PEDIATRIC PHARMACOLOGY RESEARCH UNIT

儿科药理学研究室

• 批准号: 2203788
• 负责人: JEFFREY L. BLUMER
• 金额: $ 18.75万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-09-29 至 1998-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2203788
• 关键词: artificial respiration; blood chemistry; child (0-11); clinical trials; cooperative study; dobutamine; dopamine; drug screening /evaluation; heart disorder chemotherapy; human subject; human therapy evaluation; infant human (0-1 year); pediatric pharmacology; pharmacokinetics; postoperative state; sedative /hypnotic; urinalysis

In 1968 Dr. Harry Shirkey coined the term "therapeutic orphans" to lament the paucity of information available to guide the safe and effective use of drugs in infants and children. Despite almost three decades of advances in drug therapy there has been little improvement in this situation. The proposal detailed herein is aimed at securing funding to support the research intrastructure of a center, which as part of a network of research centers, will be able to develop, initiate and conduct both single site and multi- institutional studies of drug therapy in infants and children. The purpose of such studies will be to provide an objective basis for the rational use of selected therapeutic agents in these patients and to provide the clinical data necessary for U.S. Food and Drug Administration approval for use in children. The Center for Drug Research (CDR) in the Department of Pediatrics at Case Western Reserve University under the direction of Jeffrey L. Blumer, Ph.D., M.D. has an almost ten year experience in developing and conducting clinical trials of drugs in infants and children. It is proposed that the CDR serve as the administrative and implementation framework for one of the units in the Network of Pediatric Pharmacology Research Units proposed by the National Institute of Child Health and Human Development. To this end several studies are proposed to meet the specific aims that will serve to anchor the Network. Specifically, two proposals are outlined for collaborative multi-center clinical trials related to pharmacokinetics and pharmacodynamics in children: 1) Randomized, Double-Blind Comparisons of the Pharmacokinetics and Pharmacodynamics of Dopamine and Dobutamine in Postoperative Cardiac Patients; 2) Propofol as a Sedative to Facilitate Mechanical Ventilation in Critically Ill Patients. Examples of the long history of the fruitful collaboration between the CDR and the pharmaceutical industry are detailed in: 1) Ciprofloxacin Pharmacology in Patients with Cystic Fibrosis (CF); and 2) Safety, Tolerance and Pharmacokinetic Evaluation of a Single Intravenous Dose of Meropenem in Hospitalized Infants and Children. In addition, two examples of CDR initiated proposals are described in: 1) Bumetanide Pharmacokinetics and Pharmacodynamics in Infants with Fluid Overload; and 2) A Comparison of the Efficacy and Safety of Ketamine-Midazolam-Atropine to Meperidine-Midazolam for Pediatric Oncologic Procedures. Finally, a description of the Center organization, environment, and professional training milieu is provided.

1968 年，Harry Shirkey 博士创造了“治疗性孤儿”一词 遗憾的是，可用于指导安全和安全的信息太少 婴儿和儿童有效使用药物。尽管几乎 药物治疗三十年来取得的进展几乎没有 这种情况的改善。本文详细介绍的提案是 旨在确保资金支持研究机构 一个中心，作为研究中心网络的一部分，将 能够开发、发起和进行单站点和多站点 婴儿和儿童药物治疗的机构研究。这 此类研究的目的是为以下方面提供客观基础： 在这些患者中合理使用选定的治疗药物 并提供美国食品药品监督管理局所需的临床数据 主管部门批准用于儿童。药物中心 Case Western 儿科研究 (CDR) 储备大学在 Jeffrey L. Blumer 博士的指导下， M.D. 在开发和实施方面拥有近十年的经验 婴儿和儿童药物的临床试验。建议 CDR作为行政和执行机构 儿科网络中的一个单位的框架 国立药理学研究所提出的药理研究单位 儿童健康和人类发展。为此，进行了多项研究 提出的具体目标将有助于巩固 网络。具体而言，概述了两项合作建议 药代动力学相关的多中心临床试验 儿童药效学：1) 随机、双盲 药代动力学和药效学比较 心脏病术后患者的多巴胺和多巴酚丁胺； 2） 异丙酚作为镇静剂促进机械通气 危重病人。悠久历史的例子 CDR与制药公司之间富有成效的合作 行业详述： 1) 环丙沙星在患者中的药理学 囊性纤维化 (CF)； 2) 安全性、耐受性和 单次静脉注射剂量的药代动力学评价 美罗培南在住院婴儿和儿童中的应用。此外，还有两个 CDR 发起提案的示例描述于：1) 布美他尼 婴儿液体的药代动力学和药效学 超载; 2) 功效和安全性比较 儿童用氯胺酮-咪达唑仑-阿托品至哌替啶-咪达唑仑 肿瘤程序。最后简单介绍一下中心 组织、环境和专业培训环境 假如。