Foster Jann P, Seth Rakesh, Cole Michael J
School of Nursing and Midwifery, Western Sydney University, Penrith DC, Australia.
Cochrane Database Syst Rev. 2016 Apr 4;4(4):CD001816. doi: 10.1002/14651858.CD001816.pub3.
Necrotizing enterocolitis (NEC) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period. There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa.
To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight (or both) neonates.
We used the standard search strategy of the Cochrane Neonatal Group. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2016, Issue 1), PubMed (1966 to January 2016), CINAHL (1982 to January 2016) and EMBASE (1980 to January 2016) and conference proceedings.
All randomized or quasi-randomised controlled trials where oral immunoglobulins were used as prophylaxis against NEC in preterm (less than 37 weeks' gestation) or low birth weight (less than 2500 gram), or both, neonates.
We performed data collection and analysis in accordance with the standard methods of the Cochrane Neonatal Review Group.
The search identified five studies on oral immunoglobulin for the prevention of NEC of which three met the inclusion criteria. In this review of the three eligible trials (including 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 (typical risk ratio (RR) 0.84, 95% confidence interval (CI) 0.57 to 1.25; typical risk difference (RD) -0.01, 95% CI -0.03 to 0.01; 3 studies, 1840 infants), suspected NEC (RR 0.84, 95% CI 0.49 to 1.46; RD -0.01, 95% CI -0.02 to 0.01; 1 study, 1529 infants), need for surgery (typical RR 0.21, 95% CI 0.02 to 1.75; typical RD -0.03, 95% CI -0.06 to 0.00; 2 studies, 311 infants) or death from NEC (typical RR 1.10, 95% CI 0.47 to 2.59; typical RD 0.00, 95% CI -0.01 to 0.01; 3 studies, 1840 infants).
AUTHORS' CONCLUSIONS: Based on the available trials, the evidence does not support the administration of oral immunoglobulin for the prevention of NEC. There are no randomized 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涉及胃肠道的急症。已有报道表明,口服免疫球蛋白(Ig)A和IgG对胃肠道黏膜具有免疫保护作用。
确定口服免疫球蛋白对早产或低出生体重(或两者兼具)新生儿坏死性小肠结肠炎及其他并发症发生率的影响。
我们采用了Cochrane新生儿组的标准检索策略。检索了Cochrane对照试验中心注册库(CENTRAL,《Cochrane图书馆》2016年第1期)、PubMed(1966年至2016年1月)、CINAHL(1982年至2016年1月)、EMBASE(1980年至2016年1月)以及会议论文集。
所有将口服免疫球蛋白用作预防早产(妊娠少于37周)或低出生体重(少于2500克)或两者兼具的新生儿坏死性小肠结肠炎的随机或半随机对照试验。
我们按照Cochrane新生儿综述组的标准方法进行数据收集与分析。
检索到五项关于口服免疫球蛋白预防坏死性小肠结肠炎的研究,其中三项符合纳入标准。在对这三项符合条件的试验(共2095例新生儿)进行的综述中,口服IgG或IgG/IgA组合并未显著降低确诊坏死性小肠结肠炎的发生率(典型风险比(RR)0.84,95%置信区间(CI)0.57至1.25;典型风险差值(RD)-0.01,95%CI -0.03至0.01;3项研究,1840例婴儿)、疑似坏死性小肠结肠炎的发生率(RR 0.84,95%CI 0.49至1.46;RD -0.01,95%CI -0.02至0.01;1项研究,1529例婴儿)、手术需求(典型RR 0.21,95%CI 0.02至1.75;典型RD -0.03,95%CI -0.06至0.00;2项研究,311例婴儿)或坏死性小肠结肠炎导致的死亡发生率(典型RR 1.10,95%CI 0.47至2.59;典型RD 0.00,95%CI -0.01至0.01;3项研究,1840例婴儿)。
基于现有试验,证据不支持口服免疫球蛋白用于预防坏死性小肠结肠炎。尚无单独使用口服IgA预防坏死性小肠结肠炎的随机对照试验。