4 种不同检查方法在宫颈癌筛查中的临床应用价值*

目的:了解4 种不同检查方法在宫颈癌筛查中的临床应用价值。方法:采用第二代杂交捕获技术（hybrid capture 2,HC-II）检测13种高危型人乳头瘤病毒（human papillomavirus ,HPV ）、薄层液基细胞学技术（Liquid-based cytology test,LCT ）检测宫颈脱落细胞、醋酸肉眼检查（visual inspection with acetic acid,VIA）和阴道镜检查4 种方法对2004年11月～2004年12月深圳南山区华侨城区域15～59岁有性生活女性共1 137 例进行盲法同步宫颈癌筛查。对阴道镜检查异常或可疑异常者行阴道镜下直接活检;对HPV 阳性并且LCT ≥未明确诊断意义的不典型鳞状上皮细胞（atypical squamous cells of undetetemined sign,ASCUS ）,或HPV 阴性但LCT ≥低度鳞状上皮内病变（low grade squamous intraepithelial lesion ,LSIL ）的妇女再次行阴道镜下活组织病理学检查,以病理结果作为验证4种检查方法的金标准。结果:共取病理122 例。病理结果证实该人群中无宫颈癌病例:子宫颈上皮内瘤变（cervical intraepithelial neoplasia ,CIN）Ⅲ级3 例,CIN Ⅱ级11例,CIN Ⅰ级36例;慢性宫颈炎和鳞状上皮化生69例;正常宫颈3 例。人群的高危HPV 总检出率为14.0% ;LCT 阳性率为12.6% ;VIA 阳性率为12.5% ;阴道镜阳性率为13.6% 。随宫颈病变级别升高,高危HPV 感染率及LCT 阳性率均呈趋势性增加（P<0.005）;VIA 和阴道镜阳性率在各级宫颈病变中无统计学差异,但在宫颈病变组阳性检出率明显高于正常宫颈组。高危HPV 对宫颈高度病变的敏感性、特异性、准确性、阳性预测值、阴性预测值、阳性似然比和阴性似然比分别为100% 、87.1% 、87.3% 、8.8% 、100% 、7.6% 和0;LCT 以上各指标分别为92.9% 、88.4% 、88.5% 、9.1% 、99.9% 、8.0% 和8.0% ;VIA 以上各指标分别为35.7% 、96.0% 、95.3% 、10.0% 、99.2% 、8.9% 和67.0% ;阴道镜以上各指标分别为50.0% 、86.8% 、86.4% 、4.5% 、99.3% 、3.8% 和58.0% 。结论:高危HPV 检测和LCT 检查均为目前宫颈癌筛查较好的方法,VIA 和阴道镜检查敏感性较差,漏诊率高,不适合大范围筛查,但二者阴性预测值均较高,可应用于临床病例诊断。      

宫颈细胞学、人乳头瘤状病毒检测及阴道镜在宫颈癌前病变诊断的应用

目的:探讨人乳头瘤状病毒DNA检测与细胞学检查及阴道镜检查对宫颈癌前病变的诊断价值.方法:2007年1月-2008年1月体检发现宫颈病变的患者173例,均进行宫颈刮片、高危型HPV检测及阴道镜检查,对一项或多项异常者行病理组织学检查,以病理结果为金标准.结果:高危型HPV-DNA检测的敏感度为83.82%;巴氏涂片以ASCUS为分界点的敏感度为49.71%;联合宫颈细胞学检查、HPV-DNA检测及阴道镜下病理检查的敏感度最高为95.95%.结论:联合采用宫颈细胞学检查、HPV-DNA检测及阴道镜下病理检查能及早发现宫颈癌前病变,提高检出率,降低假阴性.     

