Halim M A, Said T, Al-Otaibi T, Eleawa S, Al-Maged H, Gawish A E, Nair P, Al-Muzairai I, Nampoory M R N, Al-Mousawi M
Hamed Al-Essa Organ Transplantation Centre, Safat, Kuwait.
Transplant Proc. 2007 May;39(4):1225-7. doi: 10.1016/j.transproceed.2007.03.044.
Cyclosporine (CsA) microemulsion has been the mainstay immunosuppressive agent for renal transplant recipients for years. A single daily dosing of cyclosporine (SD) is rarely used. The objective of this study was to evaluate the efficacy of SD versus twice daily dosing of CsA. Retrospective evaluation of SD use was conducted for 44 renal transplant recipients for 12 months (study group). Equal numbers of matched recipients were selected for age, sex, HLA mismatch, donor type, and immunosuppressive regimen (control group). We measured CsA trough (C0) and peak (C2) blood levels, 12-hour CsA profile, and the area under the concentration-time curve (AUC). There were significant differences in C0, C2, and calculated AUC after shifting to SD. In the study group, the mean AUC was 4619 ng/mL/h before versus 6567 ng/mL/h after shifting to SD (P=.004). This became more therapeutic and identical to the mean AUC in the control group, which was 6551 ng/mL/h. Total daily CsA dose was significantly lower in the study group compared with the control group (P<.0001). A significantly higher incidence of hepatitis was observed among the study group (P=.011). There were significantly fewer adverse effects in patients in the study group than the control group. There were no significant differences in graft and patient outcomes between the groups. We concluded that CsA dose should be individualized in renal transplant recipients especially if they have viral hepatitis. SD has the advantage of decreasing dosage and CsA-related adverse effects while maintaining optimal graft function.
多年来，环孢素（CsA）微乳剂一直是肾移植受者的主要免疫抑制剂。每日单次给药的环孢素（SD）很少使用。本研究的目的是评估SD与CsA每日两次给药的疗效。对44例肾移植受者使用SD进行了为期12个月的回顾性评估（研究组）。选择年龄、性别、HLA错配、供体类型和免疫抑制方案相匹配的同等数量受者作为对照组。我们测量了CsA的谷值（C0）和峰值（C2）血药浓度、12小时CsA曲线以及浓度-时间曲线下面积（AUC）。转换为SD后，C0、C2和计算出的AUC存在显著差异。在研究组中，转换为SD前的平均AUC为4619 ng/mL/h，转换后为6567 ng/mL/h（P = 0.004）。这变得更具治疗效果，且与对照组的平均AUC（6551 ng/mL/h）相同。研究组的每日CsA总剂量显著低于对照组（P < 0.0001）。研究组中观察到肝炎发生率显著更高（P = 0.011）。研究组患者的不良反应明显少于对照组。两组之间的移植物和患者结局无显著差异。我们得出结论，肾移植受者尤其是患有病毒性肝炎的受者，CsA剂量应个体化。SD具有降低剂量和CsA相关不良反应的优势，同时维持最佳的移植物功能。
