青岛农村地区宫颈癌筛查的临床适用技术研究

Clinical application of cervical cancer screening in rural areas of Qingdao

目的 综合筛查方法的普及性和有效性,探讨青岛农村地区宫颈病变筛查的临床适用方法。方法选取2019年11月至2020年10月青岛市第八人民医院体检中心、妇科门诊、住院处就诊及其在青岛市郊区下乡诊疗的1 115例妇科患者,以阴道镜活检组织的病理结果为金标准,采用logistic回归分析和ROC曲线的AUC评估人乳头瘤病毒(human papilloma virus, HPV)DNA、HPV基因E6和E7的mRNA(E6/E7 mRNA)及液基薄层细胞学检查(thin-prep cytology test, TCT)分类筛查方法的灵敏度和特异度,采用决策曲线分析法(decision curve analysis, DCA)评估筛查方法的临床收益。结果 1 115例患者共检出宫颈病变515例,非宫颈病变600例。宫颈病变组的HPV DNA、HPVE6/E7mRNA、不能明确意义的非典型鳞状细胞(atypicalsquamouscellsof undetermined significance, ASC-US)、高级别鳞状上皮内病变(high-grade squamous intraepithelial lesion, HSIL)和低级别鳞状上皮内病变(low-grade squamous intraepithelial lesion, LSIL)的阳性率分别为87.7%、67.2%、38.8%、5.8%和15.1%,非宫颈病变组分别为71.9%、63.3%、42.5%、0.5%和5.7%,两组比较差异均有统计学意义(P<0.05);HPV DNA、HPV E6/E7 mRNA及TCT三联筛查(AUC=0.704)和HPV DNA及TCT二联筛查(AUC=0.691)的临床净收益最好,差异有统计学意义(P<0.05)。结论 宫颈病变筛查首选HPV DNA、HPV E6/E7 mRNA及TCT三联筛查,也可根据临床检查的普及性和成本选用HPV DNA与TCT二联筛查。

Objective To explore the clinical application of cervical lesion screening methods by integrating the universality and effectiveness of screening methods in rural areas of Qingdao. Methods A total of 1 115 gynecological patients from the physical examination center, outpatient department, inpatient department of Qingdao Eighth People ′s Hospital and their treatment in rural areas in the suburbs of Qingdao from November 2019 to Oc tober 2020 were selected. The histopathology examination of colposcopy biopsy were used as golden standard. Logistic regression analysis and AUC of receiver operator curve(ROC) were used to evaluate the sensitivity and specificity of screening methods for human papilloma virus(HPV) DNA, HPV E6/E7 mRNA, and thin-prep cytology test(TCT). Decision curve analysis(DCA) was used to evaluate the clinical benefits of screening methods. Results A total of 515 cervical lesions and 600 non-cervical lesions were detected in 1 115 patients. The positive rates of HPV DNA, HPV E6/E7 mRNA,atypical squamous cells of undetermined significance(ASC-US), high-grade squamous intraepithelial lesion(HSIL) and low-grade squamous intraepithelial lesion(LSIL) in cervical lesion group were 87.7%, 67.2%, 38.8%, 5.8% and 15.1%respectively, which were 71.9%, 63.3%, 42.5%, 0.5% and 5.7% in non-cervical lesions group, respectively, and the differences between the two groups were statistically significant(P<0.05). HPV DNA, HPV E6/E7 mRNA, TCT triple screening(AUC=0.704) and HPV DNA, TCT double screening(AUC=0.691) had the best clinical net benefits, the difference was statistically significant(P<0.05). Conclusions Three joint detections of HPV DNA, HPV E6/E7mRNA and TCT are preferred for cervical lesions screening, or two joint detections of HPV DNA and TCT can be used according to the availability and cost of clinical test.