高危型人乳头瘤状病毒检测与液基细胞学观察及其联合分析对宫颈癌筛查的意义

背景与目的:第二代杂交捕获 (hybrid capture Ⅱ, HC-Ⅱ)人乳头状瘤病毒(human papillomavirus, HPV)检测及液基细胞学测试(liquid-based cytology test, LCT)方法已经成为目前宫颈癌筛查的两种主要方法,文献报道两种方法联合应用可提高宫颈癌筛查效率.选择经济有效的筛查手段来降低子宫颈癌的发病率越来越受到人们的关注,本研究拟对HC-Ⅱ HPV和LCT两种方法不同组合的筛查方案在宫颈癌筛查中的作用进行评价,以期指导宫颈癌筛查方案的选择.方法:采用HC-Ⅱ技术和LCT两种方法对2003年5月至2005年12月北京大学深圳医院宫颈癌中心就诊妇女共2471例进行了同步盲法检测.对阴道镜检查异常或可疑异常者行阴道镜下直接活检;对HPV阳性并且LCT≥未明确诊断意义的不典型鳞状上皮细胞(atypical squamous cells of undetetemined sign, ASCUS)或者虽HPV检测结果阴性,但LCT为低级别鳞状上皮内病变(low grade squamous intraepithelial lesion, LSIL)及以上病变患者,均经阴道镜下宫颈活组织检查,以病理结果作为最终诊断,评价不同组合的筛查方案在宫颈癌筛查中的价值.结果:本次筛查共取病理287例.病理结果证实该人群中宫颈癌6例,宫颈上皮内瘤变(cervical intraepithelial neoplasia, CIN)Ⅲ级18例,CINⅡ级39例,CINⅠ级98例,其它(慢性宫颈炎和鳞状上皮化生)126例.高危型HPV阳性率为16.8%;LCT阳性率(≥ASCUS)为11.8%;HPV与LCT联合检测(平行试验-任意一项阳性)的阳性率为21.2%;HPV与LCT联合检测(系列试验-两项均阳性)的阳性率为7.4%.随宫颈病变级别升高,高危HPV感染率及LCT阳性率增加(P＜0.005).高危HPV对宫颈高级别病变的敏感性、特异性、准确性、阳性预测值、阴性预测值、阳性似然比和阴性似然比分别为98.4%,85.3%,85.6%,14.9%,100%,6.7和0.02;LCT以上各指标分别为92.1%,90.3%,90.3%,19.9%,100.0%,9.5和0.09;HPV与LCT联合检测(平行试验)的以上各指标分别为100.0%,80.8%,81.3%,12.0%,100%,5.2和0.0;HPV与LCT联合检测(系列试验)的以上各指标分别为90.5%,94.8%,94.7%,31.1%,99.7%,17.4和0.10.用于筛查宫颈高级别病变各筛查试验的受试者工作特征(receiver operating characteristic, ROC)曲线下面积分别为0.919、0.921、0.904、0.926,经Z检验认为各筛查试验筛查效率间无差异(P＞0.05).结论:HC Ⅱ HPV和LCT检测是目前宫颈癌筛查有价值的方法.联合应用不能显著提高筛查效率,但会增加单次筛查成本.     

HPV-DNA检测在宫颈病变诊断中的价值

背景与目的：宫颈癌是妇女常见的恶性肿瘤之一。目前大量的研究认为HPV是宫颈癌的主要致病因素，几乎所有CIN都伴有HPV亚型。本研究旨在评价HPV—DNA检测对宫颈病变的诊断价值。方法：对320例HPV—DNA检测患者在宫颈病变检查方面的资料进行分析。结果：①HPV—DNA高危型阳性患者无明显临床症状，妇科检查以宫颈糜烂为主要表现，②CIN发病率在HPV—DNA高危型阳性组30％，阴性组11％（P〈0．01），③HPV—DNA高危型阳性的CIN患者中17％是高度病变（CIN—Ⅱ及以上），阴性组仅2％（P〈0．05）④随细胞学检查的级别增高，HPV—DNA高危型阳性率增加（P〈0．05），HPV感染发生率增加（P〈0．01），CIN发生率增加（P〈0．05）。结论：HP—DNA高危型患者CIN发病率较高，CIN高度病变比例较高，HPV-DNA检测在宫颈病变的检查中有重要意义；如与宫颈细胞学检查和阴道镜检查结合可提高宫颈病变的检出率。     

