No abstract available.
*Colposcopes ; Early Detection of Cancer/*instrumentation ; Female ; Humans ; Optical Imaging/*instrumentation ; Uterine Cervical Dysplasia/*diagnosis ; Uterine Cervical Neoplasms/*diagnosis

Objective: To evaluate the efficacy and safety of Nocardia rubra cell wall skeleton (Nr-CWS) in the treatment of persistent cervical high-risk human papillomavirus (HR-HPV) infection. Methods: A randomized, double blind, multi-center trial was conducted. A total of 688 patients with clinically and pathologically confirmed HR-HPV infection of the cervix diagnosed in 13 hispital nationwide were recruited and divided into: (1) patients with simple HR-HPV infection lasting for 12 months or more; (2) patients with cervical intraepithelial neoplasia (CIN) Ⅰ and HR-HPV infection lasting for 12 months or more; (3) patients with the same HR-HPV subtype with no CINⅡ and more lesions after treatment with CINⅡ or CIN Ⅲ (CINⅡ/CIN Ⅲ). All participants were randomly divided into the test group and the control group at a ratio of 2∶1. The test group was locally treated with Nr-CWS freeze-dried powder and the control group was treated with freeze-dried powder without Nr-CWS. The efficacy and negative conversion rate of various subtypes of HR-HPV were evaluated at 1, 4, 8, and 12 months after treatment. The safety indicators of initial diagnosis and treatment were observed. Results: (1) This study included 555 patients with HR-HPV infection in the cervix (included 368 in the test group and 187 in the control group), with an age of (44.1±10.0) years. The baseline characteristics of the two groups of subjects, including age, proportion of Han people, weight, composition of HR-HPV subtypes, and proportion of each subgroup, were compared with no statistically significant differences (all P>0.05). (2) After 12 months of treatment, the effective rates of the test group and the control group were 91.0% (335/368) and 44.9% (84/187), respectively. The difference between the two groups was statistically significant (χ²=142.520, P<0.001). After 12 months of treatment, the negative conversion rates of HPV 16, 18, 52, and 58 infection in the test group were 79.2% (84/106), 73.3% (22/30), 83.1% (54/65), and 77.4% (48/62), respectively. The control group were 21.6% (11/51), 1/9, 35.1% (13/37), and 20.0% (8/40), respectively. The differences between the two groups were statistically significant (all P<0.001). (3) There were no statistically significant differences in vital signs (body weight, body temperature, respiration, pulse rate, systolic blood pressure, diastolic blood pressure, etc.) and laboratory routine indicators (blood cell analysis, urine routine examination) between the test group and the control group before treatment and at 1, 4, 8, and 12 months after treatment (all P>0.05); there was no statistically significant difference in the incidence of adverse reactions related to the investigational drug between the two groups of subjects [8.7% (32/368) vs 8.0% (15/187), respectively; χ²=0.073, P=0.787]. Conclusion: External use of Nr-CWS has good efficacy and safety in the treatment of high-risk HPV persistent infection in the cervix.
Female ; Humans ; Adult ; Middle Aged ; Cervix Uteri/pathology* ; Uterine Cervical Neoplasms/pathology* ; Papillomavirus Infections/diagnosis* ; Cell Wall Skeleton ; Persistent Infection ; Powders ; Uterine Cervical Dysplasia/pathology* ; Immunotherapy ; Papillomaviridae

OBJECTIVETo study the diagnostic value of p16(INK4a) in squamous intraepithelial lesion in gynecologic cytology and its relationship with types of human papillomavirus (HPV).

METHODS88 liquid-based gynecologic cytology cases with histologic correlation, including 20 cases of cervicitis, 18 cases of low-grade squamous intraepithelial lesion (LSIL), 34 cases of high-grade squamous intraepithelial lesion (HSIL) and 16 cases of squamous cell carcinoma (SCC), were enrolled into the study. Immunocytochemistry for p16(INK4a) protein and polymerase chain reaction-based HPV DNA testing (for HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66 and 68, as well as HPV types 6, 11, 42, 43 and 44) were performed.

RESULTSThe rate of expression of p16(INK4a) protein was 0, 27.8%, 100% and 100% in the cervicitis group, LSIL group, HSIL group and SCC group, respectively. The expression was significantly higher in the latter 3 groups than that in the cervicitis group (P < 0.01). Besides, the expression was significantly higher in cases associated with high-risk HPV genotypes (96.4%) than in cases associated with low-risk HPV genotypes (7.7%).

CONCLUSIONp16(INK4a) is a valuable biomarker for detection of HPV-related dysplastic squamous cells, with high sensitivity and specificity.

