*Louisiana State University and Children's Hospital, New Orleans, LA †Nationwide Children's Hospital, Columbus, OH ‡Boys Town National Research Hospital, Boys Town, NE §Digestive Healthcare Center, Hillsborough, NJ ||Sucampo Pharmaceuticals, Zug, Switzerland and Bethesda, MD.
J Pediatr Gastroenterol Nutr. 2014 Mar;58(3):283-91. doi: 10.1097/MPG.0000000000000176.
Pediatric functional constipation is common; effective, easily administered treatment options are limited. Lubiprostone is an oral chloride channel protein-2 activator that stimulates gastrointestinal fluid secretion, softens stools, and facilitates bowel movements (BMs). We evaluated the safety and effectiveness of lubiprostone in children and adolescents with functional constipation.
Patients ≥12 kg, 17 years or younger, and with <3 spontaneous BMs (SBMs; ie, BMs that did not occur within 24 hours of rescue medication use) per week were enrolled at 22 US general pediatric and pediatric gastroenterology centers (January 2007-October 2008). Patients received 4 weeks of open-label lubiprostone at doses of 12 μg once daily (QD), 12 μg twice daily (BID), or 24 μg BID based on age and weight. The primary endpoint was SBM frequency during week 1 versus baseline.
Of 127 enrolled patients, 124 were treated and analyzed (12 μg QD, n = 27; 12 μg BID, n = 65; 24 μg BID, n = 32), and 109 completed the study. The mean age of treated patients was 10.2 years (range 3-17 years); 65 were boys. Mean SBM frequency significantly increased compared with baseline at week 1 (3.1 vs. 1.5 SBMs/week, P < 0.0001). SBM frequency was improved significantly from baseline overall (P < 0.0001) and for individual dose groups (P ≤ 0.0062) during weeks 2, 3, and 4. Common (≥5%) adverse events included nausea (18.5%), vomiting (12.1%), diarrhea (8.1%), abdominal pain (7.3%), and headache (5.6%). Two patients experienced serious adverse events (unrelated abdominal pain; unrelated sickle cell crisis).
Lubiprostone was efficacious and well tolerated in children and adolescents with functional constipation.
小儿功能性便秘较为常见；有效且易于实施的治疗方法有限。鲁比前列酮是一种口服氯离子通道蛋白-2 激活剂，可刺激胃肠道分泌液，软化粪便，并促进排便（BM）。我们评估了鲁比前列酮在功能性便秘儿童和青少年中的安全性和有效性。
体重≥12kg、年龄 17 岁或以下、每周自发性排便次数（SBM）少于 3 次（即使用解救药物后 24 小时内未排便）的患者在 22 家美国普通儿科和儿科胃肠病学中心入组（2007 年 1 月至 2008 年 10 月）。患者接受为期 4 周的鲁比前列酮开放标签治疗，剂量为根据年龄和体重，每日 12μg 一次（QD）、每日 12μg 两次（BID）或每日 24μg BID。主要终点为第 1 周与基线相比 SBM 频率。
127 名入组患者中，124 名接受治疗并进行分析（12μg QD，n=27；12μg BID，n=65；24μg BID，n=32），109 名完成研究。治疗患者的平均年龄为 10.2 岁（范围 3-17 岁）；65 名男性。与基线相比，第 1 周 SBM 频率显著增加（3.1 次/周 vs. 1.5 次/周，P<0.0001）。SBM 频率在整个研究期间（P<0.0001）和各个剂量组（P≤0.0062）均显著改善。常见（≥5%）不良事件包括恶心（18.5%）、呕吐（12.1%）、腹泻（8.1%）、腹痛（7.3%）和头痛（5.6%）。两名患者发生严重不良事件（无关腹痛；无关镰状细胞危象）。
鲁比前列酮在功能性便秘儿童和青少年中有效且耐受性良好。
