Obstetric-Fetal Pharmacology Research Units Network

产科-胎儿药理学研究单位网络

• 批准号: 7942483
• 负责人: GARY D HANKINS
• 金额: $ 23.5万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-01 至 2010-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7942483
• 关键词: Aneuploidy; Animal Model; Area; Aromatase; Blood Vessels; Caring; Chronic; Clinic; Clinical; Clinical Trials; Data; Diabetes Mellitus; Discipline of obstetrics; Doctor of Philosophy; Drug Kinetics; Enzymes; Evaluation; Evaluation Studies; Funding; Genetic Polymorphism; Head; Human; Human Chorionic Gonadotropin; Hypoglycemic Agents; In Vitro; Infection; Investigation; Laboratories; Ligands; Lobule; Magnesium Sulfate; Maternal Physiology; Maternal and Child Health; Mediating; Medical; Metabolic; Modeling; Multicenter Trials; Neonatal; Neonatology; Opiates; Outcome; Papio; Patient Recruitments; Perfusion; Pharmaceutical Preparations; Pharmacology; Physiology; Placenta; Population; Pregnancy; Pregnancy Proteins; Pregnant Women; Preparation; Primates; Protocols documentation; Research; Research Personnel; Risk; Scientist; Second Pregnancy Trimester; System; Texas; Tissues; Ultrasonography; United States National Institutes of Health; Universities; Vagina; diabetic; experience; fetal; fetal medicine; in vivo; member; placental transfer; programs; protocol development; receptor; response; trophoblast

DESCRIPTION (provided by applicant): The University of Texas Medical Branch (UTMB) has the capability to participate actively as a member of the Obstetric-Fetal Pharmacology Research Units (OPRU) Network. Gary Hankins, MD, as PI, is responsible for the proposed clinical trial on the use of hypoglycemic drugs in the treatment of diabetes during pregnancy. He has extensive experience within several NIH multicenter trials, eg, First and Second Trimester Evaluation of Risk of Aneuploidy (FASTER), Beneficial Effects of Antenatal Magnesium Sulfate Study (BEAM), and the Vaginal Ultrasound Cerclage Trial. Dr. Hankins has achieved successful patient recruitment and retention by involvement with UTMB's Regional Maternal & Child Health Program (RMCHP). All RMCHP clinics follow protocols established by the Maternal-Fetal Medicine division, headed by Dr. Hankins. Over 12,000 pregnant women are cared for annually within the RMCHP clinic system, approximately 7,000 of whom deliver at UTMB. The Pharmacology/Pharmacokinetics (PK) Co-Investigator, Mahmoud S. Ahmed, PhD, has over 25 years of expertise in utilizing human placenta and derived preparations in his investigations. Dr. Ahmed is a laboratory-pioneered investigator in placental receptors, their natural ligands and mediated responses, as well as the mechanism of hCG release from trophoblast tissue. They investigated the effects of in vitro and in vivo chronic administration of opiates on placental physiology and maternal-neonatal outcome. Utilizing dual perfusion of placental lobule, they demonstrated the influence of efflux protein and placental metabolic [enzymes on the PK for placental transfer of opiates. They identified placental aromatase as a drug-metabolizing enzyme and are investigating its polymorphism. Kenneth D. Carey, DVM, PhD, as Animal Model Co-Investigator, is responsible for coordinating the baboon studies to be conducted at the Southwest National Primate Research Center (SNPRC) in San Antonio. A population of normal and diabetic baboons will be studied. Dr. Hankins is an adjunct investigator at the SNPRC and has had extensive involvement with the Primate research staff. The Department of Ob/Gyn has well-funded scientists with expertise in areas relevant to this RFA including infection, vascular physiology, and placental functions. Clinical PK Co-Investigators Susan Abdel-Rahman, Pharm D., and Wayne Snodgrass, MD, PhD, have over 30 years of combined experience in the development of protocols for PK studies, evaluation of data obtained, and PK/PD modeling. The Division of Neonatology, the GCRC, and other departments at UTMB will provide support for this project.

描述（由申请人提供）：德克萨斯大学医学分部 (UTMB) 有能力作为产科-胎儿药理学研究单位 (OPRU) 网络的成员积极参与。加里·汉金斯 (Gary Hankins) 医学博士作为 PI，负责拟议的使用降血糖药物治疗妊娠期糖尿病的临床试验。他在多项 NIH 多中心试验中拥有丰富的经验，例如妊娠早期和中期非整倍体风险评估 (FASTER)、产前硫酸镁研究的有益效果 (BEAM) 以及阴道超声环扎试验。 Hankins 博士通过参与 UTMB 的地区妇幼健康计划 (RMCHP)，成功招募和保留了患者。所有 RMCHP 诊所均遵循汉金斯博士领导的母胎医学部门制定的协议。每年有超过 12,000 名孕妇在 RMCHP 诊所系统内接受护理，其中约 7,000 名孕妇在 UTMB 分娩。药理学/药代动力学 (PK) 联合研究员 Mahmoud S. Ahmed 博士在研究中利用人胎盘及其衍生制剂方面拥有超过 25 年的专业知识。 Ahmed 博士是胎盘受体、其天然配体和介导的反应以及滋养层组织释放 hCG 机制的实验室先驱研究员。他们研究了体外和体内长期服用阿片类药物对胎盘生理和母婴结局的影响。利用胎盘小叶的双重灌注，他们证明了外排蛋白和胎盘代谢酶对阿片类药物胎盘转移 PK 的影响。他们将胎盘芳香酶鉴定为一种药物代谢酶，并正在研究其多态性。 Kenneth D. Carey，DVM，PhD，作为动物模型联合研究员，负责协调在圣安东尼奥西南国家灵长类动物研究中心 (SNPRC) 进行的狒狒研究。将研究正常和糖尿病狒狒种群。 Hankins 博士是 SNPRC 的兼职研究员，广泛参与灵长类研究人员的工作。妇产科拥有资金雄厚的科学家，他们在 RFA 相关领域拥有专业知识，包括感染、血管生理学和胎盘功能。临床 PK 联合研究员 Susan Abdel-Rahman（药学博士）和 Wayne Snodgrass（医学博士、哲学博士）在 PK 研究方案开发、获得的数据评估和 PK/PD 建模方面拥有 30 多年的综合经验。 UTMB 新生儿科、GCRC 和其他部门将为该项目提供支持。