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应用基因芯片技术检测高危型人乳头瘤病毒在宫颈癌筛查中的评价
作者姓名:Li RZ  Shi JF  Zhou QZ  Wu RF  Li N  Wu LN  Zhou YQ  Wang Q  Liu ZH  Liu B  Qiao YL
作者单位:1. 518036,北京大学深圳医院妇产科宫颈癌早诊早治中心
2. 中国医学科学院肿瘤研究所
3. 深圳南山区计生局
4. 河北医科大学第二医院妇产科
基金项目:世界卫生组织国际癌症研究所(IARC/WH0)研究项目(ICE/92/3-3CHN).志谢 以下单位的工作人员参加了本研究部分工作:中国医学科学院肿瘤研究所潘秦镜、张询;北京大学深圳医院张长淮、张礼婕、翁雷鸣、张建新;深圳市妇幼保健院刘植华、李晴、任晓慧;深圳南山区计划生育中心陈少凡、韩春艳、李俊华
摘    要:目的 评价人乳头瘤病毒(HPV)分型基因芯片检测技术在子宫颈癌筛查中的临床价值。方法 2004年11月至2004年12月,在深圳南山区华侨城社区内15~59岁有性生活妇女中进行以人群为基础的横断面调查研究。对所有筛查妇女宫颈脱落细胞采用第二代杂交捕获技术(HC2)和基因芯片技术进行高危型HPV的检测,同时以液基细胞薄层涂片技术(1ET)行宫颈细胞学检查。对HPV阳性并且LCT≥未明确诊断意义的不典型鳞状上皮细胞(ASCUS)或HPV阴性但LCT≥低度鳞状上皮内瘤样病变(LSIL)的妇女行阴道镜下活组织病理学检查,以病理结果作为验证两种HPV检测的参考标准。结果 共取组织标本122例。病理学结果证实该人群中无宫颈癌病例,子宫颈上皮内瘤样病变(CIN)Ⅲ级3例,CINⅡ级11例,CINⅠ级36例,慢性宫颈炎和鳞状上皮化生69例,正常宫颈3例。人群的HPV总检出率在HC2法为14.0%,基因芯片法为9.8%,HC2法HPV检出率明显高于基因芯片法(P〈0.001),二者一致性一般(Kappa=0.498);随子宫颈病变级别升高,两种检测方法HPV阳性率均呈趋势性增加(P〈0.001和P〈0.005)。HC2法检测高危HPV对高度宫颈上皮内瘤样病变HSIL的灵敏度、特异度、准确性、阳性预测值、阴性预测值、阳性似然比和阴性似然比分别为100%、87.1%、87.3%、8.8%、100%、7.7和0.000;HPV分型基因芯片法以上各指标分别为78.6%、91.1%、90.9%、9.9%、99.7%、8.8和0.235。结论 第二代杂交捕获技术(HC2)高危型HPV检测仍是目前宫颈癌筛查较好的方法,基因芯片HPV分型检测除灵敏度尚需提高外,其余各指标均可与HC2法相媲美。

关 键 词:乳头瘤病毒    宫颈肿瘤  杂交捕获  基因芯片
收稿时间:2005-10-13
修稿时间:2005-10-13

Evaluation of gene chip technology for high risk type human papillomavirus in cervical cancer screening
Li RZ,Shi JF,Zhou QZ,Wu RF,Li N,Wu LN,Zhou YQ,Wang Q,Liu ZH,Liu B,Qiao YL.Evaluation of gene chip technology for high risk type human papillomavirus in cervical cancer screening[J].National Medical Journal of China,2006,86(5):307-311.
Authors:Li Rui-zhen  Shi Ju-fang  Zhou Qing-zhi  Wu Rui-fang  Li Ni  Wu Lan-na  Zhou Yan-qiu  Wang Qian  Liu Zhi-hong  Liu Bin  Qiao You-lin
Institution:Centre of Early Diagnosis and Early Treatment for Cervical carcinoma, Shenzhen Hospital of Beijing University, Shenzhen 518036, China
Abstract:OBJECTIVE: To investigate the clinical value of gene chips technology for human papillomavirus (HPV) in cervical cancer screening. METHODS: A population-based cross-sectional screening study was conducted among 1137 women aged 15-59 in a community, Shenzhen city. Hybrid capture 2 (hc2) and gene chip technology were performed to examine the high risk type human papillomavirus in the exfoliated cervical cells. Liquid-based cytology test (LCT) was also performed at the same time. The HPV-positive women with LCT > or = atypical squamous cells of undetermined sign (ASCUS) and the HPV-negative women with LCT > or = low grade squamous intraepithelial lesion (LSIL) underwent biopsy under colposcopy. The pathological results were used as the gold standard to evaluate the two HPV test methods. RESULTS: Totally 122 biopsy specimens were obtained. Pathological examination showed no cervical cancer case, 3 cases of grade III cervical intraepithelial neoplasia (CIN), 11 cases of grade II CIN, 36 cases of grade I CIN, 69 cases of chronic cervicitis and metaplasia of squamous epithelium, and 3 cases of normal cervix. The HPV-positive rate was 14.0% by hc2 and 9.8% by gene chips with a HPV-positive rate by hc2 higher than that by gene chips (P < 0.001) and an mediocre accordance rate between these methods (kappa = 0.498). The. HPV-positive rate increased along with the increase of the grade of cervical lesions (P < 0.05). The sensitivity, specificity, accuracy, positive prevalue, negative prevalue, positive likelihood ratio and negative likelihood ratio of hc2 for high-risk HPV were 100%, 87.1%, 87.3%, 8.8%, 100%, 7.7 and 0.000, respectively; and those of gene chips were 78.6%, 91.1%, 90.9%, 9.9%, 99.7%, 8.8 and 0.235 respectively. CONCLUSION: At present hc2 high risk HPV testing is still the better method for cervical cancer screening. Gene chips technology is able to rival hc2 except that its sensitivity for cervical high grade lesions need be improved.
Keywords:Papillomavirus  human  Cervical neoplasms  Hybrid capture 2  Gene chips
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