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目的:分析以微乳环孢素A胶囊为基础的免疫抑制方案在肾移植术后长期应用的临床有效性及安全性,进而得出不同年限的肾移植患者服用环孢素A谷值(C0)和峰值(C2)浓度的临床有效治疗窗,以及长期肾功能稳定患者服用环孢素的有效剂量。方法:收集在我院随访的108例肾移植患者临床资料,按术后不同年限分组,对每位患者的环孢素A血药浓度、服药剂量、体质量、临床化验指标以及临床事件的发生与转归情况进行记录和分析。结果:随着肾移植术后时间的延长,环孢素峰、谷浓度的临床有效治疗窗逐渐降低(P<0.05),患者血肌酐、血糖、谷丙转氨酶和谷草转氨酶则没有随着时间的延长而显著升高(P>0.05)。移植术后前3年的患者,其环孢素的峰、谷浓度与其服药剂量、体质量校正后的服药剂量均有一定的弱相关性(P<0.05),但是术后4～7年的患者,两者不再有相关性。ROC曲线得出体质量校正后的服药剂量比C2浓度更能较为准确地预测临床事件发生的可能性。结论:长期稳定的肾移植患者其环孢素的C2浓度虽然不能准确判定和预言肾功能异常的发生率,但是对监测免疫过量、降低环孢素的肾毒性和保证移植肾功能的长期稳定仍是有益的。环孢素的用量与移植肾的长期存活密切相关,即当服药剂量为1.46～2.63 mg.kg-1.d-1时,移植肾相对存活的时间较长,对维持移植肾功能的长期稳定更有意义。
OBJECTIVE: To analyze the clinical efficacy and safety of long-term use of microcirculation cyclosporin A capsule-based immunosuppression in renal transplant recipients, and then to obtain the different years of renal transplant patients taking cyclosporin A valley (C0 ) And peak (C2) concentrations, as well as effective doses of cyclosporine in patients with long-term stable renal function. Methods: The clinical data of 108 renal transplant recipients who were followed up in our hospital were collected and divided into different groups according to the postoperative years. The concentration of cyclosporin A, the dosage, the body weight, the clinical laboratory indexes and the occurrence of clinical events And the outcome of the case record and analysis. Results: With the prolongation of renal transplantation time, the effective therapeutic window of cyclosporine peak and trough concentration gradually decreased (P <0.05), and serum creatinine, blood glucose, alanine aminotransferase and aspartate aminotransferase did not change with time Prolonged significantly increased (P> 0.05). In the first 3 years after transplantation, the peak and trough concentrations of cyclosporine had some weak correlations with their dose and body weight after administration (P <0.05) Patients, both no longer relevant. The ROC curve shows that the dose corrected for body weight can predict the probability of a clinical event more accurately than the C2 concentration. CONCLUSIONS: Long-term and stable renal transplant recipients whose cyclosporine C2 concentrations can not accurately determine and predict the incidence of renal dysfunction may be useful in monitoring overdose, cyclosporine nephrotoxicity, and long-term stability of renal graft function It is good. The amount of cyclosporine is closely related to the long-term survival of renal allografts, that is, when the dose of 1.49 ~ 2.63 mg.kg-1.d-1, the relative survival time of the graft kidney is longer, and the long-term stability more meaningful.