Christensen C, Bruden D, Livingston S, Deubner H, Homan C, Smith K, Oh E, Gretch D, Williams J, McMahon B
Liver Disease and Hepatitis Program, Alaska Native Tribal Health Consortium, Anchorage, AK, USA.
J Viral Hepat. 2006 Oct;13(10):652-8. doi: 10.1111/j.1365-2893.2006.00743.x.
Liver biopsy is the primary method of assessing liver injury in hepatitis C patients. FIBROSpect II (FS), a diagnostic panel of three extracellular matrix remodelling markers, may be useful as a noninvasive alternative to this procedure. The purpose of this study was to correlate FS results with liver fibrosis scores to determine if this test is sufficiently accurate to be a viable alternative to liver biopsy. A total of 142 serum specimens were evaluated for fibrosis with FS and were compared with Knodell and Ishak fibrosis scores. FS reports an index score ranging from 0.1 to 1.0, which corresponds to the probability of progressive liver fibrosis. Using a FS index cut-off of 0.42, 50 of 54 patients with Ishak 3-6 were classified as having advanced fibrosis (METAVIR F2-F4) and 58 of 88 patients with Ishak 0-2 as having no/mild fibrosis (METAVIR F0-F1), resulting in a sensitivity of 93%, specificity of 66%, and an overall test accuracy of 76%. With a 38% prevalence of advanced fibrosis, the negative predictive value was 94% and positive predictive value was 63%. A biopsy length of > or = 2 cm was associated with higher concordance between FS results and liver fibrosis scores (P = 0.01). FS was clinically useful in ruling out advanced fibrosis in hepatitis C by identifying patients with mild disease in whom treatment could be deferred. The limitation of this test is its decreased sensitivity and specificity in the middle of the test's reporting range between scores of 0.42 and 0.80.
肝活检是评估丙型肝炎患者肝损伤的主要方法。FIBROSpect II（FS）是一种由三种细胞外基质重塑标志物组成的诊断组合，可能作为该检查的一种非侵入性替代方法。本研究的目的是将FS结果与肝纤维化评分相关联，以确定该检测是否足够准确，可作为肝活检的可行替代方法。共对142份血清标本进行FS纤维化评估，并与Knodell和Ishak纤维化评分进行比较。FS报告的指数评分范围为0.1至1.0，这与进行性肝纤维化的概率相对应。使用FS指数临界值0.42，54例Ishak 3 - 6级患者中有50例被分类为有进展性纤维化（METAVIR F2 - F4），88例Ishak 0 - 2级患者中有58例被分类为无/轻度纤维化（METAVIR F0 - F1），敏感性为93%，特异性为66%，总体检测准确性为76%。在进展性纤维化患病率为38%的情况下，阴性预测值为94%，阳性预测值为63%。活检长度≥2 cm与FS结果和肝纤维化评分之间更高的一致性相关（P = 0.01）。FS在通过识别可推迟治疗的轻症丙型肝炎患者来排除进展性纤维化方面具有临床实用性。该检测的局限性在于其在0.42至0.80评分的检测报告范围内敏感性和特异性降低。
