术中冰冻病理切片评估保乳手术切缘状态的临床研究

Clinical study of intraoperative frozen pathological section in evaluating the margin of breast conserving surgery

目的探讨乳腺癌保乳手术中使用冰冻病理切片技术评估切缘状态的临床作用。方法回顾性分析2011年12月～2017年7月广东省中医院乳腺科751例进行了保乳手术并以冰冻病理切片作为术中切缘评估手段患者的临床资料。分析术中及术后阳性切缘发生率、二次手术率、出现阳性切缘的相关因素,比较阳性切缘组与阴性切缘组及二次手术与非二次手术在手术时间、手术费用、病理化验费用方面的差别,阳性切缘组与阴性切缘组的术后并发症总发生率,冰冻病理与石蜡病理相符率。结果 751例病例中,阴性切缘组共565例(75.2%),阳性切缘组共186例(24.8%),其中有31例(4.1%)患者经历二次手术,非二次手术病例中,有155例(20.6%)首次切缘状态冰冻病理切片提示阳性,再次取切缘后获得阴性切缘状态。阳性切缘组与阴性切缘组的年龄、肿瘤组织学类型、肿瘤大小比较,差异有统计学意义(P<0.05);阳性切缘组与阴性切缘组的活检方式、淋巴结分期、是否有淋巴管血管/神经侵犯、组织学分级、激素受体状态、Her-2状态、Ki-67状态情况比较,差异无统计学意义(P>0.05)。多因素Logistic回归分析显示,年龄≥40岁、更大的肿瘤直径(T_3)、肿瘤类型中的浸润性小叶癌为阳性切缘的危险因素(P<0.05)。阳性切缘组患者的手术时间长于阴性切缘组,手术费用、病理化验费用均高于阴性切缘组,差异有统计学意义(P<0.05)。有进行二次手术患者的手术时间长于未进行二次手术,手术费用、病理化验费用均高于未进行二次手术,差异有统计学意义(P<0.05)。阳性切缘组患者的并发症总发生率为0.4%(3/751),与阴性切缘组的0.8%(6/751)比较,差异无统计学意义(P>0.05)。751例冰冻病理结果显示,706例(94.0%)冰冻病理切片与石蜡病理结果相符合。结论冰冻病理切片作为保乳手术中对切缘评估的一种手段,有着快速、准确率高的优势,而且患者二次手术率低,能节省其手术时间、手术费用、住院天数等住院成本。但如何进一步提高其准确率以及关于切缘大小的标准仍有待进一步探讨。

Objective To explore the clinical role of frozen pathological section in the evaluation of breast cancer during breast conserving surgery. Methods The clinical data of 751 cases of patients who underwent the breast conserving surgery and used the frozen pathological section as intraoperative margin assessment from December 2011 to July 2017 were retrospectively analyzed. The incidence of positive margins, secondary surgery rate and relevant factors of positive margins were analyzed. The difference between the positive margin group and the negative margin group as well as the second surgery and non-secondary surgery in terms of operation time, operation cost and pathological examination cost, the total incidence rate of postoperative complications in the positive margin group and the negative margin group , and coincidence rate of frozen pathology and paraffin pathology were compared. Results Of the 751 cases, 565 (75.2%) were in the negative margin group, and 186 (24.8%) were in the positive margin group, of which 31 (4.1%) experienced secondary surgery, and in non-secondary surgery, 155 cases (20.6%) of the frozen pathological section showed positive in the first marginal state, and the negative margin was obtained after the margin was taken again. There were significant differences in the age, tumor histology and tumor size between the positive margin group and the negative margin group (P<0.05). There were not significant differences in the biopsy pattern, lymph node staging, lymph vessel vascular/neural invasion, histological grade, hormone receptor status, Her-2 status and Ki-67 status between the positive margin group and the negative margin group (P>0.05). Multivariate Logistic regression analysis showed that age≥40 years, larger tumor diameter (T3) and invasive lobular carcinoma of tumor type were risk factors for positive margin (P<0.05). The operation time of the positive margin group was longer than that of the negative margin group, the costs of surgery and pathological examination were higher than those of the negative margin group, and the differences were statistically significant (P<0.05). The operation time in the second surgery was longer than that in the non-secondary surgery, the costs of surgery and pathological examination were higher than those in the non-secondary surgery, and the differences were statistically significant (P<0.05). The total incidence rate of complications in the positive margin group was 0.4%(3/751), which was not statistically significant compared with 0.8%(6/751) in the negative margin group (P>0.05). The results of 751 frozen pathological findings showed that 706 (94.0%) frozen pathological sections were consistent with the pathological results of paraffin. Conclusion As a means of assessing the margin in the breast conserving surgery, the frozen pathological section has the advantages of high speed and high accuracy, and the patients′ secondary operation rate is low, which can save the hospitalization costs such as operation time, operation cost and hospitalization days. However, how to further improve its accuracy and the criteria for the size of the cutting edge remains to be further explored.