IMMUNONUTRITION AND TRANSPLANT SUCCESS

免疫营养和移植成功

• 批准号: 2560936
• 负责人: J. WESLEY ALEXANDER
• 金额: $ 7.65万
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-30 至 2001-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2560936
• 关键词: alternative medicine; arginine; blood pressure; chemoprevention; clinical research; clinical trials; cyclosporines; diet therapy; dietary supplements; hospital utilization; human subject; kidney function; kidney transplantation; nutrition; nutrition related tag; postoperative complications; transplant rejection; transplantation immunology; vegetable oils

While improvements in immunosuppression have increased the short term survival of renal allografts, the rate of loss after the first six months has changed insignificantly during the past three decades. The long-term objective of this proposal is to develop nutritional supplements that will decrease complications and allow improved long lasting allograft survival in man with minimal immunosuppression. The specific aim of this study is to perform a prospective, randomized clinical trial in patients receiving renal allografts to determine the tolerance, safety, and efficacy of a special transplant dietary supplement. Recent animal studies have shown that both arginine and canola oil, which contains both omega 3 and omega 9 fatty acids, will remarkedly prolong allograft survival when given with a short course of cyclosporine A. An ongoing study in stable posttransplant patients has shown that dietary supplementation with arginine and canola oil will improve allograft function as measured by a decrease in serum creatinine and an improvement in creatinine clearance. This supplement has also reduced responsiveness in mixed lymphocyte cultures and has caused a shift in the cytokine production from a Th1 to Th2 type response. There have been no significant adverse effects from administration of a combination of arginine and canola oil for up to 18 days. The proposed study will randomly assign patients receiving a new renal allograft into study and control groups which will receive the same chemical immunosuppression. The study group will begin dietary supplements of arginine and canola oil at transplant. Major endpoints of the study will include incidence of rejections, type and severity of rejection, time to first rejection, renal function, patient and graft survival, incidence of cardiovascular events, incidence and length of initial and rehospitalization, incidence and types of infections, incidence of chronic rejection, and effect on blood pressure. It is anticipated that each of these major endpoints will be influenced positively and that nutritional immune modulation will become an important component of therapeutic strategies to induce long-term tolerance in solid organ transplantation.

虽然免疫抑制的改善增加了短期内 移植肾存活率，前六个月后的丢失率， 在过去的三十年里，月份变化不大。 的 这项建议的长期目标是发展营养 补充剂，将减少并发症，并允许改善长期 在最小免疫抑制情况下维持同种异体移植物存活。 的 本研究的具体目的是进行一项前瞻性、随机 在接受肾移植的患者中进行的临床试验， 特殊移植饮食的耐受性、安全性和有效性 补充. 最近的动物研究表明，精氨酸和 菜籽油含有欧米茄3和欧米茄9脂肪酸， 当给予短疗程的 环孢菌素A 一项在稳定的移植后患者中进行的研究， 显示在饮食中补充精氨酸和菜籽油 通过血清肌酸酐降低来测量移植物功能改善 和肌酸酐清除率的改善。 这一补充也 混合淋巴细胞培养物的反应性降低， 细胞因子产生从Th1型应答转变为Th2型应答。那里 没有明显的不良反应， 精氨酸和芥花油的组合长达18天。 拟议 研究将接受新肾移植的患者随机分配到 接受相同化学品的研究组和对照组 免疫抑制 研究小组将开始补充 精氨酸和菜籽油。 研究的主要终点 将包括排斥发生率、排斥类型和严重程度， 首次排斥反应时间、肾功能、患者和移植物存活率， 心血管事件的发生率、初始和 再住院、感染的发生率和类型、 慢性排斥反应和对血压的影响。 预计各国 这些主要终点中的每一个都将受到积极影响， 营养免疫调节将成为一个重要组成部分， 在实体器官中诱导长期耐受的治疗策略 移植

项目成果

Transplantation without steroids.

移植无需类固醇。

• DOI: 10.1016/s0041-1345(02)02857-9
• 发表时间: 2002
• 期刊: Transplantation proceedings
• 影响因子: 0.9
• 作者: Alexander,JW;Stanley,LL;Ofstedal,TL;First,MR;Cardi,MA;Safdar,S;Mendoza,NC;Munda,R;Fidler,JP;Buell,JF;Hanaway,MJ;Woodle,ES
• 通讯作者: Woodle,ES