{"title":"比较用醋酸和卢戈尔碘对埃塞俄比亚 HPV 自采样阳性妇女进行分诊：随机对照试验。","authors":"Selamawit Fisseha Mekuria, Habtamu Biazin, Tamrat Abebe, Christer Borgfeldt, Nahom Assegid, Adane Mihret, Reta Obsi Nemomsa, Ola Forslund, Mats Jerkeman","doi":"10.1136/ijgc-2024-005694","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Most women who are high-risk human papilloma virus (hrHPV) positive in a cervical cancer screening test will spontaneously heal from their infection. Visual inspection with acetic acid (VIA) is recommended by the World Health Organization as a triage test for cervical screening, however its accuracy as a triage test has been questioned. In this study, we aimed to examine the sensitivity and specificity of VIA with and without Lugol's iodine as a triage test to detect cervical intraepithelial neoplasia (CIN2+) among women who tested positive for hrHPV after self-sampling.</p><p><strong>Method: </strong>This two-armed randomized controlled trial (RCT) took place in Adama, Ethiopia. The women who tested positive for vaginal hrHPV (Anyplex ΙΙ, Seegene) after self-sampling were randomized to VIA with or without iodine and appointed to a midwife-led clinic. The result of the triage test was categorized as positive, negative, suspicion of cancer or inconclusive, and treated accordingly. Cervical biopsies were collected from women who were hrHPV positive to serve as a gold standard.</p><p><strong>Results: </strong>22.4% (197/878) of women tested hrHPV positive. Sensitivity and specificity for VIA to detect CIN2+was 25.0% (95% CI 0.6 to 80.0) and 82.7% (95% CI 69.7 to 91.8), respectively. For VIA with iodine, the sensitivity was 50.0% (95% CI 0.7 to 93.2) and the specificity 86.3% (95% CI 71.4 to 93.0). The difference between the two methods was not statistically significant, p=0.5. The odds of detecting CIN2+ was 5.4 times higher if positive for VIA with iodine compared with a negative result. For VIA without iodine, the odds of detecting CIN2+ was 1.6 compared with a negative result. The odds of detecting CIN2+ was 6.4 times higher if the women were HIV positive than for those who were HIV negative.</p><p><strong>Conclusion: </strong>VIA with iodine improved detection of CIN2+ in women who were hrHPV DNA positive but was not significantly better than VIA alone.</p><p><strong>Trial registration number: </strong>NCT05125380.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"1691-1697"},"PeriodicalIF":4.1000,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparing visual inspection with acetic acid, with and without Lugol's Iodine for triage of HPV self-sample positive women in Ethiopia: a randomized controlled trial.\",\"authors\":\"Selamawit Fisseha Mekuria, Habtamu Biazin, Tamrat Abebe, Christer Borgfeldt, Nahom Assegid, Adane Mihret, Reta Obsi Nemomsa, Ola Forslund, Mats Jerkeman\",\"doi\":\"10.1136/ijgc-2024-005694\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Most women who are high-risk human papilloma virus (hrHPV) positive in a cervical cancer screening test will spontaneously heal from their infection. Visual inspection with acetic acid (VIA) is recommended by the World Health Organization as a triage test for cervical screening, however its accuracy as a triage test has been questioned. In this study, we aimed to examine the sensitivity and specificity of VIA with and without Lugol's iodine as a triage test to detect cervical intraepithelial neoplasia (CIN2+) among women who tested positive for hrHPV after self-sampling.</p><p><strong>Method: </strong>This two-armed randomized controlled trial (RCT) took place in Adama, Ethiopia. The women who tested positive for vaginal hrHPV (Anyplex ΙΙ, Seegene) after self-sampling were randomized to VIA with or without iodine and appointed to a midwife-led clinic. The result of the triage test was categorized as positive, negative, suspicion of cancer or inconclusive, and treated accordingly. Cervical biopsies were collected from women who were hrHPV positive to serve as a gold standard.</p><p><strong>Results: </strong>22.4% (197/878) of women tested hrHPV positive. Sensitivity and specificity for VIA to detect CIN2+was 25.0% (95% CI 0.6 to 80.0) and 82.7% (95% CI 69.7 to 91.8), respectively. For VIA with iodine, the sensitivity was 50.0% (95% CI 0.7 to 93.2) and the specificity 86.3% (95% CI 71.4 to 93.0). The difference between the two methods was not statistically significant, p=0.5. The odds of detecting CIN2+ was 5.4 times higher if positive for VIA with iodine compared with a negative result. For VIA without iodine, the odds of detecting CIN2+ was 1.6 compared with a negative result. The odds of detecting CIN2+ was 6.4 times higher if the women were HIV positive than for those who were HIV negative.