Probiotic prophylaxis after pullthrough for Hirschsprung disease to reduce incidence of enterocolitis: A prospective, randomized, double-blind, placebo-controlled, multicenter trial
Probiotic prophylaxis after pullthrough for Hirschsprung disease to reduce incidence of enterocolitis: A prospective, randomized, double-blind, placebo-controlled, multicenter trial
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DOI：
10.1016/j.jpedsurg.2012.10.028
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发表时间：
2013-01-01
影响因子：
2.4
通讯作者：
Teitelbaum, Daniel H.
中科院分区：
文献类型：
--
作者：
El-Sawaf, Mohamed;Siddiqui, Sabina;Teitelbaum, Daniel H.
目的：先天性巨结肠相关性小肠结肠炎（HAEC）是拉通术后最棘手的问题之一。我们假设，预防性管理的益生菌后拉通程序将减少HAEC.Study设计的发病率：一个前瞻性的，双盲，安慰剂对照，随机试验进行了2个儿童医院。婴儿接受pullthrough随机益生菌或安慰剂为期3个月后pullthrough。主要结局是术后HAEC的发生率。其他结果包括HAEC的严重程度，临床分级，HAEC发作次数和无神经节细胞症的程度。结果：共纳入62例患者（A组40例，B组22例），均为正常对照组。1例失访，1例术后即刻死亡未纳入最终分析。对32名患者进行了益生菌治疗。安慰剂/益生菌的分布在研究中心之间是相等的（P=0.858）。恢复期的平均年龄为6.5 ± 8.1（+/- SD）个月。HAEC的发生率为28.3%。HAEC的发病率在益生菌和安慰剂研究groups.Conclusions之间没有统计学差异：HAEC的发病率没有减少预防性益生菌。未来的研究需要更好地确定病因和预防这种复杂疾病的可能方法。(C)2013 Elsevier Inc. All rights reserved.
Objective: Hirschsprung-associated enterocolitis (HAEC) is one of the most troublesome problems encountered after a pullthrough. We hypothesized that prophylactic administration of probiotics after a pullthrough procedure would decrease the incidence of HAEC.Study Design: A prospective, double-blind, placebo-controlled, randomized trial was conducted at 2 children's hospitals. Infants undergoing pullthrough were randomized to probiotic or placebo for a period of 3 months post-pullthrough. Primary outcome was incidence of post-operative HAEC. Other outcomes included severity of HAEC by clinical grade, number of HAEC episodes and extent of aganglionosis. Pearson Chi Square analysis, as well as logistic regression, was used for statistical analysis.Results: Sixty-two patients were recruited (Sites: A=40; B=22). One was lost to follow up and one immediate post-op death was not included in final analysis. Probiotics were administered to 32 patients. Distribution of placebo/probiotics was equal between sites (P=0.858). Mean age at pullthrough was 6.5 +/- 8.1(+/- SD) months. The incidence of HAEC was 28.3%. The incidence of HAEC was not statistically different between probiotic and placebo study groups.Conclusions: Incidence of HAEC was not reduced with prophylactic probiotics. Future studies are needed to better determine the etiology and possible ways of preventing this complex condition. (C) 2013 Elsevier Inc. All rights reserved.