CARDIOVASCULAR RISK AFTER PREDNISONE WITHDRAWAL IN KIDNEY TRANSPLANT

肾移植受者通常需要服用糖皮质激素来抑制免疫。强的松有几种副作用，可能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。我们建议研究40名随机分配到强的松戒断方案的患者。本研究是一个更大的多中心强的松戒断方案的辅助研究，在该方案中，强的松戒断随机化是双盲的，戒断组服用安慰剂。我们的研究将评估强的松停药对肌肉结构和功能、身体组成、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年再次接受检测。检测包括：肌肉活检，分析纤维类型、大小、毛细血管密度，电镜分析微观结构；肌肉功能等速测试；最大跑步机运动能力测试与呼吸气体分析使用DEXA分析体脂百分比、肌肉量和骨密度；使用生活质量问卷进行生活质量评估；和使用Framingham CV风险算法的心血管风险概况。这项研究的结果将有助于了解药物副作用，并为干预措施的发展提供基础，这些干预措施也可能影响一些研究结果。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：一组随机分配到强的松停药组，另一组维持强的松治疗。该提案将涉及的测试包括：心肺健康、肌肉力量和耐力、身体组成、肌肉活检将用于分析微观结构和酶含量，心血管风险概况将使用framingham算法进行评估，健康相关的生活质量也将进行评估。

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.