Polyethylene glycol safety in children

聚乙二醇对儿童的安全性

• 批准号: 8892324
• 负责人: ROBERT O HEUCKEROTH
• 金额: $ 32.5万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-10 至 2019-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8892324
• 关键词: Polyethylene; glycol; safety; children

Project Summary/Abstract PEG 3350 is polymeric medicine that is commonly used to treat constipation and for colon cleansing prior to colonoscopy. Although PEG 3350 is only approved by the U.S. FDA for use in people ≥17 years of age for no more than seven days, this medicine is very commonly used in young children, often at adult doses, for months or years at a time. The safety of PEG 3350 use by children or for prolonged periods is not known. Furthermore, although PEG 3350 is a polymer that is poorly absorbed, batches of this medicine tested by the FDA have been found to contain small amounts of low molecular weight compounds (e.g. ethylene glycol and diethylene glycol) that might be absorbed and are known to be toxic in high enough doses. Finally, some families who have given PEG 3350 to their children have reported symptoms to the FDA that they are concerned may have been caused by PEG 3350 ingestion. In particular, there is a concern that PEG 3350 components might cause neurobehavioral symptoms. To address the potential toxicity of PEG 3350 in children (in response RFA-FD-14-088) we plan to develop exceptionally sensitive assays for PEG 3350 components and metabolites thought to be potentially toxic, enroll children, collect biospecimens, collect detailed linked clinical and behavioral data, and analyze serum specimens. Specifically, we will collect serum from children who take PEG 3350 to treat constipation, but who do not have underlying bowel problems or neurobehavioral problems. We will also collect serum from children who have bowel problems that might predispose to increased PEG 3350 component absorption or who have underlying neurological or neurobehavioral problems that might make them more sensitive to PEG 3350 components. We will also collect neurobehavioral data and clinical history for each child, and stool and urine from a subset of children. In addition, we will enroll children who are not taking PEG 3350 in case unexpected metabolites are detected in biospecimens from children who are taking PEG 3350. Sample analysis will be performed using state-of-the-art equipment in the Metabolic Disease Laboratory at our institution, the Children’s Hospital of Philadelphia. As a large pediatric gastroenterology group we have recommended PEG 3350 to many children since this medicine was first approved by the FDA for adult use and we are very interested in working with the FDA to assess the safety of this medicine in children.

项目总结/摘要 PEG 3350是聚合物药物，其通常用于治疗便秘和用于在施用前清洁结肠。 结肠镜检查尽管PEG 3350仅被美国FDA批准用于年龄≥17岁的人群， 超过七天，这种药物是非常常用的幼儿，往往在成人剂量，数月 或者几年儿童或长期使用PEG 3350的安全性尚不清楚。 此外，尽管PEG 3350是一种吸收不良的聚合物，但由FDA测试的该药物批次 FDA已经发现含有少量的低分子量化合物（例如乙二醇和 二甘醇），其可能被吸收并且已知在足够高的剂量下是有毒的。最后是一些 给孩子服用PEG 3350的家庭向FDA报告了他们的症状， 可能是由PEG 3350摄入引起的。特别是，人们担心PEG 3350 成分可能导致神经行为症状。探讨PEG 3350在儿童中的潜在毒性 (in响应RFA-FD-14-088），我们计划开发PEG 3350组分的异常灵敏的测定方法 和代谢物被认为是潜在的毒性，招募儿童，收集生物标本，收集详细的链接 临床和行为数据，并分析血清样本。具体来说，我们将从儿童身上收集血清 服用PEG 3350治疗便秘，但没有潜在的肠道问题或神经行为问题 问题我们还将从患有肠道问题的儿童中收集血清，这些儿童可能会导致 PEG 3350成分吸收增加或有潜在神经或神经行为问题的患者 这可能使它们对PEG 3350成分更敏感。我们还将收集神经行为数据， 每个儿童的临床病史，以及来自儿童子集的粪便和尿液。此外，我们将招收儿童 未服用PEG 3350的儿童，以防在来自以下儿童的生物标本中检测到非预期代谢物： 正在服用PEG 3350将使用代谢分析中心的最先进设备进行样本分析。 疾病实验室在我们的机构，费城儿童医院。作为一个大型儿科 胃肠病学小组，我们已经建议PEG 3350许多儿童，因为这种药物是第一次 FDA批准成人使用，我们非常有兴趣与FDA合作评估 这种药在儿童。