肉眼观察法联合电子阴道镜检查在宫颈癌筛查中的应用

[目的]对新疆维吾尔族妇女肉眼观察宫颈（VIA,VILI）法联合电子阴道镜检查进行宫颈癌筛查,评价其对宫颈癌及癌前病变的应用价值。[方法]对新疆和田29～60岁的2005名维吾尔族农村妇女进行宫颈癌筛查。采取VIA、VILI法,对VIA、VILI异常者结合电子阴道镜检查,在异常阴道镜图象区取宫颈活检,病理诊断为金标准。[结果]2005名农村妇女中VIA阳性41例,占2.04%（41/2005）,其灵敏度、特异度、阳性预测值、阴性预测值分别为65.63%、98.98%、51.22%、99.44%;VILI阳性49例,占2.49%（49/1964）,其灵敏度、特异度、阳性预测值、阴性预测值分别为53.57%、98.24%、30.61%、99.32%;阴道镜转诊90例,占4.49%（90/2005）;宫颈活检65例,病理诊断为炎症33例、CIN24例、宫颈癌8例。[结论]在宫颈癌筛查中采用VIA、VILI法具有一定的阴性预测价值;结合阴道镜检查能够初步判断病变的程度,确保活检部位的准确性。     

宫颈细胞学、人乳头瘤状病毒检测及阴道镜在宫颈癌前病变诊断的应用

目的：探讨人乳头瘤状病毒DNA检测与细胞学检查及阴道镜检查对宫颈癌前病变的诊断价值。方法：2007年1月～2008年1月体检发现宫颈病变的患者173例,均进行宫颈刮片、高危型HPV检测及阴道镜检查,对一项或多项异常者行病理组织学检查,以病理结果为金标准。结果：高危型HPV—DNA检测的敏感度为83．82％;巴氏涂片以ASCUS为分界点的敏感度为49．71％;联合宫颈细胞学检查、HPV—DNA检测及阴道镜下病理检查的敏感度最高为95．95％。结论：联合采用宫颈细胞学检查、HPV—DNA检测及阴道镜下病理检查能及早发现宫颈癌前病变,提高检出率,降低假阴性。     

高危型人乳头瘤病毒HC2检测在宫颈上皮内瘤变筛查中的意义

目的:评估杂交捕获法Ⅱ(HC2)检测高危型人乳头瘤病毒(HPV)在子宫颈上皮内瘤变筛查中的价值.方法:回顾性分析2009年1月至2010年10月在我院妇科门诊进行宫颈薄层液基细胞学(LCT)检测和HPV-DNA 二联检查的700例患者,以及其中进行LCT、HPV-DNA 和阴道镜下宫颈多点活检三联检查的131例患者的临床资料,以组织病理活检结果作为金标准.结果:在二联检查的700例患者中,宫颈非典型性鳞状细胞(ASC)、低级别鳞状上皮内病变(LSIL)、高级别鳞状上皮内病变(HSIL)和鳞状细胞癌(SCC)组HPV阳性率分别为67%、93.3%、100%和100%,均高于未见上皮内病变或恶性病变组(NILM)43.6%(P＜0.05).在三联检查131例患者中,轻度宫颈上皮内瘤样病变(CINⅠ)、中度宫颈上皮内瘤样病变(CINⅡ)、重度宫颈上皮内瘤样病变(CINⅢ)和浸润癌组HPV阳性率分别为71.8%、92.9%、100%和100%,呈明显升高趋势,均高于病理结果正常组(无高危型HPV感染的湿疣,炎症与正常组织)57.7%.在HPV-DNA 和LCT结果均为阴性的228例,活检未发现阳性病例(高危型HPV感染的湿疣CINⅠ、CINⅡ、CINⅢ、浸润癌);HPV-DNA 阴性、LCT阳性的133例,活检发现2例阳性病例;HPV-DNA阳性、LCT阴性的176例,活检发现9例阳性病例;HPV-DNA阳性、LCT阳性的163例,活检发现75例阳性病例;结论:高危型HPV感染与宫颈癌前病变及宫颈癌密切相关.对于宫颈癌及其癌前病变的筛查及早期诊断,应以高危型HPV-DNA HC2检测辅助宫颈细胞学检查以提高检出率.     

联合检测在门诊宫颈癌筛查中的应用价值

目的探讨联合检测方法在门诊妇女宫颈癌筛查中的临床意义及应用价值。方法选择2010年至2012年在宫颈门诊进行宫颈癌筛查的812例妇女作为研究对象,首先进行液基细胞学（TCT）、HPV—DNA及肉眼观察3种检查;3种方法检测阳性者再分别进行阴道镜检查,金标准为病理组织学结果。结果TCT的敏感度、特异度、阳性预测值及阴性预测值分别为：75．0％、97．2％、35．3％和99．5％;HPV—DNA检查的敏感度、特异度、阳性预测值及阴性预测值分别为：81．3％、77．2％、6．7％和99．5％;肉眼观察的敏感度、特异度、阳性预测值及阴性预测值分别为：75．O％、84．5％、8．9％和99．4％。结论TCT联合阴道镜的诊断价值优于其余两种方法,可作医院门诊宫颈癌筛查的首选方法;HPV—DNA和肉眼观察联合阴道镜的诊断价值相当,但是肉眼观察法更经济,可作为经济条件差的妇女首选筛查方法。     

