Background

A number of retrospective and prospective studies have documented substantial rates of regression in cervical intraepithelial neoplasia grade 2 lesions in young women. Initial observational management of cervical intraepithelial neoplasia grade 2 is increasingly accepted as appropriate for women under 25 years of age with screen-detected abnormalities and is included in a number of clinical guidelines. However, there has been a paucity of large prospective studies on observational management with strict inclusion criteria. A number of important questions remain, specifically regarding the clinical variables that are associated with the risk of progression or persistence of disease. To investigate these factors and to ensure that young women with cervical intraepithelial neoplasia grade 2 undergoing observational management were being managed in a well-monitored and an appropriately informed fashion, we conducted a large, multicenter prospective study on observational management of cervical intraepithelial neoplasia grade 2 in women under 25 years.

Objective

This study aimed to determine the regression rates and clinical, cytologic, and pathologic predictors of regression of cervical intraepithelial neoplasia grade 2 in women under 25 years undergoing observational management over 24 months.

Study Design

This study was a multicenter prospective study on observational management of cervical intraepithelial neoplasia grade 2 (ie, repeat colposcopy, cytology, and cervical biopsy every 6 months) for up to 24 months. A total of 615 consenting women under 25 years with newly-diagnosed, biopsy-proven cervical intraepithelial neoplasia grade 2 were recruited (from 2010 to 2016) through 16 hospital-based colposcopy units in New Zealand and Australia.

Results

At completion, 326 women had confirmed regression, 156 had persistent high-grade cervical intraepithelial neoplasia grade 2 or 3 or adenocarcinoma in situ, and 24 had unconfirmed regression (ie, first regression at the 24-month follow-up). A total of 109 women did not complete the protocol (41 because of delayed follow-up, 41 lost to follow-up, 22 elected treatment, 4 refused a biopsy, and 1 died of an unrelated cause). Confirmed regression was observed in 53% (326 of 615) of all women enrolled in the study and, when missing data were imputed, it was estimated that 64% of women (95% confidence interval, 60%–68%) would have experienced regression. Similarly, lesions regressed in 64% (326 of 506) of women who completed the observational protocol. Based on a multivariable analysis, detection of human papillomavirus 16 in a liquid-based cytology sample at the time of initial colposcopy decreased the chance of regression by 31% (risk ratio, 0.69; 95% confidence interval, 0.56–0.86; P<.001). In addition, at initial colposcopy, low-grade or normal colposcopic impression, later year of diagnosis, low-grade or normal cytology, and being a nonsmoker were all independently associated with an increased chance of regression.

Conclusion

More than half of women under 25 years with cervical intraepithelial neoplasia grade 2 will regress to cervical intraepithelial neoplasia grade 1 or normal within 24 months without destructive treatment. The absence of human papillomavirus 16 is the most important predictor of regression.

中文翻译：

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预测 25 岁以下女性宫颈上皮内瘤变 2 级的消退

背景

许多回顾性和前瞻性研究记录了年轻女性宫颈上皮内瘤变 2 级病变的显着消退率。宫颈上皮内瘤变 2 级的初步观察性管理越来越被接受为适合 25 岁以下筛查检测到异常的女性，并被包括在许多临床指南中。然而，很少有关于严格纳入标准的观察性管理的大型前瞻性研究。仍然存在许多重要问题，特别是与疾病进展或持续风险相关的临床变量。

客观的

本研究旨在确定接受 24 个月观察管理的 25 岁以下女性宫颈上皮内瘤变 2 级的消退率和临床、细胞学和病理学预测因子。

学习规划

这项研究是一项多中心前瞻性研究，对宫颈上皮内瘤变 2 级（即每 6 个月重复一次阴道镜检查、细胞学和宫颈活检）进行长达 24 个月的观察管理。通过新西兰和澳大利亚的 16 个医院阴道镜检查单位（从 2010 年到 2016 年）招募了 615 名 25 岁以下新诊断、活检证实为宫颈上皮内瘤变 2 级的同意女性。

结果

完成时，326 名女性确认消退，156 名有持续性高级别宫颈上皮内瘤变 2 级或 3 级或原位腺癌，24 名有未经证实的消退（即，在 24 个月的随访中首次消退）。共有 109 名女性未完成方案（41 名因延迟随访，41 名失访，22 名选择治疗，4 名拒绝活检，1 名死于无关原因）。在参与研究的所有女性中，有 53%（615 名中的 326 名）观察到确认的回归，并且在估算缺失数据时，估计 64% 的女性（95% 置信区间，60%–68%）会经历回归。同样，完成观察方案的女性中有 64%（506 名中的 326 名）病变消退。基于多变量分析，P <.001)。此外，在最初的阴道镜检查中，低级别或正常的阴道镜印象、较晚的诊断年份、低级别​​或正常的细胞学检查以及不吸烟都与消退机会增加独立相关。

结论

超过一半的 25 岁以下宫颈上皮内瘤变 2 级的女性将在 24 个月内恢复为宫颈上皮内瘤变 1 级或正常，无需进行破坏性治疗。人乳头瘤病毒 16 的缺失是最重要的回归预测指标。