏评分和24小时SNAP评分相似。治疗组在出生后第一周内无死亡，而安慰剂组有3例死亡。rhG-CSF治疗未改变所测细胞因子的血清浓度（G-CSF除外）。给药后24小时和72小时，治疗组的血清G-CSF水平、血白细胞计数、绝对中性粒细胞计数、NSP百分比和NSP/NPP比率较高。给药后两周内，治疗组（n=2）随后发生感染的发生率显著低于安慰剂组（n=9；p<0.02，RR 0.19[0.05-0.78]）。治疗组和安慰剂组在整个住院期间的总死亡率无差异。
对临床诊断为早发型败血症的早产儿给予rhG-CSF，在随后三周内医院感染发生率较低，但未改变总死亡率。
