摘要
目的比较ET-CD-Ⅰ型超声肝硬化检测仪(试验机)与已上市的同类产品FibroScan(对照机)在主要性能等方面是否相同。方法选择2010年12月—2011年5月解放军第八一医院和泸州医学院附属医院收治的慢性HBV感染者作为研究对象,分别应用试验机和对照机进行肝脏硬度测定。按试验组和对照组及不同乙型肝炎(乙肝)类型,分别比较肝脏硬度弹性值。结果入组96例,符合方案人群(per-protocol population,PPP)为94例。两中心患者在年龄、性别方面比较无显著差异;体重指数比较,解放军第八一医院(23.24±2.59)明显高于泸州医学院附属医院(21.94±2.45),P=0.013。试验总符合率为97.9%(94/96),显著高于目标值85%(P<0.001)。试验机和对照机检测肝脏硬度弹性值无显著差异,不同乙肝类型中慢性乙肝和携带者无显著差异,肝硬化患者差异明显。结论试验机可用于检测肝脏硬度,辅助肝硬化诊断,使用简单方便,有效性及其他主要性能与对照机基本相当。
Objective To compare the main diagnostic performance of ET-CD-I ultrasound device for assessing liver cirrhosis （testing device） with that of Fibrosean device （control device） which has been released to the market. Methods Patients with chronic hepatits B （CHB） treated in 81 Hospital of PLA and Affdiated Hospital of Luzhou Medical College between Dec. 2010 and May 2011 were included in the study. The testing device and the control device were used for liver stiffness measurement, and liver stiffness values measured by the two devices were compared among patients with different clinical types of CHB. Results Totally 96 patients were enrolled, and 94 were eligible for per-protocol population analysis. No significant differences in age and sex were found between the patients of the two hospitals. The body mass index of the patients of 81 Hospital of PLA was 23.24±2.59, higher than that of the patients of Affiliated Hospital of Luzhou Medical College （21.94±2.45）, and the difference between them was significant （P= 0.013）. The overall up-to-standard rate of this experiment was 97.9% （94/96）, significantly higher than the objective vague of 85% （P〈0.001）. Liver stiffness values measured by the two devices were not significantly different, and the values were not significantly different in CHB patients and HBV carries, but significantly different in patients with liver cirrhosis. Conclusions ET-CD-I ultra- sound device for diagnosing liver cirrhosis can be used for liver stiffness measurement and assist the diagnosis of liver cirrhosis. It is used in a simple and convenient manner, and its validity and other main performance are basically equivalent to Fibroscan device.
出处
《传染病信息》
2012年第3期166-169,共4页
Infectious Disease Information
关键词
乙型肝炎
慢性
肝纤维化
硬度
hepatitis B, chronic
liver fibrosis
stiffness
作者简介
[通讯作者]汪茂荣，E—mail：maorongwang@gmail．com
