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，哈里·雪奇（Harry Shirkey）博士创造了“治疗性孤儿”一词 哀叹可用于指导安全和的信息的匮乏 有效使用婴儿和儿童的药物。尽管差不多 药物治疗的三十年进步几乎没有 在这种情况下的改善。本文详细介绍的建议是 旨在确保资金支持 作为研究中心网络的一部分的中心将是 能够开发，启动和进行单个站点和多数 婴儿和儿童药物治疗的机构研究。这 此类研究的目的将为客观依据 这些患者中选定的治疗剂的合理使用 并提供美国食品和药物所需的临床数据 管理批准用于儿童。毒品中心 Case Western的儿科研究部的研究（CDR） 储备大学在Jeffrey L. Blumer博士的指导下 医学博士在开发和进行工作中拥有将近十年的经验 婴儿和儿童药物的临床试验。它是提出的 CDR充当行政和实施 小儿网络中一个单元之一的框架 国家研究所提出的药理学研究单位 儿童健康和人类发展。为此，几项研究是 提议满足将有助于锚定的特定目标 网络。具体而言，概述了两个提案以进行协作 多中心临床试验与药代动力学和 儿童的药效学：1）随机，双盲 比较药代动力学和药效学 术后心脏患者的多巴胺和多巴胺； 2） 丙泊酚作为镇静剂，以促进机械通气 重病患者。漫长历史的例子 CDR与药品之间的富有成果的合作 行业详细介绍：1）患者环丙沙星药理学 囊性纤维化（CF）； 2）安全性，宽容和 单次静脉注射剂量的药代动力学评估 医院婴儿和儿童中的美皮烯类。另外，两个 CDR发起的提案的示例如下：1）Bumetanide 液体婴儿的药代动力学和药效学 超载; 2）比较的功效和安全性 氯胺酮 - 米多唑仑 - 原子石到小儿替代替代氨酸的莫达唑仑 肿瘤学程序。最后，对中心的描述 组织，环境和专业培训环境是 假如。