中国组织工程研究Issue(5)：777-784,8.DOI:10.3969/j.issn.2095-4344.2013.05.003
肾移植后吗替麦考酚酯联合低剂量他克莫司加皮质激素的应用*◇
Application of mycophenolate mofetil combined with low-dose tacrolimus and corticosteroid regimen after renal transplantation
摘要
Abstract
BACKGROUND: Sufficient dose of mycophenolate mofetil combined with low-dose tacrolimus and corticosteroid regimen may be an ideal treatment option for renal transplant recipients, and the regimen has been widely used in clinic due to its low nephrotoxicity, few adverse reactions and strong immunosuppressive effects. OBJECTIVE: To investigate the efficacy and safety of mycophenolate mofetil combined with low-dose tacrolimus and corticosteroid regimen in renal transplantation patients with the control of mycophenolate mofetil combined with standard-dose tacrolimus and corticosteroid. METHODS: A total of 210 patients receiving a single-organ renal al ograft were randomly divided into standard-dose tacrolimus group (n=104) and low-dose tacrolimus group (n=106). Individual patients were treated for 12 months. The primary efficacy endpoints were the chronic al ograft damage index and glomerular filtration rate at 12 months after transplantation. The secondary efficacy end points mainly included the acute rejection rate, treatment failure rate, and the survival rate of patient and transplant kidney. The safety parameters such as new onset of post-transplantation diabetes mel itus, hypertension and hyperlipidemia were also evaluated. RESULTS AND CONCLUSION: The vast majorities of patients were administrated with sufficient dose of mycophenolate mofetil (1.5 g/d or above) in two groups. The majority of the patients in standard-dose tacrolimus group had the mean trough level below the protocol-defined, which led to the similar mean trough level between standard-dose and low-dose tacrolimus group. These could also confirm that the regimen of mycophenolate mofetil combined with low-dose tacrolimus and corticosteroid had been wildly accepted and used by clinicians. The efficacy and safety of two groups were similar. The mean chronic al ograft damage index of the renal pathological changes at 12 months after transplantation in standard-dose and low-dose tacrolimus group were 1.82 and 2.13 respectively (P=0.081 3), the mean glomerular filtration rates were 77.08 mL/min and 80.12 mL/min (P=0.794 9), acute rejection rates were 2.6% and 5.2% (P=0.681 2), and the survival rates of patients and transplant kidney were 100% and 99.1% (P=1.000 0). The rates of new onset of post-transplantation diabetes mel itus in the standard-dose and low-dose tacrolimus group were 2.9% and 1.9%, and the rates of hyperlipidemia were 2.9% and 3.8%, respectively. For the regimen of mycophenolate mofetil combined with tacrolimus and corticosteroid, the utilization of sufficient dose of mycophenolate mofetil could reduce the dose of tacrolimus, thereby significantly reducing the nephrotoxicity, hyperlipidemia and new onset of post-transplantation diabetes mel itus caused by tacrolimus and achieving a good balance of efficacy and toxicity when maintaining a strong immune inhibition and reducing the acute rejection incidence successful y.关键词
器官移植/肾移植/吗替麦考酚酯/他克莫司/低剂量/标准剂量/急性排斥反应/移植肾慢性损伤指数/移植后糖尿病/肾小球滤过率/生存率/国家自然科学基金分类
医药卫生引用本文复制引用
季曙明,陈江华,谭建明,张小东,朱同玉,陈立中,刘志红..肾移植后吗替麦考酚酯联合低剂量他克莫司加皮质激素的应用*◇[J].中国组织工程研究,2013,(5):777-784,8.基金项目
国家自然科学基金(81270834)。Supported by：The National Natural Science Foundation of China, No.81270834* （81270834）