Carcinoma, Squamous Cell ; diagnosis ; metabolism ; virology ; Cervical Intraepithelial Neoplasia ; diagnosis ; metabolism ; virology ; Cyclin-Dependent Kinase Inhibitor p16 ; metabolism ; Diagnosis, Differential ; Female ; Genotype ; Humans ; Immunohistochemistry ; Papillomaviridae ; genetics ; isolation & purification ; Papillomavirus Infections ; Polymerase Chain Reaction ; Sensitivity and Specificity ; Uterine Cervical Dysplasia ; diagnosis ; metabolism ; virology ; Uterine Cervical Neoplasms ; diagnosis ; metabolism ; virology ; Uterine Cervicitis ; diagnosis ; metabolism ; virology

Objective: To investigate the natural regression and related factors of high-grade squamous intraepithelial lesion (HSIL) in the cervix of childbearing age women, and to evaluate the applicability of conservative management for future fertility needs. Methods: This study included 275 patients of reproductive age with fertility needs, who were diagnosed as HSIL by biopsy from April 30, 2015 to April 30, 2022, including 229 cases (83.3%) cervical intraepithelial neoplasia (CIN) Ⅱ and 46 cases (16.7%) CIN Ⅱ-Ⅲ. They were followed-up without immediate surgery in the First Affiliated Hospital of Nanjing Medical University. The median follow-up time was 12 months (range: 3-66 months). The regression, persistence and progression of lesions in patients with HSIL were analyzed during the follow-up period, the influencing factors related to regression and the time of regression were analyzed. Results: (1) Of the 275 HSIL patients, 213 cases (77.5%, 213/275) experienced regression of the lesion during the follow-up period. In 229 CIN Ⅱ patients, 180 cases (78.6%) regressed, 21 cases (9.2%) persisted, and 28 cases (12.2%) progressed. In 46 CIN Ⅱ-Ⅲ patients, 33 cases (71.7%) regressed, 12 cases (26.1%) persisted, and 1 case (2.2%) progressed to invasive squamous cell carcinoma stage Ⅰ a1. There was no significant difference in the regression rate between the two groups (χ²=1.03, P=0.309). (2) The average age at diagnosis, age <25 years old at diagnosis were independent influencing factor of HSIL regression in univariate analysis (all P<0.05). There was no significant difference between HSIL regression and pathological grading, the severity of screening results, human papillomavirus (HPV) genotype, colposcopy image characteristics, number of biopsies during follow-up and pregnancy experience (all P>0.05). (3) The median regression times for patients aged ≥25 years and <25 years at diagnosis were 15 and 12 months, respectively. Kaplan-Meier analysis showed that age ≥25 years at diagnosis significantly increased the median regression time compared to <25 years (χ²=6.02, P=0.014). Conclusions: For HSIL patients of childbearing age, conservative management without immediate surgical intervention is preferred if CINⅡ is fully evaluated through colposcopy examination. Age ≥25 years at diagnosis is a risk factor affecting the prognosis of HSIL patients.
Pregnancy ; Humans ; Female ; Adult ; Cervix Uteri/pathology* ; Uterine Cervical Neoplasms/pathology* ; Uterine Cervical Dysplasia/pathology* ; Biopsy ; Colposcopy/methods* ; Squamous Intraepithelial Lesions/pathology* ; Carcinoma in Situ/pathology* ; Papillomaviridae/genetics* ; Papillomavirus Infections/diagnosis* ; Squamous Intraepithelial Lesions of the Cervix/pathology*

OBJECTIVETo investigate the clinical significance of atypical squamous cells of unknown significance (ASCUS) with abnormal DNA ploidy in the early diagnosis of cervical lesions.

METHODSEight thousand four hundred and forty-eight patients were included in this study and all had DNA quantitative analysis and cervical liquid-based cytology. Among 1041 cases with DNA aneuploidy and/or abnormal cervical liquid-based cytology and additional cervical biopsy, histological review was performed in 247 ASCUS cases with abnormal DNA ploidy.

RESULTS(1) Among 8448 cases, 7877 were normal or benign, 426 were ASCUS, 45 were ASC-H, 55 were LSIL and 22 were HSIL by TBS diagnosis. The presence of 1-2 abnormal DNA ploidy cells was detected in 15.3% (65/426) of ASCUS, 11.1% (5/45) of ASC-H, 9.1% (5/55) of LSIL, and 0 (0/22) of HSIL. The presence of ≥ 3 abnormal DNA ploidy cells was detected in 39.0% (166/426) of ASCUS, 75.6% (34/45) of ASC-H, 76.4% (42/55) of LSIL, and 95.5% (21/22) of HSIL. (2) A total of 67 cases of CIN 2, CIN 3 or cancers were found in 247 patients with ASCUS by colposcopy biopsies, of which 13.9% (5/36) had 1-2 abnormal DNA ploidy cells, 45.5% (56/123) had ≥ 3 abnormal DNA ploidy cells and 6.8% (6/88) had normal DNA polidy. ASCUS with 1-2 abnormal DNA ploidy cells and with ≥ 3 abnormal DNA ploidy cells were compared. The difference was statistically significant (χ(2) = 11.79, P < 0.01). But the difference between ASCUS with 1-2 abnormal DNA ploidy cells and normal DNA ploidy had no statistical significance (P > 0.05).

