Weisman L E, Stoll B J, Kueser T J, Rubio T T, Frank C G, Heiman H S, Subramanian K N, Hankins C T, Cruess D F, Hemming V G
Department of Pediatrics, Uniformed Services University of the Health Sciences, Bethesda, Maryland.
J Pediatr. 1994 Dec;125(6 Pt 1):922-30. doi: 10.1016/s0022-3476(05)82011-6.
To determine whether a single dose of intravenously administered immune globulin (IVIG) decreases late-onset sepsis in premature infants, we prospectively entered 753 neonates with birth weight 500 to 2000 gm, gestation < or = 34 weeks, and age < or = 12 hours into a multicenter, double-blind, controlled trial. Infants were randomly selected to receive a single intravenous infusion, 10 ml/kg, of either IVIG (500 mg/kg) or albumin (5 mg/kg) and were observed for 8 weeks for infection. Maternal and neonatal risk factors for infection did not differ between groups. Although serum IgG values before infusion were related to gestation (R = 0.62), the change in serum IgG or half-life of IgG after IVIG infusion was not (R < or = 0.09). The serum IgG concentration was increased (p < 0.05) in IVIG-treated patients for 8 weeks. There were 88 episodes of late-onset sepsis in 79 neonates (10.5%). Causative organisms included the following: Staphylococcus epidermidis (37 episodes), Enterococcus (9), Staphylococcus aureus (7), Candida (6), Escherichia coli (6), and multiple organisms (11). Sepsis, death, and death as a result of infection were unaffected by treatment. We conclude that a single infusion of IVIG, 500 mg/kg, shortly after birth was not effective prophylaxis for late-onset infection in premature neonates. Future studies of late-onset sepsis prophylaxis should consider IVIG with known pathogen-specific antibody concentrations against organisms causing these infections, in particular S. epidermidis.
为了确定静脉注射一剂免疫球蛋白（IVIG）是否能降低早产儿晚发性败血症的发生率，我们前瞻性地将753例出生体重500至2000克、孕周≤34周且年龄≤12小时的新生儿纳入一项多中心、双盲、对照试验。婴儿被随机选择接受一次静脉输注，剂量为10 ml/kg的IVIG（500 mg/kg）或白蛋白（5 mg/kg），并观察8周以检测感染情况。两组之间感染的母婴危险因素无差异。虽然输注前血清IgG值与孕周相关（R = 0.62），但IVIG输注后血清IgG的变化或IgG的半衰期与孕周无关（R≤0.09）。IVIG治疗的患者血清IgG浓度在8周内升高（p < 0.05）。79例新生儿（10.5%）发生了88次晚发性败血症。致病微生物包括以下几种：表皮葡萄球菌（37次）、肠球菌（9次）、金黄色葡萄球菌（7次）、念珠菌（6次）、大肠杆菌（6次）和多种微生物（11次）。治疗对败血症、死亡以及因感染导致的死亡均无影响。我们得出结论，出生后不久单次输注500 mg/kg的IVIG对预防早产儿晚发性感染无效。未来关于晚发性败血症预防的研究应考虑使用已知针对引起这些感染的病原体（特别是表皮葡萄球菌）具有特定抗体浓度的IVIG。
