Friesen Craig A, Schurman Jennifer V, Abdel-Rahman Susan M
Craig A Friesen, Division of Gastroenterology, Hepatology, and Nutrition, Children's Mercy Kansas City, Kansas City, MO 64108, United States.
World J Gastrointest Pharmacol Ther. 2015 Nov 6;6(4):96-104. doi: 10.4292/wjgpt.v6.i4.96.
At the present time, it is nearly impossible to treat pediatric functional gastrointestinal disorders associated with pain in an evidence based fashion. This is due to the overall lack of controlled studies and, even more importantly, the complexity of the contributors to disease phenotype which are not controlled or accounted for in most therapeutic trials. In this manuscript, we review the challenges of defining entry criteria, controlling for the large number of biopsychosocial factors which may effect outcomes, and understanding pharmacokinetic and pharmacodynamic factors when designing therapeutic trials for abdominal pain in children. We also review the current state of pediatric abdominal pain therapeutics and discuss trial design considerations as we move forward.
目前，以循证医学的方式治疗与疼痛相关的儿童功能性胃肠疾病几乎是不可能的。这是由于总体上缺乏对照研究，更重要的是，疾病表型的影响因素复杂，在大多数治疗试验中未得到控制或考虑。在本手稿中，我们回顾了在为儿童腹痛设计治疗试验时，确定纳入标准、控制可能影响结果的大量生物心理社会因素以及理解药代动力学和药效学因素所面临的挑战。我们还回顾了儿童腹痛治疗的现状，并讨论了未来试验设计的考虑因素。
