示踪剂乳晕皮内单点注射示踪乳腺癌前哨淋巴结的前瞻性随机对照研究

A prospective randomized controlled study of single intradermal injection of tracer to the sentinel lymph node of breast cancer

目的探讨乳腺癌前哨淋巴结活检使用示踪剂乳晕皮内单点注射方案的可行性。方法选取2017年6月起连续入住甘肃省肿瘤医院确诊的早期乳腺癌患者为研究对象,以99mTc-亚锡植酸钠(99mTc-PHY)和美兰(MB)作为前哨淋巴结活检(s SLNB)示踪剂,采用随机数字表法将入组患者分为A组和B组,A组:示踪剂于患侧乳晕区皮内单点注射(注射剂量:99mTc-PHY 0.2ml,比强度1mCi/ml;MB 2ml);B组:示踪剂乳晕及瘤周皮内3、6、9、12点方向注射(注射剂量:99mTcPHY 0.4ml,比强度1mCi/ml;MB 4ml)。两组患者均接受SLNB并依据术中前哨淋巴结(SLN)冰冻病理诊断结果判断腋窝淋巴结是否存在肿瘤转移。SLNB后所有患者接受肿瘤原发灶处理及腋窝淋巴结清扫,以淋巴清扫术后石蜡病理结果作为判断腋窝淋巴结状态的金标准。分析示踪成功率、术中SLN检出数量及SLNB诊断准确性。结果研究共入组符合纳入标准的患者126例,其中A组(62例)成功示踪SLN者62例(62/62,100%),术中检出SLN 152枚(均数2.45±1.67);B组(64例)成功示踪SLN者64例(64/64,100%),检出SLN 154枚(均数2.38±1.55)。两组患者术中检出SLN数量比较差异无统计学意义(P>0.05)。诊断准确性指标,A组:ROC曲线下面积(AUC)=0.977±0.026,约登指数(YI)=0.955,灵敏度(SEN)=95.5%,特异度(SPE)=1,阳性预测值(PV+)=1,阴性预测值(PV-)=97.6%,准确率(Ac)=98.4%;B组:AUC=0.984±0.019,YI=0.967,SEN=96.7%,SPE=1,PV+=1,PV-=97.1%,Ac=98.4%。结论在SLNB时采用乳晕皮内单点注射示踪剂的方案能够精确的示踪和定位乳腺癌前哨淋巴结,其判断腋窝淋巴结状态的诊断效能与示踪剂多部位联合注射方案相当。

Objective To investigate the feasibility of single point injection of tracer into areola for sentinel lymph node biopsy of breast cancer.Methods Selection since June 2017 consecutive stay in Gansu Provincial Cancer Hospital diagnosis of early breast cancer patients as the research object,with 99 MTC-stannous phytic acid sodium(99 MTC-PHY)and methylene blue(MB)as sentinel lymph node biopsy(s SLNB)tracer,into the group of patients using the random number table method divided into group A and group B,group A:tracer in the risk of areola area by the side of a single point injection(injection dosage:99 MTC-PHY 0.2 ml,more than 1 MCI/ml intensity;MB 2 ml);Group B:tracer areola periderm and tumor in 3,6,9,12 points direction injection(injection dosage:99 MTC-PHY 0 Yan 4 ml,more than 1 MCI/ml intensity;MB 4 ml).Both groups received SLNB and determined the presence of tumor metastasis in axillary lymph nodes based on the frozen pathological diagnosis of intraoperative sentinel lymph node(SLN).After SLNB,all patients received primary tumor treatment and axillary lymph node dissection,and the paraffin pathological results after lymph node dissection were taken as the gold standard to judge the status of axillary lymph node.The tracer success rate,the number of intraoperative SLN detection and the diagnostic accuracy of SLNB were analyzed.Results A total of 126 patients met the inclusion criteria.Among them,62 cases(62/62,100%)in group A successfully traced SLN,there were 152 SLN were detected during operation(the mean was 2.45±1.67);64 cases(64/64,100%)in group B successfully traced SLN,there were 154 SLN were detected(the mean was 2.38±1.55).There was no significant difference in the number of SLN detected between the two groups(P>0.05).Diagnostic accuracy index,group A:AUC=0.977±0.026,Yi=0.955,SEN=95.5%,SPE=1,PV+=1,PV-=97.6%,Ac=98.4%;group B:AUC=0.984±0.019,Yi=0.967,SEN=96.7%,SPE=1,PV+=1,PV-=97.1%,Ac=98.4%.Conclusion In SLNB,the single intradermal injection of tracer in the areola can accurately trace and locate the sentinel lymph nodes of breast cancer,and its diagnostic efficacy in judging the status of axillary lymph nodes is equivalent to that of the tracer multi-site injection.