细胞DNA定量分析系统宫颈癌初筛实践的应用评价

An Evaluation of Cervical Cancer Primary Screening Test by DNA Ploidy Analysis System

目的:初步评价细胞定量分析系统宫颈癌筛查试验三个截断值下的真实性、可靠性及其收益性。方法:用细胞定量分析系统为筛查试验方法,分别以少量(DNA-BCD)、中量(DNA-CD)和大量(DNA-D)细胞异常为截断值,阳性转诊阴道镜行病理活检,采用SPSS和Excel2003进行数据整理、计算、分析,计算筛查试验评价的灵敏度、特异度等13项评价指标。结果:共获得可供分析的合格对象15088人,其中阳性人数583人进行了病理活检病,诊断为CIN1-3的病例215人,浸润癌7人。三个截断值DNA-BCD、DNA-CD、DNA-D的灵敏度、特异度、约登指数和Kappa值等评价指标均不理想。结论:就本次筛查的结果而言,细胞定量分析系统初筛宫颈癌灵敏度、特异度等诸多评价指标不平衡,主要是特异度过低致使误诊率太高,适当提高筛查频率或串联其它筛查方法以提高筛查的特异度。细胞定量分析系统筛查宫颈癌真实性、可靠性和收益性还值得进行更多的研究。

Objective： To evaluate the validity,reliability and profitability of the cervical cancer screening by DNA ploidy analysis system in three cut- off values. Methods： A few cells or DNA ploidy（ DNA- BCD）,moderate numbers of cells or DNA ploidy（ DNA- CD） and a large number of cells or DNA ploidy（ DNA- D） were used as the cut- off values,respectively,DNA ploidy analysis system were usedt o screen the cervical cancer,then the positive were transferated to colposcopy and biopsy. The sensitivity,specificity and sensitivity of the screening tests were calculated and analyzed by Excel2003 and SPSS. Results： A total of 15088 eligible subjects were screened,of which 583 positive cases were treated by biopsy,including 215 diagnosed with CIN1- 3 and 7 with invasive carcinoma. The sensitivity,specificity,Youden index,Kappa value etc,were not ideal. Conclusion： As far as this result is concerned,the sensitivity and specificity of the cervical cancer screening test were not balanced,because the low specificity led to a very high misdiagnosis rate. Therefore,the appropriate screening frequency or serial tests should be improved to enhance the specificity of the screening. DNA ploidy analysis system used for cervical cancer screening test validity,reliability and yield is also worthy of more research.