A randomized controlled trial of tacrolimus versus cyclosporine after lung transplantation
A randomized controlled trial of tacrolimus versus cyclosporine after lung transplantation
复制标题
DOI：
10.1016/j.healun.2007.07.027
复制
发表时间：
2007-10-01
影响因子：
8.9
通讯作者：
Trulock, Elbert P.
中科院分区：
文献类型：
--
作者：
Hachem, Ramsey R.;Yusen, Roger D.;Trulock, Elbert P.
背景资料：肺移植后最佳的维持免疫抑制方案是不确定的。方法：我们进行了一项随机对照试验，他克莫司与环孢素联合硫唑嘌呤和泼尼松肺移植后。90名成人随机接受他克莫司（n = 44）或环孢素（n = 46）。主要终点是一个复合物的累积急性排斥反应A评分为3分或更高，累积淋巴细胞性支气管炎B评分为4分或更高，或闭塞性细支气管炎综合征（BOS）阶段0-p.结果：随机接受环孢霉素显着更有可能发展的主要终点比那些随机他克莫司。在研究期间，主要终点在46名环孢菌素受试者中的39名中出现，而在44名他克莫司受试者中的24名中出现（P = 0.002）;急性排斥反应或淋巴细胞性支气管炎终点在46名环孢菌素受试者中的29名中出现，而在44名他克莫司受试者中的18名中出现（P = 0.036）。此外，环孢素组比他克莫司组更可能发生BOS 0-p期，但这没有统计学显著性（对数秩p = 0.1）。此外，他克莫司组中糖尿病的发病率有升高的趋势，但两组间移植物存活率、感染总数、高血压、慢性肾脏疾病或癌症的发病率无显著差异。他克莫司与较低的急性排斥反应和淋巴细胞性支气管炎负担相关，并有更大程度地避免BOS 0-肺移植术后应用环孢素的效果优于环孢素。J Heart Lung Transplant 2007;26：1012-18.版权所有（c）2007国际心肺移植学会。
Background: The optimal maintenance immunosuppressive regimen after lung transplantation is uncertain.Methods: We conducted a randomized controlled trial of tacrolimus versus cyclosporine in combination with azathioprine and prednisone after lung transplantation. Ninety adults were randomized to tacrolimus (n = 44) or cyclosporine (n = 46). The primary end point was a composite of a cumulative acute rejection A score of 3 or higher, a cumulative lymphocytic bronchitis B score of 4 or higher, or the onset of bronchiolitis obliterans syndrome (BOS) stage 0-p.Results: Recipients randomized to cyclosporine were significantly more likely to develop the primary end point than those randomized to tacrolimus. During the study period, the primary end point developed in 39 of 46 cyclosporine subjects compared with 24 of 44 tacrolimus subjects (P = 0.002); acute rejection or lymphocytic bronchitis end points developed in 29 of 46 cyclosporine subjects compared with 18 of 44 tacrolimus subjects (p = 0.036). Furthermore, BOS stage 0-p was more likely to develop in the cyclosporine group than in the tacrolimus group, but this was not statistically significant (log-rank p = 0.1). In addition, there was a trend to a higher incidence of diabetes among those in the tacrolimus group, but there was no significant difference in graft survival or the total number of infections, or in the incidence of hypertension, chronic kidney disease, or cancer between the 2 groups.Conclusions: Tacrolimus is associated with a lower burden of acute rejection and lymphocytic bronchitis and a trend to a greater freedom from BOS stage 0-p than cyclosporine after lung transplantation. J Heart Lung Transplant 2007;26:1012-18. Copyright (c) 2007 by the International Society for Heart and Lung Transplantation.