Hybrid Capture II 试验与基于 PCR 检测口腔黏膜下纤维化和口腔鳞状细胞癌中人乳头瘤病毒 DNA 的比较研究。
Comparative study between the Hybrid Capture II test and PCR based assay for the detection of human papillomavirus DNA in oral submucous fibrosis and oral squamous cell carcinoma.
机构信息
Centre for Biotechnology, University of Allahabad, India.
出版信息
Virol J. 2010 Sep 23;7:253. doi: 10.1186/1743-422X-7-253.
BACKGROUND
Oral malignancy is a major global health problem. Besides the main risk factors of tobacco, smoking and alcohol, infection by human papillomavirus (HPV) and genetic alterations are likely to play an important role in these lesions. The purpose of this study was to compare the efficacy of HC-II assay and PCR for the detection of specific HPV type (HPV 16 E6) in OSMF and OSCC cases as well as find out the prevalence of the high risk HPV (HR-HPV) in these lesions.
METHODS AND MATERIALS
Four hundred and thirty patients of the potentially malignant and malignant oral lesions were taken from the Department of Otorhinolaryngology, Moti Lal Nehru Medical College, Allahabad, India from Sept 2007-March 2010. Of which 208 cases were oral submucous fibrosis (OSMF) and 222 cases were oral squamous cell carcinoma (OSCC). The HC-II assay and PCR were used for the detection of HR-HPV DNA.
RESULT
The overall prevalence of HR-HPV 16 E6 DNA positivity was nearly 26% by PCR and 27.4% by the HC-II assay in case of potentially malignant disorder of the oral lesions such as OSMF. However, in case of malignant oral lesions such as OSCC, 32.4% HPV 16 E6 positive by PCR and 31.4% by the HC-II assay. In case of OSMF, the two test gave concordant result for 42 positive samples and 154 negative samples, with an overall level of agreement of 85.4% (Cohen's kappa = 66.83%, 95% CI 0.553-0.783). The sensitivity and specificity of the test were 73.7% and 92.05% (p < 0.00). In case of OSCC, the two test gave concordant result for 61 positive samples and 152 negative samples, with an overall level of agreement of 88.3% (Cohen's kappa = 79.29, 95% CI 0.769-0.939) and the sensitivity and specificity of the test were 87.14% and 92.76% (p < 0.00).
CONCLUSION
This study concluded that slight difference was found between the positivity rate of HR-HPV infection detected by the HC-II and PCR assay in OSMF and OSCC cases and the HC II assay seemed to have better sensitivity in case of OSCC.
背景
口腔恶性肿瘤是一个全球性的主要健康问题。除了烟草、吸烟和酒精等主要危险因素外，人乳头瘤病毒（HPV）感染和遗传改变可能在这些病变中发挥重要作用。本研究旨在比较 HC-II 检测法和 PCR 检测特定 HPV 类型（HPV 16 E6）在口腔黏膜下纤维化（OSMF）和口腔鳞状细胞癌（OSCC）病例中的疗效，并找出这些病变中高危 HPV（HR-HPV）的流行率。
方法与材料
2007 年 9 月至 2010 年 3 月，从印度阿拉哈巴德莫蒂拉尔·尼赫鲁医学院耳鼻喉科采集了 430 例潜在恶性和恶性口腔病变患者。其中 208 例为口腔黏膜下纤维化（OSMF），222 例为口腔鳞状细胞癌（OSCC）。采用 HC-II 检测法和 PCR 法检测 HR-HPV DNA。
结果
在口腔黏膜下纤维化等潜在恶性口腔病变中，PCR 法和 HC-II 检测法检测 HR-HPV 16 E6 DNA 阳性率分别接近 26%和 27.4%。然而，在口腔鳞状细胞癌等恶性口腔病变中，PCR 法和 HC-II 检测法 HPV 16 E6 阳性率分别为 32.4%和 31.4%。在 OSMF 中，两种检测方法对 42 个阳性样本和 154 个阴性样本的检测结果一致，总符合率为 85.4%（Cohen's kappa = 66.83%，95%CI 0.553-0.783）。检测的灵敏度和特异性分别为 73.7%和 92.05%（p<0.00）。在 OSCC 中，两种检测方法对 61 个阳性样本和 152 个阴性样本的检测结果一致，总符合率为 88.3%（Cohen's kappa = 79.29，95%CI 0.769-0.939），检测的灵敏度和特异性分别为 87.14%和 92.76%（p<0.00）。
结论
本研究发现，HC-II 检测法和 PCR 检测法在 OSMF 和 OSCC 病例中检测 HR-HPV 感染的阳性率略有差异，HC-II 检测法在 OSCC 病例中似乎具有更高的灵敏度。
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