醋酸、碘着色肉眼观察在宫颈癌筛查中的应用

醋酸、碘着色肉眼观察（VIA、VILI）是一种宫颈癌筛查中的方法,醋酸、碘着色宫颈后直接肉眼观察宫颈的颜色变化以判断宫颈的病变。此方法简便、廉价、易学、对设备要求很低,特别适合经济欠发达地区的宫颈癌筛查,是近年来宫颈癌筛查方法讨论的热点。     

VIA、VILI在农村宫颈癌筛查中的应用

目的 寻找适合农村地区子宫颈癌及其癌前病变的筛查方法,为降低子宫颈癌的发病率及病死率提供科学方法.方法 以湖北省五峰县（宫颈癌早诊早治项目县之一）长乐坪镇30-59岁的已婚妇女作为对象,进行以人群为基础的子宫颈癌筛查,对符合条件的妇女进行危险因素、癌症及子宫颈癌认知情况的问卷调查,5%醋酸染色后肉眼观察（VIA）和2%的卢戈氏碘染色后肉眼观察（VILI）结果异常者,进行阴道镜下活组织检查并得到最终的病理学诊断,将病变检出率与同年在五峰县其它乡镇的宫颈刮片细胞学筛查结果进行比较.结果 该次筛查人群参与率为70%,最终经活检病理确诊的CINⅠ患病率为0.5%（10例）,CINⅡ0.5%（11例）,CINⅢ1.0%（20例）,子宫颈癌0.1%（2例）;宫颈癌及其癌前病变有年轻化趋势;该次单纯由肉眼观察对CINⅠ、CINⅡ的病变检出率,与同年在当地其它乡镇宫颈刮片细胞学普查结果相当,差别无统计意义,但对≥CINⅢ的病变检出率高于宫颈刮片细胞学筛查结果,有统计学意义.结论 肉眼观察是一种经济有效的宫颈癌筛查方法,适宜在农村地区推广,能使更多贫困地区的妇女及时得到子宫颈癌的早诊早治.     

肉眼观察(VIA、VILI)在中国农村地区宫颈癌筛查中的应用评价

目的评价醋酸、碘着色肉眼观察在中国农村地区宫颈癌筛查中的应用价值及可行性。方法对子宫颈癌高发区江西省修水县大桥乡妇女进行以人群为基础的研究,对2499例年龄为30～49岁农村已婚妇女进行了人乳头瘤病毒(HPV)的检测,薄层液基细胞学(TCT),醋酸、碘染色后肉眼观察(VIA、VILI)以及电子阴道镜检查。各种方法独立进行,均为双盲。对VIA、VILI或电子阴道镜中任何一项存在阳性病变进行宫颈组织活检,或行颈管刮术(ECC),另HPV或TCT阳性的妇女也给予活检。宫颈组织病理诊断均经国际癌症研究所病理检查确诊,将CIN2以上(含CIN2)病变纳入阳性结果。结果2499例受检妇女中有2432例列入研究,共检出CIN237例,CIN359例,宫颈癌3例。HPV,TCT,HPV TCT,VIA,VILI,VIA VILI和阴道镜检查等筛查方法的敏感度分别是96.67%,89.47%,97.98%,56.57%,36.36%,63.64%和39.39%;特异度分别为85.00%,96.91%,86.97%,94.60%,96.23%,92.97%和98.14%。结论VIA、VILI的灵敏度低于HPV或TCT,但因其简单、廉价、易掌握等特点,故更适合在农村地区推广应用。     

