Wertman Rebecca, Altun Ersan, Martin Diego R, Mitchell Donald G, Leyendecker John R, O'Malley Ryan B, Parsons Daniel J, Fuller Edwin R, Semelka Richard C
School of Medicine, University of North Carolina at Chapel Hill, 101 Manning Dr, CB 7510, Chapel Hill, NC 27599-7510, USA.
Radiology. 2008 Sep;248(3):799-806. doi: 10.1148/radiol.2483072093. Epub 2008 Jul 15.
To retrospectively determine the benchmark incidence of nephrogenic systemic fibrosis (NSF) related to the confirmed use of different gadolinium chelate contrast agents at four U.S. university tertiary care centers.
Institutional review board approval was obtained for this HIPAA-compliant multi-institutional study; the requirement for informed patient consent was waived. Patients who had a diagnosis of NSF between January 2000 and December 2006 were identified at four tertiary care centers with renal transplant and dialysis services. A standard checklist was used to acquire reliable data from the four centers. The diagnosis of NSF was confirmed histopathologically in all patients. The association of NSF development with gadolinium chelate contrast agent administration in each patient was assessed. The type and cumulative dose of contrast agent administered to each patient with NSF were determined at each center by using the standard checklist. The benchmark incidence of NSF was determined and expressed as the ratio of the number of patients with NSF who had undergone gadolinium chelate-enhanced magnetic resonance (MR) imaging, relative to the total number of patients who underwent gadolinium chelate-enhanced MR imaging at each tertiary care center. Benchmark incidences of NSF were compared among the four centers by using Fisher exact tests.
Gadodiamide was used at University of North Carolina at Chapel Hill (center A) and Emory University (center B), and gadopentetate dimeglumine was used at Wake Forest University (center C) and Thomas Jefferson University (center D) during the study period. Twenty-three patients at center A, nine patients at center B, three patients at center C, and one patient at center D had NSF and had undergone gadolinium chelate-enhanced MR imaging. The incidence of NSF was one in 2913 patients who underwent gadodiamide-enhanced MR examinations and one in 44,224 patients who underwent gadopentetate dimeglumine-enhanced MR examinations.
The benchmark incidence of NSF was much greater at the two centers where gadodiamide was used than at the two centers where gadopentetate dimeglumine was used.
回顾性确定美国四个大学三级医疗中心确诊使用不同钆螯合物造影剂后发生肾源性系统性纤维化（NSF）的基准发病率。
本符合健康保险流通与责任法案（HIPAA）的多机构研究获得了机构审查委员会的批准；患者知情同意的要求被豁免。在四个提供肾移植和透析服务的三级医疗中心，确定了2000年1月至2006年12月期间被诊断为NSF的患者。使用标准检查表从这四个中心获取可靠数据。所有患者的NSF诊断均经组织病理学证实。评估了每位患者NSF发生与钆螯合物造影剂给药之间的关联。通过使用标准检查表，在每个中心确定给予每位NSF患者的造影剂类型和累积剂量。确定NSF的基准发病率，并表示为接受钆螯合物增强磁共振（MR）成像的NSF患者数量与每个三级医疗中心接受钆螯合物增强MR成像的患者总数之比。使用Fisher精确检验比较四个中心之间NSF的基准发病率。
在研究期间，北卡罗来纳大学教堂山分校（A中心）和埃默里大学（B中心）使用了钆双胺，维克森林大学（C中心）和托马斯·杰斐逊大学（D中心）使用了钆喷酸葡胺。A中心有23例、B中心有9例、C中心有3例以及D中心有1例患者发生了NSF并接受了钆螯合物增强MR成像。在接受钆双胺增强MR检查的患者中，NSF发病率为1/2913，在接受钆喷酸葡胺增强MR检查的患者中，NSF发病率为1/44224。
使用钆双胺的两个中心的NSF基准发病率远高于使用钆喷酸葡胺的两个中心。
