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[摘要] 目的 探讨利德曼试剂和美康试剂检测血清α-L岩藻糖苷酶（α-L-fucosidase，AFU）的临床价值差异。 方法 收集2012年1月～2015年12月在義乌市中医医院就诊的患者121例，包括待产孕妇52例，肝癌患者29例，肝硬化患者17例，肝炎患者23例，另选取102例健康体检者作为正常对照组。同时采用利德曼试剂和美康试剂检测血清AFU，比较两种试剂在不同情况下的检测结果差异和相关性，并利用ROC曲线分析血清AFU诊断待产孕妇和肝癌的效率。 结果 AFU的总体差异有统计学意义（P<0.01），不同疾病组的AFU水平均高于健康体检组；AFU的阳性率以待产孕妇组最高，其次为肝癌组。Spearman相关分析显示，利德曼试剂和美康试剂在不同组别中的相关性良好（r=0.89、0.98、0.98、0.97、0.95，P均<0.01）；配对样本t检验显示，两品牌试剂的AFU检测结果在各组中的差异均有统计学意义（P均<0.01），利德曼试剂的结果普遍高于美康试剂；卡方分析显示，利德曼试剂的健康体检组AFU阳性率显著高于美康试剂（χ2=40.30，P<0.01），而各疾病组的AFU阳性率差异均不大（P均>0.05）。美康试剂从健康体检者中诊断待产孕妇和肝癌的ROC曲线下面积（AUC）显著大于利德曼试剂（Z=7.02，P<0.01），敏感性和特异度也更好。 结论 相较于利德曼试剂，美康试剂具备更好的临床应用价值。
[关键词] α-L岩藻糖苷酶；肝癌；妊娠；诊断
[中图分类号] R735.7 [文献标识码] B [文章编号] 1673-9701（2017）07-0115-03
[Abstract] Objective To investigate the differences of the clinical value of serum L-fucosidase（AFU） by Lidemann reagent and Meikang reagent. Methods 121 cases who were admitted to Yiwu Hospital of TCM from January 2012 to December 2015 were collected， including 52 cases of pregnant women， 29 patients with hepatocellular carcinoma， 17 patients with liver cirrhosis， and 23 patients with hepatitis. Another 102 healthy subjects were selected as the normal control group. At the same time， Lidemann reagent and Meikang reagent were used to detect serum AFU. The differences and correlations between the results of the two reagents under different conditions were compared， and the ROC curve was used to analyze the efficiency of serum AFU in the diagnosis of pregnant women and liver cancer. Results The overall difference of AFU was statistically significant（P<0.01）. The levels of AFU in different disease groups were higher than those in healthy subjects. The positive rate of AFU was the highest in pregnant women group， followed by liver cancer group. Spearman correlation analysis showed that there was a good correlation between Leadman reagent and Meikang reagent in different groups（r=0.89， 0.98， 0.98， 0.97， 0.95， P<0.01 for all）. Paired samples t-test showed that the differences of the AFU test results of the two brands of reagents in each group were statistically significant （P<0.01 for all）. Leadman reagent results were generally higher than Meikang reagent； the chi-square analysis showed that the positive rate of AFU in the healthy control group of Leadman reagent was significantly higher than that of the Meikang reagent（χ2=40.30， P<0.01）. The positive rate of AFU between disease groups was not significantly different （P>0.05 for all）. The area under the ROC curve（AUC） in the diagnosis of pregnant women and liver cancer among the healthy controls by Meikang reagent was significantly higher than that of the Leadman reagent（Z=7.02， P<0.01）. The sensitivity and specificity were also better. Conclusion Compared with the Leadman reagent， Meikang reagent has a better clinical application value.
[关键词] α-L岩藻糖苷酶；肝癌；妊娠；诊断
[中图分类号] R735.7 [文献标识码] B [文章编号] 1673-9701（2017）07-0115-03
[Abstract] Objective To investigate the differences of the clinical value of serum L-fucosidase（AFU） by Lidemann reagent and Meikang reagent. Methods 121 cases who were admitted to Yiwu Hospital of TCM from January 2012 to December 2015 were collected， including 52 cases of pregnant women， 29 patients with hepatocellular carcinoma， 17 patients with liver cirrhosis， and 23 patients with hepatitis. Another 102 healthy subjects were selected as the normal control group. At the same time， Lidemann reagent and Meikang reagent were used to detect serum AFU. The differences and correlations between the results of the two reagents under different conditions were compared， and the ROC curve was used to analyze the efficiency of serum AFU in the diagnosis of pregnant women and liver cancer. Results The overall difference of AFU was statistically significant（P<0.01）. The levels of AFU in different disease groups were higher than those in healthy subjects. The positive rate of AFU was the highest in pregnant women group， followed by liver cancer group. Spearman correlation analysis showed that there was a good correlation between Leadman reagent and Meikang reagent in different groups（r=0.89， 0.98， 0.98， 0.97， 0.95， P<0.01 for all）. Paired samples t-test showed that the differences of the AFU test results of the two brands of reagents in each group were statistically significant （P<0.01 for all）. Leadman reagent results were generally higher than Meikang reagent； the chi-square analysis showed that the positive rate of AFU in the healthy control group of Leadman reagent was significantly higher than that of the Meikang reagent（χ2=40.30， P<0.01）. The positive rate of AFU between disease groups was not significantly different （P>0.05 for all）. The area under the ROC curve（AUC） in the diagnosis of pregnant women and liver cancer among the healthy controls by Meikang reagent was significantly higher than that of the Leadman reagent（Z=7.02， P<0.01）. The sensitivity and specificity were also better. Conclusion Compared with the Leadman reagent， Meikang reagent has a better clinical application value.