CARDIOVASCULAR RISK AFTER PREDNISONE WITHDRAWAL IN KIDNEY TRANSPLANT

肾移植受者通常被要求服用糖皮质激素进行免疫抑制。泼尼松有几种副作用，可能会对长期健康和生活质量产生负面影响。这些副作用包括心血管风险增加、肌肉无力和体重过度增加。我们建议对40名患者进行研究，他们被随机分配到泼尼松停药方案。这项研究是一个更大的多中心泼尼松停药方案的辅助研究，在该方案中，泼尼松停药随机双盲，停药组服用安慰剂。我们的研究将评估停用强的松对肌肉结构和功能、身体成分、运动能力、生活质量和心血管风险的影响。患者将在基线(移植后3个月)和移植后1年再次进行测试。这些测试包括：肌肉活检，分析纤维类型、大小、毛细血管密度和微观结构的电子显微镜分析；肌肉功能，使用等速肌肉测试；运动能力，使用最大跑步机测试和呼吸气体分析；身体成分，使用DEXA分析身体脂肪百分比、肌肉质量和骨密度；生活质量评估，使用MOS问卷；以及心血管风险概况，使用Framingham CV风险算法。这项研究的结果将有助于了解药物副作用，并为制定干预措施提供基础，这些干预措施也可能影响几项研究结果。我们建议研究两组肾移植受者的肌肉功能、运动能力和心血管风险：一组随机分配到停用强的松，另一组接受强的松维持治疗。这项建议将涉及测试，其中包括：心肺功能、肌肉力量和耐力、身体成分、肌肉活检以分析微观结构和酶含量，将使用Framinham算法评估心血管风险概况，还将评估与健康相关的生活质量。

Kidney transplant recipients routinely are required to take glucocorticoids for immunosuppression. Prednisone has several side effects which may negatively impact on long term health and quality of life. These side effects include increased cardiovascular risk, muscle weakness, and excessive weight gain. We propose to study 40 patients who are randomly assigned to a prednisone withdrawal protocol. This study is an ancillary study to a larger multicenter prednisone withdrawal protocol in which the prednisone withdrawal randomization is double blinded, with those in the withdrawal group taking placebo. Our study will assess the effects of prednisone withdrawal on muscle structure and function, body composition, exercise capacity, quality of life, and cardiovascular risk profile. Patients will be tested at baseline (3 months post transplant) and again at 1 year post transplant. The testing includes: muscle biopsy with analysis of fiber type, size, capillary density, and electron microscopy analysis of microstructure; muscle function using isokinetic muscle testing; exercise capacity using maximal treadmill testing with respiratory gas analysis; body composition using DEXA for analysis of body fat%, muscle mass, and bone density; quality of life assessment using the MOS questionnaire; and cardiovascular risk profile using the Framingham CV risk algorithm. The results of this study will assist in the understanding of medication side effects and provide a basis for development of interventions which may also impact several of the study outcomes. We propose to study muscle function, exercise capacity and cardiovascular risk in two groups of kidney transplant recipients: one group randomly assigned to prednisone withdrawal and another group on maintenance prednisone therapy. This proposal will involves testing which includes: cardiorespiratory fitness, muscle strength and endurance, body composition, muscle biopsy will be obtained for analysis of microstructure and enzyme content, cardiovascular risk profile will be assessed using the Framinham algorithm, health-related quality of life will also be assessed.