CryoPop 研究:在印度卡纳塔克邦筛查高度宫颈发育不良。
The CryoPop study: Screening for high-grade cervical dysplasia in Karnataka, India.
发表日期:2023 Nov 06
作者:
Jean R Anderson, S Yogeshkumar, Enriquito Lu, Gayane Yenokyan, Katrina Thaler, Margaret Mensa, Santosh Chikaraddi, Laxmikant Lokare, Muttappa R Gudadinni, Ramalingappa Antartani, Kasturi Donimath, Basavaraj Patil, Shailaja Bidri, Shivaprasad S Goudar, Richard Derman, Anita Dalal,
来源:
Bjog-Int J Obstet Gy
摘要:
描述我们通过醋酸目视检查(VIA)和阴道镜检查来筛选患有高度癌前宫颈病变且适合冷冻治疗的女性的经验。对女性进行筛选,以确定是否有资格参加临床试验,测试一种新型、简单且廉价的冷冻治疗设备 (CryoPop®) 的安全性和有效性,该设备针对低收入和中等收入国家 (LMIC)。前瞻性队列研究。初级和城市健康印度 Belagavi、Hubballi 和 Vijayapur 的中心。年龄组 30-49 岁、绝经前、未曾进行子宫切除术且没有已知 HIV 感染的女性有资格进行筛查。在知情同意后,对符合条件的女性进行了乙酸目视检查。 VIA 阳性女性被转诊进行阴道镜检查和活检。活检由两名病理学家独立读取,如果需要,第三名病理学家将充当决胜局。主要结果指标是 VIA 筛查呈阳性的女性人数/比例,以及 VIA 筛查呈阳性的女性人数/比例。活检显示高度宫颈病变(宫颈上皮内瘤变 2/3 [CIN 2/3])。对筛查 VIA 阳性的女性和筛查 VIA 阴性的女性之间的人口统计学变量进行了比较;对活检中患有 CIN 2/3 的女性和活检中没有 CIN 2/3 的女性进行了人口统计学和有限生殖变量的单独比较。对分类数据使用卡方或 Fisher 精确检验,对数值数据使用 t 检验或方差分析,所有检验均为两侧,并在 alpha 0.05 水平的统计显着性下进行。总共 9130 名女性接受了 VIA 筛查2020 年 7 月 4 日和 2021 年 3 月 31 日。所有接受筛查的女性的平均年龄为 37 岁(标准差 = 5.6 岁),其中 6073 名女性 (66.5%) 年龄在 30-39 岁之间。只有 1% 的女性曾接受过宫颈癌筛查。共有 501 名女性 (5.5%) 呈 VIA 阳性;其中,401 名女性接受了阴道镜检查。在接受阴道镜检查的患者中,17 名(4.2%)在活检中发现高级别病变,另外 164 名(40.9%)在活检或宫颈内刮除术中发现低级别宫颈病变,1 名女性(0.2%)被发现患有浸润性癌症。 VIA 呈阳性的女性更年轻,受教育程度和收入更高;然而,与没有 CIN 2/3 的女性相比,VIA 阳性并被发现患有 CIN 2/3 的女性年龄更大,更有可能成为家庭主妇,并且家庭收入更高。 尽管发生了 COVID-19 大流行,仍有超过 9100 名女性接受了筛查VIA 治疗癌前病变。然而,只有 17 例 (4.2%) 被发现存在经活检证实的高级别宫颈病变,这凸显了 VIA 作为筛查方法的主观表现。鉴于该比率明显低于文献报道的比率,该人群中重度病变的患病率可能受到筛查更年轻和更多农村人口的影响。这项研究表明,以有组织的方式进行筛查是可行的,并且可以迅速扩大规模。然而,虽然 VIA 价格便宜且允许当天治疗,但它可能过于主观,并且不够准确,无法清楚地识别需要治疗的病变,特别是在低患病率和低风险人群中,这使其整体成本效益受到质疑。© 2023作者们。 BJOG:约翰·威利出版的国际妇产科杂志
To describe our experience of screening with visual inspection with acetic acid (VIA) and colposcopy to identify women with high-grade precancerous cervical lesions who were candidates for cryotherapy. Women were screened to determine eligibility for a clinical trial testing the safety and efficacy of a new, simple and inexpensive cryotherapy device (CryoPop®) targeted for use in low and middle-income countries (LMICs).Prospective cohort study.Primary and urban health centres in Belagavi, Hubballi and Vijayapur, India.Women in the age-group 30-49 years, premenopausal, with no prior hysterectomy and no known HIV infection were eligible for screening.Visual inspection with acetic acid was performed on eligible women following informed consent. VIA-positive women were referred for colposcopy and biopsy. Biopsies were read by two pathologists independently, with a third pathologist acting as tie-breaker if needed.The primary outcome measures were the number/proportion of women screening positive by VIA and the number/proportion of those women screening VIA-positive found to have high-grade cervical lesions on biopsy (cervical intraepithelial neoplasia 2/3 [CIN 2/3]). Demographic variables were compared between women who screened VIA-positive and those who screened VIA-negative; a separate comparison of demographic and limited reproductive variables was performed between women who had CIN 2/3 on biopsy and those without CIN 2/3 on biopsy. Chi-square or Fisher's exact tests for categorical data and t-tests or analysis of variance for numeric data were used with all tests two-sided and performed at an alpha 0.05 level of statistical significance.A total of 9130 women were screened with VIA between 4 July 2020 and 31 March 2021. The mean age of all women screened was 37 years (standard deviation = 5.6 years) with 6073 of the women (66.5%) in the 30-39 year range. Only 1% of women reported prior cervical cancer screening. A total of 501 women (5.5%) were VIA-positive; of these, 401 women underwent colposcopy. Of those who had colposcopy, 17 (4.2%) had high-grade lesions on biopsy, an additional 164 (40.9%) had low-grade cervical lesions on biopsy or endocervical curettage and one woman (0.2%) was found to have invasive cancer. VIA-positive women were younger and had higher levels of education and income; however, women who were VIA-positive and found to have CIN 2/3 were older, were more likely to be housewives and had higher household income than those without CIN 2/3.Despite the COVID-19 pandemic, over 9100 women were screened with VIA for precancerous lesions. However, only 17 (4.2%) were found to have biopsy-proven high-grade cervical lesions, underscoring the subjective performance of VIA as a screening method. Given that this is significantly lower than rates reported in the literature, it is possible that the prevalence of high-grade lesions in this population was impacted by screening a younger and more rural population. This study demonstrates that screening is feasible in an organised fashion and can be scaled up rapidly. However, while inexpensive and allowing for same-day treatment, VIA may be too subjective and have insufficient accuracy clearly to identify lesions requiring treatment, particularly in low-prevalence and low-risk populations, calling into question its overall cost-effectiveness.© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.