口服红霉素治疗早产儿喂养不耐受的多中心临床对照研究

目的探讨口服不同剂量红霉素对早产儿喂养不耐受的治疗效果及可能存在的不良反应。方法选取2008年1月至2010年3月在广东省16家三级甲等医院新生儿科住院并诊断为喂养不耐受的早产儿,随机分为3组:大剂量组(第8～10日龄起口服红霉素12.5mg/kg,每8h给药,疗程7～10天),小剂量组(口服红霉素5mg/kg,给药方法同上),对照组(完全不用胃肠动力调节药物)。记录临床资料,比较各组患儿的喂养相关指标及宫外生长迟缓(EUGR)发生率等,并评估药物不良反应。结果纳入研究的患儿共122例,其中大剂量组37例,小剂量组47例,对照组38例。入组后两治疗组患儿体重增长速度、体重开始增长日龄、肠内热卡达到基础热卡日龄、达到全肠道喂养日龄及体重EUGR发生率等方面均较对照组明显改善(P<0.05),但按胎龄32周再分亚组后比较,以体重为指标EUGR发生率差异无统计学意义(P>0.05)。所有治疗组患儿随访6个月均未见明显红霉素不良反应。结论本研究中选取的两种剂量红霉素口服对早产儿(包括胎龄<32周者)喂养不耐受均有治疗作用,所采用的红霉素治疗方案未见明显不良反应。

A multi-center controlled trial of oral erythromycin for treatment of feeding intolerance in preterm infants

Objective To evaluate the effectiveness and possible side effects of different doses of oral erythromycin(EM) in treating preterm infants with feeding intolerance(FI).Methods Preterm infants admitted to 16 tertiary neonatal centers in Guangdong Province with FI diagnosis were enrolled from January,2008 to March,2010.The patients were assigned into 3 groups randomly:EM-HD group,oral erythromycin 12.5 mg/kg,every 8 hrs for 7-10 days;EM-LD group,oral erythromycin 5 mg/kg,every 8 hrs for 7-10 days;and control group,not using any drugs influencing gastrointestinal dynamics.Several critical indicators of feeding condition were compared,the incidence of extrauterine growth retardation(EUGR) and the potential adverse effects of erythromycin were also evaluated.Results A total of 122 patients were included,37 patients in the EM-HD group,47 in the EM-LD group,and 38 as control,The body weight growth rate,the time of initial body weight gain,the time when enteral feeding reaching 50 kcal/(kg·d) and the time establishing total enteral feeding were significantly shorter in two treatment groups than the control group.The incidences of EUGR assessed by weight at discharge were lower in two treatment groups than control group,but no statistically significant difference was found in these groups by gestational age.All enrolled infants were followed up from discharge to 6 months’ age,no obvious side effects were found in the treatment groups.Conclusions In this research,both doses of oral erythromycin were effective for treating preterm infants with FI,even in the infants with gestational age less than 32 weeks.There were no obvious side effects of oral erythromycin occured.