| Cervical cancer(CC),as the most common gynecological malignant tumor in the female reproductive system,has a high morbidity and mortality rate in recent years.With the change of lifestyle,its onset age is also becoming younger,which is a serious threat to the life and health of women.As the only female malignant tumor with a clear etiology at present,persistent infection of high risk-human papillomavirus(HR-HPV)is the most important cause of cervical cancer.With the strengthening of modern women’s awareness of self-protection,cervical cancer screening programs have been paid more and more attention.At present,the main programs for cervical cancer screening mainly include: HPV DNA detection,Pap cell smear,liquid-based cytology detection,HPV E6/E7 m RNA detection.Due to the limitations of traditional screening methods and techniques,HPV E6/E7 m RNA detection has gradually become the focus and hotspot of cervical cancer screening in recent years.Existing evidence suggests that early human papilloma virus infection in the body,after HPV E6/E7 m RNA is in a state of low expression or not,at this point in the body of HPV may be cleared through the body’s own immune system,only a lot of HR-HPV persist in the body,transcribed into E6/E7 m RNA and a large number of E6/E7 cancer protein expression,to induce cells in cancer,in turn,lead to the occurrence of cervical cancer.Therefore,it may take years or even decades between HPV infection,cervical precancerous lesions and progression to cervical cancer.During this long period,early and effective cervical cancer screening can significantly reduce the incidence and mortality of cervical cancer in the female population.Currently,as the only test for HPV E6/E7 m RNA approved by FDA,FDA and CE in the United States,APTIMA assay can not only detect HR-HPV infection,but also effectively evaluate the expression activity of HPV E6/E7 oncogene in cervical epithelial cells.However,there are relatively few large sample data and prospective studies on APTIMA HPV E6/E7 m RNA detection as the primary screening for cervical cancer.Therefore,this study collected clinical data of patients undergoing HPV E6/E7 m RNA detection in our hospital,the relationship between HPV E6/E7 m RNA expression and age,HPV infection type and cervical pathological results was statistically analyzed to comprehensively evaluate the diagnostic value of quantitative detection of HPV E6/E7 m RNA by APTIMA method in cervical cancer screening,and play a guiding role in the future clinical screening work.ObjectiveThis research mainly through the Aptima method to the quantitative detection of HPV E6 / E7 m RNA,to study its classification and quantitative test results in patients with different ages,TCT results,and the distribution of the cervical biopsy pathology results,and analyzes the quantitative test results in the cervical high-grade squamous intraepithelial lesion(HSIL),the efficiency of diagnosis to the value of comprehensive evaluation of the screening method in clinical application,give some guidance for clinical screening following job in the future.MethodsA total of 11051 patients who underwent APTIMA screening for HPV E6/E7 m RNA in the Third Affiliated Hospital of Zhengzhou University from January 2019 to February 2020 were selected as subjects.At the same time,age,TCT results,cervical biopsy pathology results and HPV DNA test results of the patients with positive HPV E6/E7 m RNA were collected.The patients’ age,pregnancy and birth order,method of contraception,reproductive age and other data were recorded in detail.The differences in HPV E6/E7 m RNA expression levels among each group were statistically analyzed.The area under the curve(AUC)was obtained by using receiver operating characteristic curve(ROC)to analyze the diagnostic efficiency of HPV E6/E7 m RNA detection on HSIL+.To evaluate the diagnostic value of quantitative detection of HPV E6/E7 m RNA in cervical precancerous lesions and cervical cancer screening.Statistical analysisSPSS version 24.0 statistical software and Graphpad8.0.2 were used for statistical analysis.Kruskal-Wallis test and Mann-Whitney test were used to detect the difference of HPVE6/E7 m RNA expression between the groups and the two groups,respectively.Qualitative data were expressed as n,chi-square test was used for comparison between groups,t test was used for comparison between