Abstract：
Japan is lagging in cervical cancer prevention. The effectiveness of a self-sampling human papillomavirus (HPV) test, a possible measure to overcome this situation, has not yet been evaluated. A randomized controlled trial was performed to evaluate the effectiveness of a self-sampling HPV test on detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and screening uptake. Women between 30 and 58 years old who did not participate in the cervical cancer screening program for ≥3 years were eligible and assigned to the intervention group (cytology or self-sampling HPV test) or control group (cytology). Participants assigned to the intervention group were sent a self-sampling kit according to their ordering (opt-in strategy). A total of 7337 and 7772 women were assigned to the intervention and control groups, respectively. Screening uptake in the intervention group was significantly higher than that in the control group (20.0% vs. 6.4%; risk ratio: 3.10; 95% confidence interval [CI]: 2.82, 3.42). The compliance rate with cytology triage for HPV-positive women was 46.8% (95% CI: 35.5%, 58.4%). CIN2+ was detected in five and four participants in the intervention and control groups, respectively; there was no difference for intention-to-screen analysis (risk ratio: 1.32; 95% CI: 0.36, 4.93). Self-sampling of HPV test increased screening uptake; however, no difference was observed in the detection of CIN2+, probably due to the low compliance rate for cytology triage in HPV-positive women. Efforts to increase cytology triage are essential to maximize precancer detections.
摘要：
日本在宫颈癌预防方面落后。自我取样人乳头瘤病毒（HPV）测试的有效性，克服这种情况的可能措施，尚未评估。进行了一项随机对照试验，以评估自采样HPV检测对2级或更差的宫颈上皮内瘤变（CIN2）和筛查摄取的有效性。年龄在30至58岁之间，未参加宫颈癌筛查计划≥3年的妇女符合资格，并被分配到干预组（细胞学或自我取样HPV检测）或对照组（细胞学）。分配到干预组的参与者根据他们的顺序（选择加入策略）发送自我采样工具包。共有7337和7772名妇女被分配到干预组和对照组，分别。干预组的筛选摄取显著高于对照组(20.0%vs.6.4%；风险比：3.10；95%置信区间[CI]：2.82，3.42）。HPV阳性女性的细胞学分诊依从率为46.8%(95%CI:35.5%,58.4%）。在干预组和对照组的5名和4名参与者中检测到CIN2+，分别;意向筛查分析没有差异(风险比:1.32;95%CI:0.36,4.93).HPV检测的自我取样增加了筛查的摄取;然而，在CIN2+的检测中没有观察到差异，可能是由于HPV阳性女性的细胞学分诊依从率低.增加细胞学分类的努力对于最大化癌前检测至关重要。
