McGuirl Jennifer, Arzuaga Bonnie, Lee Ben H
Department of Pediatrics, Goryeb Children's Hospital, Atlantic Health System, Morristown, NJ 07960, USA.
Pediatr Cardiol. 2012 Jan;33(1):60-4. doi: 10.1007/s00246-011-0082-x. Epub 2011 Aug 23.
This study aimed to assess whether tocolytic fetal exposure to antenatal calcium channel blockers (aCCB) increases the risk for hemodynamically significant patent ductus arteriosus (hsPDA) in extremely low-birth-weight (ELBW) infants. This case-control study investigated ELBW infants (<1,000 g) without cardiac defects in a level 3 neonatal intensive care unit who had survived at least 7 days. Nifedipine was the only aCCB used for this study population. The measurements included the history of aCCB exposure, selected maternal data, hsPDA diagnosis, gestational age at birth, birth weight, mode of delivery, sex, maternal race, location of birth, Apgar scores, and selected neonatal morbidities. The end point of the study was hsPDA, defined as an echocardiographically confirmed PDA with clinical symptoms. A total of 180 infants met the study criteria. The diagnosis was hsPDA for 56% of these patients, 20% of whom had aCCB exposure. Of the infants without hsPDA, 11% had aCCB exposure (p = 0.09). No statistically significant associations were found between aCCB exposure and hsPDA after adjustment for gestational age (odds ratio [OR], 1.5; 95% confidence interval [CI], 0.6-3.7) or for gestational age and cumulative aCCB exposure of 100 mg or more (OR, 2.0; 95% CI, 0.6-6.5). A history of aCCB exposure does not appear to increase hsPDA risk in ELBW infants. Studies using neonatal serum nifedipine concentrations after antenatal exposure should be performed to confirm this conclusion.
本研究旨在评估产前使用钙通道阻滞剂(aCCB)进行保胎治疗时,胎儿暴露于该药物是否会增加极低出生体重(ELBW)婴儿发生血流动力学显著的动脉导管未闭(hsPDA)的风险。这项病例对照研究调查了三级新生儿重症监护病房中出生体重<1000g且无心脏缺陷、存活至少7天的婴儿。硝苯地平是本研究人群使用的唯一一种aCCB。测量指标包括aCCB暴露史、选定的母亲数据、hsPDA诊断、出生孕周、出生体重、分娩方式、性别、母亲种族、出生地点、阿氏评分以及选定的新生儿疾病。研究的终点是hsPDA,定义为经超声心动图证实且伴有临床症状的动脉导管未闭。共有180名婴儿符合研究标准。这些患者中56%被诊断为hsPDA,其中20%有aCCB暴露史。在无hsPDA的婴儿中,11%有aCCB暴露史(p = 0.09)。在对孕周进行调整后(比值比[OR],1.5;95%置信区间[CI],0.6 - 3.7),或对孕周以及累积aCCB暴露量达100mg或更多进行调整后(OR,2.0;95%CI,0.6 - 6.5),未发现aCCB暴露与hsPDA之间存在统计学显著关联。aCCB暴露史似乎不会增加ELBW婴儿发生hsPDA的风险。应开展研究,检测产前暴露于aCCB后新生儿血清硝苯地平浓度,以证实这一结论。