Abstract：
BACKGROUND: Evaluation of axillary lymph nodes status in cN0 axilla is performed by sentinel lymph node biopsy (SLNB) utilizing a combination of radioactive isotope and blue dye or alternative to isotope like Indocyanine green (ICG). Both are very resource-intensive; which has prompted development of low-cost technique of Fluorescein Sodium (FS)-guided SLNB. This systematic review and meta-analysis evaluate the diagnostic performance of FS-guided SLNB in early breast cancer.
OBJECTIVE: The objective was to evaluate the diagnostic performance of FS for sentinel lymph node biopsy.
METHODS: Eligibility criteria: Studies where SLNB was performed using FS.
METHODS: PubMed, EMBASE, Cochrane library and online clinical trial registers. Risk of bias: Articles were assessed for risk of bias using the QUADAS-2 tool.
RESULTS: The main summary measures were pooled Sentinel Lymph Node Identification Rate (SLN-IR) and pooled False Negative Rate (FNR) using random-effects model.
RESULTS: A total of 45 articles were retrieved by the initial systematic search. 7 out of the 45 studies comprising a total of 332 patients were included in the meta-analysis. The pooled SLN-IR was 93.2% (95% confidence interval [CI], 0.87-0.97; 87% to 97%). Five validation studies were included for pooling the false negative rate and included a total of 211 patients. The pooled FNR was 5.6% (95% confidence interval [CI], 2.9-9.07).
CONCLUSIONS: Fluorescein-guided SLNB is a viable option for detection of lymph node metastases in clinically node negative patients with early breast cancer. It achieves a high pooled Sentinel Lymph Node Identification Rate (SLN-IR) of 93% with a false negative rate of 5.6% for the detection of axillary lymph node metastasis.
OBJECTIVE: The objective was to evaluate the diagnostic performance of FS for sentinel lymph node biopsy.
METHODS: Eligibility criteria: Studies where SLNB was performed using FS.
METHODS: PubMed, EMBASE, Cochrane library and online clinical trial registers. Risk of bias: Articles were assessed for risk of bias using the QUADAS-2 tool.
RESULTS: The main summary measures were pooled Sentinel Lymph Node Identification Rate (SLN-IR) and pooled False Negative Rate (FNR) using random-effects model.
RESULTS: A total of 45 articles were retrieved by the initial systematic search. 7 out of the 45 studies comprising a total of 332 patients were included in the meta-analysis. The pooled SLN-IR was 93.2% (95% confidence interval [CI], 0.87-0.97; 87% to 97%). Five validation studies were included for pooling the false negative rate and included a total of 211 patients. The pooled FNR was 5.6% (95% confidence interval [CI], 2.9-9.07).
CONCLUSIONS: Fluorescein-guided SLNB is a viable option for detection of lymph node metastases in clinically node negative patients with early breast cancer. It achieves a high pooled Sentinel Lymph Node Identification Rate (SLN-IR) of 93% with a false negative rate of 5.6% for the detection of axillary lymph node metastasis.
摘要：
背景：cN0腋下腋窝淋巴结状态的评估是通过前哨淋巴结活检（SLNB）利用放射性同位素和蓝色染料的组合或同位素的替代品如吲哚菁绿（ICG）进行的。两者都非常资源密集型；这促进了低成本荧光素钠（FS）引导的SLNB技术的发展。这项系统评价和荟萃分析评估了FS指导的SLNB在早期乳腺癌中的诊断性能。
目的：目的是评估FS对前哨淋巴结活检的诊断性能。
方法：合格标准：使用FS进行SLNB的研究。
方法：PubMed，EMBASE,Cochrane图书馆和在线临床试验登记册。偏倚风险：使用QUADAS-2工具评估文章的偏倚风险。
结果：主要的总结措施是使用随机效应模型的合并前哨淋巴结识别率（SLN-IR）和合并假阴性率（FNR）。
结果：初步系统检索共检索到45篇。45项研究中有7项包括总共332名患者，纳入了荟萃分析。合并的SLN-IR为93.2%(95%置信区间[CI]，0.87-0.97；87%至97%）。包括五项验证研究以汇集假阴性率，总共包括211名患者。合并的FNR为5.6%(95%置信区间[CI]，2.9-9.07)。
结论：荧光素引导的SLNB是检测临床淋巴结阴性早期乳腺癌患者淋巴结转移的可行选择。它实现了93％的高合并前哨淋巴结识别率（SLN-IR），用于检测腋窝淋巴结转移的假阴性率为5.6％。
目的：目的是评估FS对前哨淋巴结活检的诊断性能。
方法：合格标准：使用FS进行SLNB的研究。
方法：PubMed，EMBASE,Cochrane图书馆和在线临床试验登记册。偏倚风险：使用QUADAS-2工具评估文章的偏倚风险。
结果：主要的总结措施是使用随机效应模型的合并前哨淋巴结识别率（SLN-IR）和合并假阴性率（FNR）。
结果：初步系统检索共检索到45篇。45项研究中有7项包括总共332名患者，纳入了荟萃分析。合并的SLN-IR为93.2%(95%置信区间[CI]，0.87-0.97；87%至97%）。包括五项验证研究以汇集假阴性率，总共包括211名患者。合并的FNR为5.6%(95%置信区间[CI]，2.9-9.07)。
结论：荧光素引导的SLNB是检测临床淋巴结阴性早期乳腺癌患者淋巴结转移的可行选择。它实现了93％的高合并前哨淋巴结识别率（SLN-IR），用于检测腋窝淋巴结转移的假阴性率为5.6％。
