Objective: To investigate the diagnostic value of different vaginal micro-environmental factors in low-grade cervical intraepithelial neoplasia (CIN Ⅰ) and determine the optimal model in high-risk human papillomavirus (HR-HPV) infection. Methods: A total of 926 women, including 623 with normal cervical (NC) condition and 303 CINⅠ patients, had undergone pathological examinations, and were enrolled in the study. All the women were from a community previously established cohort. Vaginal cleanliness, pH, H2O2, β-glucuronidase, coagulase, sialidase, and leukocyte esterase (LE) were detected by the combined detection method aerobic vaginitis/bacterial vaginosis in vaginal secretions. HPV genotyping was performed by using the flow-through hybridization technology. The data were analyzed by SAS 9.2 and SPSS 23.0. Results: The vaginal cleanliness, pH, sialidase, and LE were determined as the representative vaginal micro-environment factors by principal component analysis. Based on logistic regression theory to analyze the ROC curve, the results showed that the highest sensitivity was with pH value (76.2%), and the highest specificity was with sialidase (90.9%). The area under ROC curve were higher in combination detection modes of sialidase+LE (0.714), pH+sialidase+LE (0.719), vaginal cleanness+sialidase+LE (0.713) and pH+vaginal cleanness+sialidase+LE (0.709). According to HR-HPV infection status, the TOPSIS method was used to analyze the combined detection optimal model. Specifically, we found that the best diagnostic model was pH+sialidase +LE (Ci=0.585) in the HR-HPV positive group and vaginal cleanness+sialidase+LE (Ci=0.641) in the negative group. Conclusions: The combined detection of vaginal microenvironment factors could be used for auxiliary diagnosis for CINⅠ. It would be more effective when detecting pH, sialidase, and LE in HR-HPV positive women while vaginal cleanness, sialidase, and LE in HR-HPV negative women at the same time.
目的： 探讨高危型HPV（HR-HPV）感染状态下阴道微环境因子联合检测对低度宫颈上皮内瘤变（CINⅠ）的诊断价值，并确定最优检测组合模式。 方法： 从课题组前期建立的社区队列中选取正常宫颈（NC）女性623人和CINⅠ患者303人作为研究对象，应用需氧菌性阴道炎/细菌性阴道病联合检测方法检测阴道微环境因子，采用导流杂交法进行HPV分型检测。采用SAS 9.2及SPSS 23.0软件进行资料分析。 结果： 在经主成分分析获得阴道清洁度、pH值、唾液酸苷酶和白细胞酯酶为阴道微环境主要代表性因子的基础上，对以上4种因子基于logistic回归原理进行受试者工作特征曲线（ROC曲线）分析，结果显示，单项检测灵敏度以pH值最高（76.2%），特异度以唾液酸苷酶最高（90.9%），联合检测以唾液酸苷酶+白细胞酯酶、pH值+唾液酸苷酶+白细胞酯酶、阴道清洁度+唾液酸苷酶+白细胞酯酶和pH值+阴道清洁度+唾液酸苷酶+白细胞酯酶4种组合的ROC曲线下的面积较高，分别为0.714、0.719、0.713和0.709。进一步结合HR-HPV感染状况，通过逼近理想排序法对4种组合模式的诊断效果进行优化分析后显示，HR-HPV阳性组以pH值+唾液酸苷酶+白细胞酯酶的联合检测最佳（Ci=0.585），而HR-HPV阴性组则为阴道清洁度+唾液酸苷酶+白细胞酯酶（Ci=0.641）。 结论： 阴道微环境因子的联合检测可用于CIN Ⅰ的辅助诊断，pH值、唾液酸苷酶、白细胞酯酶联合检测对HR-HPV阳性女性CIN Ⅰ的诊断价值较大，而阴道清洁度、唾液酸苷酶和白细胞酯酶的联合检测对HR-HPV阴性的CIN Ⅰ诊断意义更大。.