实时光电学设备TruScreen~筛查宫颈癌的临床价值

目的评价实时光电学设备TruScreen检测技术在人群宫颈癌筛查中的价值。方法研究对象为2007年3月至2007年12月参加北京大学深圳医院针对深圳市贫困女性进行的宫颈癌筛查的妇女391名,年龄20～67岁。对所有接受筛查的妇女采用实时光电学设备TruScreen进行宫颈癌筛查,并采集宫颈脱落细胞,以液基细胞学技术行宫颈细胞学检查,以第二代杂交捕获(HC-Ⅱ)技术进行高危型HPV-DNA(HR-HPV)检测。筛查同时行阴道镜检查,对阴道镜疑诊低度鳞状上皮内病变(LSIL)及以上病变者,在可疑病变处取活检。为客观评价各种筛查方法,对各检测结果均采取盲法保存,于各检测结果确定后解盲。凡HC-Ⅱ检测HR-HPV阳性伴液基细胞学≥ASCUS,和(或)液基细胞学≥LSIL及TruScreen检查结果阳性,而筛查当时未取活检(阴道镜诊断非LSIL及以上病变)者,均于3个月内再次阴道镜下活检,明确诊断。病理为CINⅡ及以上病变者行宫颈电热圈坏切术(LEEP)手术,并取活检。有多次病理检查者以其中最高级别病理结果为该患者的最终诊断,病理诊断作为本研究4种筛查方法的评价标准。结果病理诊断CIN I 110例、CINⅡ5例、CINⅢ7例、宫颈浸润癌5例;慢性宫颈炎和鳞状上皮化生59例。TruScreen检测阳性率为28.2%;液基细胞学检测无明确诊断意义的鳞状上皮细胞病变(ASCUS)以上为23.3%,LSIL以上为7.2%;HR-HPV阳性率为34.3%。TruScreen、液基细胞学及HC-Ⅱ法HPV检查,各筛查方法对检出≥CINⅡ病变的敏感性、特异性、准确性、阳性预测值和阴性预测值分别为76.5%、77.3%、77.2%、13.3%和98.6%;液基细胞学以≥ASCUS为阳性各筛查评价指标分别为88.2%、79.7%、80.1%、16.5%和99.3%;以LSIL为阳性界值各指标为70.6%、95.7%、94.6%、42.9%和98.6%;HC-Ⅱ法HPV为94.1%、68.5%、69.6、11.9%和99.6%。结论实时光电学设备TruScreen进行宫颈癌初筛,筛查效率指标中虽敏感性不及HC-Ⅱ法HPV检测高,但与宫颈细胞学检查相当。作为一种新的宫颈癌筛查技术,具有检测无创无痛、用时较短、实时报告结果等优点,适用于贫困地区大样本人群筛查。     

宫颈不典型鳞状细胞ASCUS 的临床处理探讨

目的:探讨宫颈细胞学检查ASCUS（未明确诊断意义的不典型鳞状细胞）的临床意义和处理方法。方法:2007年8 月至2009年6 月,对上海市闵行区中医医院妇科就诊的119 例细胞学检查报告为ASCUS 患者行阴道镜评估与镜下活检并对比其检查结果,同时进行了高危人类乳头瘤病毒（High-risk human papillomarirus ,HPV ）检测。结果:ASCUS 患者中包含43例（36.13%）宫颈上皮内瘤变（CIN）及原位癌,其中CIN Ⅰ29例（24.37%）、CIN Ⅱ9 例（7.56%）、CIN Ⅲ4 例（3.36%）及原位癌1 例（0.84%）。 高危HPV 阳性51例（42.86%）,其中33例为上皮内瘤变（64.71%）,高危HPV 阴性68例,其中10例为上皮内瘤变,高危HPV 阳性组CIN检出率明显高于阴性组,两者比较有统计学意义（χ2=32.9,P<0.05）。 HPV 检测和阴道镜检查诊断上皮内瘤变的灵敏度,分别为76.74% 和81.40% ,两者比较无统计学意义（P>0.05）。 结论:宫颈细胞学诊断为ASCUS 的病例中上皮内瘤变率高,应加强对AS?CUS 患者的重视,高危HPV 检测和阴道镜检查是对ASCUS 进一步处理的有效方法,尤其对高危型HPV 阳性的病例,应在阴道镜下行活组织检查,正确运用这两种方法,可提高宫颈病变筛查的阳性率。      