measurement data groups,and receiver operating characteristic curve(ROC)was used to analyze the diagnostic efficiency of HPVE6/E7 m RNA detection for HSIL+,and to evaluate the diagnostic value of HPVE6/E7 m RNA detection for cervical cancer screening.The test between the two groups was performed with P value <0.05 was considered statistically significant.Corrected P value < was used to test between the five groups.0.005 indicates a statistically significant difference.Results1.Of the 11,051 women who met the inclusion criteria for HPV E6/E7 m RNA detection,1825 were positive,with a positive rate of 16.5%.Among the positive results of HPV E6/E7 m RNA typing,the highest number of HPV E6/E7 m RNA typing was detected in other types(31,33,35,39,51,52,56,58,59,66,68)(71.18%),followed by HPV16 and 18/45.HPV E6/E7 m RNA expression in different type don’t quantity differences are statistically significant(X~2=82.106,p=0.000),with HPV16/18/45 type mixed infection compared with other type don’t infected HPV E6/E7 m RNA quantity as the highest expression.2.The mean age of 1825(16.5%)women with positive HPV E6/E7 m RNA test was 38.47±10.93 years old,most of them were aged from 30 to 39 years old(600cases,32.9%),and the mean age of women with negative HPV test was 38.84±11.44 years old.Statistical analysis showed that the age difference between the positive and negative groups was not statistically significant(t=-1.25,p=0.211).The age group was divided into 5 groups,and the distribution of HPV E6/E7 m RNA was consistent in each age group.Each age group between HPV E6/E7 m RNA expression difference no statistical differences(X~2= 6.063,p=0.195).3.Among the positive HPV E6/E7 m RNA test results,TCT results were NILM with the highest proportion(58.94%).Different TCT results between HPV E6 / E7 m RNA expression between differences statistically significant(X~2=100.603,p=0.000),comparing the two find NILM group of HPV E6/E7 m RNA expression quantity lower than other abnormal group,the rest of the anomalies between two groups comparing the difference between the amount of HPV E6 / E7 m RNA expression has no statistical significance(p > 0.05).4.Among the 1825 HPV E6/E7 m RNA positive results,846 cases underwent cervical biopsy at the same time.Among them,the percentage of pathological results was LSIL(368/846,43.50%),followed by HSIL(245/846,28.96%).The positive prediction rate of HPV E6/E7 m RNA detection was 34.28%.Among 290 HSIL+patients,159 cases(54.83%)were infected with HPV16.The difference of HPV E6/E7 m RNA expression in different pathological groups was statistically significant(X~2=27.731,p=0.000),however there was no significant difference in HPV E6/E7 m RNA expression between LSIL-and HSIL+(z=-1.647,p=0.100).With the increase of the severity of cervical lesions,the expression of HPV E6/E7 m RNA did not show an obvious increasing trend.Using HSIL+ as the node,the ROC curve was used to analyze the diagnostic efficiency of this screening method for HSIL+,and the area under the curve was 0.537(95%CI=0.498--0.576).5.In the patients with positive HPV E6/E7 m RNA detection,99 patients underwent HPV DNA detection,among the 64 cases of HPV DNA positive group,pathological results were: chronic cervical inflammation 10 cases(15.63%),LSIL 33cases(51.56%),HSIL+21 cases(32.81%).Among the 35 HPV DNA negative groups,pathological results were as follows: chronic cervical inflammation in 3 cases(8.57%),LSILs in 16 cases(45.71%),and HSILs in 16 cases(45.71%).The expression level of HPV E6/E7 m RNA was compared between the negative and positive HPV DNA test groups,and the results showed that there was no statistical difference(z=-0.468,p=0.639).Conclusion1.The expression of HPV E6/E7 m RNA was significantly correlated with the type of HPV infection.2.There was no significant correlation between the expression of HPV E6/E7 m RNA and the severity of cervical lesions,and the expression of HPV E6/E7 m RNA showed no obvious linear increasing trend with the increase of pathological grade.3.There was no significant correlation between HPV E6/E7 m RNA expression and HPV DNA load.4.The combined application of quantitative HPV E6/E7 m RNA detection and cervical cytology detection is of higher value for the screening and diagnosis of cervical precancerous lesions and cervical cancer in the clinical. |
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