Gaber L W, Moore L W, Gaber A O, First M R, Guttmann R D, Pouletty P, Schroeder T J, Soulillou J P
Department of Pathology, The University of Tennessee-Memphis, 38103, USA.
Transplantation. 1998 Feb 15;65(3):376-80. doi: 10.1097/00007890-199802150-00013.
Standardized histological grading of transplant kidney biopsies has become a primary criterion for diagnosis of rejection in immunosuppression clinical trials.
A consortium of 19 transplant centers from North America, Europe, and Australia convened in 1995 to examine kidney transplant rejection. Data from the 1995 Efficacy Endpoints Conference were examined for frequency of adoption of Banff schema. Biopsy grading was correlated with clinical parameters of rejection and therapy response.
Histological confirmation of rejection episodes occurred in 73% of 953 cases, with Banff criteria adoption increasing in frequency between 1992 and 1995. Banff grading significantly correlated with clinical rejection severity (rejection creatinine: grade I, 2.8+/-0.2 mg/dl; grade II, 3.5+/-0.2 mg/dl; grade III, 4.1+/-0.3 mg/dl; P < 0.001), although nadir creatinines were similar. Response rates of Banff grades I and II to steroid therapy were not different, but only 42% of grade III rejections responded to steroids (P < 0.003. Banff grading also correlated with postrejection creatinine, day 15: grade I, 2.2+/-0.2 mg/dl; grade II, 3.0+/-0.2 mg/dl; grade III, 3.8+/-0.4 mg/dl (P < 0.001), and day 30: grade I, 2.1+/-0.1 mg/dl; grade II, 2.2+/-0.2 mg/dl; grade III, 2.7+/-0.2 mg/dl (P < 0.06). Banff grade III correlated with reduced graft survival at 1 year: grade I, 86%; grade II, 88%; grade III, 70% (P < 0.01).
This multicenter review of rejection severity confirms that standardized histologic classifications such as the Banff schema provide a reliable means for stratifying patient risk of treatment success or failure. These data support the use of Banff criteria in clinical trial design.
移植肾活检的标准化组织学分级已成为免疫抑制临床试验中排斥反应诊断的主要标准。
1995年,来自北美、欧洲和澳大利亚的19个移植中心组成一个联盟,对肾移植排斥反应进行研究。对1995年疗效终点会议的数据进行分析,以了解班夫标准的采用频率。活检分级与排斥反应的临床参数及治疗反应相关。
在953例病例中,73%出现了排斥反应的组织学确认,1992年至1995年间班夫标准的采用频率不断增加。班夫分级与临床排斥反应严重程度显著相关(排斥反应时肌酐水平:I级,2.8±0.2mg/dl;II级,3.5±0.2mg/dl;III级,4.1±0.3mg/dl;P<0.001),尽管最低肌酐水平相似。I级和II级班夫分级对类固醇治疗的反应率无差异,但III级排斥反应中只有42%对类固醇有反应(P<0.003)。班夫分级也与排斥反应后第15天及第30天的肌酐水平相关:第15天,I级,2.2±0.2mg/dl;II级,3.0±0.2mg/dl;III级,3.8±0.4mg/dl(P<0.001);第30天,I级,2.1±0.1mg/dl;II级,2.2±0.2mg/dl;III级,2.7±0.2mg/dl(P<0.06)。班夫III级与1年时移植肾存活率降低相关:I级,86%;II级,88%;III级,70%(P<0.01)。
这项关于排斥反应严重程度的多中心综述证实,诸如班夫标准等标准化组织学分类为分层患者治疗成功或失败的风险提供了可靠方法。这些数据支持在临床试验设计中使用班夫标准。