ALLOPURINOL AND THE PREVENTION OF DEATH, TISSUE INJURY, AND SEIZURES IN CHD

别嘌呤醇与预防冠心病死亡、组织损伤和癫痫发作

• 批准号: 6116864
• 负责人: ROBERT R CLANCY
• 金额: $ 2.47万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6116864
• 关键词: allopurinol; cardiovascular disorder chemotherapy; cardiovascular disorder prevention; cellular pathology; cerebral ischemia /hypoxia; clinical research; clinical trials; convulsions; coronary disorder; drug screening /evaluation; heart surgery; human subject; human therapy evaluation; infant human (0-1 year); infant mortality; longitudinal human study; nervous system disorder; neuroprotectants; oxidative stress; postoperative complications

This is a randomized, double-blind treatment of the putative neuroprotective effects of Allopurinol on the developing brain exposed to hypoxic-ischemic insults. Infants undergoing cardiac surgery which requires circulatory arrest are treated with either Allopurinol or a placebo prior to surgery. The major outcome measures are acute encephalopathy (including coma and seizures), and death. Infants undergo neurological examination and developmental assessment in follow-up visits up to two years of age. It has been known that hypoxic-ischemia is a potent casue of cell death and tissue necrosis. The exact biochemistry of injury is still under intense investigation. One of the most fascinating discoveries in this line of research is that aberrant oxygen metabolism plays a role in tissue injury. There is a growing body of evidence which has identified oxygen free radical formation as an important biochemical cascade operative in the ultimate production of cellular insult. This model serves to provide a potential therapuetic mechanism of intervention that might prevent or ameliorate the consequences of hypoxia reperfusion injury. Allopurinol may prevent the formation of free radicals in post ischemic tissues. Enrollment of study subjects was completed on September 15, 1997. A total of 350 patients were enrolled.

这是一项随机、双盲治疗， 别嘌呤醇对暴露于苯甲酸的发育中脑的神经保护作用 缺氧缺血性损伤接受心脏手术的婴儿， 需要循环停止的患者用别嘌呤醇或 手术前服用安慰剂。主要的结局指标是急性的 脑病（包括昏迷和癫痫）和死亡。婴儿经历 随访时进行神经系统检查和发育评估 最多两岁。众所周知，缺氧缺血是一种 细胞死亡和组织坏死的潜在原因。的确切生物化学 受伤情况仍在紧张调查中。一个最迷人的 这一研究领域的发现是， 在组织损伤中起作用。越来越多的证据表明 已经确定氧自由基的形成是一种重要的生化反应， 最终导致细胞损伤的级联反应。这 模型提供了一种潜在的干预治疗机制 可以预防或改善缺氧再灌注的后果， 损伤别嘌呤醇可防止术后自由基的形成 缺血组织研究受试者的入组工作已于9月10日完成。 1997年15日。共入组350例患者。