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目的评价初善仪子宫颈癌筛查系统(TruScreen)在宫颈液基细胞学涂片(TCT)阳性患者中的表现,评价初善仪对宫颈癌前病变(ASCUS及以上)的准确性及局限性。方法对36例在北京天坛医院妇产科门诊行TCT筛查(TCT采用TBS分类标准)、结果为阳性(ASCUS及以上)的患者依次进行TruScreen、阴道镜检查及宫颈活检术,以阴道镜下组织病理学结果为金标准。横断面研究比较初善仪子宫颈癌筛查系统与病理结果的吻合程度。进而验证初善仪对宫颈癌前病变(ASCUS及以上)的准确性。结果TruScreen阳性结果为19例,病理学检查阳性结果为16例。其敏感性为81%,特异度为70%,总符合率为77.1%。采用Kappa检验,Kappa=0.52,p<0.01,差别有统计学意义。结论本研究表明初善仪与病理学诊断有较好的一致性。初善仪可以在物资和筛查设施资源缺乏的地区替代宫颈刮片作为筛查方法的另一种选择。而在医疗资源丰富的地区初善仪可以与其它筛查方法一起使用来提高癌前病变的检出率以及不必要的阴道镜检查及活检术。其局限性在于初善仪的结果不如TBS分类那样详细,不能区分是鳞状上皮异常还是腺上皮细胞异常,这对临床医师采取临床决策时会造成一定的影响。
Objective To evaluate the performance of TruScreen in cervical liquid-based cytology smears (TCT) -positive patients and to evaluate the accuracy and limitation of early tyranny on cervical precancerous lesions (ASCUS and above) Sex. Methods Thirty-six patients with obstetrics and gynecology clinics in Beijing Tiantan Hospital underwent TCT screening (TCT was classified by TBS). The patients who were positive (ASCUS and above) were followed by TruScreen, colposcopy and cervical biopsy. Histopathology results for the gold standard. The cross-sectional study compared the goodness-of-fit cervical cancer screening system with the pathological results of the anastomosis. And then verify the good device on cervical precancerous lesions (ASCUS and above) accuracy. Results The positive results of TruScreen were 19 cases and the positive results of pathological examination were 16 cases. The sensitivity was 81%, specificity was 70%, the total coincidence rate was 77.1%. Kappa test, Kappa = 0.52, p <0.01, the difference was statistically significant. Conclusion This study shows that the first good instrument and pathological diagnosis have a good consistency. Anomaly can replace cervical smears in areas where there is a shortage of resources and screening facilities as an alternative to screening methods. In areas with abundant medical resources, anodizing apparatus can be used together with other screening methods to increase the detection rate of precancerous lesions and unnecessary colposcopy and biopsy. The limitation is that the results of the first instrument are not as detailed as the TBS classification, and the distinction between squamous epithelial abnormality and abnormality of the glandular epithelial cells can not be distinguished, which may have some impact on clinicians’ clinical decisions.