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目的观察联合应用酮康唑提高肾移植患者他克莫司血药浓度的安全性和有效性。方法 42例使用以他克莫司为基础免疫抑制方案的同种异体尸体肾移植患者,其中26例因为他克莫司血药浓度不达标,16例因为经济原因有减少他克莫司剂量要求。以上患者联合应用酮康唑50 mg.d-1,观察联合用药前后他克莫司药物剂量,全血药物浓度,患者肝、肾功能和空腹血糖的变化。结果 42例患者在联合应用酮康唑(7±s 4)mo后他克莫司剂量下降了(1.2±0.8)mg.d-1,全血药物浓度上升了(1.9±1.0)mg.L-1,与联合用药前相比均有非常显著差异(P<0.01)。观察期间患者的肝、肾功能和空腹血糖均无明显变化,无急性排斥反应发生。结论联合应用酮康唑可以安全有效地提高他克莫司的全血药物浓度。
Objective To observe the safety and efficacy of ketoconazole in improving the concentration of tacrolimus in renal transplant recipients. Methods Totally 42 patients underwent allograft cadaver transplantation with tacrolimus-based immunosuppressive regimen. Tacrolimus dose reduction was required in 26 of 26 patients for non-compliance with tacrolimus . The above combination of ketoconazole 50 mg.d-1, before and after treatment with tacrolimus drug dose, whole blood drug concentration, liver function, renal function and fasting blood glucose changes. Results The tacrolimus dose decreased by (1.2 ± 0.8) mg.d-1 in 42 patients (7 ± s 4 mo) after combination of ketoconazole and the whole blood drug concentration increased by (1.9 ± 1.0) mg.L -1, compared with before treatment, there was a significant difference (P <0.01). During the observation period, there was no significant change in liver and kidney function and fasting blood glucose, and no acute rejection occurred. Conclusions Combination of ketoconazole can increase the whole blood drug concentration of tacrolimus safely and effectively.