Transpl Int. 1994;7 Suppl 1:S247-51.
We conducted a 2-year follow-up study of the efficacy and safety of FK 506 in 104 kidney transplant patients at 32 sites in Japan. The initial daily oral dose of FK 506 was 0.3 mg/kg, which was gradually reduced to 0.15 mg/kg by month 10 and remained stable thereafter. The mean trough level of FK 506 in whole blood and the mean serum creatinine level in year 2 were 7.9 ng/ml and 1.9 mg/dl, respectively. Patient and graft survival rates for all patients were 97% and 92%, respectively. Forty-six patients (44%) experienced rejection episodes, and 84% of these episodes occurred within 3 months after transplantation. The principal adverse reactions to FK 506 therapy were hyperglycaemia, renal dysfunction and hyperkalaemia. Most of these events were dose-dependent, and disappeared or ameliorated following reduction of the FK 506 dose.
我们在日本32家机构的104例肾移植患者中开展了一项为期2年的关于FK 506疗效及安全性的随访研究。FK 506的初始口服剂量为每日0.3 mg/kg，到第10个月逐渐减至0.15 mg/kg，此后保持稳定。第2年时，FK 506全血谷浓度均值和血清肌酐均值分别为7.9 ng/ml和1.9 mg/dl。所有患者的患者生存率和移植物生存率分别为97%和92%。46例患者（44%）发生排斥反应，其中84%的排斥反应发生在移植后3个月内。FK 506治疗的主要不良反应为高血糖、肾功能不全和高钾血症。这些事件大多与剂量相关，在减少FK 506剂量后消失或改善。
