Solomon D, Schiffman M, Tarone R
Breast and Gynecologic Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
J Natl Cancer Inst. 2001 Feb 21;93(4):293-9. doi: 10.1093/jnci/93.4.293.
More than 2 million U.S. women receive an equivocal cervical cytologic diagnosis (atypical squamous cells of undetermined significance [ASCUS]) each year. Effective colposcopy triage strategies are needed to identify the minority of women who have clinically significant disease while avoiding excessive follow-up evaluation for others.
The ASCUS/LSIL (i.e., low-grade squamous intraepithelial lesion) Triage Study (ALTS) is a multicenter, randomized trial comparing the sensitivity and specificity of the following three management strategies to detect cervical intraepithelial neoplasia grade 3 (CIN3): 1) immediate colposcopy (considered to be the reference standard), 2) triage to colposcopy based on human papillomavirus (HPV) results from Hybrid Capture 2(TM) (HC 2) and thin-layer cytology results, or 3) triage based on cytology results alone. This article summarizes the cross-sectional enrollment results for 3488 women with a referral diagnosis of ASCUS. All statistical tests are two-sided.
Among participants with ASCUS, the underlying prevalence of histologically confirmed CIN3 was 5.1%. Sensitivity to detect CIN3 or above by testing for cancer-associated HPV DNA was 96.3% (95% confidence interval [CI] = 91.6% to 98.8%), with 56.1% of women referred to colposcopy. Sensitivity of a single repeat cytology specimen with a triage threshold of HSIL or above was 44.1% (95% CI = 35.6% to 52.9%), with 6.9% referred. Sensitivity of a lower cytology triage threshold of ASCUS or above was 85.3% (95% CI = 78.2% to 90.8%), with 58.6% referred.
HC 2 testing for cancer-associated HPV DNA is a viable option in the management of women with ASCUS. It has greater sensitivity to detect CIN3 or above and specificity comparable to a single additional cytologic test indicating ASCUS or above.
每年有超过200万美国女性接受意义不明确的宫颈细胞学诊断（意义不明确的非典型鳞状细胞[ASCUS]）。需要有效的阴道镜检查分流策略，以识别少数患有临床显著疾病的女性，同时避免对其他女性进行过度的后续评估。
ASCUS/LSIL（即低级别鳞状上皮内病变）分流研究（ALTS）是一项多中心随机试验，比较以下三种管理策略检测宫颈上皮内瘤变3级（CIN3）的敏感性和特异性：1）立即进行阴道镜检查（被视为参考标准），2）根据杂交捕获2（TM）（HC 2）检测的人乳头瘤病毒（HPV）结果和薄层细胞学结果分流至阴道镜检查，或3）仅根据细胞学结果进行分流。本文总结了3488名转诊诊断为ASCUS的女性的横断面入组结果。所有统计检验均为双侧检验。
在ASCUS参与者中，组织学确诊的CIN3的潜在患病率为5.1%。通过检测与癌症相关的HPV DNA来检测CIN3或更高病变的敏感性为96.3%（95%置信区间[CI]=91.6%至98.8%），56.1%的女性被转诊至阴道镜检查。以高级别鳞状上皮内病变（HSIL）或更高为分流阈值的单次重复细胞学标本的敏感性为44.1%（95%CI=35.6%至52.9%），6.9%的女性被转诊。以ASCUS或更高为较低细胞学分流阈值的敏感性为85.3%（95%CI=78.2%至90.8%），58.6%的女性被转诊。
对与癌症相关的HPV DNA进行HC 2检测是管理ASCUS女性的一种可行选择。它在检测CIN3或更高病变方面具有更高的敏感性，其特异性与单次额外的显示ASCUS或更高的细胞学检测相当。
