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目的:观察国产他克莫司胶囊对肾移植患者的疗效。方法:选取我科2009年1月～2010年1月接受肾移植的80例患者,随机分为两组,移植术后给予他克莫司+吗替麦考酚酯+甲泼尼龙三联免疫抑制药治疗。试验组和对照组分别给予国产及进口他克莫司,术后随访12个月,观察2组血药浓度变化、急性排斥反应发生率、人/肾存活率、感染发生率、肾功能、肝功能、血糖及血脂水平的变化。结果:2组患者他克莫司血药浓度在同剂量范围内无显著差异,变化趋势基本相同,均在术后2周左右达到稳态浓度。术后3、6、12个月比较,2组间他克莫司浓度、不良事件发生率比较差异无统计学意义(P>0.05)。结论:研究证实在联合应用吗替麦考酚酯+甲泼尼龙的情况下,国产他克莫司防治肾移植排斥反应安全有效。
Objective: To observe the curative effect of domestic tacrolimus capsules on renal transplant recipients. Methods: Eighty patients who underwent renal transplantation from January 2009 to January 2010 in our department were randomly divided into two groups. After transplantation, tacrolimus + mycophenolate mofetil + methylprednisolone triple immunosuppression Medicine treatment. The experimental group and the control group were given domestic and imported tacrolimus respectively. The patients were followed up for 12 months. The changes of plasma concentration, the incidence of acute rejection, the survival rate of human / kidney, the incidence of infection, renal function, liver function Function, blood glucose and blood lipid levels. Results: There was no significant difference in the concentration of tacrolimus among the two groups in the same dose range, and the trend was basically the same. Both groups reached steady state concentration about 2 weeks after operation. At 3, 6, and 12 months after operation, there were no significant differences in the concentrations of tacrolimus and the incidence of adverse events between the two groups (P> 0.05). Conclusion: The study confirmed that in combination with mycophenolate mofetil methylprednisolone cases, domestic tacrolimus prevention and treatment of renal transplant rejection is safe and effective.