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Title: [Stratified research on related risk factors of CINⅡ⁺ in CINⅠ patients diagnosed by endocervical curettage under colposcopy].
Author: Xiao JJ, Chen ZR, Wang Q, Sui L, Cong Q.
Journal: Zhonghua Fu Chan Ke Za Zhi; 2022 Aug 25; 57(8):608-617. PubMed ID: 36008288.
Abstract:
Objective: To estimate risks of cervical intraepithelial neoplasia (CIN) Ⅱ or worse (CINⅡ⁺) on loop electrosurgical excisional procedure (LEEP) specimens with the diagnosis of endocervical curettage (ECC) CINⅠ compared with biopsy CINⅠ, and also to investigate the hierarchical management scheme of ECC CINⅠ based on the relevant factors of CINⅡ⁺ risk. Methods: (1) A retrospective computer-based research for subjects enrolled in the Obstetrics and Gynecology Hospital, Fudan University from Jan. 2013 to Jun. 2021 was performed. The case group comprised women with an ECC CINⅠ (ECC results of CINⅠ with colposcopy-directed biopsy results ≤CINⅠ), and the control group comprised women with a biopsy CINⅠ (colposcopy-directed biopsy results of CINⅠ with negative ECC findings) were divided after LEEP surgery and diagnosis in the next three months. The clinical data of all patients before LEEP were analyzed, and the pathological diagnosis between two groups after LEEP was compared. (2) Variables, including age, cytology, high-risk human papillomavirus (HR-HPV), ECC results, cervical transformation zone (TZ) and colposcopy impression, were included to describe the characteristics and compare the incidence of LEEP CINⅡ⁺. (3) Univariate analysis and Multivariate logistic regression method were used to analyze the related factors that affect the LEEP CINⅡ⁺ in CINⅠ patients. Further, the specific risks caused by related factors and conduct a stratified study in LEEP CINⅡ⁺ were analyzed. Results: (1) Overall, 2 581 women with ECC CINⅠ or biopsy CINⅠ diagnosis who underwent LEEP participated in the study with the mean age (43.6±9.5) years old. Chi square test found that the age and cytology of patients in ECC CINⅠ group were statistically different from those of biopsy CINⅠ group (all P<0.05). There was no significant difference in HR-HPV detection, TZ type and colposcopy impression between the two groups (all P>0.05). ECC CINⅠ comprised 957 women, with LEEP histopathology results revealing 288 (30.1%, 288/957) CINⅡ⁺, which was significantly higher than that of biopsy CINⅠ which was comprised 1 624 women, with LEEP histopathology results showing 333 (20.5%, 333/1 624) CINⅡ⁺ (χ²=30.31, P<0.001). (2) Compared by LEEP CINⅡ⁺ with LEEP ≤CINⅠ group, there were no significant difference in the age, HR-HPV, colposcopy impression (all P>0.05); but there were significantly differences in cytology, ECC CINⅠ, type Ⅲ TZ (all P<0.001). Multivariate logistic regression analysis showed that atypical squamous epithelial cells (ASC-H; OR=2.77, 95%CI: 2.04-3.77), high-grade squamous intraepithelial lesions and worse (HSIL⁺; OR=2.93, 95%CI: 2.24-3.81), ECC CINⅠ (OR=1.89, 95%CI: 1.56-2.29) and type Ⅲ of TZ (OR=1.76, 95%CI: 1.45-2.11) were independent risk factors for LEEP CINⅡ⁺ (all P<0.05). (3) When cytology was ≤low-grade squamous intraepithelial