Department of Obstetrics and Gynaecology, University Hospital of North Staffordshire, Stoke on Trent, Staffordshire, Belgium.
J Low Genit Tract Dis. 2012 Oct;16(4):421-6. doi: 10.1097/LGT.0b013e318250acf3.
The study aimed to determine the accuracy of the colposcopy-directed punch biopsy (punch) to detect or exclude high-grade cervical intraepithelial neoplasia (CIN 2 or 3) in women with atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesion (LSIL) cytological result and minor colposcopic findings.
In a diagnostic test accuracy study, women with ASCUS or LSIL cytological result and minor colposcopic changes had a single colposcopy-targeted punch biopsy was performed immediately followed by a loop electrocautery excision procedure (LEEP) biopsy. The trial was powered to detect a level of κ for a dichotomous outcome of 0.4 (i.e., fair-to-moderate agreement), with a two-sided significance level of 5% and a power of 90%. Accuracy parameters were computed using a cutoff for positive punch biopsy result of CIN 1+ and CIN 2+ for an outcome of CIN 2+ and CIN 3+ assessed in the LEEP specimen.
Sixty-eight punch biopsy/LEEP-paired samples were analyzed. Of the 8 CIN 3 lesions, 6 and 4 were detected at cutoff CIN 1+ and CIN 2+, respectively (sensitivity, 50% and 75%). The corresponding specificities were 65% (39/60) and 97% (58/60). The punch biopsies identified only 14 (67%) or 6 (20%) of the 21 CIN 2+ lesions at cutoff CIN 1+ or CIN 2+, respectively. Of the punch biopsies, 31 (45.6%) accurately detected the severity of cervical abnormality.
A single colposcopically directed punch biopsy appears to be insufficient to exclude underlying CIN 2 or 3.
本研究旨在确定阴道镜指导下的活检(活检)在细胞学检查为非典型鳞状细胞意义不明确(ASCUS)或低度鳞状上皮内病变(LSIL)且阴道镜检查发现轻微异常的女性中检测或排除高级别宫颈上皮内瘤变(CIN 2 或 3)的准确性。
在一项诊断试验准确性研究中,细胞学检查为 ASCUS 或 LSIL 且阴道镜检查发现轻微改变的女性行单次阴道镜指导下活检,随后立即行环形电切术(LEEP)活检。该试验的目的是检测二分类结果的κ值为 0.4(即,适度一致),双侧显著性水平为 5%,效力为 90%。使用阳性活检结果为 CIN 1+ 和 CIN 2+的截止值计算准确性参数,以评估 LEEP 标本中的 CIN 2+ 和 CIN 3+结果。
分析了 68 个活检/LEEP 配对样本。8 个 CIN 3 病变中,6 个和 4 个在截止值 CIN 1+ 和 CIN 2+时被检测到(敏感性分别为 50%和 75%)。相应的特异性分别为 65%(39/60)和 97%(58/60)。在截止值 CIN 1+或 CIN 2+时,活检仅分别识别出 21 个 CIN 2+病变中的 14 个(67%)或 6 个(20%)。在活检中,31 个(45.6%)准确检测到宫颈异常的严重程度。
单次阴道镜指导下活检似乎不足以排除潜在的 CIN 2 或 3。