碘染色肉眼观察作为宫颈癌初筛方法的效果评价

Evaluation on the visual inspection with Lugol's iodine in cervical cancer screening program

目的评价碘液染色后直接肉眼观察在宫颈癌筛查中的作用,为在现阶段宫颈癌高发且经济落后地区制定宫颈癌及其癌前病变的筛查方案提供依据。方法在山西省阳城县筛查人群中,以病理组织学诊断结果为金标准,利用约登指数比较使用碘液染色后肉眼观察、阴道镜、薄层液基细胞学和人乳头瘤病毒(HPV)DNA的筛查效果。结果该人群(735名)平均年龄为40.80岁±10.7岁,宫颈高度鳞状上皮内瘤样变及癌(≥CINⅡ)的现患率为4.35%(32/735)。以病理组织学结果为金标准(≥CINⅡ),碘液染色后直接肉眼观察的灵敏度和特异度(≥阳性)分别为53.13和82.19,阴道镜的灵敏度和特异度(≥低度病变为阳性)分别为56.25和79.09。运用约登指数进行比较,碘液染色后直接肉眼观察和阴道镜检查之间差异无统计学意义(P>0.05),而碘液染色后直接肉眼观察不如液基细胞学和HPVDNA检测(P<0.05)。另外,经过现场短时间培训后,以前无经验的医生与有经验医生间使用碘液染色的水平的差异无统计学意义(P>0.05)。结论鉴于碘染色后肉眼观察的灵敏度较低,但经济易行,容易掌握,如果能够开展经常性的筛查,可以将碘液染色后直接肉眼观察作为经济落后地区宫颈癌初筛方法之一。

Objective To evaluate visual inspection with Lugol＇s iodine（VILI） in cervical cancer screening program and to provide evidence for designing a cervical cancer screening algorithm in high risk areas of existing low-resource settings to reduce the incidence and mortality of cervical cancer. Methods Women in Yangcheng county, Shanxi province were screened with VILI, colposcopy, liquid-based cytology test and human papilloma virus（HPV） DNA test. The efficacy of different screening tests was compared by Youden＇s index based on the pathology as the gold standard. Results In the population being screened, the mean age was 40,80 ± 10.75 years old. Based on pathological findings, 4.35 % （32/735） of the subjects had ≥CIN （cervical intraepithelial neoplasia） Ⅱ. The sensitivity and specificity for the VILI test （≥positive） were 53,13 and 82.19,while 56.25 and 79.09 were for colposcopy （≥low grade dysplasia） respectively. Comparing by the Youden＇ s indexs, there was no statistically significant difference（ P 〉 0.05） between VILI and colposcopy. However,statistical significant difference（P〈 0.05） was found between VILI and liquid-based cytology test and HPV DNA test. In addition, there was no statistically significant difference （P〉 0,05） found between the experienced doctors and the newly-trained doctors working in the field station. Conclusion With low sensitivity when using microscope but low cost of equipments, VILI can be one of the primary screening tests in China＇s rural area with low-resource settings if the screening frequency is to be increased,