Identifying women with cervical neoplasia - Using human papillomavirus DNA testing for equivocal Papanicolaou results
Identifying women with cervical neoplasia - Using human papillomavirus DNA testing for equivocal Papanicolaou results
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DOI：
10.1001/jama.281.17.1605
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发表时间：
1999-05-05
影响因子：
120.7
通讯作者：
Hiatt, RA
中科院分区：
文献类型：
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作者：
Manos, MM;Kinney, WK;Hiatt, RA
意义未明的非典型鳞状细胞 (ASCUS) 的巴氏 (Pap) 检测结果提出了临床挑战。只有 5% 至 10% 的 ASCUS 女性患有严重的宫颈疾病，但筛查人群中超过三分之一的高级鳞状上皮内病变 (HSIL) 是通过 ASCUS 巴氏涂片检查结果鉴定出来的。 目的 确定对液基巴氏涂片检查中残留物质进行人乳头瘤病毒 (HPV) DNA 检测以及将发现 HPV 阳性的病例直接转诊至阴道镜检查是否可以对具有 ASCUS 巴氏涂片结果的女性中的潜在 HSIL 提供灵敏的检测，设计和设置 具有 ASCUS 子宫颈抹片检查结果的女性的自然史，所有这些女性都进行了液基细胞学检查、HPV 检测，以及随后的重复巴氏涂片检查和阴道镜检查及组织学评估，这些检查于 1995 年 10 月至 1996 年 6 月期间在一个目标管理医疗组织的 12 个妇科诊所进行。确定同意参加的 ASCUS 巴氏涂片检查结果。主要结果指标宫颈组织学、HPV 检测结果和重复巴氏涂片结果，以及 HPV 检测识别组织学结果为 HSIL+ 的患者的敏感性。结果 在 995 名具有 ASCUS 巴氏涂片检查结果的参与者中，973 人同时获得明确的组织学诊断和 HPV 结果。 65 人 (6.7%) 患有组织学 HSIL 或癌症。对于组织学 HSIL+ 的女性，HPV 检测呈阳性的率为 89.2%（95% 置信区间 [CI]，78.4%-95.2%），特异性为 64.1%（95% CI，60.9%-67.2%）。 76.2% 的重复巴氏涂片结果异常（95% CI，63.5%-85.7%）。仅基于 HPV 检测或仅重复巴氏涂片检测的分诊将相似的比例（约 39%）转介给阴道镜检查。 HPV DNA 检测对 HSIL 的敏感性与重复巴氏涂片检查的敏感性相当，甚至更高。我们进一步估计，基于 HPV 的算法，包括立即对 HPV 阳性女性进行阴道镜检查，然后对所有其他女性重复进行巴氏涂片检查，总体敏感性将达到 96.9%（95% CI，88.3%-99.5%）。 结论 对于接受 ASCUS 巴氏涂片检查的女性，对常规宫颈细胞学检查收集的残留样本进行 HPV DNA 检测可以帮助识别患有潜在 HSIL 的女性。通过对初次筛查时收集的样本进行检测，可以识别出大多数高危病例，并根据单次筛查转诊进行阴道镜检查。
Context A Papanicolaou (Pap) test result of atypical squamous cells of undetermined significance (ASCUS) presents a clinical challenge. Only 5% to 10% of women with ASCUS harbor serious cervical disease, but more than one third of the high-grade squamous intraepithelial lesions (HSILs) in screening populations are identified from ASCUS Pap test results.Objective To determine whether human papillomavirus (HPV) DNA testing of residual material from liquid-based Pap tests and referral of cases found to be HPV-positive directly to colposcopy could provide sensitive detection of underlying HSILs in women with ASCUS Pap results, compared with repeat Pap testing.Design and Setting Natural history of women with ASCUS Pap smear results, all of whom had liquid-based cytology, HPV testing, and subsequent repeat Pap tests and colposcopy with histologic evaluation, conducted at 12 gynecology clinics in a targe managed care organization between October 1995 and June 1996.Participants From a cohort of 46 009 women who had routine cervical examinations, 995 women with Pap test results of ASCUS who consented to participate were identified.Main Outcome Measures Cervical histology, HPV test results, and repeat Pap smear results, and sensitivity of HPV testing to identify patients found to have HSIL+ histology.Results Of 995 participants with ASCUS Pap test results, 973 had both a definitive histologic diagnosis and HPV result. Sixty-five (6.7%) had histologic HSIL or cancer. For women with histologic HSIL+, the HPV test was positive in 89.2% (95% confidence interval [CI], 78.4%-95.2%), and the specificity was 64.1% (95% CI, 60.9%-67.2%). The repeat Pap smear result was abnormal in 76.2% (95% CI, 63.5%-85.7%). Triage based on HPV testing only or on repeat Pap testing only would refer similar proportions (approximately 39%) to colposcopy. The sensitivity of HPV DNA testing for HSIL was equivalent to, if not greater than, that of the repeat Pap test. We further estimated that an HPV-based algorithm including the immediate colposcopy of HPV-positive women, and then repeat Pap testing of all others, would provide an overall sensitivity of 96.9% (95% CI, 88.3%-99.5%).Conclusions For women with ASCUS Pap tests, HPV DNA testing of residual specimens collected for routine cervical cytology can help identify those who have underlying HSIL. By testing the specimen collected at initial screening, the majority of highrisk cases can be identified and referred for colposcopy based on a single screening.