FDA510K肝硬化程度儀器FibroScan(R)

FDA批准 FibroScan(R)用于肝病非侵入性诊断 发布时间：2013-4-16 来源：药品资讯网信息中心Echosens™ 欣然宣布，FibroScan® 设备于2013年4月5日获得美国食品及药物管理局 (FDA) 的 510(k) 认证，目前准备在美国推广这项开拓性技术。 如今，1800 台 FibroScan® 在全球范围内应用于研究和日常临床实践。美国是最后一个批准使用 FibroScan® 的主要市场。 FibroScan® 用于在临床上控制慢性丙型和乙型病毒性肝炎和脂肪肝等肝病。依托一项被称之为瞬时弹性成像的技术，FibroScan® 可在50赫兹频率下采用非侵入性和完全无痛方式，快速且轻松地测量患者肝脏剪切波速度（以米/每秒为单位）和等量硬度（以千帕为单位）。FibroScan® 最先于2003年在欧洲市场问世，开创了弹性成像量化诊断医疗领域。这款产品于2008年，2009年、2010年和2011年先后获得了中国、加拿大、巴西和日本的市场认证，目前在70个国家广泛使用。 在660多种同行评估刊物的评论中，FibroScan® 是到目前为止最具临床效果的弹性成像设备。此外，世界卫生组织 (World Health Organization)、欧洲肝脏研究学会 (EASL) 和亚太肝脏研究学会 (APASL) 等机构FibroScan® 等全球各地区医疗机构在诊治指南和推荐中介绍了 FibroScan® 的使用情况。 FibroScan® 由法国巴黎的 Echosens™ 开发。自2001年成立以来，Echosens™ 在弹性成像量化诊断领域占据强大的领导地位。Echosens™ 积极开展研发，拥有17项系列专利，主要集中在其核心技术振动控制瞬时弹性成像 (VCTE™) 技术上。

Diagnosis of cirrhosis by transient elastography (FibroScan): a prospective study  Gut. 2006 March; 55(3): 403–408.

Background Transient elastography (FibroScan) is a new, non‐invasive, rapid, and reproducible method allowing evaluation of liver fibrosis by measurement of liver stiffness. In cirrhotic patients, liver stiffness measurements range from 12.5 to 75.5 kPa. However, the clinical relevance of these values is unknown. The aim of this prospective study was to evaluate the accuracy of liver stiffness measurement for the detection of cirrhosis in patients with chronic liver disease.

Methods A total of 711 patients with chronic liver disease were studied. Aetiologies of chronic liver diseases were hepatitis C virus or hepatitis B virus infection, alcohol, non‐alcoholic steatohepatitis, other, or a combination of the above aetiologies. Liver fibrosis was evaluated according to the METAVIR score.

Results Stiffness was significantly correlated with fibrosis stage (r=0.73, p<0.0001). Areas under the receiver operating characteristic curve (95% confidence interval) were 0.80 (0.75–0.84) for patients with significant fibrosis (F>2), 0.90 (0.86–0.93) for patients with severe fibrosis (F3), and 0.96 (0.94–0.98) for patients with cirrhosis. Using a cut off value of 17.6 kPa, patients with cirrhosis were detected with a positive predictive value and a negative predictive value (NPV) of 90%. Liver stiffness was significantly correlated with clinical, biological, and morphological parameters of liver disease. With an NPV >90%, the cut off values for the presence of oesophageal varices stage 2/3, cirrhosis Child‐Pugh B or C, past history of ascites, hepatocellular carcinoma, and oesophageal bleeding were 27.5, 37.5, 49.1, 53.7, and 62.7 kPa, respectively.

Conclusion Transient elastography is a promising non‐invasive method for detection of cirrhosis in patients with chronic liver disease. Its use for the follow up and management of these patients could be of great interest and should be evaluated further.