他克莫司与环孢素A在尸肾移植中应用的长期疗效和安全性比较

目的　比较他克莫司 (FK5 0 6 )和环孢素A(CsA)在尸肾移植中应用的长期疗效和安全性。方法　 2 10例尸肾移植患者分为FK5 0 6组和CsA组 ,随访 12～ 32个月 ,观察两个组血药浓度变化、急性排斥和慢性排斥反应发生率、人 /肾 1年存活率、血肌酐、肝功能、血糖及血脂水平、药物不良反应、感染发生率以及FK5 0 6逆转顽固性急性排斥反应的效果。结果　血中FK5 0 6和CsA浓度谷值的变化趋势基本相同。FK5 0 6组与CsA组相比 ,急、慢性排斥反应发生率明显降低 (P <0 .0 5 ) ;肝功能异常发生率、高脂血症和牙龈增生发生率以及术后 3个月血肌酐水平均明显降低 (P <0 .0 5 ) ;高血糖和震颤发生率明显升高 (P <0 .0 5 ) ;感染发生率及人 /肾 1年存活率的差异无显著性。结论　与CsA相比 ,FK5 0 6是一种更高效的免疫抑制剂 ,长期使用可以有效降低肾移植后急、慢性排斥反应的发生率 ,有利于移植肾功能的恢复。

A comparison of long-term effect and safety between tacrolimus and cyclosporine in cadaveric renal transplantation

Objective To compare the long-term effect and safety between tacrolimus (FK506) and cyclosporine (CsA) in patients receiving cadaveric renal transplantation. Method A total of 210 patients were randomized to FK506 and CsA after cadaveric renal transplantation, and were followed up for 12-32 months for the variation of trough concentration in whole blood, the incidence of acute rejection and chronic rejection, one-year survival rate of patient/graft, variation of creatinine level, impairment of liver function and glucose metabolism and lipid metabolism, incidence of infection, and side effects. Results The variation of trough concentration of FK506 was similar to CsA. The incidence of acute rejection was significantly lower in FK506 group than in CsA group ( 16.3 % vs 33.0 % , P < 0.05 ). The incidence of chronic rejection was significantly lower in FK506 group than in CsA group ( 4.7 % vs 13.3 % , P < 0.05 ). There was no significant difference in one-year survival rate of the patient/graft between FK506 group and CsA group ( 97.7 % / 96.5 % vs 96.7 % / 93.6 % , P > 0.05 ). The incidence of impaired liver function and impaired lipid metabolism and gingivitis and creatinine level three months after transplantation were significantly lower in FK506 group than in CsA group ( P < 0.05 ). The incidence of impaired glucose metabolism and tremor was significantly higher in FK506 group than in CsA group ( P < 0.05 ). Conclusion FK506 is more effective than CsA in preventing acute and chronic rejection, and can significantly reduce the incidence in impairment of liver function and lipid metabolism and gingivitis, but it can increase the incidence in impairment of glucose metabolism and tremor.