Randomized clinical trial comparing blue dye with combined dye and isotope for sentinel lymph node biopsy in breast cancer
Randomized clinical trial comparing blue dye with combined dye and isotope for sentinel lymph node biopsy in breast cancer
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DOI：
10.1002/bjs.5211
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发表时间：
2005-12-01
影响因子：
9.6
通讯作者：
Yip, AWC
中科院分区：
文献类型：
--
作者：
Hung, WK;Chan, CM;Yip, AWC
背景资料：单独使用蓝色染料作为前哨淋巴结（SLN）活检的标记物是有效的，但将其与同位素标记相结合可以提高成功率。同位素的使用增加了额外的成本，并且存在潜在的辐射危害。这两种技术进行了比较，在一个随机trial.Methods：妇女早期乳腺癌（小于3厘米），没有可触及的腋窝淋巴结被招募。年龄超过70岁的多中心癌症或既往乳房或腋窝手术的女性被排除在外。患者被随机分配到单独使用蓝色染料或联合使用蓝色染料进行SLN活检。所有妇女有一个层次I和H腋窝淋巴结活检后。结果：共招募了123例患者，其中5人被排除在分析。57名妇女单独使用蓝色染料，61名妇女联合使用。两个队列的基线人口统计学数据相似。SLN活检的成功率联合标测比单独使用蓝色染料更高（100%对86%; P = 0.002）。准确性和假阴性率相似（准确性为100%的联合映射与98%的蓝色染料;假阴性率为0与5%H.CONCLUSION：联合映射是优于上级单独蓝色染料在识别SLN，但准确性和假阴性率相似。
Background: Use of blue dye alone as a marker for sentinel lymph node (SLN) biopsy is effective, but combining it with isotope marking can improve the success rate. Use of the isotope adds extra cost and there are potential radiation hazards. The two techniques were compared in a randomized trial.Methods: Women with early breast cancer (less than 3 cm) and no palpable axillary nodes were recruited. Women older than 70 years with multicentric cancers or previous surgery to the breast or axilla were excluded. Patients were randomized to either blue dye alone or combined mapping for SLN biopsy. All women had a level I and H axillary dissection after the SLN biopsy.Results: A total of 123 patients were recruited, of whom five were excluded from analysis. Blue dye alone was used in 57 women and 61 had combined mapping. Baseline demographic data were similar in the two cohorts. The success rate of SLN biopsy was higher with combined mapping than with blue dye alone (100 versus 86 per cent; P = 0.002). The accuracy and false-negative rate were similar (accuracy 100 per cent for combined mapping versus 98 per cent for blue dye; false-negative rate 0 versus 5 per cent).Conclusion: Combined mapping was superior to blue dye alone in identification of the SLN, but accuracy and false-negative rates were similar.