Abstract: Objective　To evaluate the performance of FibroTouch in combination with four hepatic fibrosis biomarkers for assessment of the degree of hepatic fibrosis among patients with chronic schistosomiasis⁃induced liver disorders. Methods　A total of 63 patients with chronic schistosomiasis⁃induced liver diseases admitted to The Third People’s Hospital of Kunshan City from January to March 2021 were enrolled as the observation group, while 50 healthy volunteers receiving health examinations in the hospital during the study period were randomly selected as the control group. The liver stiffness measurement (LSM) was determined using the FibroTouch technique, and the serum levels of four hepatic fibrosis biomarkers were detected using chemiluminescence immunoassay, including type Ⅳ collagen (Ⅳ⁃C), type Ⅲ procollagen (PC⁃Ⅲ), hyaluronidase (HA) and laminin (LN). The receiver operating characteristic (ROC) curves of LSM and four hepatic fibrosis biomarkers alone and in combination for assessing the degree of hepatic fibrosis among patients with chronic schistosomiasis⁃induced liver disorders were plotted and the area under the ROC curve (AUC) was estimated to examine the value of LSM and four hepatic fibrosis biomarkers alone and in combination for assessing the degree of hepatic fibrosis. Results　There were 63 subjects in the observation group, including 28 men and 35 women, and the participants had a mean age of (65.34 ± 12.56) years and a mean body mass index (BMI) of (24.47 ± 11.05) kg/m2. There were 50 subjects in the control group, including 22 men and 28 women, and the participants had a mean age of (64.28 ± 13.10) years and a mean BMI of (25.12 ± 11.64) kg/m2. There were no significant differences between the observation and control groups in terms of gender ratio ([χ2] = 0.002, P > 0.05), age (t = 0.437, P > 0.05) or BMI (t = 0.303, P > 0.05). The LSM [(8.65 ± 5.22) vs. (3.24 ± 1.10) kPa; t = 8.013, P < 0.05], Ⅳ⁃C [(51.80 ± 9.45) vs. (30.10 ± 10.34) ng/L; t = 11.506, P < 0.05], PC⁃Ⅲ [(77.28 ± 17.22) vs. (48.62 ± 9.54) ng/L; t = 11.224, P < 0.05], HA [(39.55 ± 5.32) vs. (84.89 ± 10.34) ng/L; t = 30.158, P < 0.05] and LN [(99.47 ± 7.37) vs. (61.93 ± 9.80) ng/L; t = 22.496, P < 0.05] were significantly greater in the observation group than in the control group, and Spearman correlation analysis showed that the degree of liver fibrosis positively correlated with LSM (rs = 0.675, P < 0.01), Ⅳ⁃C (rs = 0.421, P < 0.01), PC⁃Ⅲ (rs = 0.517, P < 0.01), HA (rs = 0.550, P < 0.01) and LN (rs = 0.539, P < 0.01) among patients with chronic schistosomiasis⁃induced liver diseases. ROC curve analysis revealed that the AUC of LSM for assessment of the hepatic fibrosis degree was 0.884 (P < 0.001), and the LSM cutoff, sensitivity and specificity were 11.75 kPa, 71.43% and 84.00% at the highest Youden index, respectively. In addition, the AUC of four hepatic fibrosis biomarkers for assessment of the hepatic fibrosis degree was 0.577 to 0.670, with 70.174 to 115.237 ng/L cutoff values, 17.46% to 68.25% sensitivity and 71.01% to 96.00% specificity. In addition, the sensitivity and specificity of LSM combined with four hepatic fibrosis biomarkers were 92.06% and 95.07% for assessment of the hepatic fibrosis degree among patients with chronic schistosomiasis⁃induced liver diseases. Conclusion　FibroTouch in combination with detection of four hepatic fibrosis biomarkers has a high sensitivity and specificity for assessing the degree of hepatic fibrosis among patients with chronic schistosomiasis⁃induced liver diseases, which deserves widespread clinical uses.

Key words: Chronic schistosomiasis, Liver fibrosis, FibroTouch, Type Ⅳ collagen, Type Ⅲ procollagen, Hyaluronidase, Laminin, Diagnostic efficiency

摘要： 目的　评价联合使用FibroTouch技术及肝纤维化四项生化指标检测对慢性血吸虫病肝病患者肝纤维化程度的效果。方法　以2021年1—3月昆山市第三人民医院收治的63例慢性血吸虫病肝病患者作为观察组，另选择同期在该院进行健康体检的50例健康志愿者作为对照组。用FibroTouch技术检测两组研究对象肝脏硬度值（LSM），用化学发光法检测两组研究对象肝纤维化四项生化指标。绘制LSM、肝纤维化四项指标单独及联合应用诊断慢性血吸虫病肝病患者肝纤维化程度的受试者工作特征（ROC）曲线，计算曲线下面积（AUC），评价单独及联合使用两种方法诊断肝纤维化程度的价值。结果　观察组共63例患者，其中男性28例、女性35例，平均年龄（65.34 ± 12.56）岁，平均体质指数（24.47 ± 11.05） kg/m2；对照组共50例，其中男性22例、女性28例，平均年龄（64.28 ± 13.10）岁，平均体质指数（25.12 ± 11.64） kg/m2。两组研究对象性别构成比（[χ2] = 0.002，P＞0.05）、年龄（t = 0.437，P＞0.05）、体质指数（t = 0.303，P＞0.05）差异均无统计学意义。观察组和对照组患者LSM [（8.65 ± 5.22） vs. （3.24 ± 1.10） kPa; t = 8.013, P < 0.05]、IV型胶原（IV⁃C） [（51.80 ± 9.45） vs. （30.10 ± 10.34） ng/L; t = 11.506, P < 0.05]、Ⅲ型前胶原（PC⁃Ⅲ） [（77.28 ± 17.22） vs.（48.62 ± 9.54） ng/L; t = 11.224, P < 0.05]、透明质酸酶（HA） [（39.55 ± 5.32） vs. （84.89 ± 10.34） ng/L; t = 30.158, P < 0.05] 和层黏连蛋白（LN） [（99.47 ± 7.37） vs. （61.93 ± 9.80） ng/L; t = 22.496, P < 0.05] 水平差异均有统计学意义，前者均高于后者。Spearman相关分析显示，慢性血吸虫病肝病患者肝纤维化程度与LSM、Ⅳ⁃C、PC⁃Ⅲ、HA、LN水平均呈正相关（rs = 0.675、0.421、0.517、0.550、0.539，P均< 0.01）。ROC曲线分析显示， LSM预测慢性血吸虫病肝病肝纤维化程度的AUC值为0.864（P < 0.001），当约登指数最大时，LSM截断值为11.75 kPa，灵敏度为71.43%，特异度为84.00%；肝纤维化四项指标预测慢性血吸虫病肝病肝纤维化程度的AUC值为0.577～0.670，截断值为70.174～115.237 ng/L，灵敏度为17.46%～68.25%，特异度为71.01%～96.00%；两者联合应用诊断慢性血吸虫病肝病肝纤维化程度的灵敏度为92.06%，特异度为95.07%。结论　联合应用FibroTouch和肝纤维化四项指标检测诊断慢性血吸虫病肝纤维化灵敏度、特异度高，值得临床推广应用。

关键词: 慢性血吸虫病, 肝纤维化, FibroTouch, Ⅳ型胶原, Ⅲ型前胶原, 透明质酸酶, 层黏连蛋白, 诊断效能