Fleiner F, Budde K, Dragun D, Hartmann M, Neumayer H H, Fritsche L
Department of Nephrology, University Hospital Charité, Campus Mitte, Schumannstrasse 20/21, 10098 Berlin, Germany.
Transplant Proc. 2005 Jun;37(5):2048-50. doi: 10.1016/j.transproceed.2005.03.121.
This study examined the use of different definitions for acute rejection in recent large multicenter trials performed in America and Europe in order to assess whether systematic differences exist between both scientific cultures. We systematically selected recent publications on multicenter randomized controlled trials, investigating immunosuppressive regimens in de novo kidney transplant recipients. Publications included were classified according to the type of acute rejection reported: group 1 reported no or only one type of rejection rate (biopsy-proven or treated); group 2 reported information on both treated and biopsy-proven rates. Other potential factors (journal's impact-factor, study size) were compared within the subgroups. To determine the rates of treated but not biopsy-proven acute rejections, additional analyses were performed within subgroup 2. The reviewed publications were 24/44 (54.5%) European (E) and 20/44 (45.5%) American (A) origin. Eighteen of 44 publications reported no or only one type of rejection rate (group 1); 26 publications reported treated as well as biopsy-proven rates (group 2). Significantly more European publications reported both treated and biopsy-proven rates (E: 18/24 [75.0%] vs A: 8/20 [40.0%]; P = .019). Group 1 American papers were published in higher-ranked journals than European ones. The rate of blindly treated rejections did not differ significantly (A: 6.13% [range 0% to 12.8%] vs E: 8.43% [range 0% to 16.9%]) and the proportion of blindly treated rejections was slightly lower in American studies (A: 18.5% vs E: 26.5%). Our systematic review showed large discrepancies with a trend to report biopsy-proven rejection rates only in recent years.
本研究调查了美国和欧洲近期大型多中心试验中对急性排斥反应的不同定义的使用情况，以评估两种科学文化之间是否存在系统性差异。我们系统地筛选了近期关于多中心随机对照试验的出版物，这些试验研究了初发肾移植受者的免疫抑制方案。纳入的出版物根据报告的急性排斥反应类型进行分类：第1组报告无或仅有一种排斥反应发生率（活检证实或经治疗的）；第2组报告了经治疗和活检证实的发生率的信息。在各亚组中比较了其他潜在因素（期刊影响因子、研究规模）。为了确定经治疗但未经活检证实的急性排斥反应的发生率，在第2亚组内进行了额外分析。所审查的出版物中有24/44（54.5%）来自欧洲（E），20/44（45.5%）来自美国（A）。44篇出版物中有18篇报告无或仅有一种排斥反应发生率（第1组）；26篇出版物报告了经治疗和活检证实的发生率（第2组）。报告经治疗和活检证实的发生率的欧洲出版物显著多于美国出版物（E：18/24 [75.0%] 对 A：8/20 [40.0%]；P = 0.019）。第1组美国论文发表在比欧洲论文排名更高的期刊上。盲目治疗的排斥反应发生率无显著差异（A：6.13% [范围0%至12.8%] 对 E：8.43% [范围0%至16.9%]），美国研究中盲目治疗的排斥反应比例略低（A：18.5% 对 E：26.5%）。我们的系统评价显示，近年来仅报告活检证实的排斥反应发生率的趋势存在很大差异。
