Siebers Albertus G, Klinkhamer Paul J J M, Grefte Johanna M M, Massuger Leon F A G, Vedder Judith E M, Beijers-Broos Angelique, Bulten Johan, Arbyn Marc
Department of Pathology, Radboud University Nijmegen Medical Centre, 824, PO Box 9101, 6500 HB Nijmegen, The Netherlands.
JAMA. 2009 Oct 28;302(16):1757-64. doi: 10.1001/jama.2009.1569.
Liquid-based cytology has been developed as an alternative for conventional cervical cytology. Despite numerous studies and systematic reviews, controversy remains about its diagnostic accuracy.
To assess the performance of liquid-based cytology compared with conventional cytology in terms of detection of histologically confirmed cervical intraepithelial neoplasia (CIN).
DESIGN, SETTING, AND PARTICIPANTS: Cluster randomized controlled trial involving 89,784 women aged 30 to 60 years participating in the Dutch cervical screening program at 246 family practices. One hundred twenty-two practices were assigned to use liquid-based cytology and screened 49,222 patients and 124 practices were assigned to use the conventional Papanicolaou (Pap) test and screened 40,562 patients between April 2004 and July 1, 2006. Patients were followed up for 18 months through January 31, 2008.
Screening for CIN using liquid-based cytology or conventional papanicolaou (Pap) test and the blinded review of all follow-up of screen-positive women (blinded to the type of cytology and the initial result).
Intention-to-treat and per-protocol analysis of the detection rates of and positive predictive values for histologically verified CIN in both cytology systems. Outcomes are presented as crude and adjusted rate ratios (adjustment for age, urbanization, study site, and period).
The adjusted detection rate ratios for CIN grade 1+ was 1.01 (95% confidence interval [CI], 0.85-1.19); for CIN grade 2+, 1.00 (95% CI, 0.84-1.20); for CIN grade 3+, 1.05 (95% CI, 0.86-1.29); and for carcinoma, 1.69 (95% CI, 0.96-2.99). The adjusted positive predictive value (PPV) ratios, considered at several cytological cutoffs and for various outcomes of CIN did not differ significantly from unity.
This study indicates that liquid-based cytology does not perform better than conventional Pap tests in terms of relative sensitivity and PPV for detection of cervical cancer precursors.
trialregister.nl Identifier: NTR1032.
液基细胞学已发展成为传统宫颈细胞学的替代方法。尽管有大量研究和系统评价，但关于其诊断准确性仍存在争议。
评估液基细胞学与传统细胞学在检测经组织学确诊的宫颈上皮内瘤变（CIN）方面的性能。
设计、地点和参与者：整群随机对照试验，涉及89784名年龄在30至60岁之间、在246家家庭诊所参加荷兰宫颈筛查项目的女性。2004年4月至2006年7月1日期间，122家诊所被分配使用液基细胞学，筛查了49222名患者；124家诊所被分配使用传统巴氏（Pap）试验，筛查了40562名患者。对患者随访至2008年1月31日，为期18个月。
使用液基细胞学或传统巴氏（Pap）试验筛查CIN，并对所有筛查阳性女性的随访结果进行盲法审查（对细胞学类型和初始结果进行盲法处理）。
两种细胞学系统中经组织学证实的CIN的检测率和阳性预测值的意向性分析和符合方案分析。结果以粗率和校正率比表示（校正年龄、城市化程度、研究地点和时期）。
CIN 1级及以上的校正检测率比为1.01（95%置信区间[CI]，0.85 - 1.19）；CIN 2级及以上为1.00（95%CI，0.84 - 1.20）；CIN 3级及以上为1.05（95%CI，0.86 - 1.29）；癌为1.69（95%CI，0.96 - 2.99）。在几个细胞学临界值和CIN的各种结果下考虑的校正阳性预测值（PPV）比与1无显著差异。
本研究表明，在检测宫颈癌前病变的相对敏感性和PPV方面，液基细胞学并不比传统巴氏试验表现更好。
trialregister.nl标识符：NTR1032
