核素联合亚甲蓝示踪法在国内乳腺癌前哨淋巴结活检中应用价值的Meta分析

Application value of radioisotope combined with methylene blue dye in sentinel lymph node biopsy of breast cancer in China:a Meta-analysis

背景与目的前哨淋巴结活检(SLNB)已经是临床腋窝阴性早期乳腺癌患者的标准诊疗手段,SLNB是否成功,与示踪剂的选择有密切关系。核素和亚甲蓝示踪是临床上应用最广泛的两种示踪剂,但由于中国的SLNB应用晚于国外,目前的调查研究发现仅14.55%的医院使用核素联合亚甲蓝双示踪法,62.73%的医院仍主要是亚甲蓝单示踪法。对联合使用示踪剂的汇总研究较少。本研究通过Meta分析的方法评价核素联合亚甲蓝双示踪法在国内乳腺癌SLNB中的应用价值。方法检索万方、中国知网、维普数据库,Pubmed和Cochrane Library自建库至2020年12月公开发表的,并来自中国医疗机构开展的关于乳腺癌SLNB中核素联合亚甲蓝双示踪法与亚甲蓝单示踪法的对比研究的文献。严格按照纳入和排除标准筛选文献,对纳入文献进行数据提取,使用RevMan5.4软件进行Meta分析,比较两种示踪法的前哨淋巴结检出率,前哨淋巴结的检出数目,假阴性率,灵敏度,准确率的差异,用漏斗图评价发表偏倚。结果最终纳入18篇中文文献,均为国内医疗机构研究。Meta分析结果显示,对比亚甲蓝单示踪法,核素联合亚甲蓝双示踪法的前哨淋巴结检出率(OR=5.81,95%CI=4.04~8.37,P<0.00001)、灵敏度(OR=3.35,95%CI=2.17~5.17,P<0.00001)和准确率(OR=3.45,95%CI=2.20~5.41,P<0.00001)明显增加;假阴性率(OR=0.26,95%CI=0.17~0.39,P<0.00001)明显降低。使用18篇文献报道的前哨淋巴结检出率的漏斗图显示发表偏倚的可能性小。结论核素联合亚甲蓝双示踪法在国内乳腺癌SLNB中具有较好的应用价值。有望在国内各大医院普及。

Background and Aims Sentinel lymph node biopsy(SLNB)has become a standard treatment method for early breast cancer patients with negative axillary lymph nodes.The success or not of SLNB is closely related to the choice of tracer.Radioisotope and methylene blue are the two most widely used tracers in clinical practice.However,because the application of SLNB in China is lagged behind as compared to other countries,the current investigation showed that only 14.55%hospitals use the double-tracer technique of radioisotope plus methylene blue dye,with 62.73%hospitals still mainly use the single tracer method of methylene blue dye.There are few summary studies on the combined use of tracers.This study was conducted to evaluate the application value of radioisotope plus methylene blue dye method in SLNB of breast cancer in China by Meta-analysis.Methods The publicly published studies comparing using radioisotope plus methylene blue dye and single methylene blue dye method in SLNB performed by Chinese medical institutes were searched in Wangfang Data,CNKI,VIP database,Pubmed and Cochrane Library from the inception to December 2020.The literature was screened strictly according to the inclusion and exclusion criteria,and the data of the included studies were extracted.Meta-analysis was carried out by Revman 5.4 software,and the differences in the detection rate and detection number of sentinel lymph nodes(SLNs),as well as the false negative rate,sensitivity and accuracy rate between the two methods were compared.The publication bias was evaluated by funnel plot.Results A total of 18 studies were finally included,and all of them were domestic studies.Meta-analysis results showed that the identification rate of SLNs(OR=5.81,95%CI=4.04-8.37,P<0.00001),sensitivity(OR=3.35,95%CI=2.17-5.17,P<0.00001)and accuracy rate(OR=3.45,95%CI=2.20-5.41,P<0.00001)were significantly increased and the false negative rate(OR=0.26,95%CI=0.17-0.39,P<0.00001)was significantly decreased by using method of radioisotope plus methylene blue dye compared with the single methylene blue tracer method.The detection rates of SLNs reported in the 18 articles were used to assess publication bias,and the funnel plot showed that a low possibility of publication bias.Conclusion Radioisotope combined with methylene blue dye method has good application value in SLNB of breast cancer in China.It is expected to be widely used in majority of hospitals in China.