A prospective randomized trial on azathioprine addition to cyclosporine versus cyclosporine monotherapy at steroid withdrawal, 6 months after renal transplantation.
A prospective randomized trial on azathioprine addition to cyclosporine versus cyclosporine monotherapy at steroid withdrawal, 6 months after renal transplantation.
复制标题
肾移植后 6 个月，类固醇停药时硫唑嘌呤联合环孢素与环孢素单药治疗的前瞻性随机试验。
作者：
S. Sandrini;R. Maiorca;F. Scolari;G. Cancarini;G. Setti;P. Gaggia;L. Cristinelli;R. Zubani;S. Bonardelli;R. Maffeis;N. Portolani;F. Nodari;S. Giulini
背景
为了避免肾移植患者的许多副作用，已经进行了许多尝试以撤回类固醇治疗。到目前为止，结果是有争议的。在这项随机前瞻性研究中，我们比较了在移植后6个月停用类固醇时，硫唑嘌呤替代品与环孢素相比，环孢素单药治疗在预防急性排斥反应方面的疗效。
方法
116例肾功能良好且稳定（血肌酐<2 mg/dl）的肾移植患者在前6个月接受了环孢素+类固醇。然后将他们随机分为两组（A和B），并在2个月内停止类固醇治疗。A组（58例患者）继续接受环孢素单药治疗，而B组（58例患者）在随机化开始时添加硫唑嘌呤（1 mg/kg/天），并继续接受环孢素+硫唑嘌呤治疗。在两组中，患者在急性排斥反应首次发作时恢复类固醇治疗。随机化后的随访时间为5.3+/-1.6年。
结果
5年后，A组和B组的类固醇恢复率分别为57%和29%（P<0.02），其中68%和88%的患者在随机化后6个月内恢复使用类固醇。抗排斥治疗总是成功的。A组5年患者和移植物存活率分别为90%和88%，B组分别为100%和91%。在随访时，血肌酐没有差异。B组中仅硫唑嘌呤引起的轻度和可逆性白细胞减少症的副作用不同。
结论
环孢素联合硫唑嘌呤比环孢素单药治疗更能有效降低激素停药后急性排斥反应的发生率。慢性排斥反应导致的移植物丢失，两组均为轻度，无差异。停用类固醇是可行和有利的，并且添加硫唑嘌呤允许我们选择的患者中有71%保持无类固醇。
BACKGROUND
Many attempts have been made to withdraw steroid therapy in renal transplant patients in order to avoid its many side effects. Results have been, so far, controversial. In this randomized prospective study, we compare the efficacy of azathioprine adjuncts to cyclosporine at the time of steroid withdrawal, 6 months after transplantation, versus Cyclosporine monotherapy, in preventing acute rejection.
METHODS
One hundred and sixteen kidney transplant patients with good and stable renal function (creatininemia <2 mg/dl) received, in the first 6 months, cyclosporine + steroid. They were then randomized into two groups (A and B), and steroid therapy was withdrawn over 2 months. Group A (58 patients) continued on cyclosporine monotherapy, whereas group B (58 patients) added azathioprine (1 mg/kg/day) at the beginning of randomization and continued on cyclosporine + azathioprine. In both groups, patients resumed steroid therapy at the first episode of acute rejection. Follow-up after randomization was 5.3+/-1.6 years.
RESULTS
After 5 years, the incidence of steroid resumption was 57% in group A and 29% in group B (P<0.02); of those, 68% and 88% of them were within 6 months from randomization. Anti-rejection therapy was always successful. Five-year patient and graft survival rates were 90% and 88% in group A and 100% and 91% in group B. Creatininemia did not differ, at follow-up. Side effects differed only for mild and reversible leukopenia caused by azathioprine in group B.
CONCLUSION
Cyclosporine plus azathioprine is more effective than cyclosporine monotherapy in reducing the incidence of acute rejection after steroid withdrawal. Graft loss as a result of chronic rejection, mild in both groups, did not differ. Steroid withdrawal is feasible and advantageous, and the addition of azathioprine allowed 71% of our selected patients to remain steroid-free.
影响因子：
158.5
作者：
JULIAN, BA;LASKOW, DA;QUARLES, LD
通讯作者：
QUARLES, LD