A prospective randomized trial of FK506-based immunosuppression after renal transplantation.
A prospective randomized trial of FK506-based immunosuppression after renal transplantation.
复制标题
肾移植后基于 FK506 的免疫抑制的前瞻性随机试验。
DOI：
10.1097/00007890-199559040-00007
复制
发表时间：
1995
期刊：
影响因子：
6.2
通讯作者：
Mitchell,S
中科院分区：
文献类型：
--
作者：
Shapiro,R;Jordan,ML;Scantlebury,VP;Vivas,C;Fung,JJ;McCauley,J;Randhawa,P;Demetris,AJ;Irish,W;Mitchell,S
在1991年8月1日至1992年10月11日期间，一组204名成年患者进入了一项前瞻性随机试验，比较FK506/强的松与FK506/硫唑嘌呤/强的松在肾移植后的疗效。该研究的目的是观察添加硫唑嘌呤是否会降低排斥反应的发生率并提高移植物的存活率。受体人群未被选择，61例（30%）患者接受了再移植，37例（18%）患者的整体反应性抗体大于40%，33例（16%）年龄超过60岁。平均年龄为43.8±13.7岁（17.6 ~ 78岁）。平均供体年龄为34.0±20.1岁（0.3 ~ 75岁）；13%的尸体肾脏来自3岁以下的儿童供体，全部移植。平均冷缺血时间为31.4±8.4 hr。13%的肾脏来自活体捐献者。平均随访22±4个月（范围12 ~ 29）。总体一年实际患者生存率为94%。总的一年实际移植物存活率为87%。开始双重治疗的患者一年实际生存率为96%，一年实际移植生存率为92%。开始接受三联治疗的患者一年实际生存率为91%（与双重治疗相比P = ns），一年实际移植物生存率为82%（与双重治疗相比P < 0.02）。首次尸体移植的总体结果包括患者一年的实际生存率为94%，移植体一年的实际生存率为88%，双疗法和三联疗法之间没有差异。总排斥发生率为48%，双药组为54%，三联药组为41% （P < 0.07）。需要抗淋巴细胞治疗（OKT3或ATGAM）的类固醇抵抗性排斥反应发生率为13%，两组和三联治疗组之间没有差异。平均血清肌酐为1.8±0.8 mg/dl。平均BUN为33±21 mg/dl，两组间差异无统计学意义。平均血清胆固醇为192±49 mg/dl。总共有56%的患者停用了强的松，35%的患者没有服用任何抗高血压药物。其他并发症包括巨细胞病毒- 14%；新发糖尿病- 16%（其中一半是可逆的）；移植后淋巴细胞增生性疾病- 1%。两组间交叉发生率高，双治疗组27%的患者需要加用硫唑嘌呤，三联治疗组45%的患者需要停药（通常是暂时停药）。这些结果表明，FK506是一种很好的肾移植后免疫抑制剂，而硫唑嘌呤作为第三种药物并不常规有效。高质量的生活源于不使用（56%）或低剂量维持类固醇的能力。
A group of 204 adult patients was entered into a prospective, randomized trial comparing FK506/prednisone with FK506/azathioprine/prednisone after renal transplantation between August 1, 1991 and October 11, 1992. The purpose of the study was to see if the addition of azathioprine would reduce the incidence of rejection and improve graft survival. The recipient population was unselected, with 61 (30%) patients undergoing retransplantation, 37 (18%) having a panel-reactive antibody greater than 40%, and 33 (16%) over 60 years of age. The mean recipient age was 43.8 ± 13.7 years (range 17.6–78). The mean donor age was 34.0 ± 20.1 years (range 0.3–75); 13% of the cadaveric kidneys were from pediatric donors less than 3 years of age and were transplanted en bloc. The mean cold ischemia time was 31.4 ± 8.4 hr. Living donors were the source of 13% of the kidneys. The mean follow-up was 22 ± 4 months (range 12–29). Overall one-year actual patient survival was 94%. Overall one-year actual graft survival was 87%. Patients starting on double therapy had a one-year actual patient survival of 96% and a one-year actual graft survival of 92%. Patients starting on triple therapy had a one-year actual patient survival of 91% (P = ns compared with double therapy), and a one-year actual graft survival of 82% (P < 0.02, compared with double therapy). Overall results with first cadaver transplants included a one-year actual patient survival of 94% and one-year actual graft survival of 88%, with no differences between double and triple therapy. The overall incidence of rejection was 48%, with 54% in the double therapy group and 41% in the triple therapy group (P < .07). The incidence of steroid-resistant rejection requiring antilymphocyte therapy (OKT3 or ATGAM) was 13%, and was not different between the double and triple therapy groups. The mean serum creatinine was 1.8 ± 0.8 mg/dl. The mean BUN was 33 ± 21 mg/dl, with no significant difference between the therapy groups. The mean serum cholesterol was 192 ± 49 mg/dl. A total of 56% of the patients are off prednisone, and 35% of the patients are not taking any antihypertensive medications. Other complications included cytomegalovirus—14%; new-onset diabetes—16% (half of which was reversible); and posttransplant lymphoproliferative disorder—1%. There was a high incidence of crossover between the two groups, 27% of the patients in the double therapy group requiring the addition of azathioprine, and 45% of the patients in the triple therapy group requiring its discontinuation (usually temporary). These results show that FK506 is an excellent immunosuppressive agent after renal transplantation and that azathioprine is not routinely effective as a third agent. A high quality of life resulted from the ability to use no (56%) or low-dose maintenance steroids.