Diagnostic Value of the CareTM HPV Test in Screening for Cervical Intraepithelial Neoplasia Grade 2 or Worse

Background: Cervical cancer is the fourth leading cause of cancer death in women worldwide. Persistent infection with a high risk human papillomavirus (HR-HPV) is the main etiological factor, so that early early detection of HR-HPV is very important. The aim of this study was to investigate the efficacy of CareTM HPV, a new method, as compared with Pap smear, PCR, and biopsy for screening purposes. Material and Method: In this cross-sectional study, 200 sexually active women aging from 25-50 years referred to the oncology clinic of Shahid Sodoughi Yazd Hospital in 2015 with a variety of cervix epithelial lesions or a need for colposcopy were enrolled. Results for CareTM HPV test (cervical), Pap smear, PCR, and biopsy were analyzed using SPSS 15 software and chi-square test, McNemar, and ROC curve analysis. Qualitative variables were compared using a Chi-square test. Results: CareTM HPV test sensitivity in detecting cervical intraepithelial neoplasia grade II (CIN-II) and also positive and negative predictive values were higher as compared to with other tests (p<0.05). The Pap smear test specificity was highest. There was no significant differences between CareTM HPV and PCR tests regarding detection of HPV-DNA in cases of CIN-II and worse (p>0.05). Conclusion: The CareTM HPV test has high sensitivity and predictive values for detecting HPV infection, with higher efficacy than the Pap smear test for tracking CIN-II. Therefore it may be recommended for use as a screening test in low-income areas.     

Colposcopy Requirement of Papanicolaou Smear after Atypical Squamous Cells of Undetermined Significance (ASC-US) by Follow-up Protocol in an Urban Gynaecology Clinic,a Retrospective Study in Thailand

Background: ASC-US cases are managed according to the current American Society for Colposcopy andCervical Pathology (ASCCP) guideline in which a human papillomavirus (HPV) test and repeat Pap smear areperformed in the next 1 year. Colposcopy in cases of positive high risk HPV and persistent ASC-US or morein subsequent Pap smear is recommended. The HPV test is more expensive and still not currently a routinepractice in Thailand. Objective: To identify the risk factors of persisted abnormal Pap smear and the colposcopicrequirement rate in women with ASC-US. Materials and Methods: During 2008-2013, this study was conductedin Prapokklao Hospital, Chanthaburi, Thailand. Participants were women who attended gynaecology clinicfor cervical cancer screening. Women who had cytological reports with ASC-US were recruited. During thestudy period, 503 cases were enrolled. Colposcopic requirement was defined as those who were detected with anASC-US or more in subsequent Pap smears up to 1 year follow-up. Results: The colposcopic referral rate was23.2 (85/365) percent at 12 months. Prevalence of cervical intraepithelial neoplasia (CIN) 2/3 was 3.3 (12/365)percent. Loss follow-up rate of subsequent Pap smear and colposcopic appointment were 27.4 (138/503) and48.2 (41/85) percent, respectively. There was no invasive cancer. High risk factors for persisted abnormal Papsmears in subsequent test were premenopausal status, HIV infected patients and non-oral contraceptive pills(COC) users. Conclusions: Referral rate for colposcopy in women with ASC-US reports was rather high. Lossto follow-up rate was the major limitation. Immediate colposcopy should be offered for women who had highrisk for silent CIN.     

