PEDIATRIC PHARMACOLOGY RESEARCH UNIT

1968年，Harry Shirkey博士创造了“治疗孤儿”一词， 遗憾的是，缺乏信息，以指导安全和 在婴儿和儿童中有效使用药物。尽管几乎 三十年来药物治疗的进步 改善这种情况。本文详细介绍的建议是 旨在确保资金，以支持研究的内部结构， 作为研究中心网络的一部分， 能够开发，启动和进行单站点和多站点， 婴儿和儿童药物治疗的机构研究。的 这些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 并为美国食品和药物管理局提供必要的临床数据。 用于儿童的行政许可。药物中心 凯斯韦斯特儿科研究（CDR） 储备大学的指导下，杰弗里L。布鲁默博士， M.D.拥有近十年的开发和管理经验， 婴儿和儿童的药物临床试验。拟 CDR作为行政和执行 儿科网络中一个单位的框架 国家药物研究所提出的药理学研究单位 儿童健康和人类发展。为此， 提出的具体目标，将有助于锚 网络具体而言，提出了两项合作建议， 与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 药物动力学和药效学的比较 多巴胺和多巴酚丁胺在心脏术后患者中的应用 异丙酚镇静辅助机械通气在老年患者中的应用 危重病人。历史悠久的例子 CDR和制药公司之间富有成效的合作 1）环丙沙星在患者中的药理学 囊性纤维化（CF）;和2）安全性、耐受性和 单次静脉给药的药代动力学评价 美罗培南在住院婴儿和儿童中的应用铸件的二种 CDR启动的方案的实例描述于：1）布美他尼 婴儿液体中的药代动力学和药效学 过载;和2）比较的疗效和安全性 小儿氯胺酮-咪达唑仑-阿托品改为哌替啶-咪达唑仑 肿瘤手术。最后，对中心的描述 组织、环境和专业培训环境是 提供了

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.