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首页> 外文期刊>Clinical kidney journal. >Gadolinium-induced nephrogenic systemic fibrosis: the rise and fall of an iatrogenic disease
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Gadolinium-induced nephrogenic systemic fibrosis: the rise and fall of an iatrogenic disease

机译：d诱导的肾原性系统性纤维化：医源性疾病的兴衰

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Background. In 2006, nephrologists in Denmark unexpectedly identified chronic kidney disease (CKD) patients with a new syndrome, nephrogenic systemic fibrosis (NSF). Subsequently, 1603 NSF patients were reported to the Food and Drug Administration. Sixty hospitals in the USA account for 93% of these cases, and two hospitals in Denmark account for 4% of these reports. We review Denmark's identification and subsequent rapid eradication of NSF. Methods. NSF reports from clinicians, the Danish Medicines Agency (DMA) and gadolinium-based contrast agents (GBCAs) manufacturers were reviewed (2002–11). Results. In 1994, the DMA approved a non-ionic linear GBCA, gadodiamide (0.1 mmol/kg), for magnetic resonance imagings (MRIs), with a renal insufficiency contraindication. In 1996, 0.3 mmol/kg dosing received DMA approval. In 1998, the DMA removed renal contraindications. In 1997 and 2002, radiologists at Skejby Hospital and Herlev Hospital, respectively, began performing gadodiamide-enhanced magnetic resonance angiography scans (0.3 mmol/kg) of CKD patients. In 2005, Herlev clinicians requested assistance in evaluating etiological causes of NSF occurring among 10 CKD patients who had developed NSF. This investigation, focusing on infectious agents, was inconclusive. In 2006, Herlev clinicians reported that of 108 CKD patients who had received gadodiamide-enhanced MRI, 20 had developed probable NSF. Herlev radiologists voluntarily discontinued administering gadodiamide to all patients and no new NSF cases at Herlev Hospital developed subsequently. After meeting with Herlev radiologists, Skejby radiologists also discontinued administering gadodiamide to all patients. In 2007, the European Medicines Agency and the DMA contraindicated gadodiamide administration to CKD patients. In 2008, in response to these advisories, radiologists at the other 36 Danish hospitals discontinued administering gadodiamide to all patients, following on practices adopted at Skejby and Herlev Hospitals. In 2009, clinicians at Skejby Hospital reported that a look-back survey identified 33 CKD patients with NSF developing after undergoing GBCA-enhanced MRIs between 1999 and 2007. In 2010, an independent review, commissioned by the Minister of Health, concluded that the DMA had erred in rescinding gadodiamide's renal insufficiency contraindication in 1998 and that this error was a key factor in the development of NSF in Denmark. In 2011, three NSF cases associated with macrocyclic GBCA-associated NSF and three NSF patients with Stages 3 and 4 CKD disease from Skejby Hospital were reported. Conclusion. A confluence of factors led to the development and eradication of NSF in Denmark.
机译：背景。在2006年，丹麦的肾脏科医生意外地发现了患有新综合征，肾源性系统性纤维化（NSF）的慢性肾脏病（CKD）患者。随后，向食品药品监督管理局报告了1603名NSF患者。美国的60所医院占这些病例的93％，丹麦的两家医院占这些报告的4％。我们回顾了丹麦的鉴定以及随后对NSF的快速消除。方法。审查了来自临床医生，丹麦药品管理局（DMA）和g基造影剂（GBCA）制造商的NSF报告（2002-11年）。结果。 1994年，DMA批准了一种非离子型线性GBCA加达二酰胺（0.1 mmol / kg）用于磁共振成像（MRI），并伴有肾功能不全的禁忌症。 1996年，以0.3 mmol / kg的剂量获得DMA批准。 1998年，DMA取消了肾脏禁忌症。在1997年和2002年，Skejby医院和Herlev医院的放射科医生分别开始对CKD患者进行加多巴胺增强磁共振血管造影（0.3 mmol / kg）扫描。 2005年，Herlev临床医生请求协助评估10例患有NSF的CKD患者中发生NSF的病因。这项针对感染因子的调查尚无定论。 2006年，Herlev临床医生报告说，在接受gadodiamide增强MRI检查的108名CKD患者中，有20名可能出现了NSF。 Herlev放射科医生自愿停止对所有患者施用加多二酰胺，随后在Herlev医院没有新的NSF病例发生。与Herlev放射科医生会面后，Skejby放射科医生还停止对所有患者施用加多二酰胺。 2007年，欧洲药品管理局（European Medicines Agency）和DMA禁止对CKD患者使用gadodiamide。 2008年，根据这些建议，丹麦其他36家医院的放射科医生按照斯凯比医院和赫列夫医院采用的做法，停止对所有患者使用加多二酰胺。 2009年，斯凯比医院的临床医生报告说，一项回顾调查确定了1999年至2007年之间接受GBCA增强MRI检查后发展为NSF的33例CKD患者。2010年，由卫生部委托进行的一项独立审查得出结论，即DMA在1998年取消了gadodiamide的肾功能不全禁忌症时犯了错误，并且该错误是丹麦NSF发展的关键因素。 2011年，据报道，斯凯比医院（Skejby Hospital）报告了3例与大环GBCA相关的NSF相关的NSF病例以及3例CKD为3期和4期CKD疾病的NSF患者。结论。各种因素的融合导致丹麦NSF的发展和根除。

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