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Objective@#This study aimed to evaluate the clinical performance of p16/Ki-67 dual staining for triage high risk HPV (HR-HPV) infected women.@*Method@#Target objects were women who infected HR-HPV and received colposcopy examination between April and December of 2016 at the Second Affiliated Hospital of Zhengzhou University. Gynecologists collected the cervical exfoliated cells from eligible women for p16/Ki-67 dual staining, LBC testing and HPV DNA testing. Histology diagnosis were used as gold standard. Sensitivities, specificities, positive predictive values (PPVs), negative predictive values (NPVs) of p16/Ki-67 dual staining, LBC testing and HPV16/18 testing for triage of HR-HPV positive population were calculated and compared.@*Results@#A total of 295 HR-HPV infected women were selected, and the mean age was (44.29±11.48) years old. Positive rates of p16/Ki-67 dual staining, HPV16/18 testing and LBC testing were 70.17% (207), 56.95% (168) and 85.76% (253), respectively. When CIN2+as the endpoint, among the three triage methods, sensitivity of p16/Ki-67 dual staining was 90.00% (95%CI: 85.06%-93.43%), higher than the value of HPV 16/18 testing, but lower than the value of LBC testing. Specificity, PPV and NPV of p16/Ki-67 dual staining were the highest [71.58% (95%CI: 61.81%-79.67%), 86.96% (95%CI:81.69%-90.88%) and 77.27% (95%CI: 67.49%-84.78%)]. When detection for CIN3+, sensitivity of p16/Ki-67 dual staining was 92.90% (95%CI: 87.74%-95.99%), lower than the value of LBC testing, but higher than the value of HPV16/18 testing. Specificity of p16/Ki-67 dual staining was 55.00% (95%CI: 46.74%-63.00%), lower than the value of HPV16/18 testing, but higher than the value of LBC testing. PPV of p16/Ki-67 dual staining was 69.57% (95%CI: 62.99%-75.43%), lower than the value of HPV 16/18 testing, but higher than the value of LBC testing. NPV of p16/Ki-67 dual staining was 87.50% (95%CI: 78.99%-92.87%), higher than value of HPV 16/18 testing, but lower than the value of LBC testing.@*Conclusion@#p16/Ki-67 dual staining has better clinical effects than HPV 16/18 testing and LBC testing for triage women with HR-HPV infection.
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This study aimed to evaluate the clinical performance of p16/Ki-67 dual staining for triage high risk HPV (HR-HPV) infected women. Target objects were women who infected HR-HPV and received colposcopy examination between April and December of 2016 at the Second Affiliated Hospital of Zhengzhou University. Gynecologists collected the cervical exfoliated cells from eligible women for p16/Ki-67 dual staining, LBC testing and HPV DNA testing. Histology diagnosis were used as gold standard. Sensitivities, specificities, positive predictive values (PPVs), negative predictive values (NPVs) of p16/Ki-67 dual staining, LBC testing and HPV16/18 testing for triage of HR-HPV positive population were calculated and compared. A total of 295 HR-HPV infected women were selected, and the mean age was (44.29±11.48) years old. Positive rates of p16/Ki-67 dual staining, HPV16/18 testing and LBC testing were 70.17% (207), 56.95% (168) and 85.76% (253), respectively. When CIN2+as the endpoint, among the three triage methods, sensitivity of p16/Ki-67 dual staining was 90.00% (95: 85.06%-93.43%), higher than the value of HPV 16/18 testing, but lower than the value of LBC testing. Specificity, PPV and NPV of p16/Ki-67 dual staining were the highest [71.58% (95: 61.81%-79.67%), 86.96% (95:81.69%-90.88%) and 77.27% (95: 67.49%-84.78%)]. When detection for CIN3+, sensitivity of p16/Ki-67 dual staining was 92.90% (95: 87.74%-95.99%), lower than the value of LBC testing, but higher than the value of HPV16/18 testing. Specificity of p16/Ki-67 dual staining was 55.00% (95: 46.74%-63.00%), lower than the value of HPV16/18 testing, but higher than the value of LBC testing. PPV of p16/Ki-67 dual staining was 69.57% (95: 62.99%-75.43%), lower than the value of HPV 16/18 testing, but higher than the value of LBC testing. NPV of p16/Ki-67 dual staining was 87.50% (95: 78.99%-92.87%), higher than value of HPV 16/18 testing, but lower than the value of LBC testing. p16/Ki-67 dual staining has better clinical effects than HPV 16/18 testing and LBC testing for triage women with HR-HPV infection.
