A Single Institution, Randomized, Prospective Trial of Cyclosporine Versus Azathioprine‐Antilymphocyte Globulin for Immunosuppression in Renal Allograft Recipients
A Single Institution, Randomized, Prospective Trial of Cyclosporine Versus Azathioprine‐Antilymphocyte Globulin for Immunosuppression in Renal Allograft Recipients
复制标题
环孢素与硫唑嘌呤抗淋巴细胞球蛋白对同种异体肾移植受者进行免疫抑制的单一机构、随机、前瞻性试验
作者：
D. Fryd;M. Strand;P. D;N. Ascher;W. Payne;R. Simmons;D. Sutherland
1980年9月26日至1983年12月31日，230例脾切除输血肾移植受者被随机分为环孢菌素-泼尼松(N=121，糖尿病患者68例，非糖尿病患者53例；身体肾移植73例，亲属供肾48例)和硫唑嘌呤-泼尼松-抗淋巴细胞球蛋白(N=109例，糖尿病患者61例，非糖尿病患者48例；身体肾移植69例，亲属供肾40例)。1984年3月31日对结果进行了分析。两年后环孢素组的患者存活率为88%，硫唑嘌呤组为91%(p=0.649)。两年后移植肾存活率环孢素组为82%，硫唑嘌呤治疗组为77%(p=0.150)；亲属供肾移植受者为87%，身体供肾移植受者为78%(p=0.656)，身体供肾移植受者为73%(p=0.178)。移植肾2年存活率环孢素组为81%，硫唑嘌呤治疗组为74%(p=0.150)，环孢素组为83%，非糖尿病组为81%(p=0.604)。在环孢素和硫唑嘌呤治疗组中，糖尿病患者和非糖尿病患者的移植物存活率差异不显著(p分别为0.822和0.423)。虽然移植肾存活率没有显著差异，但环孢素组移植后一年内排斥反应的累积发生率(34%)显著低于硫唑嘌呤治疗组(60%)(p=0.001)。在技术上成功的身体肾移植受者中，环孢素组急性肾小管坏死的发生率为31%，硫唑嘌呤治疗组为30%(p=0.822)。接受硫唑嘌呤和环孢菌素治疗的受体中，接受或未接受ATN的移植物存活率分别为72%和%(p=0.011)。平均值(+/-S.D.)1年后，环孢素组(2.0+/-0.6)的血肌酐水平(mg/dl)高于硫唑嘌呤组(1.5+/-0.5)(p=<0.001)。在接受环孢素治疗的患者中，96名(70%)因肾毒性需要减少环孢素的剂量，25名患者改用硫唑嘌呤治疗(21%)。在接受环孢素治疗的患者中，所有感染的发生率大约是接受硫唑嘌呤治疗的患者的一半，只有9%的接受环孢素治疗的患者在移植后的第一年被诊断为巨细胞病毒感染，而在接受硫唑嘌呤治疗的患者中，这一比例为28%(p=0.002)。
Between September 26, 1980 and December 31, 1983, 230 splenectomized, transfused renal allograft recipients were randomized to treatment with either cyclosporin-prednisone (N = 121, 68 diabetic and 53 nondiabetic recipients; 73 cadaver and 48 related donor grafts) or azathioprine-prednisone-antilymphocyte globulin (N = 109, 61 diabetic and 48 nondiabetic recipients; 69 cadaver and 40 related donor grafts). The results were analyzed on March 31, 1984. Actuarial patient survival rates at 2 years were 88% in the cyclosporin and 91% in the azathioprine groups (p = 0.649). Graft survival rates at 2 years were 82% in all cyclosporin and 77% in all azathioprine-treated recipients (p = 0.150); the corresponding figures in the recipients of related donor grafts were 87% vs. 83% (p = 0.656), and in the recipients of cadaver donor grafts were 78% vs. 73% (p = 0.178). The 2-year graft survival rates were 81% in cyclosporin and 74% in azathioprine-treated diabetic recipients (p = 0.150) and 83% in cyclosporin and 81% in azathioprine-treated nondiabetic recipients (p = 0.604). Within the cyclosporin and azathioprine treatment groups, the differences in graft survival rates between diabetic and nondiabetic recipients were not significant (p = 0.822 and 0.423, respectively). Although there were no significant differences in graft survival rates, the cumulative incidence of rejection episodes within the first post-transplant year was significantly lower in the cyclosporin (34%) than in the azathioprine (60%) treated recipients (p = 0.001). In recipients of technically successful cadaver kidney grafts, the incidence of acute tubular necrosis (ATN) was 31% in cyclosporin and 30% in azathioprine-treated recipients (p = 0.822). Graft survival rates in azathioprine- and cyclosporin-treated recipients who did or did not undergo ATN were 72% vs. 89% (p = 0.011). The mean (+/- S.D.) serum creatinine levels (mg/dl) at 1 year were higher in cyclosporin (2.0 +/- 0.6) than in azathioprine (1.5 +/- 0.5) treated recipients (p = less than 0.001). A reduction in cyclosporin dose because of nephrotoxicity was required in 96 of the cyclosporin-treated patients (70%), and 25 were switched to treatment with azathioprine (21%). The incidence of all infections in cyclosporin-treated patients was approximately half of that in azathioprine-treated patients, and only nine per cent of the cyclosporin-treated patients were diagnosed to have cytomegalovirus infections during the first post-transplant year vs. 28% in azathioprine-treated patients (p = 0.002).(ABSTRACT TRUNCATED AT 400 WORDS)