Gharial Jaspreet, Laving Ahmed, Were Fred
Department of Paediatrics , Gertrude's Children's Hospital , Nairobi , Kenya.
Department of Paediatrics and Child Health, University of Nairobi College of Health Sciences, Nairobi, Kenya; Department of Paediatrics, Aga Khan University, Nairobi, Kenya.
BMJ Open Gastroenterol. 2017 Jan 3;4(1):e000124. doi: 10.1136/bmjgast-2016-000124. eCollection 2017.
Diarrhoea is the second most common cause of death in children under 5 years of age in Kenya. It is usually treated with oral rehydration, zinc and continued feeding. Racecadotril has been in use for over 2 decades; however, there is a paucity of data regarding its efficacy from Africa.
The objectives of this study were: to compare the number of stools in the first 48 hours in children with severe gastroenteritis requiring admission and treated with either racecadotril or placebo, to study the impact of racecadotril on duration of inpatient stay as well as duration of diarrhoea and to describe the side effect profile of racecadotril.
This was a randomised, double-blinded, placebo-controlled trial. It enrolled children between the age of 3 and 60 months who were admitted with severe acute gastroenteritis. They received either racecadotril or placebo in addition to oral rehydration solution (ORS) and zinc and were followed up daily.
120 children were enrolled into the study. There were no differences in the demographics or outcomes between the 2 groups. Stools at 48 hours: median (IQR) of 5 (3-7) and 5 (2.5-7.5), respectively; p=0.63. The duration of inpatient stay: median (IQR): 4 days (1.5-6.5) and 4.5 (1.8-6.3); p=0.71. The duration of illness: 3 days (2-4) and 2 days (1-3); p=0.77. The relative risk of a severe adverse event was 3-fold higher in the drug group but was not statistically significant (95% CI 0.63 to 14.7); p=0.16.
Racecadotril has no impact on the number of stools at 48 hours, the duration of hospital stay or the duration of diarrhoea in children admitted with severe gastroenteritis and managed with ORS and zinc.
PACTR201403000694398; Pre-results.
腹泻是肯尼亚5岁以下儿童第二大常见死因。通常采用口服补液、补锌及继续喂养的方法进行治疗。消旋卡多曲已使用20多年；然而，非洲地区关于其疗效的数据较少。
本研究的目的是：比较因严重胃肠炎入院并接受消旋卡多曲或安慰剂治疗的儿童在最初48小时内的排便次数，研究消旋卡多曲对住院时间以及腹泻持续时间的影响，并描述消旋卡多曲的副作用情况。
这是一项随机、双盲、安慰剂对照试验。纳入3至60个月因严重急性胃肠炎入院的儿童。除口服补液盐（ORS）和锌外，他们分别接受消旋卡多曲或安慰剂治疗，并每日进行随访。
120名儿童纳入研究。两组在人口统计学特征或结局方面无差异。48小时时的排便次数：中位数（四分位间距）分别为5次（3 - 7次）和5次（2.5 - 7.5次）；p = 0.63。住院时间：中位数（四分位间距）为4天（1.5 - 6.5天）和4.5天（1.8 - 6.3天）；p = 0.71。疾病持续时间：3天（2 - 4天）和2天（1 - 3天）；p = 0.77。药物组严重不良事件的相对风险高3倍，但无统计学意义（95%置信区间0.63至14.7）；p = 0.16。
对于因严重胃肠炎入院并采用ORS和锌进行治疗的儿童，消旋卡多曲对48小时时的排便次数、住院时间或腹泻持续时间无影响。
PACTR201403000694398；预结果。