lesion (LSIL) and ≥ASC-H, the detection rate of CINⅡ⁺ in ECC CINⅠ was significantly higher than that of biopsy CINⅠ (all P<0.001). In ECC CINⅠ, the rate of CINⅡ⁺ with cytology ≤LSIL was significantly lower than that in cytology ≥ASC-H (56.0% vs 25.9%; χ²=49.38, P<0.001). In type Ⅰ/Ⅱ of TZ, the detection rate of CINⅡ⁺ between ECC CINⅠand biopsy CINⅠ had no significantly different; while in type Ⅲ of TZ, there was significantly different (72.7% vs 46.2%; χ²=4.02, P=0.045). In ECC CINⅠ, type Ⅲof TZ was significantly higher in the rate of CINⅡ⁺ than that of type Ⅰ/Ⅱ of TZ (72.7% vs 21.7%; χ²=16.38, P<0.001). When cytology ≥ASC-H, type Ⅲ of TZ and colposcopy impression of HSIL were combined, the rate of CINⅡ⁺ in ECC CINⅠ was 6/6 while 1/3 in biopsy CINⅠ. Conclusions: Cytology ≥ASC-H, ECC CINⅠ and type Ⅲ TZ are the risk factors of LEEP CINⅡ⁺. However, cytology ≥ASC-H is more valuable in predicting LEEP CINⅡ⁺ than ECC CINⅠ. For patients with ECC CINⅠ to perform LEEP, it is recommended that cytology ≥ASC-H is taken as the first level stratification, and type Ⅲ TZ is taken as the second level stratification. The colposcopy impression of patients is recommended for a reference parameter. 目的： 探讨阴道镜引导下子宫颈管搔刮术（ECC）后诊断的子宫颈上皮内瘤变（CIN）Ⅰ患者中存在CINⅡ及以上病变（CINⅡ⁺）的相关风险因素，并进行风险分层研究。 方法： （1）回顾性分析2013年1月至2021年6月复旦大学附属妇产科医院在阴道镜引导下诊断的CINⅠ（包括ECC诊断和点活检诊断）并进一步行子宫颈环形电切术（LEEP）患者的临床资料。患者分为两组，ECC CINⅠ组：LEEP术前3个月内行ECC后诊断的CINⅠ患者，且子宫颈点活检术后诊断≤CINⅠ；点活检CINⅠ组：LEEP术前3个月内行子宫颈点活检术后诊断的CINⅠ患者，且ECC阴性（指ECC术后病理诊断为正常子宫颈管）。对两组CINⅠ患者的LEEP术前临床资料及LEEP术后CINⅡ⁺的检出率进行比较。（2）对阴道镜引导下诊断的CINⅠ患者LEEP术后病理升级为CINⅡ⁺的相关影响因素进行分析，单因素分析采用χ²检验，多因素分析采用logistic回归法。（3）对LEEP术后病理升级为CINⅡ⁺的风险因素进行分层分析。 结果： （1）本研究纳入阴道镜引导下诊断的CINⅠ并进一步行LEEP的患者共2 581例，其年龄为（43.6±9.5）岁；其中ECC CINⅠ组957例，点活检CINⅠ组1 624例。两组患者的年龄、细胞学结果分别比较，差异均有统计学意义（P均<0.05）；而两组患者的高危型人乳头状瘤病毒（HR-HPV）检测、转化区（TZ）类型和阴道镜印象分别比较，差异则均无统计学意义（P均>0.05）。ECC CINⅠ组LEEP术后病理升级为CINⅡ⁺者288例（30.1%，288/957），点活检CINⅠ组333例（20.5%，333/1 624），两组比较，差异有统计学意义（χ²=30.31，P<0.001）。（2）2 581例CINⅠ患者中，LEEP术后病理诊断为≤CINⅠ 1 960例、CINⅡ⁺ 621例。单因素分析显示，两者的细胞学检查、ECC术后诊断、TZ类型分别比较，差异均有统计学意义（P均<0.001）；而两者的年龄、HR-HPV检测、阴道镜印象分别比较，差异则均无统计学意义（P均>0.05）。多因素logistic回归分析显示，细胞学结果为不除外高度病变的不典型鳞状上皮细胞（ASC-H；OR=2.77，95%CI为2.04~3.77）和高级别鳞状上皮内病变及以上病变（HSIL⁺；OR=2.93，95%CI为2.24~3.81）、ECC术后诊断为CINⅠ（OR=1.89，95%CI为1.56~2.29）及TZ类型为Ⅲ型（OR=1.76，95%CI为1.45~2.11）是影响阴道镜引导下诊断的CINⅠ患者LEEP术后病理升级为CINⅡ⁺的独立危险因素（P均<0.05）。（3）以细胞学结果为≤LSIL、≥ASC-H进行分层时，ECC CINⅠ患者LEEP术后CINⅡ⁺的检出率均显著高于点活检CINⅠ者（前者分别为25.9%、16.7%，χ²=26.25，P<0.001；后者分别为56.0%、34.2%，χ²=18.79，P<0.001）；在ECC CINⅠ患者中，细胞学结果≥ASC-H者LEEP术后CINⅡ⁺的检出率显著高于细胞学结果≤LSIL者（分别为56.0%、25.9%；χ²=49.38，P<0.001）。以TZ类型进行分层时，在Ⅰ/Ⅱ型（包括Ⅰ型和Ⅱ型）TZ患者中，ECC CINⅠ患者LEEP术后CINⅡ⁺的检出率与点活检CINⅠ患者比较无显著差异（分别为21.7%、15.2%；χ²=0.91，P=0.341），而在Ⅲ型TZ患者中，ECC CINⅠ患者LEEP术后CINⅡ⁺的检出率显著高于点活检CINⅠ患者（分别为72.7%、46.2%；χ²=4.02，P=0.045）；ECC CINⅠ患者中，Ⅲ型TZ患者LEEP术后CINⅡ⁺的检出率显著高于Ⅰ/Ⅱ型TZ患者（分别为72.7%、21.7%；χ²=16.38，P<0.001）。以阴道镜印象联合细胞学结果及TZ类型进行分层时，发现在细胞学结果≥ASC-H、Ⅲ型TZ及阴道镜印象≥HSIL时，ECC CINⅠ患者LEEP术后CINⅡ⁺的检出率为6/6，点活检ECC CINⅠ患者为1/3。 结论： 细胞学结果≥ASC-H、ECC术后诊断为CINⅠ及Ⅲ型TZ为影响LEEP术后病理升级为CINⅡ⁺的独立危险因素，其中细胞学结果≥ASC-H预测LEEP术后诊断CINⅡ⁺的价值高于ECC术后诊断为CINⅠ。对于ECC CINⅠ患者行LEEP术后的分层管理，建议以细胞学结果≥ASC-H作为一级分层，Ⅲ型TZ作为二级分层，同时结合患者阴道镜印象综合评估，制定个体化治疗方案。.

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