HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study.
HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study.
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对自己收集的宫颈阴道灌洗标本进行 HPV 检测作为未参加宫颈筛查的女性的筛查方法：队列研究。
DOI：
10.1136/bmj.c1040
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发表时间：
2010-03-11
影响因子：
105.7
通讯作者：
Meijer, Chris J. L. M.
中科院分区：
文献类型：
--
作者：
Gok, Murat;Heideman, Danielle A. M.;van Kemenade, Folkert J.;Berkhof, Johannes;Rozendaal, Lawrence;Spruyt, Johan W. M.;Voorhorst, Feja;Belien, Jeroen A. M.;Babovic, Milena;Snijders, Peter J. F.;Meijer, Chris J. L. M.
目的 确定对未参加常规宫颈筛查项目的女性进行宫颈阴道材料自我取样进行高危人乳头瘤病毒 (HPV) 检测是否是一种有效的筛查方法。设计队列研究（PROHTECT 试验）。设置荷兰北荷兰省和弗莱福兰省，2006年12月至2007年12月，包括13个实验室、妇科医生和800多名全科医生。参与者 28 073 名未回应两次定期宫颈筛查计划邀请的女性：27 792 名女性被分配到自我采样组，并被邀请提交自我采集的宫颈阴道样本进行 HPV 检测； 281 人被分配到回忆对照组，并再次接受常规细胞学检查。干预措施 自我样本材料高危 HPV 检测结果呈阳性的女性被转介给全科医生。细胞学结果异常的女性被转诊进行阴道镜检查。一年后，对细胞学结果正常的女性进行细胞学和高危 HPV 检测的重新评估，如果任一结果呈阳性，则转诊进行阴道镜检查。主要结果指标 两组的就诊率以及自我取样应答者中 II/III 级或更严重的宫颈上皮内瘤变 (≥CIN II/≥CIN III) 的发生率。结果 自采样组的依从率显着高于对照组（粗值26.6% vs 16.4%，P<0.001；调整后27.5% vs 16.6%，P<0.001）。自采样应答者中检测到的≥CIN II 和≥CIN III 病变数量分别为 99 个（1.3%）和 76 个（1.0%）。与上一轮筛查中自我抽样的女性 (57%) 相比，未参加上一轮筛查的自我抽样应答者 (43%) ≥CIN II（2.04，95% 置信区间 1.27 至 3.28）和 ≥CIN III（2.28，1.31 至 3.96）的相对风险增加。结论 通过向未参加定期筛查的女性发送用于高危 HPV 检测的宫颈阴道标本采集装置进行自我采样，是提高筛查计划覆盖率的可行且有效的方法。反应率和高级病变的发生率支持对此类女性实施这种方法。试用注册ISRCTN45527158。
Objective To determine whether offering self sampling of cervicovaginal material for high risk human papillomavirus (HPV) testing is an effective screening method for women who do not attend regular cervical screening programmes. Design Cohort study (the PROHTECT trial). Settings Noord-Holland and Flevoland regions of the Netherlands, December 2006 to December 2007, including 13 laboratories, gynaecologists, and more than 800 general practitioners. Participants 28 073 women who had not responded to two invitations to the regular cervical screening programme: 27 792 women were assigned to the self sampling group and invited to submit a self collected cervicovaginal sample for HPV testing; 281 were assigned to the recall control group and received a second re-invitation for conventional cytology. Intervention Women with a positive result on the high risk HPV test on their self sample material were referred to their general practitioner. Women with abnormal results on cytology were referred for colposcopy. Women with normal results on cytology were re-evaluated after one year by cytology and high risk HPV testing and referred for colposcopy if either result was positive. Main outcome measures Attendance rate in both groups and yield of cervical intraepithelial neoplasia grade II/III or worse (≥CIN II/≥CIN III) in self sampling responders. Results The compliance rate in the self sampling group was significantly higher than in the control group (crude 26.6% v 16.4%, P<0.001; adjusted 27.5% v 16.6%, P<0.001). The number of detected ≥CIN II and ≥CIN III lesions in self sampling responders was 99 (1.3%) and 76 (1.0%), respectively. Self sampling responders who had not participated in the previous round of screening (43%) had increased relative risks of ≥CIN II (2.04, 95% confidence interval 1.27 to 3.28) and ≥CIN III (2.28, 1.31 to 3.96) compared with self sampling women who had been screened in the previous round (57%). Conclusions Offering self sampling by sending a device for collecting cervicovaginal specimens for high risk HPV testing to women who did not attend regular screening is a feasible and effective method of increasing coverage in a screening programme. The response rate and the yield of high grade lesions support implementation of this method for such women. Trial registration ISRCTN45527158.
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影响因子：
3.4
作者：
Bulk, S;van Kemenade, FJ;Meijer, CJLM
通讯作者：
Meijer, CJLM
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：
9.4
作者：
Hesselink, A. T.;Bulkmans, N. W. J.;Snijders, P. J. F.
通讯作者：
Snijders, P. J. F.
影响因子：
7.2
作者：
Sawaya, GF;Grimes, DA
通讯作者：
Grimes, DA
影响因子：
6.4
作者：
Bais, Aagje G.;van Kemenade, Folkert J.;Meijer, Chris J. L. M.
通讯作者：
Meijer, Chris J. L. M.