Ng Steven Chin-Yuen, Gomez Joseph Manuel, Rajadurai Victor Samuel, Saw Seang-Mei, Quak Seng-Hock
Department of Neonatology, Children's Medical Institute, National University Hospital, Singapore.
J Pediatr Gastroenterol Nutr. 2003 Nov;37(5):554-8. doi: 10.1097/00005176-200311000-00009.
A prospective, double-blind, randomized, controlled trial was conducted to evaluate the effect of low-dose erythromycin on the time taken to attain full enteral feedings in preterm infants with very low birth weight and feeding intolerance.
Two groups of preterm infants (birth weight </= 1500 g) with feeding intolerance were randomized to either low-dose erythromycin (5 mg/kg every 8 hours) or 5% dextrose placebo, both of which were discontinued 1 week after full enteral feedings were tolerated. The primary outcome variable was the time taken to attain full enteral feedings of at least 130 mL/kg/d.
The gestational age at birth was similar in the two groups (erythromycin, 27.1 +/- 1.9 weeks; placebo, 27.5 +/- 2.9 weeks). The mean birth weight of the erythromycin group was lower (806.3 +/- 215.6 g) than the placebo group (981.4 +/- 285.4 g; P = 0.18), and included more infants who were small for gestational age (4/13 = 31% versus 1/11 = 9%; P = 0.224). There was no difference between the two groups with regard to the volume of feedings they were receiving at the time of enrollment. Reduction in symptoms of gastroesophageal reflux was similar in the two groups. 3 of 13 in the erythromycin group and 4 of 11 in the placebo group improved during the study (P = 0.565). The mean time to attain full enteral feedings after enrollment was 24.9 + 2.9 days in the erythromycin group and 30.8 +/- 4.1 days in the placebo group, a difference that did not reach statistical significance (P = 0.17).
Low-dose erythromycin did not reduce the time taken to attain full enteral feedings in preterm infants with very low birth weight and feeding intolerance. Gastroesophageal reflux decreased as a consequence of maturation of the gastrointestinal tract and not because of erythromycin. These preliminary results justify verification in larger multicenter trials.
进行一项前瞻性、双盲、随机对照试验,以评估低剂量红霉素对极低出生体重且有喂养不耐受的早产儿达到完全肠内喂养所需时间的影响。
两组有喂养不耐受的早产儿(出生体重≤1500g)被随机分为低剂量红霉素组(每8小时5mg/kg)或5%葡萄糖安慰剂组,在完全耐受肠内喂养1周后停止使用这两种药物。主要结局变量是达到至少130mL/kg/d完全肠内喂养所需的时间。
两组的出生孕周相似(红霉素组,27.1±1.9周;安慰剂组,27.5±2.9周)。红霉素组的平均出生体重(806.3±215.6g)低于安慰剂组(981.4±285.4g;P = 0.18),且孕周小于胎龄的婴儿更多(4/13 = 31%对1/11 = 9%;P = 0.224)。两组在入组时接受的喂养量方面没有差异。两组胃食管反流症状的减轻相似。红霉素组13例中有3例、安慰剂组11例中有4例在研究期间有所改善(P = 0.565)。入组后达到完全肠内喂养的平均时间在红霉素组为24.9 + 2.9天,在安慰剂组为30.8±4.1天,差异无统计学意义(P = 0.17)。
低剂量红霉素并未减少极低出生体重且有喂养不耐受的早产儿达到完全肠内喂养所需的时间。胃食管反流的减轻是由于胃肠道成熟,而非红霉素的作用。这些初步结果证明需要在更大规模的多中心试验中进行验证。