Fanaroff A A, Korones S B, Wright L L, Wright E C, Poland R L, Bauer C B, Tyson J E, Philips J B, Edwards W, Lucey J F
Case Western Reserve University, Cleveland, OH.
N Engl J Med. 1994 Apr 21;330(16):1107-13. doi: 10.1056/NEJM199404213301602.
Nosocomial infections are a major cause of morbidity and mortality in premature infants. As a rule, their low serum gamma globulin levels at birth subsequently decline to hypogammaglobulinemic values; hence, prophylactic administration of intravenous immune globulin may reduce the rate of hospital-acquired infections.
In this prospective, multicenter, two-phase controlled trial, 2416 infants were stratified according to birth weight (501 to 1000 g and 1001 to 1500 g) and randomly assigned to an intravenous immune globulin group (n = 1204) or a control group (n = 1212). Control infants were given placebo infusions during phase 1 of the study (n = 623) but were not given any infusions during phase 2 (n = 589). Infants weighing 501 to 1000 g at birth were given 900 mg of immune globulin per kilogram of body weight, and infants weighing 1001 to 1500 g at birth were given a dose of 700 mg per kilogram. The immune globulin infusions were repeated every 14 days until the infants weighed 1800 g, were transferred to another center, died, or were sent home from the hospital.
Nosocomial infections of the blood, meninges, or urinary tract occurred in 439 of the 2416 infants (18.2 percent): 208 (17.3 percent) in the immune globulin group and 231 (19.1 percent) in the control group (relative risk, 0.91; 95 percent confidence interval, 0.77 to 1.08). Septicemia occurred in 15.5 percent of the immune globulin recipients and 17.2 percent of the controls. During phase 1 the rate of nosocomial infections was 13.4 percent in the immune globulin group and 17.8 percent in the control group; the respective rates during phase 2 were 21.0 percent and 20.4 percent. The predominant organisms included gram-positive cocci (53.0 percent), gram-negative bacilli (22.4 percent), and candida species (16.0 percent). Adverse reactions were rarely observed during the infusions. Immune globulin therapy had no effect on respiratory distress syndrome, bronchopulmonary dysplasia, intracranial hemorrhage, the duration of hospitalization, or mortality. The incidence of necrotizing enterocolitis was 12.0 percent in the immune globulin group and 9.5 percent in the control group.
Prophylactic use of intravenous immune globulin failed to reduce the incidence of hospital-acquired infections in very-low-birth-weight infants.
医院感染是早产儿发病和死亡的主要原因。通常，他们出生时血清γ球蛋白水平较低，随后会降至低丙种球蛋白血症水平；因此，预防性静脉注射免疫球蛋白可能会降低医院获得性感染的发生率。
在这项前瞻性、多中心、两阶段对照试验中，2416名婴儿根据出生体重（501至1000克和1001至1500克）进行分层，并随机分为静脉注射免疫球蛋白组（n = 1204）或对照组（n = 1212）。对照组婴儿在研究的第1阶段接受安慰剂输注（n = 623），但在第2阶段未接受任何输注（n = 589）。出生体重为501至1000克的婴儿每公斤体重给予900毫克免疫球蛋白，出生体重为1001至1500克的婴儿每公斤体重给予700毫克剂量。每14天重复一次免疫球蛋白输注，直到婴儿体重达到1800克、转至另一中心、死亡或出院回家。
2416名婴儿中有439名发生了血液、脑膜或尿路感染（18.2%）：免疫球蛋白组208名（17.3%），对照组231名（19.1%）（相对风险，0.91；95%置信区间，0.77至1.08）。免疫球蛋白接受者中败血症发生率为15.5%，对照组为17.2%。在第1阶段，免疫球蛋白组医院感染率为13.4%，对照组为17.8%；第2阶段的相应发生率分别为21.0%和20.4%。主要病原体包括革兰氏阳性球菌（53.0%）、革兰氏阴性杆菌（22.4%）和念珠菌属（16.0%）。输注期间很少观察到不良反应。免疫球蛋白治疗对呼吸窘迫综合征、支气管肺发育不良、颅内出血、住院时间或死亡率没有影响。免疫球蛋白组坏死性小肠结肠炎的发生率为12.0%，对照组为9.5%。
预防性使用静脉注射免疫球蛋白未能降低极低出生体重婴儿医院获得性感染的发生率。