两次醋酸染色肉眼观察在宫颈癌筛查中的价值

[目的]探讨两次醋酸染色肉眼观察(VIA)在宫颈癌筛查中的应用价值。[方法]2011年对2463名河南省新密市25～65岁的妇女进行HPV检测、VIA的联合筛查,任一筛查阳性者和10%随机抽取的筛查阴性者共855名妇女进行第二次VIA和阴道镜检查。[结果]最终完成两次VIA、阴道镜检查及宫颈活检的855名妇女,其中未绝经组561人,绝经组294人。未绝经组和绝经组第一次VIA的阳性率分别为19.8%(111/561)和7.1%(21/294),灵敏度分别为59.1%和20.0%,特异性分别为81.8%和93.6%。未绝经组和绝经组进行第二次VIA的阳性率分别为15.7%(88/561)和5.8%(17/294)。未绝经组和绝经组进行两次VIA检查总的阳性率分别为27.3%和10.2%,两次VIA检查并联的灵敏度分别为81.8%和40.0%,特异性分别为75.0%和91.4%。未绝经组通过两次VIA检查比单独一次VIA检查多发现5例CIN2+的漏诊病例(1例CIN2,4例CIN3),绝经组通过两次VIA检查比单独一次VIA检查多发现3例CIN3的漏诊病例。[结论]宫颈癌筛查中,两次VIA检查不仅可以明显提高单次VIA检查的灵敏度,还可以发现单次VIA检查漏诊的高度CIN病例。两次VIA在未绝经女性宫颈癌筛查中的价值优于绝经组。     

适宜农村地区子宫颈癌筛查方法的研究

目的探索适合宫颈癌高发且经济欠发达地区子宫颈癌及其癌前病变的筛查方法,以最终降低子宫颈癌的发病率和死亡率。方法以山西省襄垣县下良乡35￣55岁的妇女作为对象,进行以人群为基础的宫颈癌筛查。对符合条件的妇女进行危险因素、癌症及子宫颈癌认知情况的问卷调查,用醋酸染色后肉眼观察(VIA)和碘染色后肉眼观察(VILI)进行宫颈检查,结果异常者进行阴道镜下活组织检查并得到最终的病理学诊断。将该次筛查对不同级别病变的检出率与历年来的襄垣地区的筛查结果进行比较。结果该次筛查人群参与率为74.8%。患宫颈糜烂和滴虫感染的妇女分别占受检人群的48.3%和14.8%。最终经活检病理确诊的CINⅠ的现患率为0.8%(10例)、CINⅡ0.7%(9例)、CINⅢ1.1%(13例)、子宫颈癌0.2%(3例)。该次单纯肉眼观察对CINⅡ和对≥CINⅢ病变的检出率略低于已往当地普查项目,但差别无统计学意义。结论在资源有限,经济不发达的农村地区,由经过培训的医生进行肉眼观察的宫颈癌筛查是可行的,单纯肉眼观察是一种经济有效的筛查方法,建议进一步在农村地区进行推广。     

改良宫颈肉眼醋酸试验方法在宫颈癌初筛中的应用

[目的]研究改良的宫颈肉眼醋酸试验方法用于宫颈癌初筛并评价效果。[方法]采取整群随机抽样方法获得深圳市福田区教育局和宝安区观澜街道社区样本人群。采用肉眼醋酸试验方法（VIA）和改良肉眼醋酸试验（VIAM）方法进行宫颈癌筛查,异常者转诊阴道镜,病理诊断为金标准。采用转诊率、活检并发症发生率、检出率、早诊率和病理诊断相符率进行比较。[结果]深圳市福田教育局人群用肉眼醋酸试验方法（VIA）筛查1736例,阳性193例,转诊率11.12%;观澜街道人群用改良肉眼醋酸试验方法（VIAM）筛查1826例,阳性116例,转诊率6.35%,两者相比差异有显著性（χ2=25.50,P〈0.01）。VIA方法活检出血6例,占3.11%,VIAM方法活检出血2例,占1.72%,两者相比,差异无统计学意义。VIA方法筛查,病理诊断相符率9.33%;VIAM方法筛查,质量控制后病理诊断相符率17.24%,两者相比差异有显著意义（χ2=4.2,P=0.04）,其中21例初筛阴性质量控制后阳性病例,经病理诊断检出≥CINⅡ6例。[结论]肉眼醋酸试验需要建立有效的质量控制方法,使用改良的肉眼醋酸试验方法降低了转诊率并有效防止漏诊。筛查质量控制是宫颈癌早诊早治的重要保证。     

