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美国食品和药物管理局警告后,肾病患者使用钆增强磁共振研究的变化:2005-2008 年退伍军人事务部医疗保健系统数据的横断面研究。

Change in use of gadolinium-enhanced magnetic resonance studies in kidney disease patients after US Food and Drug Administration warnings: a cross-sectional study of Veterans Affairs Health Care System data from 2005-2008.

机构信息

Renal Section, State University of New York at Stony Brook, Stony Brook, NY 11794, USA.

出版信息

Am J Kidney Dis. 2010 Sep;56(3):458-67. doi: 10.1053/j.ajkd.2010.03.027. Epub 2010 Jun 26.

DOI:10.1053/j.ajkd.2010.03.027
PMID:20580477
Abstract

BACKGROUND

Exposure to gadolinium in patients with kidney disease has been linked to risk of developing nephrogenic systemic fibrosis. The US Food and Drug Administration (FDA) has issued warnings against the use of gadolinium in this population. We studied the impact of these warnings on the use of gadolinium-enhanced magnetic resonance (GE-MR) studies in patients with decreased estimated glomerular filtration rate (eGFR) and the practice of measuring serum creatinine before gadolinium exposure.

STUDY DESIGN

Cross-sectional study of patients who had undergone MR studies from October 2002 to September 2008.

SETTING & PARTICIPANTS: Patients receiving medical care in the US Department of Veterans Affairs Health Care System.

PREDICTOR

Date of MR imaging, serum creatinine level, and eGFR using the 4-variable Modification of Diet in Renal Disease (MDRD) Study equation.

OUTCOMES & MEASUREMENTS: The rate of MR studies performed with and without gadolinium from July 2005 to September 2008 in patients with different stages of kidney disease, defined using eGFR. The proportion of GE-MR studies with a screening serum creatinine level.

RESULTS

There was a 71% decrease in the rate of GE-MR use in patients with GFR<30 mL/min/1.73 m2 2 years after the release of the first public health advisory, although studies continued to be performed in patients with stages 4 and 5 chronic kidney disease. The proportion of GE-MR studies with serum creatinine measured within 1 month before the study increased by 99%.

LIMITATIONS

Data available up to September 30, 2008. Indications for the GE-MR studies were not assessed. The accuracy of Current Procedural Terminology and International Classification of Diseases, Ninth Revision coding was not assessed.

CONCLUSION

There was a large decrease in the use of GE-MR studies in patients with GFR<30 mL/min/1.73 m2 and a large but not universal increase in the practice of measuring serum creatinine before GE-MR after the release of the FDA warnings.

摘要

背景

患有肾脏疾病的患者接触钆会增加罹患肾源性系统性纤维化的风险。美国食品药品监督管理局(FDA)已发布针对此类人群使用钆的警告。我们研究了这些警告对肾小球滤过率(eGFR)降低的患者进行钆增强磁共振(GE-MR)检查的使用情况和进行钆暴露前检测血清肌酐的实践的影响。

研究设计

对 2002 年 10 月至 2008 年 9 月间进行 MR 检查的患者进行横断面研究。

研究场所和参与者

在美国退伍军人事务部医疗保健系统接受治疗的患者。

预测因素

使用基于 4 变量肾脏病饮食改良公式(MDRD)研究方程的磁共振成像日期、血清肌酐水平和 eGFR。

结果

在发布第一份公共卫生咨询报告后的 2 年内,eGFR<30 mL/min/1.73 m2 的患者进行 GE-MR 检查的比率下降了 71%,尽管在慢性肾脏病 4 期和 5 期的患者中仍继续进行此类检查。在研究前 1 个月内测量血清肌酐的 GE-MR 检查的比例增加了 99%。

局限性

数据截至 2008 年 9 月 30 日。未评估 GE-MR 检查的适应证。未评估当前操作术语和国际疾病分类,第九修订版编码的准确性。

结论

在 eGFR<30 mL/min/1.73 m2 的患者中,GE-MR 检查的使用率大幅下降,在发布 FDA 警告后,进行 GE-MR 检查前测量血清肌酐的实践有了大幅但并非普遍的增加。

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