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Background: Identification of 14 high-risk human papillomavirus (HR-HPV) is immensely important in elucidating molecular epidemiology, patient monitoring and evidence-based treatment. There is paucity of such data from Chhattisgarh state of Central India. The present study has evaluated tagging oligonucleotide cleavage and extension-mediated Anyplex HR-HPV genotyping assay in identification of 14 HR-HPV genotypes attributable to premalignant and malignant cervical lesion in comparison to GP5+/6+ assay, cytology and colposcopy. Materials and Methods: A total of 185 clinically suspected cases of premalignant and malignant cervical lesion were investigated by HR-HPV genotyping, GP5+/6+, cytology and colposcopy. Results: Genotyping assay showed clinical sensitivity and specificity of 86.5% (confidence interval [CI]: 80.7–91.0) and 100% (CI: 86.3–100) respectively and found noninferior to GP5+/6+ assay (P > 0.05). HR-HPV prevalence was 76.3%, 88.4%, 94.8%, 100% and 100% among cervical intraepithelial neoplasia (CIN) Grade I–III, squamous cell carcinoma and adenocarcinoma cases, respectively. The four most common genotypes detected in CIN I–III were HPV 16 (63.9%), HPV 39 (15.0%), HPV 18 (6.0%) and HPV 33 (5.3%). In cervical cancer (CC) cases, HPV 16 (44.4%), HPV 39 (11.1%), dual infection of HPV 16, 18 (11.1%) and triple infection of HPV 16, 18, 33 (11.1%) were the four most identified genotypic aetiologies. A novel coinfection of HR-HPV 35, 39 were found in two and one cases of CIN I and II. Finding of HPV 39 as the second most prevalent genotype was unusual and underscores the importance of genotyping screening. Conclusion: Anyplex HR-HPV assay is arguably the useful assay for better patient management and can be useful for HR-HPV screening by its unique individual genotype identification of all HR-HPV. Finding of HPV 16, 39, 18, 33 and coinfection of 16,18 and 16, 18, 33 in CIN and CC would help vaccine manufacturer to design specific future HPV polyvalent vaccine preparation to curb down the CC-associated mortality.
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Objective@#To evaluate and compare the screening performance of primary high-risk HPV(HR-HPV) screening and HR-HPV screening plus liquid-based cytology (LBC) cotesting in diagnosis of cervical cancer and precancerous lesions (CIN2+).@*Methods@#We pooled 17 population-based cross-sectional studies which were conducted across China from 1999 to 2008. After obtaining informed consent, all women received liquid-based cytology(LBC)testing, HR-HPV DNA testing. Totally 28 777 women with complete LBC, HPV and biopsy results were included in the final analysis. Screening performance of primary HR-HPV DNA screening and HPV screening plus LBC co-testing in diagnosis of CIN2+ were calculated and compared among different age groups.@*Results@#Among the whole population, the detection rates of primary HR-HPV screening and HR-HPV screening plus LBC co-testing are 3.05% (879 CIN2+) and 3.13%(900 CIN2+), respectively. The sensitivity were 96.4% and 98.7% (χ2=19.00, P<0.001), and the specificity were 86.2% and 78.8% (χ2=2 067.00, P<0.001), respectively. Areas under the receiver operating characteristic (ROC) curve (AUC) showed that the primary HR-HPV screening performed better than co-testing (AUC were 0.913 and 0.888; Z=6.16, P<0.001). Compared with primary HR-HPV screening, co-testing showed significantly higher colposcopy referral rates (16.5% and 23.6%, respectively, χ2=132.00, P<0.001) and the number of colposcopy examination for detecting per CIN2+ (5.4 and 7.6, respectively).In the group aged 25-29, the colposcopy referral rates was 8.7 (10.9%(199 cases) vs 1.3%(23 cases)) times as much as the detection rate of primary HR-HPV screening in diagnosis of CIN2+, and was 12.5 (15.7%(288 cases) vs 1.3%(23 cases)) times as much as the detection rate of HR-HPV screening plus cytology contesting.@*Conclusion@#Compared with primary HR-HPV screening, HR-HPV screening plus cytology co-testing does not show better results in the screening performance for CIN2+ detection, and the cost-effectiveness is not good enough, especially in younger age group.
