五酯胶囊对肾移植受者他克莫司全血浓度的影响

Effect of Wuzhi capsules on whole blood concentration of Tacrolimus in renal transplantation recipients

背景:国内有关于健康受试者他克莫司与五酯胶囊合用后他克莫司峰浓度和药时曲线下面积明显增加的报道,但关于该药物组合对临床肾移植受者的影响还未见报道。目的:观察五酯胶囊对肾移植受者他克莫司全血浓度的影响。方法:将38例采用他克莫司+霉酚酸酯+泼尼松三联免疫方案的首次肾移植受者作为观察对象,按随机数字表法分成2组,试验组21例同时服用五酯胶囊,对照组17例未服用五酯胶囊,检测并比较两组受者肾移植后第1,3,6个月达到治疗窗他克莫司全血浓度时的他克莫司剂量和肾功能,观察两组肾移植后6个月内急性排斥反应发生率、肝肾功能及糖尿病发生率。结果及结论:试验组肾移植后第1,3,6个月达到治疗窗他克莫司全血浓度时的他克莫司剂量均显著低于对照组(P<0.05)。两组肾功能、肝功能损害发生率、急性排斥反应发生率、糖尿病发生率差异均无显著性意义(P>0.05)。结果提示,五酯胶囊能明显提高肾移植受者他克莫司全血浓度,减少他克莫司服用量及其产生的毒性作用。

BACKGROUND：It has reported that the combination of Tacrolimus and Wuzhi capsules can increase the peak concentration and area under curve of Tacrolimus recipients,however,the effects of this combination on recipients is poorly understood.OBJECTIVE：To investigate the effects of Wuzhi capsules on the blood concentration of Tacrolimus recipients.METHODS：A total of 38 renal transplantation recipients receiving triple therapy regime（Tacrolimus＋mycophenolate ＋Prednisolone） were involved in the study and were divided into the experimental group（n=21） and control group（n=17）.Recipients in the experimental group were taking Wuzhi capsules simultaneously,and those in the control group were not taking Wuzhi capsules.The Tacrolimus dosage to therapeutic concentration window and renal function were compared between the two groups at months 1,3 and 6 after transplantation.The incidence rates of acute rejection and diabetes mellitus,and renal and liver functions were observed at 6 months after transplantation.RESULTS AND CONCLUSION：The Tacrolimus dosage to therapeutic concentration window of the experimental group was significantly smaller than that of the control group（P0.05）.However,incidence rate of acute rejection,diabetes mellitus,and renal and liver functions had no dramatically difference in 2 groups（P0.05）.Results suggest that Wuzhi capsules may improve the immunosuppressive efficacy of Tacrolimus in renal recipients,therefore,can decrease the toxic effect of Tacrolimus with reduction dosage.