Obstetric-Fetal Pharmacology Research Units Network

描述(由申请者提供)：德克萨斯大学医学部(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，医学博士，以PI的身份，负责拟议的关于在妊娠期使用降血糖药物治疗糖尿病的临床试验。他在多个NIH多中心试验中拥有丰富的经验，例如，非整倍体风险的早期和中期评估(FAST)、产前硫酸镁的有益效果研究(BEAM)和阴道超声环扎试验。汉金斯博士通过参与UTMB的地区母婴健康计划(RMCHP)，成功地招募和留住了患者。所有RMCHP诊所都遵循由汉金斯博士领导的母胎医学部制定的方案。每年有12,000多名孕妇在妇幼保健计划诊所系统内得到护理，其中约7,000人在妇幼保健院分娩。药理学/药代动力学(PK)合作研究员马哈茂德·S·艾哈迈德博士在他的研究中利用人胎盘和衍生制剂方面拥有超过25年的专业经验。艾哈迈德博士是胎盘受体、胎盘受体的天然配体和介导的反应，以及滋养层组织释放hCG的机制方面的实验室先驱。他们调查了体外和体内长期服用阿片类药物对胎盘生理学和母婴结局的影响。利用胎盘小叶的双重灌流，他们展示了外流蛋白和胎盘代谢酶对胎盘阿片类药物转移的PK的影响。他们确认胎盘芳香酶是一种药物代谢酶，并正在研究其多态性。肯尼斯·D·凯里，DVM，博士，动物模型联合调查员，负责协调将在圣安东尼奥的西南国家灵长类研究中心(SNPRC)进行的狒狒研究。研究人员将研究一组正常的和患有糖尿病的狒狒。汉金斯博士是SNPRC的兼职研究员，曾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，他们在感染、血管生理学和胎盘功能等与RFA相关的领域拥有专业知识。临床PK研究人员苏珊·阿卜杜勒-拉赫曼(Susan Abdel-Rahman)和韦恩·斯诺德格拉斯医学博士在PK研究方案的开发、获得的数据评估和PK/PD建模方面拥有30多年的联合经验。UTMB的新生儿科、GCRC和其他部门将为该项目提供支持。

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.