Comparing PAP smear cytology, aided visual inspection, screening colposcopy, cervicography and HPV testing as optional screening tools in Latin America. Study design and baseline data of the LAMS study

OBJECTIVES: This is a European Commission (EC)-funded ongoing study known as the LAMS (Latin American Screening) study, where PAP smear/liquid-based cytology and screening colposcopy were compared with i) three optional screening tools [visual inspection with acetic acid (VIA), or Lugol's iodine (VILI), cervicography] and with ii) Hybrid Capture II from a) conventional samples and from b) self-samples, in women at different risk for cervical cancer in Brazil and Argentina. STUDY DESIGN: During 2002-2003, a cohort of 12,107 women attending four clinics: Campinas (CA), Sao Paulo (SP), Porto Alegre (PA) and Buenos Aires (BA), were interviewed for risk factors, and examined using the 8 diagnostic arms. Colposcopy was performed for women positive in any test and for 5% of women with baseline PAP-negative and 20% of HCII-negatives. All high-grade lesions (CIN2/3) were treated, and low-grade CIN are prospectively followed-up. RESULTS: Of the 12,107 women, the following baseline data are available: epidemiological data (n=11,996), conventional PAP smears (n=10,363), LBC, SurePATH (n=320), LBC, DNA-Citoliq (n=1,346), VIA (n=12.067), VILI (n=3,061), cervicography (n=279), screening colposcopy (n=3,437), HCII conventional (n=4,710), HCII self-sampling (n=246) and cervical biopsies (n=1,524). The four sub-cohorts differ significantly in all their baseline data on the implicated risk factors of cervical cancer, consonant with their origin from regions with different cancer incidence. Around 95% of all PAP smears were negative, with slight variations in the prevalence of LSIL and HSIL between the four centers. Significant differences were found in the detection rates of abnormal findings in VIA, VILI and colposcopy between the four centers (p=0.0001). The prevalence of HPV was practically identical (16.5-18.8%) in all four cohorts (p=0.486), with no differences in the relative viral loads. Biopsy results were different depending on whether the women underwent screening colposcopy (BA) or elective colposcopy (others). CONCLUSION: Four cohorts with significantly different baseline data are available, and prospective follow-up of these women permits analysis of whether variations in cervical cancer incidence in these regions is due to i) different natural history of the precursor lesions, or ii) due to different levels of exposure to the known risk factors.     

醋酸涂抹法在宫颈癌筛查中的应用价值

背景与目的：目前,宫颈癌发病率在我国一些经济落后地区仍较高。原因之一是在这些地区难以开展宫颈细胞学涂片检查宫颈癌的普查工作。本研究通过分析应用醋酸涂抹法检测宫颈上皮内瘤样病变(cervical intraepithelial neoplasia,CIN)及宫颈癌的敏感性和特异性,从而评价其在宫颈癌筛查中的应用价值。方法：对山西省襄垣县年龄为35-45岁的1997名妇女进行宫颈癌普查,首先应用5％醋酸涂抹法,同时对每名妇女均进行高危型人乳头状瘤病毒(human papillomavirua,HPV)DNA的检查、液基细胞学及阴道镜检查,在阴道镜下对病变区或每个正常象限的宫颈鳞柱上皮交界处的2、4、8、10点取活检,并行宫颈管刮出物病检,病理检查结果为金标准。结果：病理检查证实CINⅡ级43例,CINⅢ级31例,宫颈浸润癌12例。2例妇女仅颈管刮出物阳性,其中l例为CINⅡ级,另l例为CINⅢ级。醋酸涂抹法诊断结果为：正常1445例(72．4％),低度病变525例(26．3％),高度病变2l例(1．0％),宫颈癌6例(0．3％)。醋酸涂抹法诊断为低度病变或其以上病变者中,经病理检查证实为CINⅡ级及其以上病变的检出敏感性为70．9％(6l／86),特异性为74．3％(1420／1911),对小病灶的敏感性为64．9％(37／57),而大的病灶达88．9％(24／27)。阴道镜对高度病变的检出率为8l.4％(70／86),特异性为76．5％(1462／1911)。结论：醋酸涂抹法具有较高的特异性和敏感性。对CINⅡ级及其以上病变,醋酸涂抹法和阴道镜检查具有相似的特异性。由于醋酸涂抹法简便、费用低廉,对于经济落后地区不失为宫颈癌筛查中一种有效可行的初筛方法。     

P16/Ki-67 Dual Staining in Positive Human Papillomavirus DNA Testing for Predictive Diagnosis of Abnormal Cervical Lesions in Northeastern Thai Women

