应用2011年版阴道镜术语对子宫颈病变行阴道镜诊断与病理诊断的一致性分析

Agreement between colposcopic diagnosis with 2011 international terminology of colposcopy and cervical pathology in cervical lesions

目的：探讨应用国际子宫颈病理与阴道镜联盟（IFCPC）2011年版阴道镜术语对子宫颈病变行阴道镜诊断与病理诊断的一致性。方法采用回顾性队列研究方法，选择2014年9—11月就诊于复旦大学附属妇产科医院阴道镜门诊的患者376例，应用2011年版阴道镜术语对子宫颈病变行阴道镜诊断，以子宫颈活检或锥切术后病理诊断为“金标准”，对两者进行一致性检验及各项特征变量的相关性分析。结果应用2011年版阴道镜术语后，阴道镜诊断与子宫颈病理诊断的完全符合率为60.9%（229/376），一致性检验Kappa值为0.401（P〈0.01），1个级别以内（指两者诊断病变的级别一致或仅相差1个级别）的符合率为97.6%（367/376）；过高诊断率（19.9%，75/376）与过低诊断率（19.1%，72/376）相似；不同病变中阴道镜诊断与病理诊断的符合率比较，差异无统计学意义（χ2=1.996，P=0.573）。阴道镜诊断高级别鳞状上皮内病变（HSIL）及以上病变的阳性预测值为84.4%，诊断低级别鳞状上皮内病变（LSIL）及以下病变的阴性预测值为88.8%；假阳性率为3.5%，假阴性率为39.3%。3种转化区类型与患者年龄呈明显的线性变化趋势（χ2回归=45.910，P〈0.01），而病灶大小与病变程度无明显的线性变化趋势（χ2回归=0.690，P=0.406）。在1级、2级及非特异性征象中，发生率最高的征象分别为薄醋酸白上皮、厚醋酸白上皮及碘染不着色，约登指数分别为0.170（薄醋酸白上皮诊断LSIL）、0.373（厚醋酸白上皮诊断HSIL）以及0.145、0.069（分别为碘染不着色诊断LSIL和HSIL）。新增术语（内部边界和隆起）诊断HSIL的阳性预测值达100.0%。不同经验检查者的诊断符合率比较，差异无统计学意义（χ2=1.197，P=0.550）。结论2011年版阴道镜术语可明显提高阴道镜诊断与病理诊断的符合率以及多项诊断效能指标，且不随病变程度及检查者经验而产生差异；常见征象归类科学，部分征象可靠性高，对指导活检意义大；但3种转化区类型的可重复性及病灶大小的诊断价值尚有待探讨。

Objective To evaluate the agreement between colposcopic diagnosis with 2011 colposcopic terminology of the International Federation for Cervical Pathology and Colposcopy （IFCPC） and cervical pathology in cervical lesions. Methods A retrospective cohort study was performed, which included 376 patients who underwent colposcopy with 2011 international terminology of colposcopy at Obstetrics and Gynecology Hospital of Fudan University from September 2014 to November 2014. With conization or cervical biopsy pathology as the gold standard, the agreement between colposcopic diagnosis and pathologic diagnosis was calculated and correlations between variables were analyzed. Results With 2011 international terminology of colposcopy, agreement of colposcopic diagnosis and cervical pathology was 60.9%（229/376）perfectly matched, and the strength of agreement with weighted Kappa statistic was 0.401 （P〈0.01）, and agreement within one grade was 97.6%（367/376）, which were improved compared with traditional methods. Colposcopic diagnosis were 19.9%（75/376） overestimated and 19.1%（72/376）＆amp;nbsp;underestimated. There were no significant difference between agreements in various grade lesions （χ2=1.996, P=0.573）. Positive predictive value of high grade colposcopy or more was 84.4%, the negative predictive value of low grade colposcopy or less was 88.8%, whereas false positives were 3.5%and false negatives were 39.3%. A linear trend among three types of transformation zone and patient ages was found （χ2=45.910, P〈0.01）, whereas lesion sizes were not linearly correlated with lesion degrees （χ2=0.690, P=0.406）. In grade 1, grade 2 and nonspecific findings, thin acetowhite epithelium, dense acetowhite epithelium and Lugol′s non-staining were most frequent, the Youden indexes of each were 0.170, 0.373 and 0.145, 0.069 respectively. Positive predictive value of some other findings （such as fine mosaic） and two new signs （inner border sign and ridge sign） were 100.0%. There were no significant difference between agreements in examiners with different levels of experience （χ2=1.197,P=0.550）. Conclusions Compared to traditional methods （such as Reid index）, 2011 international terminology of colposcopy could improve the agreement between colposcopic diagnosis and pathologic diagnosis, without significant differences by the severity of lesion and the level of examiners′experience. Common findings were classified reasonably, and some signs were highly reliable, which is important for guiding biopsy. However, the reproducibility of transformation zone types and the implication of lesion size need to be further discussed.