醋酸染色肉眼观察法筛查宫颈病变的效果及其误判的影响因素

[目的]分析醋酸染色肉眼观察(VIA)筛查宫颈病变的效果,并初步探讨其误判的影响因素。[方法]将3179名进行HPV检测、VIA检查的联合筛查妇女纳入分析,任意一种筛查方法阳性妇女和10%随机抽取的所有筛查试验阴性的1112名妇女进行阴道镜检查,阴道镜下可见病变处直接取活检,不可见病变且筛查阳性时四象限随机活检+宫颈管搔刮术(ECC),以病理诊断为金标准。[结果 ]在3179名纳入分析的筛查对象中,HPV感染率为24.6%(782/3179),VIA阳性率为6.2%(197/3179)。VIA检出宫颈高度以上病变(CIN2+)病变的灵敏度仅为31.5%,特异性为94.2%,漏诊率为68.5%,误诊率为5.8%。多因素分析结果显示,绝经妇女行VIA检查更容易被漏诊;而年龄小、鳞柱交界满意和有宫颈炎的妇女行VIA检查更容易被误诊。[结论]影响VIA检查准确性的因素较多,临床判断的主观性较大,需要对临床医生开展标准化培训,对于绝经和有生殖道炎症的妇女行VIA检查时更需慎重。     

醋酸染色法联合碘染色法在宫颈癌筛查中的应用

[目的]评价醋酸染色法（VIA）联合碘染色法（VILI）对农村地区宫颈癌筛查的可行性和价值。[方法]采用VIA/VILI在杭州市萧山区农村28-55岁的妇女人群中开展宫颈癌筛查。VIA或VILI阳性者行阴道镜检查,阴道镜检查阳性者转送上级医院进一步检查。[结果]2007-2009年期间,总筛查1697人次,其中低级别CIN17例、高级别CIN10例、浸润癌2例。[结论]在资源、设备有限的农村地区,VIA/VILI方法对妇女开展宫颈癌及癌前病变的筛查是可行的,有利于宫颈癌的早发现及早诊早治。     

醋酸染色肉眼观察在子宫颈癌筛查分流中的应用价值

目的:评价醋酸染色肉眼观察(VIA)在宫颈癌筛查中分流自我取样人乳头瘤病毒(HPV) DNA阳性人群的可行性及应用价值.方法:对2 500名河南省新密市25～65岁的妇女进行宫颈癌筛查.初次访视时每位妇女均接受了自我取样HPV DNA检测和VIA.任何筛查阳性及随机10％阴性的妇女进行第2次VIA和阴道镜检查.阴道镜下可见病变处直接活检;无可见病变但筛查阳性时行四象限随机活检+宫颈管搔刮术(ECC).以病理诊断为金标准.结果:最终有2 463名妇女纳入分析.目标人群自我取样HPV的阳性率为17.3％(427/2 463),检出CINⅡ+的灵敏度为89.2％(33/37),特异度为83.8％(2 032/2 426),阳性预测值(PPV)为7.7％(33/427).用VIA对自我取样HPV DNA阳性者进行分流,阴道镜转诊率由17.3％(427/2 463)降至2.5％(61/2 463),x2=304.7,P＜0.001;特异度和PPV可分别达到98.3％(2 384/2 426)(x2=350.0,P＜0.001)和31.2％(19/61),x2=30.7,P＜0.001,灵敏度为51.4％.结论:用VIA分流自我取样HPV DNA阳性妇女,可以显著提高宫颈癌筛查的特异度和PPV值,明显降低阴道镜转诊率,对于未绝经妇女,意义更为显著.这种分流方法可以有效节约卫生资源,有望成为宫颈癌筛查分流的一种新选择.     

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。     

农村地区醋酸/碘染色法筛查子宫颈癌的3年结果分析

背景与目的:我国至今还没有一个系统的子宫颈癌防治计划,尤其是广大农村地区更缺乏子宫颈癌的防治技术和经验。本研究报道山西省襄垣县子宫颈癌早诊早治示范基地的人群筛查资料,评价基层医生采用醋酸或碘染色法(VIA/VILI)在农村地区筛查子宫颈癌及其癌前病变的效果。方法:采用醋酸染色法(VIA)和碘染色法(VILI)在山西省襄垣县30～59岁的妇女人群中开展子宫颈癌筛查,VIA或VILI阳性者进行阴道镜检查,阴道镜检异常者在病变处取活检进行病理学诊断。采用同样的程序对人群进行复查,通过比较1年筛查、连续2年筛查和连续3年筛查的结果,评价该方案的筛查效果。结果:在2005～2008年期间,有7145名适龄妇女参加了筛查,平均年龄为42.16岁,筛查人群平均参与率为74.75%。其中2005～2007年期间,对1287人连续筛查了3年,第1轮筛查CIN2、CIN3及子宫颈癌的检出率分别为0.70%(9例)、1.01%(13例)、0.23%(3例);第2轮(976人)筛查检出率分别为0.22%(2例)、0.11%(1例)、0;第3轮筛查仅增加了1例CIN2病例。2006～2007年期间对3490人连续筛查了2年,第1轮(3...     

