Human papillomavirus DNA testing for the detection of cervical intraepithelial neoplasia grade 3 and cancer: 5-year follow-up of a randomised controlled implementation trial
Human papillomavirus DNA testing for the detection of cervical intraepithelial neoplasia grade 3 and cancer: 5-year follow-up of a randomised controlled implementation trial
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DOI：
10.1016/s0140-6736(07)61450-0
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发表时间：
2007-11-24
期刊：
影响因子：
168.9
通讯作者：
Meijer, C. J. L. M.
中科院分区：
文献类型：
--
作者：
Bulkmans, N. W. J.;Berkhof, J.;Meijer, C. J. L. M.
背景高危型人乳头状瘤病毒（HPV）DNA检测对宫颈上皮内瘤变3级或更严重（CIN 3+）的敏感性高于细胞学检测，但这种检测在宫颈筛查中的必要性一直存在争议。我们的目的是确定是否提高宫颈筛查的有效性时，HPV DNA检测implemented.Methods妇女年龄在29-56岁谁参加定期宫颈筛查计划在荷兰被随机分配到细胞学和HPV DNA检测相结合或传统的细胞学检测。5年后，两组均行细胞学和HPV DNA联合检测。主要结局指标是检测到的CIN 3+病变数量。本试验注册为国际标准随机对照试验，编号ISRCTN 20781131。结果干预组和对照组分别招募了8575名和8580名妇女，随访时间足够长（≥ 6.5年），符合我们分析的合格标准。干预组在基线时检测到的CIN 3+病变多于对照组（68/8575 vs 40/8580，增加70%，95% CI 15-151; p=0.007）。干预组在随后一轮中检测到的CIN 3+病变数量低于对照组（24/8413 vs 54/8456，减少55%，95% CI 28-72; p=0-001）。两轮中CIN 3+病变的数量在组间没有差异。解释在宫颈筛查中实施HPV DNA检测导致CIN 3+病变的早期检测。早期发现此类病变可延长筛查间隔。
Background Tests for the DNA of high-risk types of human papillornavirus (HPV) have a higher sensitivity for cervical intraepithelial neoplasia grade 3 or worse (CIN3+) than does cytological testing, but the necessity of such testing in cervical screening has been debated. Our aim was to determine whether the effectiveness of cervical screening improves when HPV DNA testing is implemented.Methods Women aged 29-56 years who were participating in the regular cervical screening programme in the Netherlands were randomly assigned to combined cytological and HPV DNA testing or to conventional cytological testing only. After 5 years, combined cytological and HPV DNA testing were done in both groups. The primary outcome measure was the number of CIN3+ lesions detected. Analyses were done by intention to treat. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN20781131.Findings 8575 women in the intervention group and 8580 in the control group were recruited, followed up for sufficient time (>= 6.5 years), and met eligibility criteria for our analyses. More CIN3+ lesions were detected at baseline in the intervention group than in the control group (68/8575 vs 40/8580, 70% increase, 95% CI 15-151; p=0.007). The number of CIN3+ lesions detected in the subsequent round was lower in the intervention group than in the control group (24/8413 vs 54/8456, 55% decrease, 95% CI 28-72; p=0-001). The number of CIN3+ lesions over the two rounds did not differ between groups.Interpretation The implementation of HPV DNA testing in cervical screening leads to earlier detection of CIN3+ lesions. Earlier detection of such lesions could permit an extension of the screening interval.