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Objective To discuss the efficacy of Baofukang combined with clindamycin injection in treatment of chronic cervicitis patients with high-risk human papilloma virus infection (hr-HPV).Methods Totally 100 patients who had chronic cervicitis with hr-HPV were selected and divided into two groups randomly.The patients in control group (49 cases) were given Baofukang.The patients in observation group (51 cases) were given Baofukang combined with clindamycin injection.The efficacy of Baofukang combined with clindamycin injection in treatment of chronic cervicitis patients with hr-HPV was evaluated by efficacy,HPV negative rate,inflammatory factors before and after treatment and adverse reaction during treatment.Results After treatment,the effective rate of observation group was 92.1％,and the effective rate of control group was 75.5％,the effective rate of observation group was higher than that of control group (P ＜ 0.05).After treatment,the HPV negative rate in observation group was 90.2％,the control group was 59.2％,the HPV negative rate of observation group was higher than that of control group (P ＜ 0.05).Before treatment,there was no statistical significance on hs-CRP,IL-6,and TNF-α between two groups.After treatment,the hs-CRP,IL-6,and TNF-α were decreased in two groups (P ＜ 0.05).The hs-CRP,IL-6,and TNF-α of observation group were lower than those of control group (P ＜ 0.05).There was no statistical significance on adverse reaction between two groups.Conclusion Baofukang combined with clindamycin injection had a good therapeutic effect on chronic cervicitis with hr-HPV.It could inhibit HPV and inflammatory factors well.It was safe and worthy of clinical use.
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Objective To evaluate the diagnostic value of thinprep cytologic test (TCT) combined with high-risk human papillomavirus (HR-HPV) DNA for cervical cancer (CC). Methods 141 cases of patients with abnormal cervical lesions were abnormal examined by TCT and were graded by the results of TCT and cervical biopsy, the HR-HPV-DNA was detected by surface plasmon resonance (SPR). Results The cervical biopsy positive rate 65.2% (92/141) was significantly higher than the positive rate of TCT 39.0% (55/141) (χ2=19.45, P < 0.05). The positive rate of HR-HPV-DNA was 66.0% (93/141) was significantly higher than the positive rate of TCT 39.0% (55/141), (χ2=20.53, P < 0.05). Conclusion TCT, HR-HPV-DNA and cervical biopsy are important clinical diagnostic methods for cervical lesions, combine detection of TCT and HR-HPV-DNA can improve the detection rate of cervical lesions.
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Purpose To study of predictive value for detection of high-grade cervical intraepithelial neoplasia (CIN2 +) by p16/Ki-67 dual-stained liquid-based cytology.Methods Random collection of 123 women including 103 samples of atypical squamous cell of undetermined significance (ASC-US) and above with results of high-risk human papillomavirus (HR-HPV)testing and cervical biopsy,20 samples of negative for intraepithelial lesion or malignancy (NILM) by using immunocytochemical p16/Ki-67 dual-stained and the morphology assessment.Results In normal control group,the expression of p16/Ki-67 dual-stained in squamous epithelial cells were negative.Sensitivity of p16/Ki-67 dual-staind cytology for biopsy-confirmed CIN2 + was 66.67％ (ASC-US),91.67％ (LSIL) and 92.86％ (HSIL),specificity rates were 95.92％ (ASC-US),95.00％ (LSIL) and 0 (HSIL),positive predictive value were 50.00％ (ASC-US),91.67％ (LSIL) and 92.86％ (HSIL),negative predictive value were 97.92％ (ASC-US),95.00％(LSIL) and 0 (HSIL),respectively.Condusion p16/Ki-67 dual-stained cytology are improved obviously the predictive value for detection of CIN2 +,p16/Ki-67 dual-stained cytology may efficiently complement HPV-based screening programs to prevent cervical cancer.
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Purpose To study the infection mode and distribution of high risk human papillomavirus (HR-HPV) in lowgrade squamous intraepithelial lesions (LSILs) and to analysis its effect.Methods HPV genotype of 328 cervical tissues embedded by paraffin which contained 168 LSILs and 160 highgrade squamous intraepithelial lesions (HSILs) were detected by the methods of real-time fluorescence quantitative PCR and in situ hybridization.Results Diseased cells of LSIL stained with hematoxylin and eosin(HE) were concentrated in the upper layer of the cervical squamous epithelium,whereas HSIL were concentrated in the lower layer of the epithelium in HE staining.In LSIL,the positive ratcs of HR-HPV was 95.2％.In LSIL and HSIL,HPV 16/18 positive rates were 26.2％,57.5％,respectively.Other HR-HPV positive rates were 80.9％,55.0％,respectively.The differences were statistically significant (P ＜0.001).HR-HPV positive rate was 70.2％ in the group of in situ hybridization.The positive cells were confined to the surface and middle layer of the LSIL cervical squamous epithelium.Conclusion HR-HPV infection is closely related to LSIL,especially other HR-HPV (except for HPV 16/18).The infection mode of HR-HPV in LSIL starts from the surface layer of the cervical squamous epithelium.
