Comparison of three management strategies for patients with atypical squamous cells of undetermined significance: Baseline results from a randomized trial
Comparison of three management strategies for patients with atypical squamous cells of undetermined significance: Baseline results from a randomized trial
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DOI：
10.1093/jnci/93.4.293
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发表时间：
2001-02-21
期刊：
影响因子：
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通讯作者：
Tarone, R
中科院分区：
文献类型：
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作者：
Solomon, D;Schiffman, M;Tarone, R
背景：每年有200多万美国妇女接受可疑的宫颈细胞学诊断(未确定意义的非典型鳞状细胞[ASCUS])，需要有效的阴道镜分诊策略来识别少数有临床意义的疾病的妇女，同时避免对其他人进行过多的随访评估。方法：ASCUS/LSIL(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，比较以下三种处理策略检测宫颈上皮内瘤变3级(CIN3)的敏感性和特异性：1)立即阴道镜检查(被认为是参考标准)，2)根据杂交捕获2(TM)(HC 2)和薄层细胞学结果对阴道镜进行分流，或3)仅基于细胞学结果进行分流。本文总结了3488名转诊为ASCUS的妇女的横断面登记结果，所有统计检验都是双侧的。结果：在ASCUS患者中，经组织学证实的CIN3的潜在患病率为5.1%。HPV DNA检测CIN3或以上的敏感性为96.3%(95%可信区间=91.6%~98.8%)，其中56.1%的妇女转诊于阴道镜检查，以HSIL或以上为分流阈值的单次重复细胞学标本的敏感性为43.1%(95%CI=35.6%~52.9%)，其中6.9%为参考。ASCUS或以上细胞学分流阈值下限的敏感度为85.3%(95%Ct=78.2%~90.8%)，参考阈值为58.6%。结论：HPVDNA HC-2检测是治疗女性ASCUS的一种可行方法，对检测CIN3或以上具有更高的敏感性，其特异性可与单项细胞学检测ASCUS或以上相当。
Background: 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. Methods: 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. Results: 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 43.1% (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% Ct = 78.2% to 90.8%), with 58.6% referred. Conclusions: 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.