Ormarsson Orri Thor, Asgrimsdottir Gudrun Marta, Loftsson Thorsteinn, Stefansson Einar, Lund Sigrun Helga, Bjornsson Einar Stefan
Landspitali-University Hospital, Reykjavík, Iceland.
Lipid Pharmaceuticals, Reykjavík, Iceland.
Acta Paediatr. 2016 Jun;105(6):689-94. doi: 10.1111/apa.13394. Epub 2016 Apr 8.
A well-documented, clinically proven per rectum treatment for childhood constipation is needed. This phase two clinical trial evaluated the efficacy of suppositories containing free fatty acids (FFA) compared with Klyx docusate sodium and sorbitol enemas.
A randomised, controlled, single-blind study was undertaken on 77 children aged between one and 17 who presented to an emergency department in Iceland and were diagnosed with constipation. In stage one, 23 patients were randomised to receive lower dose FFA suppositories or Klyx (n = 33). In stage two, 21 different patients were randomised to receive higher dose suppositories and compared with the same Klyx control subjects.
The suppositories were effective at bowel emptying in 39% of the group who received the lower FFA doses and 81% of the group receiving higher doses, compared with 88% in the Klyx control group. Symptom relief was obtained in 30% of the group receiving the lower doses and 71% of the group receiving the higher doses, compared with 73% in the control group.
The higher dose FFA suppositories were as effective as the Klyx enemas with regard to bowel emptying and symptom relief and might provide an important and less invasive alternative for childhood constipation.
需要一种有充分文献记载且经临床验证的儿童便秘直肠治疗方法。这项二期临床试验评估了含游离脂肪酸(FFA)栓剂与克利克斯(Klyx)多库酯钠和山梨醇灌肠剂相比的疗效。
对冰岛一家急诊科收治的77名年龄在1至17岁且被诊断为便秘的儿童进行了一项随机、对照、单盲研究。在第一阶段,23名患者被随机分配接受低剂量FFA栓剂或克利克斯(n = 33)。在第二阶段,21名不同的患者被随机分配接受高剂量栓剂,并与相同的克利克斯对照组进行比较。
与克利克斯对照组的88%相比,接受低剂量FFA的组中有39%的患者在排便时栓剂有效,接受高剂量FFA的组中有81%的患者有效。接受低剂量FFA的组中有30%的患者症状得到缓解,接受高剂量FFA的组中有71%的患者症状得到缓解,而对照组为73%。
高剂量FFA栓剂在排便和缓解症状方面与克利克斯灌肠剂一样有效,可能为儿童便秘提供一种重要且侵入性较小的替代方法。