Evaluation of visual inspection as a screening test for cervical cancer.

Visual inspection of the uterine cervix by paramedical personnel has been proposed for the early detection of cervical cancer, as an alternative to routine cytology screening in developing countries. We evaluated the performance of this procedure in detecting precursor lesions and cancer in a study involving 2843 married women in Kerala, India. Two thresholds were used to define a positive test. In the lower one, any abnormality was considered as positive. The cut-off point for the high threshold was one or more of the high-risk findings: bleeding on touch, suspicious growth/ulcer and hard, irregular, oedematous cervix. A Pap smear was performed on all subjects, and a biopsy was done for those with moderate dysplasia and above. A combination of cytology and histology findings was used as the ''gold standard''. Using the low threshold, 1279 (45%) women were positive on visual inspection, and with the higher threshold 179 (6.3%) were positive. There were six moderate dysplasias, nine severe dysplasias, ten carcinomas in situ and 13 invasive carcinomas. With the lower threshold, sensitivity and specificity to detect moderate dysplasia and above were 65.8% and 55.3% respectively; the values for severe dysplasia and above were 71.9% and 55.3% respectively and for invasive cancer were 92.3% and 55.2% respectively. With the higher threshold, the sensitivity decreased considerably (28.9% to detect moderate dysplasia lesions, 31.3% for severe dysplasia and 53.8% for clinical cancer) and the specificity increased to approximately 94%. At a lower threshold, the sensitivity was not satisfactory, and the test was highly non-specific; at a higher threshold sensitivity was even lower. Thus, the test characteristics of visual inspection are not very promising either as a preselection procedure for cytology or as a low-technology measure for cervical cancer screening in developing countries.     

The role of low-level magnification in visual inspection with acetic acid for the early detection of cervical neoplasia

Several studies have investigated the accuracy of naked eye visual inspection with acetic acid (VIA) in the early detection of cervical neoplasia. It is not clear whether low-level (2-4x) magnification (VIAM) can improve the sensitivity and specificity of VIA. The accuracy of both VIA and VIAM, provided by independent health workers, were evaluated in three cross-sectional studies involving 18,675 women aged 25-65 years in Kolkata and Mumbai in India. All screened women were investigated with colposcopy and biopsies were obtained based on colposcopy findings. The final disease status was based on the reference standard of histology (if biopsies had been taken) or colposcopy. Data from the studies were pooled to calculate the test characteristics for the detection of high-grade squamous intraepithelial lesions (HSIL). 14.1% and 14.2% were positive on testing with VIA and VIAM respectively. Two hundred twenty-nine were diagnosed with HSIL and 68 with invasive cancer. The pooled sensitivity, specificity, positive and negative predictive values for VIA in detecting high-grade squamous intraepithelial lesions (HSIL) were 60.3% (95% CI: 53.6-66.7), 86.8% (95% CI: 86.3-87.3), 5.9% (95% CI: 5.0-7.0), and 99.4% (95% CI: 99.2-99.5), respectively. The values were 64.2% (95% CI: 57.6-70.4), 86.8% (95% CI: 86.2-87.3), 6.3% (95% CI: 5.3-7.3) and 99.4% (95% CI: 99.3-99.6), respectively, for VIAM. Low-level magnification did not improve the test performance of naked eye visualization of acetic acid impregnated uterine cervix.     

Accuracy of visual inspection with acetic acid to detect cervical cancer precursors among HIV‐infected women in Kenya

