Detection rates of precancerous and cancerous cervical lesions within one screening round of primary human papillomavirus DNA testing: prospective randomised trial in Finland.
Detection rates of precancerous and cancerous cervical lesions within one screening round of primary human papillomavirus DNA testing: prospective randomised trial in Finland.
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在原发性人乳头瘤病毒DNA测试的一个筛查中，癌前和癌性宫颈病变的检测率：芬兰前瞻性随机试验。
DOI：
10.1136/bmj.e7789
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发表时间：
2012-11-29
期刊：
影响因子：
--
通讯作者：
Anttila A
中科院分区：
文献类型：
--
作者：
Leinonen MK;Nieminen P;Lönnberg S;Malila N;Hakama M;Pokhrel A;Laurila P;Tarkkanen J;Anttila A
目的比较人乳头状瘤病毒(HPV)DNA检测与常规细胞学筛查对宫颈癌前病变和癌前病变的检出率。设计前瞻性随机试验。在为期五年的一轮筛查中，对两个队列进行了跟踪，最初通过初级HPV DNA检测或初级巴氏试验进行筛查。在芬兰制定以人群为基础的宫颈癌筛查方案。参与者2003-07年间邀请25-65岁的妇女进行筛查(人乳头瘤病毒组101例 678，常规细胞学组101例 747)。干预妇女被随机分配(1：1)进行初次HPV DNA筛查，如果结果为阳性，则进行细胞学分类，或者进行初级细胞学筛查。筛查访问中披露了筛查方法。参与试验的人员知道所有的测试结果。主要观察指标宫颈上皮内瘤变(CIN)、原位腺癌(AIS)和浸润性宫颈癌在第二次筛查前(五年后)或2008年12月31日之前的累积检测率。包括筛查时和五年间隔期间检测到的病变。结果在平均3.6年的随访期内，HPV组和细胞学组分别检出癌前病变1010例和癌前病变701例。在受邀女性中，CIN 1级的风险比为1.53(95%可信区间1.28~1.84)，CIN 2级的风险比为1.54(1.33~1.78)，CIN 3或AIS的风险比为1.32(1.09~1.59)，宫颈癌的风险比为0.81(0.48~1.37)。在25-34岁的参与者中，HPV筛查的累积风险(或累积检测率)为0.0057(0.0045至0.0072)，而传统筛查为0.0046(0.0035至0.0059)；35岁及以上女性的相应数据分别为0.0022(0.0019至0.0026)和0.0017(0.0014至0.0021)。结论在五年的一轮筛查中，初次HPV DNA筛查检出的宫颈病变多于初次细胞学筛查。即使CIN 3或AIS在两个年龄组的HPV臂中的检出率增加，35岁或35岁以上女性的累积发病率的绝对差异也很小。通过仔细选择年龄组和筛查间隔，HPV筛查只能略微提高宫颈癌前病变的总体发现率。然而，这些发现应该在芬兰发生的高水平机会性筛查的背景下进行解释。试验注册国际标准随机对照试验ISRCTN23885553。
Objective To compare the detection rates of precancerous and cancerous cervical lesions by human papillomavirus (HPV) DNA testing and by conventional cytology screening. Design Prospective randomised trial. Two cohorts were followed over one screening round of five years, screened initially by primary HPV DNA testing or by primary Pap test. Setting Population based programme for cervical cancer screening in Finland. Participants Women aged 25-65 years invited for screening in 2003-07 (101 678 in HPV arm; 101 747 in conventional cytology arm). Intervention Women were randomly allocated (1:1) to primary HPV DNA screening followed by cytology triage if they had positive results, or to primary cytology screening. Screening method was disclosed at the screening visit. Trial personnel involved were aware of all test results. Main outcome measures Cumulative detection rates of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS), and invasive cervical cancer before the second screening (after five years) or before 31 December 2008. Lesions detected at screening and during the five year interval were included. Results 1010 and 701 precancerous or cancerous lesions were detected during an average follow-up of 3.6 years in the HPV and cytology arms, respectively. Among invited women, the hazard ratio was 1.53 (95% confidence interval l.28 to 1.84) for CIN grade 1, 1.54 (1.33 to 1.78) for CIN 2, 1.32 (1.09 to 1.59) for CIN 3 or AIS, and 0.81 (0.48 to 1.37) for cervical cancer. In 25-34 year old participants, the cumulative hazard (or cumulative detection rate) was 0.0057 (0.0045 to 0.0072) for HPV screening versus 0.0046 (0.0035 to 0.0059) for conventional screening; corresponding data for women aged 35 years and older were 0.0022 (0.0019 to 0.0026) and 0.0017 (0.0014 to 0.0021), respectively. Conclusions Primary HPV DNA screening detects more cervical lesions than primary cytology within one screening round of five years. Even if the detection rate of CIN 3 or AIS increased in the HPV arm in both age groups, the absolute difference in cumulative rates in women aged 35 years or older was small. By carefully selecting age groups and screening intervals, HPV screening could increase the overall detection rate of cervical precancerous lesions only slightly. However, these findings should be interpreted in the context of the high level of opportunistic screening that occurs in Finland. Trial registration International Standard Randomised Controlled Trial ISRCTN23885553.
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影响因子：
168.9
作者：
Bulkmans, N. W. J.;Berkhof, J.;Meijer, C. J. L. M.
通讯作者：
Meijer, C. J. L. M.
影响因子：
6.4
作者：
Meijer, Chris J. L. M.;Berkhof, Johannes;Castle, Philip E.;Hesselink, Albertus T.;Franco, Eduardo L.;Ronco, Guglielmo;Arbyn, Marc;Bosch, F. Xavier;Cuzick, Jack;Dillner, Joakim;Heideman, Danielle A. M.;Snijders, Peter J. F.
通讯作者：
Snijders, Peter J. F.
影响因子：
5.5
作者：
Cuzick, Jack;Arbyn, Marc;Meijer, Chris J. L. M.
通讯作者：
Meijer, Chris J. L. M.
影响因子：
3.1
作者：
Lonnberg, Stefan;Leinonen, Maarit;Anttila, Ahti
通讯作者：
Anttila, Ahti
影响因子：
6.4
作者：
Sasieni, Peter;Castanon, Alejandra;Cuzick, Jack
通讯作者：
Cuzick, Jack