口服葡萄糖溶液治疗持续性无症状新生儿低血糖：一项随机、双盲、安慰剂对照试验。
完整摘要 · 中文译文
未标注：为评估50%葡萄糖溶液（D50W）治疗高危晚期早产儿和足月儿持续性无症状出生后低血糖的疗效及其对静脉（IV）葡萄糖治疗的影响。一项在泰国曼谷两家高危新生儿病房开展的多中心、随机、双盲、安慰剂对照试验。孕周≥34周、存在持续性无症状低血糖（定义为首次喂养后30分钟血糖水平仍低于出生后按年龄依赖的方案阈值）的高危新生儿，被随机分配接受颊黏膜D50W（200 mg/kg，0.4 mL/kg；OG组）或安慰剂，随后进行肠内喂养。主要结局为需要静脉葡萄糖治疗的婴儿比例。次要结局包括血糖（BG）水平变化和高血糖发生情况。共纳入400名婴儿（OG组：n = 205；安慰剂组：n = 195）。两组出生体重中位数相当。治疗前血糖水平相似（OG组37.0 [33.0, 39.0] mg/dL 对比安慰剂组37.0 [33.0, 39.0] mg/dL；p = 0.47）。OG组需要静脉葡萄糖治疗的比例较低，但差异无统计学意义（4.9% 对比 8.7%；p = 0.18）。治疗后血糖升高中位数OG组显著高于安慰剂组（28.0 [18.0, 40.0] 对比 22.5 [14.0, 35.0] mg/dL；p < 0.01）。两组均未发生高血糖。线性混合效应分析显示，D50W显著提高血糖浓度，而出生后日龄增加及小于或大于胎龄状态与血糖水平降低相关。 所有血糖反应。 结论：对无症状低血糖新生儿进行口腔颊黏膜给予50%葡萄糖水（D50W）并未显著减少静脉葡萄糖治疗的需求，尽管与安慰剂相比，其使血糖水平升高幅度更大。需要进一步研究以确定其在新生儿低血糖管理中的临床作用。 已知信息：• 口服40%葡萄糖凝胶被推荐用于无症状新生儿低血糖，但在许多资源匮乏的医疗环境中无法获得。• 静脉葡萄糖有效，但可能干扰母婴接触和母乳喂养。 新增信息：• 颊黏膜给予50%葡萄糖比安慰剂更能升高血糖，但并未减少静脉葡萄糖的使用。• 在常规临床监测期间，两组均未观察到高血糖、窒息、呕吐或黏膜刺激事件。 试验注册：泰国临床试验注册中心（TCTR），注册号TCTR20181204005，注册日期为2018年12月4日。https://www.thaiclinicaltrials.org/show/TCTR20181204005。
完整摘要 · 英文原文
UNLABELLED: To evaluate the efficacy of 50% dextrose solution (D50W) for treating persistent asymptomatic postnatal hypoglycemia in at-risk late preterm and term neonates and the effect on intravenous (IV) dextrose therapy. A multicenter, randomized, double-blind, placebo-controlled trial conducted at two high-risk nurseries in Bangkok, Thailand. At-risk neonates ≥ 34 weeks' gestation with persistent asymptomatic hypoglycemia, defined as a blood glucose level that remained below the postnatal, age-dependent protocol threshold 30 min after the first feeding, were randomized to receive either buccal D50W (200 mg/kg, 0.4 mL/kg; OG group) or placebo, followed by enteral feeding. The primary outcome was the proportion of infants requiring IV dextrose. Secondary outcomes included changes in blood glucose (BG) levels and hyperglycemia. Four-hundred infants were enrolled (OG: n = 205; placebo: n = 195). Median birthweight was comparable between groups. Pre-treatment BG levels were similar (OG 37.0 [33.0, 39.0] mg/dL vs. placebo 37.0 [33.0, 39.0] mg/dL; p = 0.47). The proportion requiring IV dextrose was lower in the OG group but did not differ significantly (4.9% vs. 8.7%; p = 0.18). Median BG increment post-treatment was significantly greater in the OG group than in the placebo group (28.0 [18.0,40.0] vs. 22.5 [14.0, 35.0] mg/dL; p < 0.01). Hyperglycemia did not occur in either group. Linear mixed-effects analysis demonstrated that D50W significantly increased BG concentrations, whereas increasing postnatal age and small- or large-for-gestational-age status were associated with smaller BG responses. CONCLUSIONS: Buccal D50W administration did not significantly reduce the need for IV dextrose therapy in asymptomatic neonates with hypoglycemia, although it resulted in a greater increase in BG levels than placebo. Further studies are needed to determine its clinical role in the management of neonatal hypoglycemia. WHAT IS KNOWN: • Oral 40% dextrose gel is recommended for asymptomatic neonatal hypoglycemia but is unavailable in many under-resourced healthcare settings. • Intravenous dextrose is effective but may disrupt mother-infant contact and breastfeeding. WHAT IS NEW: • Buccal 50% dextrose increased blood glucose more than placebo but did not reduce IV dextrose use. • No episodes of hyperglycemia, choking, vomiting, or mucosal irritation were observed in either group during routine clinical monitoring. TRIAL REGISTRATION: Thai Clinical Trials Registry (TCTR), TCTR20181204005, registered on December 4, 2018. https://www.thaiclinicaltrials.org/show/TCTR20181204005.