</p><p><strong>Conclusion: </strong>VIA with iodine improved detection of CIN2+ in women who were hrHPV DNA positive but was not significantly better than VIA alone.</p><p><strong>Trial registration number: </strong>NCT05125380.</p>\",\"PeriodicalId\":14097,\"journal\":{\"name\":\"International Journal of Gynecological Cancer\",\"volume\":\" \",\"pages\":\"1691-1697\"},\"PeriodicalIF\":4.1000,\"publicationDate\":\"2024-11-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Gynecological Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/ijgc-2024-005694\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Gynecological Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/ijgc-2024-005694","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景：大多数在宫颈癌筛查中发现高危人乳头瘤病毒（hrHPV）阳性的妇女都会自愈。世界卫生组织建议将醋酸目视检查（VIA）作为宫颈癌筛查的分流检测方法，但其作为分流检测方法的准确性一直受到质疑。在本研究中，我们的目的是研究在自我采样后检测出 hrHPV 阳性的妇女中，用 VIA 加碘或不加碘作为分流试验检测宫颈上皮内瘤变（CIN2+）的灵敏度和特异性：这项双臂随机对照试验（RCT）在埃塞俄比亚的阿达玛进行。自我采样后阴道 hrHPV（Anyplex ΙΙ，Seegene）检测呈阳性的妇女被随机分配到加碘或不加碘的 VIA 检测中，并被指定到助产士领导的诊所就诊。分检结果分为阳性、阴性、疑似癌症或不确定，并进行相应处理。对 hrHPV 阳性的妇女进行宫颈活检，作为金标准。VIA 检测 CIN2+ 的敏感性和特异性分别为 25.0% (95% CI 0.6 至 80.0) 和 82.7% (95% CI 69.7 至 91.8)。碘VIA的敏感性为50.0%（95% CI 0.7至93.2），特异性为86.3%（95% CI 71.4至93.0）。两种方法的差异无统计学意义（P=0.5）。与阴性结果相比，含碘 VIA 阳性结果检测出 CIN2+ 的几率要高出 5.4 倍。与阴性结果相比，不含碘的 VIA 检测出 CIN2+ 的几率为 1.6。如果妇女的 HIV 阳性，则发现 CIN2+ 的几率是 HIV 阴性的 6.4 倍：结论：碘伏VIA提高了hrHPV DNA阳性妇女CIN2+的检出率，但并不明显优于单纯VIA：NCT05125380。
Comparing visual inspection with acetic acid, with and without Lugol's Iodine for triage of HPV self-sample positive women in Ethiopia: a randomized controlled trial.
Background: Most women who are high-risk human papilloma virus (hrHPV) positive in a cervical cancer screening test will spontaneously heal from their infection. Visual inspection with acetic acid (VIA) is recommended by the World Health Organization as a triage test for cervical screening, however its accuracy as a triage test has been questioned. In this study, we aimed to examine the sensitivity and specificity of VIA with and without Lugol's iodine as a triage test to detect cervical intraepithelial neoplasia (CIN2+) among women who tested positive for hrHPV after self-sampling.
Method: This two-armed randomized controlled trial (RCT) took place in Adama, Ethiopia. The women who tested positive for vaginal hrHPV (Anyplex ΙΙ, Seegene) after self-sampling were randomized to VIA with or without iodine and appointed to a midwife-led clinic. The result of the triage test was categorized as positive, negative, suspicion of cancer or inconclusive, and treated accordingly. Cervical biopsies were collected from women who were hrHPV positive to serve as a gold standard.
Results: 22.4% (197/878) of women tested hrHPV positive. Sensitivity and specificity for VIA to detect CIN2+was 25.0% (95% CI 0.6 to 80.0) and 82.7% (95% CI 69.7 to 91.8), respectively. For VIA with iodine, the sensitivity was 50.0% (95% CI 0.7 to 93.2) and the specificity 86.3% (95% CI 71.4 to 93.0). The difference between the two methods was not statistically significant, p=0.5. The odds of detecting CIN2+ was 5.4 times higher if positive for VIA with iodine compared with a negative result. For VIA without iodine, the odds of detecting CIN2+ was 1.6 compared with a negative result. The odds of detecting CIN2+ was 6.4 times higher if the women were HIV positive than for those who were HIV negative.
Conclusion: VIA with iodine improved detection of CIN2+ in women who were hrHPV DNA positive but was not significantly better than VIA alone.
期刊介绍：
The International Journal of Gynecological Cancer, the official journal of the International Gynecologic Cancer Society and the European Society of Gynaecological Oncology, is the primary educational and informational publication for topics relevant to detection, prevention, diagnosis, and treatment of gynecologic malignancies. IJGC emphasizes a multidisciplinary approach, and includes original research, reviews, and video articles. The audience consists of gynecologists, medical oncologists, radiation oncologists, radiologists, pathologists, and research scientists with a special interest in gynecological oncology.
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