CONCLUSIONSASCUS with ≥ 3 abnormal DNA ploidy cells has higher risk for developing CIN 2, CIN 3 or invasive carcinoma. The application of DNA quantitative analysis and cervical liquid-based cytology test can help in guiding clinical follow-up and treatment options in patients with ASCUS.

Adenocarcinoma ; diagnosis ; genetics ; pathology ; Adolescent ; Adult ; Aged ; Aneuploidy ; Carcinoma in Situ ; diagnosis ; genetics ; pathology ; Carcinoma, Squamous Cell ; diagnosis ; genetics ; pathology ; Cervical Intraepithelial Neoplasia ; diagnosis ; genetics ; pathology ; Colposcopy ; DNA, Neoplasm ; genetics ; Female ; Humans ; Middle Aged ; Uterine Cervical Dysplasia ; diagnosis ; genetics ; pathology ; Uterine Cervical Neoplasms ; diagnosis ; genetics ; pathology ; Young Adult

OBJECTIVEIn cervical lesions, the overexpression of p16INK4a has been reported to be closely associated with human papillomavirus (HPV) infection. This study is designed to evaluate the role of p16INK4a as a biomarker in liquid-based cervical cytology screening.

METHODSSeventy-four specimens from the patients in our hospital were collected for this study. After cytological examination with liquid-based cervical smears, high-risk HPV (HR-HPV) DNA was then detected by Hybrid Capture II assay, and the rest cells were immunostained for p16INK4a.

RESULTSOf the 74 specimens, 10 were diagnosed as negative, 15 as atypical squmous cells of undetermined significance (ASC-US), 28 as low-grade squamous intraepithelial lesion (LSIL), 5 as atypical squmous cells which could not be excluded as HSIL (ASC-H), 11 high-grade squamous intraepithelial lesion (HSIL) and 5 as squamous cell carcinoma (SCC). The positive specimens of p16INK4a were 2, 5, 8, 3, 9, 5, respectively, in the above subgroups; meanwhile, the positive specimens of HR-HPV were 1, 4, 9, 3, 7, 5, respectively, in the above groups. The positive rate of both p16INK4a and HR-HPV in HSIL, ASC-H and SCC were obviously higher than that in LSIL, ASC-US and negative cases.

CONCLUSIONPositive rate of p16INK4a and HR-HPV is highly correlated with the grade of the cervical lesion. p16INK4a immunocytochemical staining may be used as a biomarker to increase the sensitivity of cervical cytology screening and the specificity of HPV test.

Adult ; Aged ; Biomarkers, Tumor ; analysis ; Carcinoma, Squamous Cell ; chemistry ; diagnosis ; virology ; Cervical Intraepithelial Neoplasia ; chemistry ; diagnosis ; virology ; Cyclin-Dependent Kinase Inhibitor p16 ; analysis ; Cytodiagnosis ; methods ; DNA, Viral ; analysis ; Female ; Humans ; Immunohistochemistry ; Middle Aged ; Papillomaviridae ; genetics ; Papillomavirus Infections ; diagnosis ; metabolism ; Uterine Cervical Dysplasia ; chemistry ; diagnosis ; virology ; Uterine Cervical Neoplasms ; chemistry ; diagnosis ; virology ; Vaginal Smears ; methods ; Young Adult

OBJECTIVETo investigate the value of computer-assisted slide-screening system (ThinPrep imaging system, TIS) in the diagnosis of cervical Thinprep smears.

METHODSA total of 19 600 ThinPrep smears were collected, including 9800 slides by TIS-assisted screening from September 2011 to March 2012 and 9800 slides by manual screening from September 2010 to April 2011 as control. The detection rates of abnormal cells and common microbial infection by the different screening methods were compared. With histopathological diagnosis of colposcopic biopsy as the gold standard, the screening efficiency and correlation of cytologic diagnosis among different screening methods were analyzed.

