摘要目的探讨高危型HPV分型检测作为子宫颈癌及其癌前病变初筛手段的可行性。方法2013年1月—2014年6月，在中日友好医院妇科门诊就诊且自愿接受高危型HPV分型检测的妇女共15192例，其年龄为（33±8）岁，高危型HPV分型检测采用荧光PCR技术，可检测13种高危型HPV亚型，包括HPV16、18、31、33、35、39、45、51、52、56、58、59和68型；对其中4315例行液基细胞学（LCT）检查；在HPV分型检测阳性患者（共2366例）中，对其中LCT检查阳性、LCT检查阴性但HPV16型阳性、非HPV16阳性但临床症状明确者（共648例）行阴道镜下活检后病理检查，将病理诊断≥子宫颈上皮内瘤变（CIN）Ⅱ或≥子宫颈腺上皮内瘤变（CGIN）Ⅱ者视为病理检查阳性，病理诊断≤CINⅠ或≤CGINⅠ者视为病理检查阴性。（1）分析15192例妇女高危型HPV感染状况。（2）以病理诊断为诊断子宫颈病变的“金标准”，分析高危型HPV感染及其病毒负荷量与子宫颈病变的关系。（3）评价高危型HPV分型检测作为子宫颈癌及其癌前病变初筛手段的价值。结果（1）接受HPV分型检测的15192例妇女中，HPV阳性（即感染）2366例，总感染率为15.57%（2366/15192）。其中，HPV单一亚型感染者1767例，单一亚型感染率为11.63%（1767/15192）；HPV多重感染（即两种及以上亚型感染）者599例，多重感染率为3.94%（599/15192）。13种HPV亚型中，感染率最高的3种亚型依次为HPV16、52、58型，其感染率分别为3.95%（600/15192）、2.86%（435/15192）和2.67%（406/15192）。（2）以病理诊断为金标准，与≥CIN Ⅱ病变最相关的亚型是HPV16、52和58型，占所有≥CINⅡ病变的57.7%（154/267）；与≥CGINⅡ病变最相关的亚型是HPV18型，3例≥CGINⅡ病变均为单一HPV18型感染。在HPV病毒负荷量≤103拷贝数/104个细胞的患者中，病理检查阳性患者所占比例为18.2%（25/137），而在HPV病毒负荷量≥104拷贝数/104个细胞的患者中，病理检查阳性患者所占比例则为33.3%（247/742），两者比较，差异有统计学意义（χ2=27.06，P=0.000）。（3）HPV分型检测筛查子宫颈癌及其癌前病变的敏感度为96.11%，特异度为85.76%，阳性预测值为30.94%，阴性预测值为99.70%。结论高危型HPV分型检测在子宫颈癌及其癌前病变的筛查中具有指导意义，HPV16、52和58型感染者发生≥CINⅡ病变的可能性大，HPV18型虽不是主要HPV感染亚型，但其与≥CGINⅡ病变密切相关。在有条件的医院，机会性筛查首选HPV分型检测作为初筛手段是可行的。

abstractsObjective To explored high-risk HPV genotyping PCR testing whether as a feasible means for the early screening of cervical cancer and precancerous lesions. Methods From January 2013 to June 2014, 15 192 outpatients in China-Japan Friendship Hospital voluntary were tested by high-risk type HPV genotyping PCR. The average age of them were (33±8) years old. High-risk HPV types genotyping PCR tested by fluorescence PCR technology,in which 13 kinds of high-risk HPV subtypes were detected, <br> including HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68. A total of 4 315 cases of them were tested by the liquid-based cytology (LCT), among them with positive of high-risk HPV genotyping tested by PCR (n=2 366) were biopsy under colposcope (648 cases) in those LCT results were positive or LCT negative but HPV16 positive or LCT negative but had the clear clinical symptoms or and non-HPV16 positive but with clear clinical symptoms. (1) Analysis high-risk HPV infection status of 15 192 women.(2)As the pathological diagnosis was the gold standard in the diagnosis of cervical lesions, analysis of the relationship among high-risk HPV infection,virus loads and cervical lesions. (3) To evaluated the value of high-risk HPV genotyping PCR tested method in screening of cervical cancer and precancerous lesions. Results ⑴ Of 15 192 cases tested by high-risk HPV genotyping PCR, 2 366 cases were HPV positive (HPV infection), the overall infection rate was 15.57%(2 366/15 192), in which a single subtype of HPV infection in 1 767 cases, infection rate was 11.63%(1 767/15 192), and multiple subtypes of HPV infection (two and more subtypes HPV infection) in 599 cases, infection rate was 3.94%(599/15 192). The HPV16, 52 and 58 infections were the most common HPV subtypes in 13 subtypes, the infection rate was 3.95% (600/15 192), 2.86%(435/15 192) and 2.67% (406/15 192), respectively. (2) The most relevant subtypes with cervical intraepithelial neoplasia (CIN)Ⅱand even higher lesion were HPV16, 52 and 58, accounted for 57.7%(154/267) of all above CINⅡlesions. The most relevant subtype with the cervical glandular intraepithelial neoplasia (CGIN) Ⅱ or above lesions was HPV18, 3 cases with CGIN Ⅱ or above lesions were all single HPV18 infection. The pathologic examination positive percentage of patients which HPV virus loads≤103 copys/104 cells was 18.2%(25/137), while the pathologic examination positive proportion was 33.3%(247/742) which HPV virus loads≥104 copys/104 cells , there was statistically significant difference between them (χ2=27.06, P=0.000).(3)Sensitivity, specificity, positive predictive value and negative predictive value for detection of CINⅡ or above using HPV genotyping PCR were 96.11%, 85.76%, 30.94% and 99.70%, respectively. Conclusions There were a guiding significance for high-risk HPV genotyping PCR tested in screening of cervical cancer and precancerous lesion. HPV16, 52 and 58 were related to the severe cervical squamous epithelial lesions, while HPV18 was related to cervical severe glandular cell pathological changes. HPV genotyping is feasible and economical as the first choice of opportunistic screening in tertiary hospitals.