Atlanta Sickle Cell Disease Clinical Research Consortium

镰刀细胞病的射频治疗(SCO)临床研究网络(CRN)的目的是建立 拥有15个临床中心的基础设施，这些中心将设计和执行多中心治疗试验以改善 镰状细胞病患者的健康结局。来自埃默里和莫尔豪斯的临床研究人员 医学院提议在亚特兰大建立15个临床中心之一。该提案包括 三个要素： 临床研究核心将有助于上海合作组织CRN研究的设计和实施，并招募 亚特兰大儿童保健和格雷迪健康系统的受试者。 项目1将检验这样的假设，即血管紧张素受体拮抗剂氯沙坦将降低 镰状肾病患者的肾脏疾病进展。这一假设将分两个阶段进行检验。 组：大量白蛋白尿伴临床肾病患者和微量白蛋白尿患者。在……里面 除了确定对进展性肾脏疾病的影响外，这项研究还将比较 长期服用氯沙坦与安慰剂治疗镰状细胞白蛋白尿患者的耐受性比较 肾病。 项目2是一项前瞻性的第三阶段随机试验，以检验纳布芬优于 吗啡治疗上肢血管闭塞性疼痛是因为患者急性发作次数较少 胸部综合征，副作用较少，因为呼吸抑制较少，减少 释放组胺。第二个假设是，高剂量的自控镇痛和低剂量的镇痛剂输注是 优于低剂量自控镇痛配合大剂量输注。这一假设将通过一项四臂研究进行验证，该研究将 比较吗啡与纳布芬及低剂量持续输注与大剂量自控镇痛与大剂量自控镇痛的比较 每种镇痛剂均采用小剂量自控镇痛。 CRN的工作将对减少因以下并发症引起的发病率和死亡率作出重要贡献 上海合作组织。两个拟议的项目将改善疼痛的治疗，这是最常见和最致残的 表现为慢性肾脏病，减轻慢性肾脏疾病的影响。

The purpose of the RFA for a Sickle Cell Disease (SCO) Clinical Research Network (CRN) is to establish an infrastructure with 15 clinical centers that will design and perform multi-center therapeutic trials to improve health outcomes in persons with sickle cell disease. Clinical investigators from the Emory and Morehouse Schools of Medicine propose to establish one of the 15 clinical centers in Atlanta. The proposal includes three elements: The Clinical Research Core will contribute to the design and implementation of SCO CRN studies, and enroll subjects at Children's Healthcare of Atlanta and the Grady Health System. Project 1 will test the hypothesis that losartan, an angiotensin receptor antagonist, will reduce the rate of progression of renal disease in patients with sickle nephropathy. The hypothesis will be tested in two groups: patients with macroalbuminuria and overt nephropathy, and patients with microalbuminuria. In addition to determining the effect on progressive renal disease, the study will compare the safety and tolerability of losartan vs. placebo when administered long-term in albuminuric patients with sickle cell nephropathy. Project 2 is a prospective phase III randomized trial to test the hypothesis that nalbuphine is superior to morphine in the treatment of vaso-occlusive pain in SCO because patients will suffer fewer episodes of acute chest syndrome and will suffer fewer side effects because of less respiratory suppression and reduced release of histamine. A second hypothesis is that high-dose PCA with low-dose infusion of analgesic is superior to low-dose PCA with high-dose infusion. The hypothesis will be tested by a four-arm study that will compare morphine to nalbuphine and low-dose constinuous infusion with high-dose PCA to high-dose infusion with low-dose PCA for each analgesic. The work of the CRN will contribute importantly to lessening morbidity and mortality from complications of SCO. Two two proposed projects will improve treatment of pain, the most common and disabling manifestation of SCO and lessen the impact of chronic kidney disease.