Robert E Fechner Laboratory of Surgical Pathology, University of Virginia Health System, Charlottesville, VA, USA.
Int J Cancer. 2011 Mar 15;128(6):1354-62. doi: 10.1002/ijc.25470.
We evaluated the overall agreement between colposcopically directed biopsies and the definitive excisional specimens within the context of three clinical trials. A total of 737 women aged 16-45 who had a cervical biopsy taken within 6 months before their definitive therapy were included. Per-protocol, colposcopists were to also obtain a representative cervical biopsy immediately before definitive therapy. Using adjudicated histological diagnoses, the initial biopsies and the same day biopsies were correlated with the surgically excised specimens. The overall agreement between the biopsies taken within 6 months of definitive therapy, and the definitive therapy diagnoses was 42% (weighted kappa = 0.34) (95% CI: 0.29-0.39). The overall underestimation of cervical intraepithelial neoplasia grade 2/3 or adenocarcinoma in situ (CIN2-3/AIS) and CIN3/AIS was 26 and 42%, respectively. When allowing for one degree of variance in the correlation, the overall agreement was 92% for CIN2-3/AIS. The overall agreement between the same day biopsy and definitive therapy specimen was 56% (weighted kappa = 0.41) (95% CI: 0.36-0.47), and the underestimation of CIN2-3/AIS was 57%. There were significant associations in the agreement between biopsies and excisional specimen diagnoses when patients were stratified by age, number of biopsies, lesion size, presence of human papillomavirus (HPV)16/18 and region. Of 178 diagnostic endocervical curettages performed, 14 (7.9%) found any HPV disease. Colposcopic accuracy improved when CIN2 and CIN3/AIS were grouped as a single predictive measure of high-grade disease. Colposcopy functioned well when allowed a one-degree difference between the biopsy and the surgical histologic interpretations, as done in clinical practice. Taking more than one biopsy improved colposcopic accuracy and could improve patient management.
我们在三项临床试验的背景下评估了阴道镜指导下活检与明确的切除标本之间的总体一致性。共纳入了 737 名年龄在 16-45 岁之间的女性，她们在接受明确治疗前的 6 个月内进行了宫颈活检。按照方案，阴道镜医生还应在明确治疗前立即获得有代表性的宫颈活检。使用裁定的组织学诊断，将初始活检和同一天的活检与手术切除标本进行比较。在明确治疗后 6 个月内进行的活检与明确治疗诊断之间的总体一致性为 42%（加权 kappa = 0.34）（95%CI：0.29-0.39）。宫颈上皮内瘤变 2/3 级或原位腺癌（CIN2-3/AIS）和 CIN3/AIS 的总体低估率分别为 26%和 42%。当允许相关性有一度变化时，CIN2-3/AIS 的总体一致性为 92%。同一天活检与明确治疗标本之间的总体一致性为 56%（加权 kappa = 0.41）（95%CI：0.36-0.47），CIN2-3/AIS 的低估率为 57%。当根据年龄、活检数量、病变大小、人乳头瘤病毒（HPV）16/18 存在情况和区域对患者进行分层时，活检和切除标本诊断之间的一致性存在显著关联。在进行的 178 次诊断性宫颈刮宫术中有 14 次（7.9%）发现任何 HPV 疾病。当将 CIN2 和 CIN3/AIS 组合为高级别疾病的单一预测指标时，阴道镜的准确性得到了提高。当允许活检和手术组织学解释之间有一度差异时，阴道镜的功能良好，这与临床实践中一样。多做一次活检可以提高阴道镜的准确性，并改善患者的管理。
