El-Dahshan Khalid Farouk, Bakr Mohamed Adel, Donia Ahmed Farouk, Badr Ali El-Sayed, Sobh Mohamed Abdel-Kader
Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.
Am J Nephrol. 2006;26(3):293-8. doi: 10.1159/000094133. Epub 2006 Jun 22.
BACKGROUND/AIMS: In developing countries, kidney transplantation is greatly hindered by financial problems, especially due to costly newer immunosuppressive medications. Ketoconazole increases blood levels of tacrolimus and cyclosporine through inhibition of cytochrome P450 microsomal enzymes. We previously reported on the 6-month safety and the outstanding impact on treatment costs of the ketoconazole-tacrolimus combination in kidney transplant recipients. Data of this combination are still lacking in the literature. We hereby report on the 2-year results of our trial.
This prospective, randomized study included 70 live-donor kidney transplant recipients receiving tacrolimus (age 16-45 years, 54 males and 16 females). Patients were randomized into two equal groups: group 1, where ketoconazole 100 mg/day was added, and group 2 (control group).
After 2 years, group 1 (ketoconazole) patients still showed a highly significant reduction of the tacrolimus dose (by 53.8%) and cost (by 52.9%) compared with the control group (p < 0.001) and a significant improvement in graft function in comparison to their own initial graft function (p = 0.002). Throughout the 2 years, no side effects of ketoconazole were noted.
We conclude that the long-term ketoconazole-tacrolimus combination therapy in kidney transplant recipients during the 2 years is safe, has an outstanding impact on treatment costs and improves graft outcome.
背景/目的：在发展中国家，肾移植受到经济问题的严重阻碍，尤其是新型免疫抑制药物成本高昂。酮康唑通过抑制细胞色素P450微粒体酶来提高他克莫司和环孢素的血药浓度。我们之前报道了酮康唑 - 他克莫司联合用药在肾移植受者中的6个月安全性及对治疗费用的显著影响。文献中仍缺乏该联合用药的数据。在此，我们报告该试验的2年结果。
这项前瞻性随机研究纳入了70例接受他克莫司治疗的活体供肾肾移植受者（年龄16 - 45岁，男性54例，女性16例）。患者被随机分为两组，每组人数相等：第1组添加每日100 mg酮康唑，第2组为对照组。
2年后，与对照组相比，第1组（酮康唑组）患者的他克莫司剂量仍显著降低（降低53.8%），费用显著降低（降低52.9%）（p < 0.001），且与自身初始移植功能相比，移植功能有显著改善（p = 0.002）。在整个2年期间，未观察到酮康唑的副作用。
我们得出结论，肾移植受者在2年期间长期使用酮康唑 - 他克莫司联合治疗是安全的，对治疗费用有显著影响，并改善了移植结局。
