OʼReilly Elma Anna, Prichard Ruth S, Al Azawi Dhafir, Aucharaz Nitin, Kelly Gabrielle, Evoy Denis, Geraghty James, Rothwell Jane, OʼDoherty Ann, Quinn Cecily, Skehan Stephen J, McDermott Enda W
Department of *Surgery, St Vincent's Healthcare Group, Elm Park, Dublin 4, Ireland †School of Mathematical Sciences, University College Dublin, Dublin 4, Ireland; and Departments of ‡Radiology, and §Pathology, St Vincent's Healthcare Group, Elm Park, Dublin 4, Ireland.
Ann Surg. 2015 Aug;262(2):243-8. doi: 10.1097/SLA.0000000000001213.
Sentinel lymph node biopsy (SLNB) has become the gold standard for axillary staging. Debate remains as to the optimal method of SLN detection.
Determine whether patients undergoing an SLNB required the addition of isosulfan blue dye to radioisotope when an SLN was identified on a preoperative lymphoscintigram.
A prospective randomized controlled trial comparing the combination of radioisotope and blue dye versus radioisotope alone was performed between March 2010 and September 2012. The trial protocol was registered with Current Controlled Trials. Women with clinically and radiologically node-negative breast cancer with a positive preoperative lymphoscintigram were eligible for inclusion.
A total of 667 patients were included in the analysis with 342 patients receiving the combination (blue dye and radioisotope) and 325 patients receiving radioisotope alone. The groups were evenly matched both demographically and pathologically. The mean age was 48 years (48.3 vs 47.7 years; P = 0.47), the mean tumour size was 24.2 mm (24.3 mm vs 24.1 mm; P = 0.7) and there was no statistically significant difference in the grade of the tumors between the 2 groups (P = 0.58). There was no difference in the identification rate, nor was that in the number of nodes retrieved between the 2 groups (P = 0.30). There was no difference in the number of positive lymph nodes that were identified between the 2 groups (23.8% vs 22.1%; P = 0.64).
This study failed to demonstrate an advantage with the addition of isosulfan blue dye to radioisotope in the identification of the SLN in the presence of a positive preoperative lymphoscintigram.
前哨淋巴结活检（SLNB）已成为腋窝分期的金标准。关于前哨淋巴结（SLN）检测的最佳方法仍存在争议。
确定在前哨淋巴结术前淋巴闪烁造影中发现SLN时，接受SLNB的患者是否需要在放射性同位素基础上加用异硫蓝染料。
2010年3月至2012年9月进行了一项前瞻性随机对照试验，比较放射性同位素与蓝色染料联合使用与单独使用放射性同位素的效果。该试验方案已在“当前对照试验”中注册。临床和影像学检查腋窝淋巴结阴性且术前淋巴闪烁造影阳性的乳腺癌女性患者符合纳入标准。
共有667例患者纳入分析，其中342例接受联合治疗（蓝色染料和放射性同位素），325例仅接受放射性同位素治疗。两组在人口统计学和病理学方面均衡匹配。平均年龄为48岁（48.3岁对47.7岁；P = 0.47），平均肿瘤大小为24.2毫米（24.3毫米对24.1毫米；P = 0.7），两组肿瘤分级无统计学显著差异（P = 0.58）。两组在识别率上无差异，所获取淋巴结数量也无差异（P = 0.30）。两组之间识别出的阳性淋巴结数量无差异（23.8%对22.1%；P = 0.64）。
本研究未能证明在术前淋巴闪烁造影阳性的情况下，在放射性同位素基础上加用异硫蓝染料在识别SLN方面具有优势。
