李凌①, 李隆玉①, 杨起楠②, 徐小玲③, 童希忠④, 王利民⑤. 高危型 HPV 载量与分型检测对宫颈高级别病变预测价值的前瞻性队列研究*[J]. 中国肿瘤临床, 2016, 43(9): 376-380. DOI: 10.3969/j.issn.1000-8179.2016.09.018
引用本文: 李凌①, 李隆玉①, 杨起楠②, 徐小玲③, 童希忠④, 王利民⑤. 高危型 HPV 载量与分型检测对宫颈高级别病变预测价值的前瞻性队列研究*[J]. 中国肿瘤临床, 2016, 43(9): 376-380. DOI: 10.3969/j.issn.1000-8179.2016.09.018
Ling LI1, Longyu LI1, Qinan YANG2, Xiaoling XU3, Xizhong TONG4, Limin WANG5. Prospective cohort study on the value of high- risk human papillomavirus viral load and subtype tests in predicting cervical intraepithelial neoplasia[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2016, 43(9): 376-380. DOI: 10.3969/j.issn.1000-8179.2016.09.018
Citation: Ling LI1, Longyu LI1, Qinan YANG2, Xiaoling XU3, Xizhong TONG4, Limin WANG5. Prospective cohort study on the value of high- risk human papillomavirus viral load and subtype tests in predicting cervical intraepithelial neoplasia[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2016, 43(9): 376-380. DOI: 10.3969/j.issn.1000-8179.2016.09.018

高危型 HPV 载量与分型检测对宫颈高级别病变预测价值的前瞻性队列研究*

Prospective cohort study on the value of high- risk human papillomavirus viral load and subtype tests in predicting cervical intraepithelial neoplasia

  • 摘要: 目的:评价高危型人乳头瘤病毒(highriskhumanpapillomavirus,hrHPV )载量和分型检测在中国农村地区妇女人群中预测宫颈鳞状上皮高级别病变发生的价值。方法:2012年5 月至2015年5 月以农村妇女人群为基础选取江西省兴国县、靖安县和玉山县2 257 例,年龄35~64岁纳入本前瞻性队列研究。同时采用HC- 2(hybridcapture-2)和导流杂交技术(HybriMax )两种方法分别检测hrHPV 载量和亚型,两种方法中任一亚型阳性者行阴道镜及活检检查,并将HC- 2 检测阳性结果中病毒载量< 10.0 RLU/CO认定为低病毒载量,病毒载量≥ 10.0 RLU/CO为高病毒载量。对hrHPV 结果阴性或病理诊断为CIN 1 的2 211 例妇女行24个月无干预随访。根据随访分别评价hrHPV 载量和HybriMax 分型两种检测方法预测宫颈鳞状上皮高级别病变(CINgrade2 orworse,CIN 2 +)的效果。结果:纳入基线、随访数据完整的女性共1 636 例。2 年内采用HC- 2 检测的132 例基线高病毒载量妇女中CIN 2 +的发生率为3.03%(4/ 132),其相对危险度(RR)值为42.24(95%CI 为4.76~375.2);采用HybriMax 分型检测的159 例基线分型HPV 16或18型阳性妇女中CIN 2 + 的发生率为2.51%(4/ 159),RR值为33.06(95%CI 为3.72~293.9)。 对2 年内HC- 2 检测中高病毒载量例数和HybriMax 分型检测中HPV 16/ 18型别阳性例数进行比较,CIN 2 + 的发病率差异无统计学意义(P > 0.05)。 结论:HPV高载量和HPV 16/ 18型别阳性妇女人群进展为CIN 2 + 的风险均较高。在不具有持续监测hrHPV 条件的农村地区,HC- 2 检测的病毒载量≥ 10.0 RLU/CO阈值设定,与HybriMax 分型检测HPV 16/ 18型别均对hrHPV 初筛有分流作用,并对CIN 2+ 发生有预测作用。

     

    Abstract: Objective:To evaluate high-risk human papillomavirus (hrHPV) genotyping and viral load in predicting CIN (cervical intraepi -thelial neoplasia (CIN) grade 2 or worse in a Chinese rural area population with limited health resources. Methods:We performed a population- based prospective study and enrolled 2,257 women aged35to 64years from three rural screening sites of Jiangxi prov -ince. We conducted a hybrid capture (HC- 2) assay to predict viral load. A HC- 2 relative light unit (RLU) threshold of 10was set to differ-entiate samples between low (<10) and high ( ≥ 10) viral loads. We also carried out a HybriMax test to detect different hrHPV geno -types in the samples. Women exhibiting positive HC- 2 or HybriMax results underwent colposcopy and colposcopically directed biopsy. Women with negative or positive hrHPV test results but with normal biopsy or CIN1 were followed-up for 24months without interven-tion (n=2,211 ). We used histopathological findings as outcome. Results:Of the 2,211 women,1,636 provided complete follow-up data. Of the 132 women with a high viral load,4 (3. 03%) developed CIN2 + in the same period. The relative risk (RR) of CIN2 + for HC- 2 posi -tivity at baseline was 42. 24(95% CI=4. 76- 375 . 2). Of the 159 women who were positive for HPV16or HPV 18upon screening, 4 (2. 52%) progressed to CIN2 + (RR= 33. 06, 95% CI=3. 72- 293 . 9). The 2- year cumulative incidence rates of CIN 2 + did not significantly differ be -tween the high viral load group and the HPV16/18group. Conclusion: The risks of CIN 2 + progression were higher among women with a high viral load or HPV 16/18positivity than among women with negative hrHPV. Increasing the HC- 2 cut-off value to 10RLU or using HPV 16/18positivity may be similarly used to triage hrHPV- positive women for immediate colposcopy and comprehensive follow- up.Both approaches were equally predictive of the CIN 2 + risk in rural area. Increasing the HC-2 cut-off value to 10RLU may also help allo- cate health resources effectively.

     

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