宫颈上皮内瘤变（CIN）患者 LLETZ 治疗前后 6 个月 p16/Ki-67 双染细胞学结果与治疗后 3 年随访方案的相关性：一项回顾性队列研究。
Association between p16/Ki-67 dual stain cytology results prior to and 6 months after LLETZ treatment for CIN and the follow-up regimen three years after treatment: a retrospective cohort study.
机构信息
Department of Obstetrics and Gynecology, University Hospitals of Leuven (UZ Leuven), Herestraat 49, 3000, Louvain, Belgium.
Department of Development and Regeneration, Unit Woman and Child, Catholic University of Leuven (KU Leuven), Herestraat 49, 3000, Louvain, Belgium.
出版信息
Arch Gynecol Obstet. 2024 Jul;310(1):493-499. doi: 10.1007/s00404-024-07553-8. Epub 2024 May 28.
OBJECTIVE
Investigate the association between p16/Ki-67 dual stain cytology test (DST) results, obtained prior to- and 6 months after LLETZ surgery for treatment of CIN, and the follow-up regimen three years after treatment.
METHODS
Secondary analysis of a prospective cohort study. Cervical cytology samples were obtained just prior to- and 6 months after LLETZ and underwent conventional liquid-based cytology (LBC) and p16/Ki-67 dual staining, as well as high-risk HPV genotyping. Clinical management after the LLETZ was according to Belgian national guidelines, with clinicians being blinded to DST results at both time points. Case records were reviewed in 01/2023 to document the follow-up regimen on average three years afterwards: women had either been advised to return to routine screening (i.e., three-annual LBC testing according to the Belgian guideline at that time), or were still subject to more frequent posttreatment surveillance (i.e., more frequent visits because of persistent hrHPV infection or absence of cytological regression).
RESULTS
The follow-up regimen was recorded in 79/110 women originally recruited (72%). The need for continued intense posttreatment surveillance was associated with hrHPV infection 6 months after treatment (79.3% vs. 18.0%, p < 0.001), a positive DST result at baseline and follow-up (41.4% vs. 84.0%, p < 0.001-55.2% vs. 16.0%, p < 0.001), and persistent cytological anomalies at 6 months (at an ASCUS or worse threshold, 37.9% vs. 16.0%, p = 0.028). In multivariable logistic regression analysis, a positive DST at baseline (aOR 20.1, 95%CI 2.03-199.1) was independently associated with the need for intense post-treatment surveillance multiple years after treatment.
CONCLUSION
This exploratory study suggests a possible role of dual-stain cytology in predicting treatment outcome multiple years after LLETZ surgery.
目的
探讨 LLETZ 手术治疗 CIN 前后 6 个月行 p16/Ki-67 双染细胞学检查（DST）结果与治疗后 3 年随访方案之间的关系。
方法
这是一项前瞻性队列研究的二次分析。在 LLETZ 手术前和手术后 6 个月采集宫颈细胞学样本，进行常规液基细胞学（LBC）和 p16/Ki-67 双染以及高危型 HPV 基因分型检测。LLETZ 手术后的临床管理根据比利时国家指南进行，临床医生在两个时间点均对 DST 结果设盲。于 2023 年 01 月回顾病例记录，记录平均 3 年后的随访方案：女性要么被建议恢复常规筛查（即根据当时的比利时指南每 3 年进行一次 LBC 检测），要么仍需接受更频繁的治疗后监测（即因持续存在高危型 HPV 感染或细胞学无恢复而更频繁地就诊）。
结果
最初招募的 110 名女性中有 79 名（72%）记录了随访方案。治疗后 6 个月时存在高危型 HPV 感染（79.3%比 18.0%，p<0.001）、基线和随访时 DST 结果阳性（41.4%比 84.0%，p<0.001-55.2%比 16.0%，p<0.001）以及 6 个月时细胞学异常持续存在（在 ASCUS 或更高级别，37.9%比 16.0%，p=0.028）与持续需要强化治疗后监测显著相关。多变量逻辑回归分析显示，基线时 DST 阳性（优势比 20.1，95%置信区间 2.03-199.1）与治疗后多年需要强化治疗后监测独立相关。
结论
这项探索性研究表明，DST 在预测 LLETZ 手术后多年的治疗结果方面可能具有一定作用。
Zotero 插件