DOUBLE BLIND STUDY OF GCSF ADMINISTRATION TO NEONATES WITH NEUTROPENIA

这项研究现在已经完成，结果已经发表（儿科学（1998），102:6-13）。本研究涉及重组G-CSF（或安慰剂）给新生儿中性粒细胞减少症相关的早发性败血症，产妇高血压，晚发性败血症，或坏死性小肠结肠炎。通过测量四个结果变量来评估治疗或安慰剂的效果：血液中性粒细胞浓度、中性粒细胞产生和功能、疾病严重程度和疾病持续时间。研究表明，G-CSF可有效纠正感染性新生儿常见的中性粒细胞减少症。尽管纠正了中性粒细胞减少症，但几乎没有证据表明缩短了重症监护病房的住院时间或缩短了总住院时间。

This study has now been completed, and the results have been published (Pediatrics (1998), 102:6-13). This study involved the administration of recombinant G-CSF (or placebo) to newborn infants with neutropenia associated with either early-onset sepsis, maternal hypertension, late-onset sepsis, or necrotizing enterocolitis. The effects of treatment or placebo were assessed by measuring four outcome variables: blood neutrophil concentration, neutrophil production and function, severity of illness, and duration of illness. The study demonstrated that G-CSF was effective in correcting the neutropenia commonly found in septic newborn infants. In spite of correction of the neutropenia, there was little evidence of shortened Intensive Care Unit stays or of shortened total hospitalization time.