Objective: Cervical cancer screening can effectively reduce new cervical cancer cases, including in Thailand. The abnormal results are subsequently referred for colposcopy. To avoid unnecessary colposcopy, an efficient triage is still needed for validation. This study aimed to investigate the overall positivity of cytology-based screening, HPV detection, and p16/Ki-67 dual staining and evaluate different triage strategies for predictive diagnosis of abnormal cervical lesions in northeastern Thailand. Methods: Cervical cells were collected from 191 women who came for cervical screening in the gynecological outpatient department during March 2019-February 2020. Pap smear samples were classified into 6 groups including 17 atypical glandular cells (AGC), 21 atypical squamous cells of undetermined significance (ASC-US), 7 atypical squamous cells - cannot exclude HSIL (ASC-H), 26 low-grade squamous intraepithelial lesions (LSILs), 19 high-grade SILs (HSILs) and 101 no squamous intraepithelial lesion (noSIL). Polymerase chain reaction (PCR) was performed for HPV DNA detection. HPV genotyping was determined by reverse line blot hybridization. P16/Ki-67 dual staining was performed by using CINtec PLUS Cytology kit. Biopsies from abnormal screening were collected for surgical pathology classification. Results: High-risk HPV (HR-HPV) infection was 2.97%, 29.41%, 38.10%, 57.14%, 46.15% and 84.21% in noSIL, AGC, ASC-US, ASC-H, LSIL and HSIL cytology respectively. P16/ Ki-67 in noSIL, AGC, ASC-US, ASC-H, LSIL and HSIL was 0.99%, 5.88%, 9.52%, 42.86%, 26.92% and 63.16%, respectively (P-value < 0.001). Among p16/Ki-67 positive cases, 96.15% (25/26) were infected with HPV and 84.62% (22/26) were HR-HPV. The overall positivity of each and co-testing between cytology or HPV DNA testing or p16/Ki-67 dual staining was evaluated. In each cervical lesion, primary HPV DNA testing showed the highest sensitivity, but low specificity. The combined all HPV/HR-HPV with p16/Ki-67 detection increased the specificity of abnormal cervical lesions. Conclusion: P16/Ki-67 dual stain cytology in HPV-positive women performs well for diagnosis of abnormal cervical lesions and should be considered for management of HPV-positive women to avoid unnecessary colposcopy referrals.     

Accuracy of the Triple Test Versus Colposcopy for the Diagnosis of Premalignant and Malignant Cervical Lesions

Background: Despite the World Health Organization (WHO) recommendations concerning the use of alternative tests for the detection of cervical cancer precursor lesions in low-income countries, the accuracy of these tests is a debated issue. In the present study we compare the diagnostic accuracy of the triple test with that of colposcopy for the diagnosis of premalignant and malignant cervical lesions. Methods: A cross-sectional study was performed in 328 women referred to the gynecology clinic at Shahid Sadoughi Hospital, affiliated to Yazd University of Medical Sciences (SSUMS), Yazd, Iran, from March 2016 to June 2018. As the first step, a Pap smear was obtained from all participants. Visual inspection with acetic acid (VIA) and Lugol’s iodine (VILI) was performed in accordance with the known protocol. A colposcopy was then conducted in all participants, biopsy samples were obtained, and histological features studied. Finally, the results were compared by statistical analysis. Results: The age range of the participants was 30 - 50 years. Of 328 women, 60 (18.3 %) were postmenopausal. Two-hundred and five patients (62.5 %) had an abnormal Pap smear, 165 (50.3 %) had abnormal results on colposcopy, and 141 (43 %) had abnormal histopathology reports. The VIA was positive in 129 patients (39.3 %) and the VILI in 177 (54 %). The results of the triple test were reported to be positive in 205 cases (51.52 %). The sensitivity of the triple test in the detection of premalignant and malignant cervical lesions was 78.7 % and 69 %, respectively. The sensitivity and specificity of colposcopy in the detection of premalignant and malignant cervical lesions was 80.1 % and 72.2 %, respectively. The diagnostic accuracy of the triple test and colposcopy in the detection of premalignant and malignant cervical lesions was 73 % versus 75 %. Conclusion: Since the results of the study showed that the diagnostic accuracy of the triple test is equivalent that of colposcopy, the former may be used in low-income countries and areas lacking access to colposcopy.     

