Elamin Sarra, El-Magzoub Abdul-Rahman A, Dablouk Najat, Mahmoud Fatma, Abbas Manal
Renal Unit, Ahmed Gasim Cardiac Surgery and Kidney Transplant Center, Khartoum, Sudan.
Saudi J Kidney Dis Transpl. 2014 Jul;25(4):814-8. doi: 10.4103/1319-2442.135033.
To evaluate the effects of the co-administration of tacrolimus and ketoconazole to a group of kidney transplant recipients, we studied 30 kidney transplant recipients with stable kidney function who were maintained on tacrolimus-based immunosuppression. They were prescribed ketoconazole (100 mg/day) with a concomitant reduction in daily tacrolimus dose to maintain its level within the therapeutic range. The study included 19 males and 11 females with a mean age of 36 ± 12 years. All patients were at least three months post-transplant and had tacrolimus trough levels within the therapeutic range of 5-7 ng/mL. Desired tacrolimus trough levels could be achieved in 29/30 patients after the addition of ketoconazole. This resulted in a significant reduction of the median tacrolimus dose from 5 mg/day (range 3-20 mg/day) at baseline to 2 mg/day (range 1-4 mg/day) (P = 0.00). The median reduction in the tacrolimus dose was 63% (range 50-83%). The median monthly tacrolimus cost dropped from 375 US$ per patient (range 225-1440 US$) to 150 US$ per patient (range 120-300 US$). There were no reported adverse drug effects during the study period. After one year of follow-up, there was a small but significant improvement in the estimated glomerular filtration rate (72 ± 18 versus 78 ± 20 mL/min, P = 0.01) and a significant reduction in serum uric acid levels (7.7 ± 1.7 versus 5.9 ± 0.8 mg/dL, P = 0.003). The co-administration of ketoconazole and tacrolimus to kidney trans-plant recipients is safe and significantly reduces the cost of immunosuppression. In addition, this combination appears to have a beneficial effect on kidney function.
为评估他克莫司与酮康唑联合应用于一组肾移植受者的效果，我们研究了30例肾功能稳定、接受以他克莫司为基础的免疫抑制治疗的肾移植受者。给他们开具酮康唑（100毫克/天），同时减少每日他克莫司剂量，以将其水平维持在治疗范围内。该研究包括19名男性和11名女性，平均年龄为36±12岁。所有患者均在移植后至少三个月，且他克莫司谷浓度在5 - 7纳克/毫升的治疗范围内。添加酮康唑后，30例患者中有29例达到了期望的他克莫司谷浓度。这导致他克莫司剂量中位数从基线时的5毫克/天（范围为3 - 20毫克/天）显著降至2毫克/天（范围为1 - 4毫克/天）（P = 0.00）。他克莫司剂量的中位数降低了63%（范围为50 - 83%）。他克莫司的月均费用从每位患者375美元（范围为225 - 1440美元）降至每位患者150美元（范围为120 - 300美元）。研究期间未报告有药物不良反应。经过一年的随访，估计肾小球滤过率有小幅但显著的改善（72±18对比78±20毫升/分钟，P = 0.01），血清尿酸水平显著降低（7.7±1.7对比5.9±0.8毫克/分升，P = 0.003）。肾移植受者联合应用酮康唑和他克莫司是安全的，且能显著降低免疫抑制的费用。此外，这种联合用药似乎对肾功能有有益影响。
