人乳头瘤病毒和巴氏涂片检查用于宫颈癌筛查。

Human papillomavirus and Papanicolaou tests to screen for cervical cancer.

作者信息

Naucler Pontus, Ryd Walter, Törnberg Sven, Strand Anders, Wadell Göran, Elfgren Kristina, Rådberg Thomas, Strander Björn, Johansson Bo, Forslund Ola, Hansson Bengt-Göran, Rylander Eva, Dillner Joakim

机构信息

Department of Medical Microbiology, Malmö University Hospital, Lund University, Malmö, Sweden.

出版信息

N Engl J Med. 2007 Oct 18;357(16):1589-97. doi: 10.1056/NEJMoa073204.

DOI:10.1056/NEJMoa073204

PMID:17942872

Abstract

BACKGROUND

Screening for cervical cancer based on testing for human papillomavirus (HPV) increases the sensitivity of detection of high-grade (grade 2 or 3) cervical intraepithelial neoplasia, but whether this gain represents overdiagnosis or protection against future high-grade cervical epithelial neoplasia or cervical cancer is unknown.

METHODS

In a population-based screening program in Sweden, 12,527 women 32 to 38 years of age were randomly assigned at a 1:1 ratio to have an HPV test plus a Papanicolaou (Pap) test (intervention group) or a Pap test alone (control group). Women with a positive HPV test and a normal Pap test result were offered a second HPV test at least 1 year later, and those who were found to be persistently infected with the same high-risk type of HPV were then offered colposcopy with cervical biopsy. A similar number of double-blinded Pap smears and colposcopies with biopsy were performed in randomly selected women in the control group. Comprehensive registry data were used to follow the women for a mean of 4.1 years. The relative rates of grade 2 or 3 cervical intraepithelial neoplasia or cancer detected at enrollment and at subsequent screening examinations were calculated.

RESULTS

At enrollment, the proportion of women in the intervention group who were found to have lesions of grade 2 or 3 cervical intraepithelial neoplasia or cancer was 51% greater (95% confidence interval [CI], 13 to 102) than the proportion of women in the control group who were found to have such lesions. At subsequent screening examinations, the proportion of women in the intervention group who were found to have grade 2 or 3 lesions or cancer was 42% less (95% CI, 4 to 64) and the proportion with grade 3 lesions or cancer was 47% less (95% CI, 2 to 71) than the proportions of control women who were found to have such lesions. Women with persistent HPV infection remained at high risk for grade 2 or 3 lesions or cancer after referral for colposcopy.

CONCLUSIONS

The addition of an HPV test to the Pap test to screen women in their mid-30s for cervical cancer reduces the incidence of grade 2 or 3 cervical intraepithelial neoplasia or cancer detected by subsequent screening examinations. (ClinicalTrials.gov number, NCT00479375 [ClinicalTrials.gov].).

摘要

背景

基于人乳头瘤病毒（HPV）检测进行宫颈癌筛查可提高高级别（2级或3级）宫颈上皮内瘤变的检测敏感性，但这种获益是代表过度诊断还是预防未来的高级别宫颈上皮内瘤变或宫颈癌尚不清楚。

方法

在瑞典一项基于人群的筛查项目中，12527名32至38岁的女性按1:1比例随机分组，分别接受HPV检测加巴氏涂片检查（干预组）或仅接受巴氏涂片检查（对照组）。HPV检测阳性且巴氏涂片检查结果正常的女性至少1年后接受第二次HPV检测，对那些被发现持续感染同一种高危型HPV的女性，随后进行阴道镜检查及宫颈活检。在对照组中随机选择的女性中进行了数量相近的双盲巴氏涂片检查及阴道镜检查加活检。利用综合登记数据对这些女性平均随访4.1年。计算入组时及后续筛查检查时检测到的2级或3级宫颈上皮内瘤变或癌症的相对发生率。

结果

入组时，干预组中被发现患有2级或3级宫颈上皮内瘤变或癌症的女性比例比对照组中发现有此类病变的女性比例高51%（95%置信区间[CI]，13至102）。在后续筛查检查中，干预组中被发现患有2级或3级病变或癌症的女性比例比对照组中发现有此类病变的女性比例低42%（95%CI，4至64），患有3级病变或癌症的女性比例比对照组中发现有此类病变的女性比例低47%（95%CI，2至71）。转诊接受阴道镜检查后，持续HPV感染的女性仍有发生2级或3级病变或癌症的高风险。