Fassett Robert G, Healy Helen, Driver Ritza, Robertson Iain K, Geraghty Dominic P, Sharman James E, Coombes Jeff S
Renal Research, Royal Brisbane and Women's Hospital, Herston, Brisbane, Queensland, Australia.
BMC Nephrol. 2008 Dec 18;9:17. doi: 10.1186/1471-2369-9-17.
There is evidence that renal transplant recipients have accelerated atherosclerosis manifest by increased cardiovascular morbidity and mortality. The high incidence of atherosclerosis is, in part, related to increased arterial stiffness, vascular dysfunction, elevated oxidative stress and inflammation associated with immunosuppressive therapy. The dietary supplement astaxanthin has shown promise as an antioxidant and anti-inflammatory therapeutic agent in cardiovascular disease. The aim of this trial is to investigate the effects of astaxanthin supplementation on arterial stiffness, oxidative stress and inflammation in renal transplant patients.
This is a randomised, placebo controlled clinical trial. A total of 66 renal transplant recipients will be enrolled and allocated to receive either 12 mg/day of astaxanthin or an identical placebo for one-year. Patients will be stratified into four groups according to the type of immunosuppressant therapy they receive: 1) cyclosporine, 2) sirolimus, 3) tacrolimus or 4) prednisolone+/-azathioprine, mycophenolate mofetil or mycophenolate sodium. Primary outcome measures will be changes in 1) arterial stiffness measured by aortic pulse wave velocity (PWV), 2) oxidative stress assessed by plasma isoprostanes and 3) inflammation by plasma pentraxin 3. Secondary outcomes will include changes in vascular function assessed using the brachial artery reactivity (BAR) technique, carotid artery intimal medial thickness (CIMT), augmentation index (AIx), left ventricular afterload and additional measures of oxidative stress and inflammation. Patients will undergo these measures at baseline, six and 12 months.
The results of this study will help determine the efficacy of astaxanthin on vascular structure, oxidative stress and inflammation in renal transplant patients. This may lead to a larger intervention trial assessing cardiovascular morbidity and mortality.
ACTRN12608000159358.
有证据表明肾移植受者存在动脉粥样硬化加速现象，表现为心血管疾病发病率和死亡率增加。动脉粥样硬化的高发病率部分与动脉僵硬度增加、血管功能障碍、氧化应激升高以及与免疫抑制治疗相关的炎症有关。膳食补充剂虾青素已显示出作为心血管疾病抗氧化和抗炎治疗剂的潜力。本试验的目的是研究补充虾青素对肾移植患者动脉僵硬度、氧化应激和炎症的影响。
这是一项随机、安慰剂对照的临床试验。总共将招募66名肾移植受者，并分配他们接受12毫克/天的虾青素或相同的安慰剂，为期一年。患者将根据他们接受的免疫抑制治疗类型分为四组：1）环孢素，2）西罗莫司，3）他克莫司，或4）泼尼松龙+/-硫唑嘌呤、霉酚酸酯或麦考酚钠。主要结局指标将是：1）通过主动脉脉搏波速度（PWV）测量的动脉僵硬度变化，2）通过血浆异前列腺素评估的氧化应激，以及3）通过血浆五聚素3评估的炎症。次要结局将包括使用肱动脉反应性（BAR）技术评估的血管功能变化、颈动脉内膜中层厚度（CIMT）、增强指数（AIx）、左心室后负荷以及氧化应激和炎症的其他测量指标。患者将在基线、6个月和12个月时进行这些测量。
本研究结果将有助于确定虾青素对肾移植患者血管结构、氧化应激和炎症的疗效。这可能会导致一项更大规模的评估心血管疾病发病率和死亡率的干预试验。
ACTRN12608000159358。
