评价宫颈癌筛查中高危人乳头瘤病毒阳性妇女的分诊策略:中国不同资源环境下的一项多中心随机对照试验

Le Dang, Linghua Kong, Yuqian Zhao, Yi Dai, Li Ma, Lihui Wei, Shulan Zhang, Jihong Liu, Mingrong Xi, Long Chen, Xianzhi Duan, Qing Xiao, Guzhalinuer Abulizi, Guonan Zhang, Ying Hong, Qi Zhou, Xing Xie, Li Li, Mayinuer Niyazi, Zhifen Zhang, Jiyu Tuo, Yiling Ding, Youlin Qiao, Jinghe Lang
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引用次数: 0

摘要

目的:我们旨在评估中国初级卫生保健机构对高危人乳头瘤病毒(hrHPV)阳性妇女不同分诊策略的有效性。方法:本研究在11个农村和9个城市进行。女性年龄在35-64岁之间。hrhpv阳性妇女被随机分配到液体细胞学检查(LBC),醋酸和卢戈尔碘目视检查(VIA/VILI)(仅限农村)分诊,或直接转介阴道镜检查(直接COLP)。在24个月时,进行hrHPV检测、LBC和VIA/VILI联合筛查。结果:在农村地区,分析了1949名hrhpv阳性妇女。共有852、218和480名妇女被随机分配到直接COLP、LBC和VIA/VILI组。在基线时,LBC或VIA/VILI分诊的阴道镜转诊率可降低70%-80%。与直接COLP (n=14和n=23)相比,LBC (n=3和n=7)或VIA/VILI (n=8和n=26)可显著减少检测1例宫颈上皮内瘤变(CIN) 2及以上和CIN3+所需的阴道镜检查次数。对于CIN2+的24个月累积检出率,VIA/VILI分诊是LBC分诊的0.50倍,是直接COLP的0.46倍。当按年龄分层时,基线LBC分诊+表现最佳(p趋势=0.002)。在城市地区,1728名妇女hrHPV基因分型检测呈阳性。共有408、571和568名妇女被随机分配到HPV16/18+的直接COLP,其他hrHPV亚型+的直接COLP,以及其他hrHPV亚型+的LBC分诊。与直接COLP (n=14和n=44)相比,LBC (n=12和n=31)显著减少了检测一种CIN2+和CIN3+所需的阴道镜检查次数。结论:农村地区hrHPV阳性妇女采用LBC分诊,城市地区HPV16/18+妇女采用直接COLP和其他hrHPV亚型+妇女采用LBC分诊可能是可行的策略。
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Evaluation of triage strategies for high-risk human papillomavirus-positive women in cervical cancer screening: A multicenter randomized controlled trial in different resource settings in China.

Objective: We aimed to evaluate the effectiveness of different triage strategies for high-risk human papillomavirus (hrHPV)-positive women in primary healthcare settings in China.

Methods: This study was undertaken in 11 rural and 9 urban sites. Women aged 35-64 years old were enrolled. HrHPV-positive women were randomly allocated to liquid-based cytology (LBC), visual inspection with acetic acid and Lugol's iodine (VIA/VILI) (rural only) triage, or directly referred to colposcopy (direct COLP). At 24 months, hrHPV testing, LBC and VIA/VILI were conducted for combined screening.

Results: In rural sites, 1,949 hrHPV-positive women were analyzed. A total of 852, 218 and 480 women were randomly assigned to direct COLP, LBC and VIA/VILI. At baseline, colposcopy referral rates of LBC or VIA/VILI triage could be reduced by 70%-80%. LBC (n=3 and n=7) or VIA/VILI (n=8 and n=26) could significantly decrease the number of colposcopies needed to detect one cervical intraepithelial neoplasia (CIN) 2 or worse and CIN3+ compared with direct COLP (n=14 and n=23). For the 24-month cumulative detection rate of CIN2+, VIA/VILI triage was 0.50-fold compared with LBC triage and 0.46-fold with the direct COLP. When stratified by age, baseline LBC triage+ performed best (P<0.001), peaking among women aged 35-44 years (Ptrend=0.002). In urban sites, 1,728 women were hrHPV genotyping test positive. A total of 408, 571 and 568 women were randomly assigned to direct COLP for HPV16/18+, direct COLP for other hrHPV subtypes+, and LBC triage for other hrHPV subtypes+. LBC (n=12 and n=31) significantly decreased the number of colposcopies needed to detect one CIN2+ and CIN3+ compared with direct COLP (n=14 and n=44). HPV16/18+ increased the 24-month cumulative detection rate of CIN2+ (17.89%, P<0.001).

Conclusions: LBC triage for hrHPV-positive women in rural settings and direct COLP for HPV16/18+ women and LBC triage for other hrHPV subtype+ women in urban settings might be feasible strategies.

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