Michael H J, Francos G C, Burke J F, Besarab A, Moritz M, Gillum D, Jarrell B
Department of Medicine, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19107.
Transplantation. 1989 Nov;48(5):805-8. doi: 10.1097/00007890-198911000-00016.
There has been concern that cyclosporine's nephrotoxicity increases the incidence of delayed graft function (DGF), prolongs periods of oliguria, and reduces graft survival. In order to further study whether CsA should be used in DGF, we conducted a randomized prospective trial of the effect of CsA versus antilymphocyte globulin on the effects of DGF. Between 12/22/85 and 3/11/88, all patients with DGF after an initial 12-24 hr of CsA were randomized to either daily Minnesota ALG and prednisone or lower-dose CsA (10 mg/kg/day) and prednisone. Resolution of DGF was defined as a lack of dialysis dependency and a 25% fall in the serum creatinine (CR). If DGF was not resolved by 2 weeks, transplant renal biopsies were performed to assess the presence of occult rejection. CsA (10 mg/kg/day) was initiated in the ALG group only after resolution of the DGF. Of the 45 patients who recovered graft function, 19 received ALG and 26 received CsA. CsA significantly prolonged the duration of DGF (ALG 9.74 days, CsA 13.69 days, P = 0.035) but did not result in a prolongation of hospitalization. No difference in CR was found between the two groups at 1 month, 3 months, 6 months, or 12 months. Mean CR at 12 months was 1.98 mg/dl for ALG versus 1.96 mg/dl for CsA. Overall graft survival did not differ in the CsA and ALG groups (P = 0.33). CsA does slightly increase the duration of DGF as compared with ALG but has no effect on one-year serum CR or one-year graft survival. Since there appeared to be no harmful long-term effects of the slight lengthening of DGF, a lower-dose of CsA protocol with biopsy surveillance for occult rejection can be used in patients with DGF.
有人担心环孢素的肾毒性会增加移植肾功能延迟恢复(DGF)的发生率,延长少尿期,并降低移植肾存活率。为了进一步研究环孢素是否应用于移植肾功能延迟恢复,我们进行了一项随机前瞻性试验,比较环孢素与抗淋巴细胞球蛋白对移植肾功能延迟恢复的影响。在1985年12月22日至1988年3月11日期间,所有在最初使用12 - 24小时环孢素后出现移植肾功能延迟恢复的患者被随机分为两组,一组每日使用明尼苏达抗淋巴细胞球蛋白和泼尼松,另一组使用低剂量环孢素(10mg/kg/天)和泼尼松。移植肾功能延迟恢复的缓解定义为不再依赖透析且血清肌酐(CR)下降25%。如果2周内移植肾功能延迟恢复未缓解,则进行移植肾活检以评估是否存在隐匿性排斥反应。仅在移植肾功能延迟恢复缓解后,抗淋巴细胞球蛋白组才开始使用环孢素(10mg/kg/天)。在45例恢复移植肾功能的患者中,19例接受了抗淋巴细胞球蛋白治疗,26例接受了环孢素治疗。环孢素显著延长了移植肾功能延迟恢复的持续时间(抗淋巴细胞球蛋白组为9.74天,环孢素组为13.69天,P = 0.035),但并未导致住院时间延长。两组在1个月、3个月、6个月或12个月时的血清肌酐水平无差异。抗淋巴细胞球蛋白组12个月时的平均血清肌酐为1.98mg/dl,环孢素组为1.96mg/dl。环孢素组和抗淋巴细胞球蛋白组的总体移植肾存活率无差异(P = 0.33)。与抗淋巴细胞球蛋白相比,环孢素确实会使移植肾功能延迟恢复的持续时间略有增加,但对一年期血清肌酐或一年期移植肾存活率无影响。由于移植肾功能延迟恢复的轻微延长似乎没有有害的长期影响,因此对于移植肾功能延迟恢复的患者,可以采用低剂量环孢素方案并进行活检监测隐匿性排斥反应。