RESULTSCompared with manual screening, the detection rate of abnormal cells in 9800 cases by TIS-assisted screen was increased from 5.4% (525/9800) to 6.8% (665/9800), mainly in the categories of ASCUS and LSIL (P < 0.05). TIS had a higher accordance rate between cytologic diagnosis and histopathological diagnosis in the NILM and ASCUS than that by manual screening. False-negative rate of finding abnormal cells by TIS decreased from 8.5% (17/200) to 0.7% (2/289, P < 0.01) with an increased sensitivity compared to manual screening, although the specificity was similar. Both TIS and manual screening had advantages and disadvantages respectively in the detection of microbial organisms. TIS improved screening efficiency by 50%.

CONCLUSIONTIS improves not only the screening efficiency but also the detection of abnormal cells with a reduced false negativity, and it therefore has a broad application prospect.

Adenocarcinoma ; diagnosis ; pathology ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Candida ; isolation & purification ; Carcinoma, Squamous Cell ; diagnosis ; pathology ; Cervical Intraepithelial Neoplasia ; diagnosis ; pathology ; Cytodiagnosis ; False Negative Reactions ; Female ; Humans ; Image Processing, Computer-Assisted ; instrumentation ; Mass Screening ; Middle Aged ; Sensitivity and Specificity ; Trichomonas vaginalis ; isolation & purification ; Uterine Cervical Dysplasia ; diagnosis ; pathology ; Uterine Cervical Neoplasms ; diagnosis ; pathology ; Vaginal Smears ; Young Adult

OBJECTIVETo evaluate the value of p16INK4a immuncytochemical examination in cytological screening of cervical carcinoma and precancerous lesions.

METHODSp16JNK4a immuncytochemical detection was performed on 220 specimens remaining from liquid-based cytology, followed up by biopsy histology , and compared with the results of high-risk human papillomavirus ( HR - HPV ) DNA tests . Results In patients with cytological diagnosis of squamous cell carcinoma( SCC) , high-grade squamous intraepithelial lesion (HSIL) , low-grade squamous intraepithelial lesion (LSIL) , atypical squamous cells-cannot exclude HSIL (ASC-H) , and atypical squamous cells of undetermined significance (ASC-US) , the positive rates of p16INK4a were 100.0% (7/7), 92. 2% (107/116) , 24. 3% (17/70) , 100. 0% (14/14) and 36.4% (4/ 11) , respectively. In 111 of the 150 p6INK4a positive cases, we found 97 (87.4% ) cases which had biopsy diagnosises of > or =CIN2, but none in 18 of 70 p16INK4a negative cases was. The difference in the positive rates for p16INK4a between cervical intraepithelial neoplasia (CIN) 1 and > or =CIN2 lesions had statistical significance (P < 0. 01) , whereas for HR-HPV DNA test it was not.

CONCLUSIONp16LNK4a is over-expressed in a HSIL, and it may be useful in cytological screening of high risk patients.

Carcinoma, Squamous Cell ; diagnosis ; metabolism ; virology ; Cervical Intraepithelial Neoplasia ; diagnosis ; metabolism ; virology ; Cyclin-Dependent Kinase Inhibitor p16 ; analysis ; Cytodiagnosis ; DNA, Viral ; analysis ; Female ; Humans ; Immunohistochemistry ; Papillomaviridae ; genetics ; isolation & purification ; Papillomavirus Infections ; diagnosis ; metabolism ; virology ; Predictive Value of Tests ; Uterine Cervical Dysplasia ; diagnosis ; metabolism ; virology ; Uterine Cervical Neoplasms ; diagnosis ; metabolism ; virology

Cervical Intraepithelial Neoplasia ; diagnosis ; metabolism ; pathology ; Cervix Uteri ; metabolism ; pathology ; Cyclin-Dependent Kinase Inhibitor p16 ; metabolism ; Diagnosis, Differential ; Female ; Humans ; Ki-67 Antigen ; metabolism ; Membrane Proteins ; metabolism ; Neoplasm Invasiveness ; Uterine Cervical Dysplasia ; diagnosis ; metabolism ; pathology ; Uterine Cervical Neoplasms ; diagnosis ; metabolism ; pathology

Carcinoembryonic Antigen ; metabolism ; Carcinoma in Situ ; immunology ; pathology ; virology ; Carcinoma, Ductal, Breast ; immunology ; pathology ; virology ; Cervical Intraepithelial Neoplasia ; immunology ; pathology ; virology ; DNA, Viral ; analysis ; Diagnosis, Differential ; Female ; Human papillomavirus 16 ; genetics ; isolation & purification ; Humans ; Ki-67 Antigen ; metabolism ; Uterine Cervical Dysplasia ; immunology ; pathology ; virology ; Uterine Cervical Neoplasms ; immunology ; pathology ; virology