一步核酸扩增法检测早期宫颈癌前哨淋巴结转移的效果

蒋丽萍; 陈海霞; 周敏; 王旭禛; 赵华; 赵绍杰

doi:10.12025/j.issn.1008-6358.2023.20230562

一步核酸扩增法检测早期宫颈癌前哨淋巴结转移的效果

One-step nucleic acid amplification in sentinel lymph node metastasis of early cervical cancer

摘要

摘要:
目的评价一步核酸扩增法（one-step nucleic acid amplification，OSNA）检测早期宫颈癌前哨淋巴结（sentinel lymph node，SLN）转移的效能及对非前哨淋巴结（nSLN）转移的预测价值。
方法前瞻性纳入68例早期宫颈癌患者，收集术中SLN组织标本。所有患者均行系统盆腔淋巴结清扫。术中将每枚SLN分为2份，一份行OSNA检测，一份行快速冰冻切片（frozen section，FS）检测；术后病理检测结果作为诊断金标准。分析OSNA、FS与术后病理结果评估微转移（micrometastasis，MM）及宏转移（macrometastases，MC）的一致性，并比较评估特异度、灵敏度；比较OSNA与FS评估MC及MM的灵敏度。比较OSNA检出不同SLN阳性数患者盆腔nSLN阳性比例。
结果 68例患者中，共收集SLN 130枚，43例检出1枚SLN、22例检出2枚SLN、3例检出2枚以上SLN，平均每例患者1.9枚SLN。术后病理检出阳性SLN 26枚（20.0%），其中13枚为MC、13枚为MM。OSNA检出阳性SLN 29枚（22.3%），其中13枚为MC、16枚为MM，4枚为假阳性；101枚OSNA阴性的SLN中，1枚术后病理检测为阳性。OSNA检测SLN转移的特异度、灵敏度、阴性预测值、阳性预测值分别为96.2%、96.2%、99.0%、86.2%（P=0.375），与术后病理一致性较好（Kappa值=0.885）；FS检测SLN转移的特异度、灵敏度、阴性预测值、阳性预测值分别为100%、61.5%、91.2%、100%（P=0.002），与术后病理一致性一般（Kappa值=0.719）。对于MC SLN，OSNA与FS检出的灵敏度均为100%；对于MM SLN，OSNA检出灵敏度为92.3%、FS检出灵敏度为23.1%（P=0.030）。盆腔nSLN阳性患者中，OSNA检出阳性SLN>1枚患者比例高于检出1枚SLN阳性患者（77.8%vs 22.2%，P=0.041）。OSNA检出SLN阳性患者术后病理显示肿瘤细胞分化更差、增殖指数更高，且存在淋巴脉管侵犯。
结论 OSNA操作简便、快速，检测SLN转移的灵敏度与术后病理相近，高于FS，可用于术中判断早期宫颈癌SLN转移。

Abstract:
Objective To evaluate effect of the one-step nucleic acid amplification (OSNA) method on detecting sentinel lymph node (SLN) metastasis in early cervical cancer, and its predictive value for non-SLN (nSLN) metastasis.
Methods 68 patients with early cervical cancer were prospectively included, and SLN tissue specimens were collected during operation. Systematic pelvic lymph node dissection was performed in all patients. Each SLN was divided into two parts during operation: one was tested by OSNA, and other was underwent frozen section (FS). The results of postoperative pathological examination were used as the gold standard for diagnosis. The consistency, specificity and sensitivity of OSNA, FS and postoperative pathological results were compared in the evaluation of micrometastasis (MM) and macrometastasis (MC), and the sensitivity between OSNA and FS were compared. The pelvic nSLN rate in patients with different positive SLN number detected by OSNA.
Results 130 SLNs were successfully detected in 68 patients during the operation, including 43 patients with 1 SLN, 22 patients with 2 SLNs, and 3 patients with more than 2 SLNs, with an average of 1.9 SLNs per patient. The postoperative H-E stain and IHC detected 26 (20.0%) positive SLNs, including 13 MC and 13 MM. OSNA detected 29 (22.3%) positive SLN, including 13 MC and 16 MM, and 4 were false positive. Among 101 negative SLNs detected by OSNA, 1 was found to be positive for MM by postoperative pathological examination. The specificity, sensitivity, negative predictive value and positive predictive value of OSNA for SLN metastasis were 96.2%, 96.2%, 99.0% and 86.2%, respectively (P=0.375) and its consistency with postoperative pathological detection was good (Kappa value=0.885). The specificity, sensitivity, negative predictive value and positive predictive value of FS for SLN metastasis were 100%, 61.5%, 91.2% and 100%, respectively (P=0.002), and its consistency with postoperative pathological detection was general (Kappa value=0.719). For MC SLN, the sensitivity of OSNA detection was 100%, and that of FS detection was 100%; for MM SLN, the sensitivity of OSNA detection was 92.3%, and that of FS was 23.1% (P=0.030). Compared with patients with 1 positive SLN detected by OSNA, the patients proportion of >1 positive SLNs detected by OSNA was higher in patients with pelvic nSLN (77.8% vs 22.2%, P=0.041). Postoperative pathological results showed that the patients with positive SLN detected by OSNA had worse tumor differentiation, higher tumor proliferation index, and lymphatic vessel invasion.
Conclusions The OSNA detection is simple and rapid, has similar sensitivity with postoperative pathological detection for SLN metastases, which is higher than FS, so it could be used as a new method for rapid intraoperative diagnosis of cervical cancer SLN metastases in patiehts with early cervical cancer.

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