Foster J, Cole M
QE11 Building (DO2) Building, University of Sydney, Sydney, NSW, Australia.
Cochrane Database Syst Rev. 2004(1):CD001816. doi: 10.1002/14651858.CD001816.pub2.
Necrotizing enterocolitis (NEC) is the most common emergency of the gastrointestinal tract occurring in the neonatal period. There have been published reports which suggest that oral immunoglobulins IgA and IgG produce an immunoprotective effect in the gastrointestinal mucosa. This systematic review was undertaken to clarify the issue.
To assess whether oral immunoglobulin administered to preterm and low birth-weight neonates reduces the incidence of necrotizing enterocolitis without adverse effects.
The databases MEDLINE, CINAHL, EMBASE (1966 to October 26, 2003) and the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2003) were searched. Proceedings of the Perinatal Society of Australia and New Zealand were hand searched. The computer neonatal discussion site 'Nicu Net' was also used. Additionally, all references in the identified trials were checked and authors were contacted to request any additional published or unpublished data. No new trials were identified.
All randomised or quasi-randomised controlled trials where oral immunoglobulins were used as prophylaxis against necrotizing enterocolitis in preterm (<37 weeks gestation) and/or low birth-weight (<2500 gms) neonates.
The procedures of the Cochrane Neonatal Review Group (CNRG) were used. The two reviewers independently assessed the trials for their methodological quality and subsequent inclusion in the review. Relative risk (RR), risk difference (RD), and number needed to treat (NNT) were used in the analysis.
Five studies on oral immunoglobulin for the prevention of necrotizing enterocolitis were identified of which three met the inclusion criteria. In this review of the three eligible trials (including a total of 2095 neonates) the oral administration of IgG or an IgG/IgA combination did not result in a significant reduction in the incidence of definite NEC [RR 0.84 (95% CI 0.57, 1.25), RD -0.01 (95% CI -0.03, 0.01)], suspected NEC [RR 0.84 (95% CI 0.49, 1.46), RD -0.01 (95% CI -0.02, 0.01)], need for surgery [RR 0.21 (95% CI 0.02, 1.75), RD -0.03 (95% CI -0.06, 0.00)] or death from NEC [RR 1.10 (95% CI 0.47, 2.59), RD 0.00 (95% CI -0.01, 0.01)].
REVIEWER'S CONCLUSIONS: Based on the available trials, the evidence does not support the administration of oral immunoglobulin for the prevention of NEC. There are no randomised controlled trials of oral IgA alone for the prevention of NEC.
坏死性小肠结肠炎（NEC）是新生儿期最常见的胃肠道急症。已有报道表明，口服免疫球蛋白IgA和IgG对胃肠道黏膜具有免疫保护作用。进行本系统评价以阐明该问题。
评估给早产和低出生体重新生儿口服免疫球蛋白是否可降低坏死性小肠结肠炎的发病率且无不良反应。
检索了MEDLINE、CINAHL、EMBASE（1966年至2003年10月26日）数据库以及Cochrane对照试验中央注册库（CENTRAL，Cochrane图书馆，2003年第3期）。手工检索了澳大利亚和新西兰围产期协会的会议记录。还使用了计算机新生儿讨论网站“Nicu Net”。此外，检查了纳入试验中的所有参考文献，并与作者联系以索取任何其他已发表或未发表的数据。未发现新的试验。
所有将口服免疫球蛋白用作预防早产（妊娠<37周）和/或低出生体重（<2500克）新生儿坏死性小肠结肠炎的随机或半随机对照试验。
采用Cochrane新生儿评价组（CNRG）的程序。两名评价者独立评估试验的方法学质量以及随后是否纳入评价。分析中使用了相对危险度（RR）、危险度差值（RD）和需治疗人数（NNT）。
确定了5项关于口服免疫球蛋白预防坏死性小肠结肠炎的研究，其中3项符合纳入标准。在对这3项符合条件的试验（共2095例新生儿）的评价中，口服IgG或IgG/IgA组合并未显著降低确诊NEC的发病率[RR 0.84（95%CI 0.57，1.25），RD -0.01（95%CI -0.03，0.01）]、疑似NEC的发病率[RR 0.84（95%CI 0.49，1.46），RD -0.01（95%CI -0.02，0.01）]、手术需求[RR 0.21（95%CI 0.02，1.75），RD -0.03（95%CI -0.06，0.00）]或NEC导致的死亡[RR 1.10（95%CI 0.47，2.59），RD 0.00（95%CI -0.01，0.01）]。
基于现有试验，证据不支持口服免疫球蛋白用于预防NEC。尚无单独口服IgA预防NEC的随机对照试验。
