Treatment of Neonatal Sepsis with Intravenous Immune Globulin
Treatment of Neonatal Sepsis with Intravenous Immune Globulin
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DOI：
10.1056/nejmoa1100441
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发表时间：
2011-09-29
影响因子：
158.5
通讯作者：
Tarnow-Mordi, William
中科院分区：
文献类型：
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作者：
Brocklehurst, Peter;Farrell, Barbara;Tarnow-Mordi, William
背景：尽管有抗生素治疗，新生儿败血症仍是死亡和并发症的主要原因。需要有效的辅助治疗。新生儿内源性免疫球蛋白相对缺乏。对静脉注射免疫球蛋白治疗疑似或已证实的新生儿败血症的荟萃分析表明，任何原因的死亡率都有所降低，但这些试验规模较小，质量参差不齐。方法在9个国家的113家医院中，我们招募了3493名因疑似或证实严重感染而接受抗生素治疗的婴儿，并随机分配他们接受两次输注多价IgG免疫球蛋白（剂量为每公斤体重500 mg）或相匹配的安慰剂，间隔48小时。主要结局是2岁时死亡或严重残疾。结果1759例接受静脉注射免疫球蛋白的婴儿中有686例（39.0%）出现主要转归，1734例接受安慰剂的婴儿中有677例（39.0%）出现主要转归（相对危险度为1.00；95%可信区间为0.92 ~ 1.08），组间无显著差异。同样，在次要结局的发生率上也没有显著差异，包括随后脓毒症发作的发生率。在对2岁婴儿的随访中，两组在主要致残率和非主要致残率以及不良事件发生率方面没有显著差异。结论静脉注射免疫球蛋白对怀疑或证实的新生儿败血症的预后没有影响。（由联合王国医学研究理事会和其他机构资助；国际医学信息研究所当前对照试验编号，ISRCTN94984750。）
BACKGROUNDNeonatal sepsis is a major cause of death and complications despite antibiotic treatment. Effective adjunctive treatments are needed. Newborn infants are relatively deficient in endogenous immunoglobulin. Meta-analyses of trials of intravenous immune globulin for suspected or proven neonatal sepsis suggest a reduced rate of death from any cause, but the trials have been small and have varied in quality.METHODSAt 113 hospitals in nine countries, we enrolled 3493 infants receiving antibiotics for suspected or proven serious infection and randomly assigned them to receive two infusions of either polyvalent IgG immune globulin (at a dose of 500 mg per kilogram of body weight) or matching placebo 48 hours apart. The primary outcome was death or major disability at the age of 2 years.RESULTSThere was no significant between-group difference in the rates of the primary outcome, which occurred in 686 of 1759 infants (39.0%) who received intravenous immune globulin and in 677 of 1734 infants (39.0%) who received placebo (relative risk, 1.00; 95% confidence interval, 0.92 to 1.08). Similarly, there were no significant differences in the rates of secondary outcomes, including the incidence of subsequent sepsis episodes. In follow-up of 2-year-old infants, there were no significant differences in the rates of major or nonmajor disability or of adverse events. CONCLUSIONSTherapy with intravenous immune globulin had no effect on the outcomes of suspected or proven neonatal sepsis. (Funded by the United Kingdom Medical Research Council and others; INIS Current Controlled Trials number, ISRCTN94984750.)