Valeri A, Radhakrishnan J, Ryan R, Powell D
Department of Medicine, Columbia University, College of Physicians and Surgeons New York, New York, USA.
Clin Nephrol. 1996 Dec;46(6):402-9.
Previous experimental and human data suggests a detrimental effect on the course of acute renal failure related to exposure of blood to artificial dialysis membranes of poor biocompatibility. We performed a 2.5-year prospective randomized trial to compare the clinical course of acute renal failure (post-operative ischemic acute tubular necrosis, ATN) in patients receiving a cadaveric renal transplant requiring supportive hemodialysis in the immediate post-transplant setting. Patients were randomized to either a cuprophane or polymethylmethacrylate (PMMA) conventional hollow fiber dialyzer. All patients received a standard immunosuppressive regimen which included induction therapy with either horse anti-thymocyte gamma globulin (ATGAM) or the murine anti-CD3 monoclonal antibody (OKT3). Of 53 patients randomized, 17 were excluded (2 for intervening biopsy-proven rejection prior to recovery from ATN, 10 for primary graft nonfunction and 5 for other reasons), leaving 36 evaluable cases of uncomplicated ATN, 18 in each group. There was no difference by age, race, gender, cause of ESRD, immunosuppressive regimen, cold or warm ischemia time, use of pre-transplant dialysis, percent oliguria or the incidence of intra-dialytic hypotension between the 2 groups. There was no difference in the mean time to recovery from ATN posttransplant (8.9 days in the cuprophane group vs 9.5 days in the PMMA group, p = NS) or in the average number of hemodialysis treatments required (3.6 in both groups, p = NS). There was also no difference in long term allograft outcome in terms of the nadir serum creatinine, the number of episodes of subsequent acute rejection or in the development of chronic rejection. An intent-to-treat analysis of all 53 originally randomized patients similarly yielded no significant differences. A subsequent, non-randomized study using a membrane of intermediate biocompatibility (Hemophan) also showed no difference in recovery time from ATN. Bioincompatible membranes do not seem to have a significant clinical impact on the course of recovery of this form of acute renal failure. The striking benefits of biocompatibility in the course of ARF seen in other human trials may relate more to the non-renal systemic toxic effects of bioincompatibility.
先前的实验和人体数据表明,血液接触生物相容性差的人工透析膜会对急性肾衰竭病程产生有害影响。我们进行了一项为期2.5年的前瞻性随机试验,以比较在尸体肾移植术后立即需要支持性血液透析的患者中急性肾衰竭(术后缺血性急性肾小管坏死,ATN)的临床病程。患者被随机分为使用铜仿膜或聚甲基丙烯酸甲酯(PMMA)传统中空纤维透析器。所有患者均接受标准免疫抑制方案,其中包括用马抗胸腺细胞γ球蛋白(ATGAM)或鼠抗CD3单克隆抗体(OKT3)进行诱导治疗。在随机分组的53例患者中,17例被排除(2例因在从ATN恢复前经活检证实有介入性排斥反应,10例因原发性移植物无功能,5例因其他原因),剩下36例可评估的无并发症ATN病例,每组18例。两组在年龄、种族、性别、终末期肾病病因、免疫抑制方案、冷或热缺血时间、移植前透析的使用、少尿百分比或透析中低血压发生率方面无差异。移植后从ATN恢复的平均时间(铜仿膜组为8.9天,PMMA组为9.5天,p =无显著性差异)或所需血液透析治疗的平均次数(两组均为3.6次,p =无显著性差异)也无差异。在最低血清肌酐、随后急性排斥反应的发作次数或慢性排斥反应的发生方面,长期移植物结局也无差异。对所有最初随机分组的53例患者进行的意向性分析同样未得出显著差异。随后一项使用具有中等生物相容性的膜(Hemophan)的非随机研究也显示,从ATN恢复的时间无差异。生物不相容膜似乎对这种形式的急性肾衰竭的恢复病程没有显著临床影响。在其他人体试验中看到的生物相容性在急性肾衰竭病程中的显著益处可能更多地与生物不相容性的非肾脏全身毒性作用有关。