Cucchiara S, Staiano A, Capozzi C, Di Lorenzo C, Boccieri A, Auricchio S
Arch Dis Child. 1987 May;62(5):454-7. doi: 10.1136/adc.62.5.454.
Twenty children (age range 75 days-47 months) with reflux oesophagitis entered a random double blind trial in which they received either Cisapride (Janssen Pharmaceutical Ltd), a new prokinetic agent, or an identical placebo syrup. Diagnosis of gastro-oesophageal reflux was made by measurement of intraluminal oesophageal pH combined with manometry. Oesophagitis was assessed in all patients by histological examination of mucosal specimens taken during oesophagogastroduodenoscopy. Manometry, pH test, and endoscopy with biopsy examination were repeated at the end of the treatment period. Seventeen patients completed the trial, eight of whom were taking the drug and nine the placebo. Mean total clinical score and post-prandial reflux time (% of reflux) significantly improved in patients in the group given Cisapride but not in the group given placebo. Furthermore, there was a significant improvement of the histological oesophagitis score only in the children in the group given Cisapride, whereas placebo was ineffective. It is concluded that Cisapride is a useful agent both for the relief of symptoms of gastro-oesophageal reflux and for the healing of peptic oesophagitis in infancy.
20名患有反流性食管炎的儿童(年龄范围为75天至47个月)进入了一项随机双盲试验,他们分别接受了新型促动力剂西沙必利(杨森制药有限公司生产)或一种外观相同的安慰剂糖浆。通过测量食管腔内pH值并结合测压法来诊断胃食管反流。通过对在食管胃十二指肠镜检查期间采集的黏膜标本进行组织学检查,对所有患者的食管炎进行评估。在治疗期结束时重复进行测压、pH测试以及活检内镜检查。17名患者完成了试验,其中8名服用药物,9名服用安慰剂。服用西沙必利组患者的平均总临床评分和餐后反流时间(反流百分比)显著改善,而服用安慰剂组则没有。此外,仅服用西沙必利组的儿童组织学食管炎评分有显著改善,而安慰剂无效。结论是,西沙必利对于缓解婴儿胃食管反流症状以及治愈消化性食管炎是一种有用的药物。