MDFS评分系统用于慢性乙型肝炎肝纤维化诊断的敏感性、特异性研究

【目的】建立诊断慢性乙型肝炎(CHB)明显肝纤维化程度的简易评分系统,并观察其诊断的敏感性、特异性。【方法】将233例经肝穿活检术确诊的CHB患者随机分为模型组(N=154)和验证组(N=79)。记录患者的一般资料及生化学、影像学等指标,在模型组中将有无明显纤维化设为研究终点,建立诊断评分系统,利用ROC曲线确定界值、灵敏度、特异度等,并在验证组验证该模型诊断效能。【结果】(1)由模型组分析得到由性别、乙型肝炎病毒(HBV)-DNA、瞬时弹性成像(FS)值、脾大等构成的CHB肝纤维化MDFS诊断评分系统。其中,男性、HBV-DNA重度复制(≥10~7 U/m L)、FS值≥7.3 k Pa、脾大分别赋予1分、-2分、3分及2分。(2)MDFS评分系统的最佳诊断界值为2分。(3)模型组ROC曲线提示其特异度和灵敏度分别为92.86%、54.76%,ROC曲线下面积(AUC)为0.790,约登指数为0.476 2。在验证组中,将2分作为诊断界值,灵敏度、特异度、阳性似然比、阴性似然比分别为52.17%、82.35%、2.96、0.58。(4)不同证型MDFS评分比较结果为瘀血阻络湿热蕴结脾肾阳虚肝郁脾虚=肝郁气滞。【结论】MDFS评分系统对CHB肝纤维化的诊断具有中等效能,其特异性较高,对明显肝纤维化的误诊率较低,可为CHB肝纤维化的诊断提供无创、简便、易操作的诊断方法。

Sensitivity and Specificity of MDFS Scoring System in Diagnosis of Liver Fibrosis in Chronic Hepatitis B

Objective To establish a simple scoring system for the diagnosis of liver fibrosis in chronic hepatitis B (CHB), and to observe its sensitivity and specificity. Methods Two hundred and thirty-three patients diagnosed as CHB by liver biopsy were divided into model group (N = 154) and validation group (N = 79). The general information, biochemical parameters and imaging data of all patients were observed. With hepatic fibrosis being obvious or not as the end point of primary study in the model group, we established a simple scoring system for the diagnosis. The cut-off, sensitivity and specificity of the system were tested in the model group by ROC curve, and its diagnostic efficacy was tested in the validation group. Results(1) A simple scoring system for the diagnosis of liver fibrosis called MDFS was established in the model group, and the dimensions of the system included sex, HBV-DNA, Fibroscan (FS) value and splenomegaly. In MDFS, male, HBV-DNA≥ 107 U/mL,FS value≥7.3 kPa, and splenomegaly were assigned 1 point, -2 points, 3 points, and 2 points respectively. (2) The best cut-off value in MDFS was 2 points.(3) ROC curve of the model group indicated that the specificity and sensitivity were 92.86% and 54.76% respectively, the area under curve(AUC) was 0.790, and the Youden index was 0.4762. In the validation group, the diagnostic cut-off value was over 2 points, and the sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio were 52.17%, 82.35%, 2.96, and 0.58 respectively. (4) The scoring results of MDFS for different traditional Chinese medical syndromes of CHB showed that the scores of blood stasis blocking collaterals > damp-heat accumulation > deficiency of spleen and kidney yang> liver depression and spleen deficiency = stagnation of liver Qi. Conclusion The MDFS diagnostic scoring system has medium efficiency. The specificity of MDFS is relatively high and MDFs has a relatively low misdiagnosis rate for the diagnosis of obvious hepatic fibrosis in CHB. The MDFS is expected to be a noninvasive and simple diagnosing way for hepatic fibrosis in CHB.