Evaluation of alternative methods of cervical cancer screening for resource-poor settings

BACKGROUND: Noncytologic methods of screening for cervical carcinoma and its precursor lesions are needed for resource-poor settings in which cervical carcinoma continues to be an important cause of morbidity and mortality. METHODS: Two thousand nine hundred forty-four women ages 35-65 years were recruited from Cape Town, South Africa and screened using a combination of a Papanicolaou (Pap) smear, human papillomavirus (HPV) DNA testing, direct visual inspection after the application of a 5% acetic acid solution (DVI), and cervicography. Cervicography was considered primarily as a method with which to quality control the DVI examinations. Women with squamous intraepithelial lesions (SIL) or carcinoma on Pap smear, positive DVI examination (acetowhite lesion or cervical ulcer/growth), high levels of high risk HPV DNA (relative light units [RLU] > 10x positive control), or positive Cervigramtrade mark were referred for colposcopy and cervical biopsy. RESULTS: Pap smears were positive in 8.1% of all women screened and identified 65 (78%) of all cases of biopsy confirmed high grade disease (high grade SIL or invasive carcinoma). DVI and cervicography were classified as positive in 18.1% and 10.5%, respectively, of women screened and identified 58 (67%) and 46 (58%) of all cases of high grade disease, respectively. The results of HPV DNA testing varied depending on the cutoff value used to define a positive result. At the standard cutoff level (RLU > 1x positive control), 16.2% of women screened were classified as high risk HPV DNA positive, as were 63 women with high grade disease (73%). CONCLUSIONS: DVI and HPV DNA testing identified similar numbers of high grade SIL (cervical intraepithelial neoplasia Grade 2,3) and invasive carcinoma cases as Pap smears. However, both classify considerably more women without cervical disease as being test positive.     

Value of colposcopy in the early diagnosis of cervical cancer in patients with abnormal pap smears at Shahid Sadoughi hospital, Yazd

Background and objectives: Cervical cancer is preventable, although it is common in developing countries and Iran, where there is no defined approach to “atypical squamous cells of undetermined significance” (ASCUS) on Pap smears. This study determined the value of colposcopy in the early diagnosis of cervix cancer in females with ASCUS. Materials and methods: This accuracy study examined 213 ASCUS cases referred from different cities from 2007 to 2009. All patients underwent a repeated conventional Pap smear, colposcopy, endocervical curettage, and a cervical biopsy, considered the gold-standard diagnostic test. Results: There was no significant relationship between age, age of first intercourse, smoking, or number of children and a positive cervical biopsy. The sensitivity and specificity of a repeat Pap smear for ASCUS were 15 and 93%, respectively, while the respective values for diagnosing cervical cancer with colposcopy were 80 and 80%. Endocervical curettage had 64% sensitivity and 100% specificity for diagnosing cervical cancer, and 11 positive neoplastic or malignant lesions reported on endocervical curettage were confirmed by biopsy. Discussion: Based on the low accuracy of the Pap smear in Iran as a developing country and the need for an early diagnosis of cervical cancer, a cervical biopsy and colposcopy are recommended for these patients. Colposcopy and endocervical curettage alone are better diagnostic tools than a repeat Pap smear for unsatisfactory Pap smears.     

Initial results of population based cervical cancer screening program using HPV testing in one million Turkish women

To evaluate the Turkey's nationwide HPV DNA screening program on the basis of first 1 million screened women. Women over age 30 were invited for population based screening via HPV DNA and conventional cytology. Samples were collected by family physicians and the evaluations and reports had been performed in the National Central HPV laboratories. The acceptance rate for HPV based cervical cancer screening after first invitation was nearly 36.5%. Since HPV DNA tests have been implemented, cervical cancer screening rates have shown 4–5‐fold increase in primary level. Through the evaluation of all, HPV positivity was seen in 3.5%. The commonest HPV genotypes were 16, followed by 51, 31, 52 and 18. Among the 37.515 HPV positive cases, cytological abnormality rate was 19.1%. Among HPV positive cases, 16.962 cases had HPV 16 or 18 or other oncogenic HPV types with abnormal cytology (>ASC‐US). These patients were referred to colposcopy. The colposcopy referral rate was 1.6%. Among these, final clinico‐pathological data of 3.499 patients were normal in 1.985 patients, CIN1 in 708, CIN2 in 285, CIN3 in 436 and cancer in 85 patients and only pap‐smear program could miss 45.9% of ≥CIN3 cases. The results of 1 million women including the evaluation of 13 HPV genotypes with respect to prevalence, geographic distribution and abnormal cytology results shows that HPV DNA can be used in primary level settings to have a high coverage rated screening program and is very effective compared to conventional pap‐smear.