Sutter General Hospital, Sacramento, CA, USA.
J Clin Pharm Ther. 2013 Dec;38(6):445-9. doi: 10.1111/jcpt.12084. Epub 2013 Jul 19.
Probiotic therapy has been shown to reduce morbidity and mortality of necrotizing enterocolitis (NEC) in premature infants in several international studies using various probiotic agents. The purpose of this study(*) is to describe our experience of using probiotic therapy in preventing NEC in infants with very low birth weight (VLBW) in a neonatal intensive care unit (NICU) and to evaluate whether our records provide evidence of effectiveness for probiotic therapy.
In a retrospective cohort study, the efficacy of probiotic therapy in preventing NEC in VLBW infants was investigated via chart review. A probiotic administration protocol using a three-strain (Streptococcus thermophilus, Bifidobacterium infantis and Bifidobacterium bifidum) supplement was implemented in August 2007. Patients admitted to the NICU from August 2003 through July 2011 were screened. Primary outcomes are the morbidity and mortality of NEC. The secondary outcomes were severity of NEC and incidence of where infant feeds were stopped but NEC was not diagnosed (NEC scare).
There was a significant increased baseline risk of NEC development in the probiotics group, including younger gestational age, higher incidence of patent ductus arteriosus (PDA) and use of indomethacin. The incidence of NEC is similar between the control group (2·8%) and probiotics group (2·4%) (hazard ratio, 1·15; 95% confidence interval [CI], 0·42, 3·12). Mortality of NEC is also not statistically different. Incidence of NEC scare was decreased from 2·8% in control group to 1·4% in probiotics group, although the difference was not statistically significant (P = 0·38).
Our findings suggest that probiotics are safe in NEC prevention in VLBW infants. We had no cases of infection related to the strains of bacteria used in our product. With the low incidence of NEC (2·8%) and NEC scare (2·8%) in our cohort, we do not have enough power to detect any change in outcome, particularly as our study was observational. However, it is hoped that our data give useful information for others on probiotic prophylactic therapy in the routine clinical management of VLBW infants.
几项国际研究使用各种益生菌制剂表明,益生菌疗法可降低早产儿坏死性小肠结肠炎(NEC)的发病率和死亡率。本研究的目的是描述我们在新生儿重症监护病房(NICU)中使用益生菌疗法预防极低出生体重(VLBW)婴儿 NEC 的经验,并评估我们的记录是否为益生菌疗法的有效性提供证据。
在回顾性队列研究中,通过图表审查研究了益生菌疗法预防 VLBW 婴儿 NEC 的疗效。自 2007 年 8 月起,采用含有三株菌(嗜热链球菌、婴儿双歧杆菌和两歧双歧杆菌)补充剂的益生菌给药方案。筛选了 2003 年 8 月至 2011 年 7 月期间入住 NICU 的患者。主要结局是 NEC 的发病率和死亡率。次要结局是 NEC 的严重程度和停止婴儿喂养但未诊断 NEC(NEC 恐慌)的发生率。
益生菌组 NEC 发展的基线风险显著增加,包括胎龄较小、动脉导管未闭(PDA)发生率较高和使用吲哚美辛。对照组(2.8%)和益生菌组(2.4%)的 NEC 发生率相似(危险比,1.15;95%置信区间 [CI],0.42,3.12)。NEC 的死亡率也无统计学差异。NEC 恐慌的发生率从对照组的 2.8%下降到益生菌组的 1.4%,尽管差异无统计学意义(P=0.38)。
我们的研究结果表明,益生菌在预防 VLBW 婴儿 NEC 方面是安全的。我们没有发现与我们产品中使用的细菌菌株有关的感染病例。在我们的队列中,NEC(2.8%)和 NEC 恐慌(2.8%)的发生率较低,我们没有足够的能力检测到任何结局的变化,特别是因为我们的研究是观察性的。然而,我们希望我们的数据为其他人在 VLBW 婴儿的常规临床管理中使用益生菌预防性治疗提供有用的信息。