肾移植患者慢性肾移植失败风险人群中，他克莫司作为二线干预措施与继续使用环孢素的五年研究。

Five-year study of tacrolimus as secondary intervention versus continuation of cyclosporine in renal transplant patients at risk for chronic renal allograft failure.

作者信息

Jevnikar Anthony, Arlen Dianne, Barrett Brendan, Boucher Anne, Cardella Carl, Cockfield Sandra M, Rush David, Paraskevas Steven, Shapiro Jean, Shoker Ahmed, Yilmaz Serdar, Zaltzman Jeffrey S, Kiberd Bryce

机构信息

London Health Sciences Centre, University Campus, London, ON, Canada.

出版信息

Transplantation. 2008 Oct 15;86(7):953-60. doi: 10.1097/TP.0b013e318186dd0c.

DOI:10.1097/TP.0b013e318186dd0c

PMID:18852662

Abstract

BACKGROUND

Chronic allograft nephropathy is the most frequent cause of long-term kidney allograft loss. Studies are desperately needed to improve long-term survival. Tacrolimus has been associated with less rejection and better kidney function compared with cyclosporine in clinical trials. This study tested the hypothesis that conversion from cyclosporine to tacrolimus might improve long-term outcomes in patients with chronic allograft damage.

METHODS

In this multicenter Canadian clinical trial, cyclosporine-treated patients with biopsy-proven chronic allograft nephropathy and impaired renal function were randomly assigned (2:1) to convert to tacrolimus or continue on cyclosporine therapy. A total of 106 (70 tacrolimus and 36 cyclosporine treated) patients were followed-up for up to 5 years. The primary outcome was graft survival.

RESULTS

In an intention to treat analysis, subsequent graft (73% vs. 81%, P=0.2835, log-rank test) and patient survival (91% vs. 92%, P=0.8668, log-rank test) were not different between the tacrolimus and cyclosporine groups, respectively. Changes in Chronic Allograft Damage Index scores on protocol biopsies from baseline to 3 years were not different (+0.4+/-1.8 vs. +1.3+/-3.2, P=0.5910, cyclosporine vs. tacrolimus, respectively). There were no significant differences in biopsy-proven acute rejection (6 [8.6%] vs. 2 [5.6%], tacrolimus vs. cyclosporine, respectively, P=0.5906).

CONCLUSIONS

In this study, patients with chronic allograft damage converted from cyclosporine to tacrolimus demonstrated no apparent benefit.

摘要

背景

慢性移植肾肾病是长期移植肾丢失的最常见原因。迫切需要开展研究以提高长期存活率。在临床试验中，与环孢素相比，他克莫司与更少的排斥反应及更好的肾功能相关。本研究检验了从环孢素转换为他克莫司可能改善慢性移植肾损伤患者长期预后的假设。

方法

在这项加拿大多中心临床试验中，经活检证实患有慢性移植肾肾病且肾功能受损的环孢素治疗患者被随机分配（2:1）转换为他克莫司或继续接受环孢素治疗。共106例患者（70例接受他克莫司治疗，36例接受环孢素治疗）接受了长达5年的随访。主要结局为移植肾存活。

结果

在意向性分析中，他克莫司组和环孢素组的后续移植肾存活率（73%对81%，P=0.2835，对数秩检验）和患者存活率（91%对92%，P=0.8668，对数秩检验）并无差异。从基线至3年，方案规定活检时慢性移植肾损伤指数评分的变化也无差异（分别为+0.4±1.8对+1.3±3.2，P=0.5910，环孢素组对他克莫司组）。经活检证实的急性排斥反应也无显著差异（分别为6例[8.6%]对2例[5.6%]，他克莫司组对环孢素组，P=0.5906）。