Hegar Badriul, Alatas Safira, Advani Najib, Firmansyah Agus, Vandenplas Yvan
Department of Child Health, University of Indonesia, Jakarta, Indonesia.
Acta Paediatr. 2009 Apr;98(4):750-5. doi: 10.1111/j.1651-2227.2008.01158.x. Epub 2008 Dec 10.
Although domperidone is used frequently to treat infant regurgitation, efficacy data are scarce. Cisapride was previously used in the same indication.
Domperidone and cisapride were compared in an investigator-blinded, prospective comparative trial by evaluating (a) the frequency of regurgitation, (b) acid reflux and (c) cardiac side effects in infants regurgitating >4 times/day since >2 weeks and with reflux-associated symptoms of discomfort, after conservative treatment failure.
Within the first treatment week, the frequency of regurgitation decreased in both groups, more rapidly in the cisapride group: the median regurgitation decreased from 6.22 to 3.50 in the cisapride group versus from 4.80 to 3.70 in the domperidone group. The decrease in regurgitation was still significant after 1 month: cisapride from 6.22 to 1.55 versus domperidone from 4.80 to 1.25. However, the natural decrease in the incidence of regurgitation induced by age should also be considered. The median reflux index decreased after 1 month in the cisapride group from 3.60 to 1.75 versus from 2.70 to 2.45 in the domperidone group. One child treated with cisapride developed a significant QT prolongation.
The decrease in regurgitation was comparable in both groups, although acid reflux decreased more in the cisapride group. Cisapride induced QT prolongation in one infant.
尽管多潘立酮常用于治疗婴儿反流,但疗效数据稀缺。西沙必利曾用于相同适应症。
在一项研究者设盲的前瞻性对照试验中,对多潘立酮和西沙必利进行比较,评估自2周龄起每日反流超过4次且伴有反流相关不适症状、保守治疗失败的婴儿的(a)反流频率、(b)胃酸反流和(c)心脏副作用。
在治疗的第一周内,两组的反流频率均下降,西沙必利组下降更快:西沙必利组反流次数中位数从6.22降至3.50,而多潘立酮组从4.80降至3.70。1个月后反流次数的减少仍具有显著性:西沙必利组从6.22降至1.55,多潘立酮组从4.80降至1.25;然而,也应考虑年龄引起的反流发生率的自然下降。西沙必利组1个月后反流指数中位数从3.60降至1.75,而多潘立酮组从2.70降至2.45。一名接受西沙必利治疗的儿童出现显著的QT间期延长。
两组反流次数的减少相当,尽管西沙必利组胃酸反流减少更多。西沙必利在一名婴儿中引起QT间期延长。