Division of Cancer Studies, King's College, London, UK.
Guy's and St Thomas' Hospitals NHS Foundation Trust, London, UK.
Br J Surg. 2016 Oct;103(11):1409-19. doi: 10.1002/bjs.10283. Epub 2016 Sep 9.
BACKGROUND: The standard for sentinel lymph node biopsy (SLNB), the dual technique (radiolabelled tracer and blue dye), has several drawbacks. A novel magnetic technique without these drawbacks has been evaluated in a number of clinical trials. It uses a magnetic tracer and a handheld magnetometer to identify and excise sentinel lymph nodes. A systematic review and meta-analysis was performed to assess the performance and utility of the magnetic in comparison to the standard technique. METHODS: MEDLINE, PubMed, Embase and the Cochrane online literature databases were used to identify all original articles evaluating the magnetic technique for SLNB published up to April 2016. Studies were included if they were prospectively conducted clinical trials comparing the magnetic with the standard technique for SLNB in patients with breast cancer. RESULTS: Seven studies were included. The magnetic technique was non-inferior to the standard technique (z = 3·87, P < 0·001), at a 2 per cent non-inferiority margin. The mean identification rates for the standard and magnetic techniques were 96·8 (range 94·2-99·0) and 97·1 (94·4-98·0) per cent respectively (risk difference (RD) 0·00, 95 per cent c.i. -0·01 to 0·01; P = 0·690). The total lymph node retrieval was significantly higher with the magnetic compared with the standard technique: 2113 (1·9 per patient) versus 2000 (1·8 per patient) (RD 0·05, 0·03 to 0·06; P = 0·003). False-negative rates were 10·9 (range 6-22) per cent for the standard technique and 8·4 (2-22) per cent for the magnetic technique (RD 0·03, 0·00 to 0·06; P = 0·551). The mean discordance rate was 3·9 (range 1·7-6·9) per cent. CONCLUSION: The magnetic technique for SLNB is non-inferior to the standard technique, with a high identification rate but with a significantly higher lymph node retrieval rate.
背景:前哨淋巴结活检(SLNB)的标准,即双技术(放射性示踪剂和蓝色染料),存在一些缺点。一种新型的无这些缺点的磁性技术已在多项临床试验中进行了评估。它使用磁性示踪剂和手持式磁强计来识别和切除前哨淋巴结。进行了系统评价和荟萃分析,以评估磁性技术与标准技术相比的性能和实用性。
方法:使用 MEDLINE、PubMed、Embase 和 Cochrane 在线文献数据库,检索截至 2016 年 4 月发表的所有评估用于 SLNB 的磁性技术的原始文章。如果前瞻性临床试验将磁性技术与乳腺癌患者的标准技术进行比较,则纳入研究。
结果:纳入了 7 项研究。磁性技术与标准技术相比非劣效(z = 3.87,P < 0.001),在 2%的非劣效性边界内。标准技术和磁性技术的平均识别率分别为 96.8(范围 94.2-99.0)和 97.1(94.4-98.0)%(差异 0.00,95%置信区间 -0.01 至 0.01;P = 0.690)。与标准技术相比,磁性技术的总淋巴结检出率显著更高:2113(1.9 个/患者)与 2000(1.8 个/患者)(差异 0.05,0.03 至 0.06;P = 0.003)。标准技术的假阴性率为 10.9(范围 6-22)%,磁性技术的假阴性率为 8.4(2-22)%(差异 0.03,0.00 至 0.06;P = 0.551)。平均不一致率为 3.9(范围 1.7-6.9)%。
结论:用于 SLNB 的磁性技术与标准技术相比非劣效,具有较高的识别率,但淋巴结检出率显著更高。
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