Safety of histamine-2 receptor blockers in hospitalized VLBW infants.
Safety of histamine-2 receptor blockers in hospitalized VLBW infants.
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DOI：
10.1016/j.earlhumdev.2016.05.010
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发表时间：
2016-08
影响因子：
2.5
通讯作者：
Best Pharmaceuticals for Children Act – Pediatric Trials Network
中科院分区：
文献类型：
--
作者：
Romaine A;Ye D;Ao Z;Fang F;Johnson O;Blake T;Benjamin DK Jr;Cotten CM;Testoni D;Clark RH;Chu VH;Smith PB;Hornik CP;Best Pharmaceuticals for Children Act – Pediatric Trials Network
尽管缺乏人群特异性疗效和安全性数据，但组胺-2受体（H2）阻滞剂通常用于极低出生体重儿。我们试图描述住院极低出生体重（VLBW）婴儿使用组胺-2受体（H2）阻滞剂的安全性和时间趋势。我们使用美国348个新生儿重症监护病房共享的电子健康记录填充的临床数据库进行了一项回顾性队列研究。我们纳入了所有无重大先天性异常的VLBW婴儿。我们使用多变量逻辑回归和广义估计方程来评估H2受体阻滞剂暴露天数与以下风险之间的关联：1）死亡或坏死性小肠结肠炎（NEC）; 2）死亡或败血症; 3）死亡、NEC或败血症。在127，707名婴儿中，20，288名（16%）暴露于H2受体阻滞剂共6，422，352天。暴露于H2受体阻滞剂的婴儿的中位胎龄为27周（第25 - 75百分位数26，29）。H2阻滞剂的使用从1997年的18%下降到2012年的8%（p<0.001）。在多变量分析中，暴露于H2阻滞剂的婴儿死亡、NEC或脓毒症的综合结局风险增加（比值比= 1.14（95%置信区间1.08，1.19）。H2受体阻滞剂的使用与住院VLBW婴儿死亡、NEC或败血症的联合结局风险增加相关。
Histamine-2 receptor (H2) blockers are often used in very low birth weight infants despite lack of population specific efficacy and safety data. We sought to describe safety and temporal trends in histamine-2 receptor (H2) blocker use in hospitalized very low birth weight (VLBW) infants. We conducted a retrospective cohort study using a clinical database populated by an electronic health record shared by 348 neonatal intensive care units in the United States. We included all VLBW infants without major congenital anomalies. We used multivariable logistic regression with generalizing estimating equations to evaluate the association between days of H2 blocker exposure and risk of: 1) death or necrotizing enterocolitis (NEC); 2) death or sepsis; and 3) death, NEC, or sepsis. Of 127,707 infants, 20,288 (16%) were exposed to H2 blockers for a total of 6,422,352 days. Median gestational age for infants exposed to H2 blockers was 27 weeks (25th 75th percentile 26, 29). H2 blocker use decreased from 18% of infants in 1997 to 8% in 2012 (p<0.001). On multivariable analysis, infants were at increased risk of the combined outcome of death, NEC, or sepsis on days exposed to H2 blockers (odds ratio = 1.14 (95% confidence interval 1.08, 1.19). H2 blocker use is associated with increased risk of the combined outcome of death, NEC, or sepsis in hospitalized VLBW infants.