PEDIATRIC PHARMACOLOGY RESEARCH UNIT

1968年，哈里·舍基博士创造了“治疗性孤儿”一词 遗憾的是，可用来指导国家安全局和 婴儿和儿童的有效用药。尽管几乎 三十年来，药物治疗的进展甚微。 这种情况的改善。在此详述的建议是 旨在获得资金以支持研究的内部结构 作为研究中心网络的一部分，一个中心将是 能够开发、启动和实施单站点和多站点 婴幼儿药物治疗的机构研究。这个 这些研究的目的将是为以下各项提供客观依据 选择治疗药物在这些患者中的合理使用 并为美国食品和药物管理局提供必要的临床数据 用于儿童的行政审批。药物研究中心 凯斯韦斯特大学儿科研究(CDR) 在杰弗里·L·布鲁默博士的指导下， M.D.拥有近十年的开发和指挥经验 婴儿和儿童的药物临床试验。有建议说 CDR作为管理和实施 儿科网络中的一个单位的框架 美国国家药理学研究所建议成立的药理研究单位 儿童健康与人类发展。为此，有几项研究是 提出以满足特定目标，这些目标将有助于 网络。具体地说，概述了两项关于协作的建议 与药物动力学和药物动力学相关的多中心临床试验 儿童药效学：1)随机、双盲 阿司匹林的药代动力学与药效学比较 心脏术后患者的多巴胺和多巴酚丁胺 异丙酚用于机械通气的镇静作用 危重病人。的悠久历史的例子 美国疾病控制与预防中心与制药公司之间富有成效的合作 行业详情如下：1)环丙沙星在患者中的药理 囊性纤维化(CF)；2)安全性、耐受性和 单次静脉给药的药代动力学研究 美罗培南在住院婴幼儿中的应用此外，还有两个 CDR发起的提案的例子描述在：1)丁美坦尼 婴儿积液的药代动力学和药效学研究 超负荷；2)疗效和安全性的比较 氯胺酮-咪达唑仑-阿托品与度冷丁-咪达唑仑在儿科的应用 肿瘤学手术。最后，对中心的描述 组织、环境和专业培训环境是 如果是这样的话。

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.