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.

项目摘要/摘要 聚乙二醇3350是一种聚合物药物，通常用于治疗便秘和结肠清洁。 结肠镜检查。尽管PEG3350只被美国食品和药物管理局批准用于17岁以下的人≥，但没有 在七天多的时间里，这种药物通常在幼儿中使用，通常是成人剂量，持续数月 或者一次几年。儿童使用或长时间使用PEG3350的安全性尚不清楚。 此外，尽管聚乙二醇3350是一种吸收能力很差的聚合物，但这种药物的批次经过了 FDA已被发现含有少量的低分子化合物(如乙二醇和 二甘醇)，可能会被吸收，已知在足够高的剂量下是有毒的。最后，一些 给孩子服用PEG3350的家庭向FDA报告了他们的症状 可能是由于摄入了聚乙二醇3350而引起的。尤其令人担忧的是，PEG3350 这些成分可能会导致神经行为症状。为了解决聚乙二醇3350对儿童的潜在毒性 (作为回应RFA-FD-14-088)我们计划开发对PEG3350组分的异常灵敏的分析方法 和被认为有潜在毒性的代谢物，招募儿童，收集生物杀虫剂，收集详细的链接 临床和行为数据，并分析血清标本。具体来说，我们将收集儿童的血清 服用聚乙二醇3350治疗便秘，但没有潜在的肠道问题或神经行为 有问题。我们还将收集有肠道问题的儿童的血清，这些儿童可能容易患上 聚乙二醇3350成分吸收增加或有潜在神经或神经行为问题的人 这可能会使它们对聚乙二醇3350成分更加敏感。我们还将收集神经行为数据和 每个儿童的临床病史，以及部分儿童的大便和尿液。此外，我们还将招收儿童 他们没有服用PEG3350，以防在来自以下儿童的生物标本中检测到意外的代谢物 正在服用聚乙二醇3350。样品分析将使用最先进的设备在新陈代谢 疾病实验室在我们的机构，费城儿童医院。作为一名大型儿科医生 胃肠病组自PEG3350问世以来，我们一直向许多儿童推荐这种药物 已获FDA批准用于成人使用，我们非常有兴趣与FDA合作评估 这种药是儿童用的。