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Objective This study aimed to explore the overall prevalence and type distribution of High Risk Human Papilloma Virus (HR -HPV)in invasive cervical cancer in China.Methods Literatures published on China National Knowledge Infrastructure (CNKI)and PubMed database from January 2000 to January 2013 were systematically searched. The generic inverse variance model and direct equal -weighted sum model were used.Results 33 studies were included in this meta -analysis.The pooled infectious rate of HR -HPV was 86.41% (95%confidence interval (CI)85.44% -87.38%).Top five HR -HPV types in invasive cervical cancer (ICC)women were HPV16,HPV18,HPV58,HPV52 and HPV33.The generic inverse variance model showed the pooled infectious rate of HR -HPV types was 86.99%(95%CI 83.45% -90.69%)with a significant heterogeneity among studies (I2 =90.19%,P <0.05).The infectious rate of HR -HPV in northern China was significantly higher than that in southern China (P <0.05).Conclusion The main types of HR -HPV infection are HPV16,HPV18,HPV58,HPV52 and HPV33 in China and the distribution varies in regions.
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Objective To research the treatment of cervical HR-HPV infection by vaginal douching with eight kinds of antiviral herbs such as Radix Arnebiae and patrinia.Methods 42 patients with 13 types of cervical HR-HPV infection were selected from Outpatient.27 patients were recruited into a treatment group and 15 patients were recruited into a control group voluntarily.The treatment group was applied with antiviral herbs and the control group was applied with policresulen vaginal suppositories for 3 courses (one course for 7 days per month).The clearance rate and loading dose of 13 types of cervical HR-HPV were observed.Results The negative conversion ratio of the treatment group and the control group was 88.5％ and 15.4％ respectively,and the total efficiency was 100％ and 46.2％ in the treatment group and the control group respectively.The total efficiency between the two groups were significantly different(x2=17.062,P＜0.01).Conclusion The therapeutic effect of antiviral herbs for cervical HR-HPV infection was definite and with no side reactions.
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ObjectiveThrough the study of cervical lesions vagina inmage to investigate the micro-syndrome identified methods for cervical lesions. MethodsThrough the methods of retrospective study, collecting cases of HR-HPV infection (HC Ⅱ positive) and colposcopy detection, the objective evaluation of micro-syndrome differentiation was primarily established. ResultsRGB mode quantitative analysis for colposcopy images showed category 3 (the purple samples) occupied 44.4％, category 2 (the red samples)occupied 12.6％; category 1 (the white samples) occupied 43％. ConclusionsRGB mode quantitative analysis for colposcopy images was appropriate exploration of micro-differentiation in cervical lesions. There is a close relationship between traditional Chinese medicine syndrome and mucosai color differentiation by colposcopy.
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OBJECTIVE: To examine whether the presence of high risk-human papilloma virus (HR-HPV) after conization of the cervix was a risk factor for persistence or recurrence of cervical intraepithelial neoplasia (CIN) and whether HR-HPV test could be a guideline for post-therapy surveillance. METHODS: The study retrospectively analyzed data from 243 patients who underwent LLETZ or CKC of the cervix due to CIN. RESULTS: A positive HR-HPV test result which was performed between 3 and 6 months after procedure was a risk factor for persistent or recurrent cytological (p<0.001, odds ratio [OR]=22.51, 95% confidence interval [CI]=9.74-52.02) and pathological (p<0.001, OR=18.28, 95% CI=5.55-60.20) abnormalities. CONCLUSION: HR-HPV positive patients between 3 and 6 months after procedure should undergo frequent and meticulous post-therapy surveillance, while HR-HPV negative patients do not require such high-level surveillance and could undergo routine surveillance.
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Female , Humans , Uterine Cervical Dysplasia , Cervix Uteri , Conization , Follow-Up Studies , Odds Ratio , Papilloma , Recurrence , Retrospective Studies , Risk Factors , VirusesABSTRACT
OBJECTIVE To investigate the clinic significance of screening high risk human papillona virus DNA(HR-HPV-DNA) in pregnant and postpartum women.METHODS HR-HPV-DNA screening was carried by HC-Ⅱ in 711 pregnant and postpartum women.RESULTS In 711 specimens,the infection rate of HR-HPV was 15.07%,15.92% in pregnant women,and 10.11% in postpartum ones;13.43% in the group