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目的探讨核酸扩增荧光检测(real-timePCR)方法在筛查宫颈癌及其癌前病变中的临床应用价值。方法对2008年7月至2009年4月在中日友好医院妇产科就诊的948例妇女进行宫颈细胞学检测、杂交捕获二代(HCⅡ)和real-timePCR两种高危型人乳头瘤病毒(HPV)检测。对其中液基细胞学(LCT)、HCⅡ和real-timePCR3种检测任一或一个以上结果异常者进行组织病理学检查。结果 948例妇女中有870例妇女两种HPV检测结果一致,总体符合率达91.77%,一致性检验Kappa值=0.789;两者之间具有极好的一致性。在对高级别宫颈上皮内瘤变(CIN)的检测中LCT、HCⅡ和real-timePCR的敏感性分别为90.98%、95.08%和94.26%,阴性预测值分别为98.37%、99.10%和98.97%。结论 real-timePCR与HCⅡ检测具有很好的一致性,可用于临床宫颈癌及其癌前病变的筛查;联合LCT和高危型HPV检测可明显提高宫颈癌前病变和宫颈癌的检出率。
Objective To investigate the clinical value of nucleic acid amplification fluorescence detection (real-time PCR) in the screening of cervical cancer and its precancerous lesions. Methods Cervical cytology was performed on 948 women attending obstetrics and gynecology department of China-Japan Friendship Hospital from July 2008 to April 2009 to capture two high risk human papillomavirus (HCⅡ) and real-time PCR HPV) test. Histopathological examination was performed on one or more abnormalities in liquid-based cytology (LCT), HCII and real-time PCR assays. Results The HPV test results of 870 women among 948 women were consistent. The overall coincidence rate was 91.77%. The Kappa value of consistency test was 0.789. There was an excellent agreement between the two. The sensitivity of LCT, HCⅡ and real-time PCR in the detection of high-grade cervical intraepithelial neoplasia (CIN) were 90.98%, 95.08% and 94.26% respectively, and the negative predictive values were 98.37%, 99.10% and 98.97% respectively. Conclusion The real-time PCR and HCⅡ test are in good agreement and can be used for the screening of clinical cervical cancer and precancerous lesions. Combined LCT and high-risk HPV test can significantly improve the detection rate of cervical precancerous lesions and cervical cancer.