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目的:评价以西罗莫司(SRL)为基础,环孢素(CsA)早期减量和撤除的免疫抑制方案在肾移植患者中的疗效和安全性。方法:2004年7月～2005年9月间17例肾移植患者使用SRL+CsA+激素的免疫抑制方案。术后第3个月,使SRL浓度在4～12μg/L,同时逐渐减少CsA用量;至术后第6～9个月,使CsA浓度降至50～100ng/ml或停用CsA,SRL浓度维持在6～12μg/L(减量者)或8～15μg/L(停CsA者)。术后定期监测血肌酐(SCr)水平,观察不良反应及人、肾存活情况。结果:13例于术后第6～9个月完成CsA减量(mCsA,10例)或撤除(eCsA,3例)方案,10例mCsA患者的CsA用量由(4.6±0.71)mg/(kg.d)减至(2.9±1.10)mg/(kg.d)(P<0.05)。术后2年,患者和移植肾全部存活,各有3例、5例分别维持eCsA和mCsA方案,CsA用量减至(1.1±0.26)mg/(kg.d)。完成并维持eCsA和mCsA方案的患者,术后第12、24个月的SCr分别为(101±32.7)μmol/L(n=10)、(101±25.8)μmol/L(n=8)。1例在CsA减量前发生急性排斥(AR),1例CsA减量后因自行停用SRL发生AR。主要不良反应有高脂血症(n=11)、肝功能损害(n=7)和感染(n=7)等。结论:以西罗莫司为基础用药而减少或停用CsA,可有效防治AR,同时可减少CsA的肾毒性等不良反应。高脂血症和肝功能异常等是主要不良反应,西罗莫司的不良反应及对停用CsA的疑虑会影响该方案的实施。
OBJECTIVE: To evaluate the efficacy and safety of sirolimus (SRL) -based immunosuppressive regimens of CsA in early renal allograft recipients. Methods: Seventeen patients with renal transplantation from July 2004 to September 2005 were immunosuppressed with SRL + CsA + hormone. At the third month after operation, the concentration of SRL was reduced to 4 ~ 12μg / L, while the dosage of CsA was gradually decreased. From the 6th to the 9th month after operation, the concentration of CsA was reduced to 50 ~ 100ng / ml or CsA was discontinued Maintained at 6 ~ 12μg / L (reduction) or 8 ~ 15μg / L (stop CsA). Postoperative serum creatinine (SCr) levels were regularly monitored adverse reactions and renal and renal survival. Results: CsA dose reduction (mCsA, n = 10) or removal (eCsA, n = 3) was performed in 13 of the 6 to 9 months after operation. The CsA dosage in 10 mCsA patients was increased from (4.6 ± 0.71) mg / .d) to (2.9 ± 1.10) mg / (kg.d) (P <0.05). Two years after operation, all the patients and allografts survived. There were 3 cases in each group. Five cases maintained eCsA and mCsA regimen respectively. The dosage of CsA was reduced to (1.1 ± 0.26) mg / (kg.d). Patients who completed and maintained the eCsA and mCsA regimens had an SCr of (101 ± 32.7) μmol / L (n = 10) and (101 ± 25.8) μmol / L at n = 8 and 12 months, respectively. One patient developed acute rejection (AR) before CsA reduction and one patient developed SRL after ARA reduction due to self-administration of SRL. The main adverse reactions were hyperlipidemia (n = 11), impaired liver function (n = 7) and infection (n = 7). Conclusion: The reduction or discontinuation of CsA on the basis of sirolimus can effectively prevent and treat AR while reducing the adverse effects of CsA on nephrotoxicity. Hyperlipidemia and abnormal liver function are the main adverse reactions, the adverse reactions of sirolimus and doubts about the withdrawal of CsA will affect the implementation of the program.