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基于3项无创指标的肝硬化诊断模型的建立及验证

Establishment and verification of a diagnostic model for liver cirrhosis based on three non-invasive indexes

  • 摘要:
    目的 穿刺活检是评估肝硬化的金标准方法,但存在出血风险。本研究拟筛选无创指标,建立与病理诊断高度相关的肝硬化诊断方法。
    方法 选取2015年7月至2016年11月在复旦大学附属中山医院肝脏外科治疗的460例患者。以病理诊断为金标准,通过套索(LASSO)算法建立无创诊断模型。采用受试者工作特征(ROC)曲线进行模型的诊断效能评估,并用独立队列的病例(n=152)对模型结果进行验证。
    结果 肝硬化患者的弹性超声值(13.60±4.98)kPa vs(9.67±3.68)kPa,P < 0.01、乙型肝炎表面抗原(HBsAg)阳性率(63.5%vs 30.4%,P < 0.01)、Ⅳ型胶原(74.23±45.57)ng/mL vs(61.30±41.22)ng/mL,P=0.01、碱性磷酸酶(84.21±30.94)U/L vs(98.49±68.30)U/L,P=0.02、凝血酶原时间(11.75±0.89)s vs(11.39±0.78)s,P < 0.01)、透明质酸显著高于非肝硬化患者。而血小板计数(150.94±70.28)×109/L vs(195.39×67.99)×109/L,P < 0.01显著低于非肝硬化患者。基于3个无创参数(弹性超声、血小板计数、HBsAg)的肝硬化诊断模型的建模组曲线下面积(AUC)为0.823(0.776~0.864),验证组为0.860(0.795~0.911),显著优于既往的无创检测模型(P < 0.001)。
    结论 本研究建立的无创肝硬化评估模型与病理诊断结果符合度高,操作简单,可使大部分患者避免有创肝穿刺活检。

     

    Abstract:
    Objective Liver biopsy is the gold standard for assessment of cirrhosis. However, there is a risk of bleeding for liver biopsy. This study aims to screen non-invasive indicators to establish a highly pathology-correlated diagnostic method for liver cirrhosis.
    Methods From July 2015 to November 2016, 460 patients from liver surgery department of Zhongshan Hospital Fudan University were enrolled. Using pathological diagnosis as the gold standard, a non-invasive diagnostic model was established by least absolute shrinkage and selection operator (LASSO). Receiver operator characteristic (ROC) curve was used to evaluate the diagnostic effectiveness of the model, and an independent cohort of patients (n=152) was used to verify the model results.
    Results Patients with cirrhosis showed significantly high two-dimensional shear-wave elastography (2D-SWE), (13.60±4.98 kPa vs 9.67±3.68kPa, P < 0.01), positive rate of hepatitis B surface antigen (HBsAg63.5% vs 30.4%, P < 0.01), collagen Ⅳ (74.23±45.57ng/mL vs 61.30±41.22ng/mL, P=0.01), alkaline phosphatase (84.21±30.94U/L vs 98.49±68.30U/L, P=0.02), prothrombin time (11.75±0.89s vs 11.39±0.78s, P < 0.01), hyaluronic acid (152.71±143.36U/L vs 99.64±71.08U/L, P < 0.01) than non-cirrhosis patients, while platelet (150.94±70.28×109/L vs195.39±67.99×109/L, P < 0.01) was lower than non-cirrhosis patients. This paper established a diagnostic model based on three non-invasive parameters (2D-SWE, platelet and HBsAg). The area under curve (AUC) for diagnosis of cirrhosis was 0.823(0.776-0.864)for modeling group and 0.860(0.795-0.911)for validation group, which was significantly better than the previous reported non-invasive detection model (P < 0.001).
    Conclusions The non-invasive cirrhosis prediction model established in this study correlates well with pathology, and may allow most patients to avoid invasive liver biopsy.

     

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