Am J Obstet Gynecol. 2003 Jun;188(6):1383-92. doi: 10.1067/mob.2003.457.
This study was undertaken to compare alternative strategies for the initial management of a cytologic diagnosis of atypical squamous cells of undetermined significance (ASCUS).
A total of 3488 women with a community-based ASCUS interpretation were randomly assigned to immediate colposcopy, triage that was based on enrollment HPV DNA testing and liquid-based cytology at a colposcopy referral threshold of high-grade squamous intraepithelial lesion (HSIL), or conservative management based on repeat cytology at a referral threshold of HSIL. All arms included 2 years of semiannual follow-up and colposcopy at exit. Loop electrosurgical excision procedure was offered to women with histologic diagnoses of cervical intraepithelial neoplasia (CIN) grade 2 or 3 at any visit or persistent CIN grade 1 at exit. The study end point was 2-year cumulative diagnosis of CIN grade 3.
The 2-year cumulative diagnosis of CIN grade 3 was 8% to 9% in all study arms. The immediate colposcopy strategy yielded 53.6% sensitivity for cumulative cases of CIN grade 3 diagnosed over 2 years. The human papillomavirus (HPV) triage strategy referred 55.6% of women and detected 72.3% of cumulative cases of CIN grade 3. A conservative management strategy of repeat cytology at the HSIL threshold referred 12.3% of women while detecting 54.6% of cumulative CIN grade 3. To compare triage tests, we re-estimated the performance of HPV and cytology in successfully referring women with underlying CIN grade 3 (ie, ignoring the insensitivity we discovered in colposcopically directed biopsies). A single enrollment HPV test identified 92.4% of the women diagnosed with CIN grade 3. Serial cytology, even at an ASCUS threshold, would have required two visits to achieve similar sensitivity (95.4%) and would have referred 67.1% to colposcopy.
HPV triage is at least as sensitive as immediate colposcopy for detecting CIN grade 3 and refers about half as many women to colposcopy. Follow-up that used repeat cytology is sensitive at an ASCUS referral threshold but requires two follow-up visits and ultimately more colposcopic examinations than HPV triage.
本研究旨在比较对意义不明确的非典型鳞状细胞（ASCUS）细胞学诊断进行初始管理的替代策略。
共有3488名社区ASCUS诊断的女性被随机分配至立即行阴道镜检查组、基于入组时HPV DNA检测及液基细胞学检查且以高级别鳞状上皮内病变（HSIL）作为阴道镜转诊阈值进行分流组，或基于HSIL转诊阈值重复细胞学检查的保守管理组。所有组均包括2年的半年随访及随访结束时的阴道镜检查。对在任何一次就诊时组织学诊断为宫颈上皮内瘤变（CIN）2级或3级或随访结束时持续CIN 1级的女性提供环形电切术。研究终点为2年CIN 3级的累积诊断率。
所有研究组2年CIN 3级的累积诊断率为8%至9%。立即行阴道镜检查策略对2年内诊断的CIN 3级累积病例的敏感性为53.6%。HPV分流策略转诊了55.6%的女性，并检测出72.3%的CIN 3级累积病例。在HSIL阈值下重复细胞学检查的保守管理策略转诊了12.3%的女性，同时检测出54.6%的CIN 3级累积病例。为比较分流检测，我们重新估计了HPV和细胞学在成功转诊潜在CIN 3级女性方面的表现（即忽略我们在阴道镜引导活检中发现的不敏感性）。单次入组HPV检测可识别出92.4%诊断为CIN 3级的女性。连续细胞学检查，即使在ASCUS阈值下，也需要两次就诊才能达到类似的敏感性（95.4%），并且会将67.1%的女性转诊至阴道镜检查。
HPV分流在检测CIN 3级方面至少与立即行阴道镜检查一样敏感，且转诊至阴道镜检查的女性数量约为立即行阴道镜检查的一半。在ASCUS转诊阈值下使用重复细胞学检查进行随访是敏感的，但需要两次随访就诊，最终需要的阴道镜检查比HPV分流更多。