Visual inspection with acetic acid (VIA) is becoming a more widely recommended and implemented screening tool for cervical cancer prevention programs in low‐resource settings. Many of these settings have a high prevalence of HIV‐infected women. We carried out a cross‐sectional validation study to define the sensitivity, specificity and predictive values of VIA among HIV‐infected women. Women enrolled in HIV care at the Family AIDS Care and Education Services clinic in Kisumu, Kenya, were recruited for participation. All participants underwent VIA followed by colposcopy performed by a second blinded clinician. At colposcopy, lesions suspicious for cervical intraepithelial neoplasia 2 or greater (CIN2+) were biopsied. Disease status was determined by final histopathologic diagnosis in women who underwent biopsies. A satisfactory colposcopy with no lesions was considered a negative result. From October 2010 to June 2012, 1,432 women underwent VIA and colposcopy. A total of 514 (35.7%) women had a positive VIA, and 179 (12.2%) had CIN2+ confirmed by colposcopically directed biopsy. Sensitivity, specificity, positive and negative predictive values of VIA for CIN2+ were 86.6, 71.6, 30.3 and 97.4%, respectively. Specificity, but not sensitivity, increased with older age. Among older women, sensitivity was affected by CD4+ count and use of antiretroviral therapy. Although they are impacted by age and immune status, test characteristics for VIA among HIV‐infected women are similar to what has been reported for general populations. Recommendations to use VIA as a screening tool should not vary by HIV status.     

Effectiveness of a two‐stage strategy with HPV testing followed by visual inspection with acetic acid for cervical cancer screening in a low‐income setting

The World Health Organization recently advocated a two‐stage strategy with human papillomavirus (HPV) testing followed by visual inspection of the cervix with acetic acid (VIA) as a suitable option for cervical cancer screening. However, its accuracy has never been directly assessed in the context of primary screening. To evaluate effectiveness of HPV testing on self‐obtained specimens (self‐HPV) followed by VIA (sequential testing) in a low‐income setting, we recruited 540 women aged between 30 and 65 years in two Cameroonian periurban areas. Eligible women were counseled about cervical cancer and how to perform self‐sampling. HPV positive and a random sample of HPV‐negative women were called back for VIA and biopsy. Disease was defined by interpretation of cervical intraepithelial neoplasia Grade 2 or worse (CIN2+). Performances of VIA, self‐HPV and sequential testing were determined after adjustment for verification bias. HPV prevalence was 27.0%. VIA positivity was 12.9% and disease prevalence was 5%. Sensitivity and specificity of VIA for CIN2+ were 36.4% [95% confidence interval (CI): 15.2–64.6%] and 90.4% (95% CI: 85.4–93.7%), respectively. Sensitivity of self‐HPV [100.0% (95% CI: 79.6–100.0%)] was 66% higher than that of sequential testing [33.3% (95% CI: 15.2–58.3%)]. Meanwhile, specificity of self‐HPV [74.5% (95% CI: 70.6–78.1%)] was 22% lower than that of sequential testing [96.7% (95% CI: 94.8–97.9%)]. A two‐stage screening strategy with self‐HPV followed by VIA improves specificity of cervical cancer screening, but at the cost of an important loss of sensitivity. Ways to improve VIA performance or other tools are needed to increase positive predictive value of HPV testing.     

Test characteristics of visual inspection with 4% acetic acid (VIA) and Lugol's iodine (VILI) in cervical cancer screening in Kerala,India

Simple and inexpensive methods based on visual examination of the cervix are currently being investigated as alternative methods of cervical screening. The test characteristics of visual inspection with 4% acetic acid (VIA), and Lugol's iodine (VILI) and conventional cytology were investigated in a cross-sectional study involving 4,444 women aged 25 to 65 years in Kerala, India. While detection of any acetowhite area constituted a low-threshold positive VIA, detection of well-defined, opaque acetowhite lesions close to or touching the squamocolumnar junction constituted a high-threshold positive VIA test. Detection of definite yellow iodine nonuptake areas in the transformation zone close to or touching the squamocolumnar junction constituted a positive VILI test. Cytology was considered positive if reported as atypia or worse lesions. All screened women were evaluated by colposcopy and biopsies were directed in 1,644 women (37.0%), which allowed the direct estimation of sensitivity, specificity and predictive values. The reference diagnosis was based on a combination of histology and/or colposcopy. True disease status was defined as CIN 2 and worse lesions. A total of 149 (3.4%) women had CIN 2 or worse lesions. The sensitivities of low-threshold VIA, high-threshold VIA, VILI and cytology to detect CIN 2 or worse disease were 88.6%, 82.6%, 87.2% and 81.9%, respectively; the corresponding specificities were 78.0%, 86.5%, 84.7% and 87.8%. Our results indicate that VIA and VILI are suitable alternate screening tests to cytology for detecting cervical neoplasia in low-resource settings.