Emma Children's Hospital/Academic Medical Center, Department of Paediatric Gastroenterology and Nutrition, Meibergdreef 9, H7-225, 1105 AZ Amsterdam, The Netherlands.
Expert Opin Drug Saf. 2012 Jan;11(1):71-82. doi: 10.1517/14740338.2011.604631. Epub 2011 Jul 29.
Functional constipation is a common and often enduring problem in childhood. Although functional constipation is well defined by the Rome III criteria, these criteria have not always been integrated in general practice. Early diagnosis and treatment are key factors with respect to successful long-term outcome, as chronic constipation has a negative effect on the quality of life and is a burden for the public healthcare system. The safety of laxatives used for paediatric-functional constipation is based on well-designed trials carried out mostly in adults. Therefore, we conducted a review of the literature outlining the evidence for the efficacy and safety of laxatives used in chronic paediatric-functional constipation.
This review clearly shows a lack of large well-designed placebo-controlled trials in children with constipation. Therefore, any interpretation with regards to the evidence for the effectiveness or safety of laxatives used in children is difficult and we extended the search for side effects to the adult literature.
In adults, new promising drugs are on the virtue of breaking through in the treatment of chronic constipation. Carrying out well-defined placebo-controlled trials in children should be the next step before using these drugs.
功能性便秘是儿童期常见且常持续存在的问题。尽管罗马 III 标准对功能性便秘进行了明确定义，但这些标准在一般实践中并未得到普遍应用。早期诊断和治疗是成功长期治疗结果的关键因素，因为慢性便秘会对生活质量产生负面影响，且会给公共医疗保健系统带来负担。用于治疗儿童功能性便秘的泻药的安全性是基于在成人中进行的精心设计的试验。因此，我们对文献进行了综述，概述了在慢性儿童功能性便秘中使用泻药的疗效和安全性的证据。
这篇综述清楚地表明，在患有便秘的儿童中缺乏大型精心设计的安慰剂对照试验。因此，对于在儿童中使用的泻药的有效性或安全性的任何解释都很困难，我们将对副作用的搜索扩展到成人文献。
在成年人中，新的有前途的药物在治疗慢性便秘方面取得了突破。在使用这些药物之前，应该在儿童中进行明确的安慰剂对照试验。
