示踪用盐酸米托蒽醌注射液与核素用于乳腺癌前哨淋巴结活检的疗效对比研究

Compared the efficacy of mitoxantrone hydrochloride injection for tracing with radionuclide in sentinel lymph node biopsy of breast cancer

背景与目的:国内外指南均推荐核素用作前哨淋巴结活检术(sentinel lymph node biopsy,SLNB)示踪剂,但多种原因导致该技术在国内未得到普及。示踪用盐酸米托蒽醌注射液(mitoxantrone hydrochloride injection for tracing,MHI)是一种新型乳腺癌前哨淋巴结(sentinel lymph node,SLN)示踪剂,其在乳腺癌SLNB中的效果尚未明确。本研究是一项大样本阳性对照临床试验,旨在评价MHI和核素在SLNB中的示踪差异。方法:试验纳入了2019年12月—2020年7家医院的早期乳腺癌患者。所有入组的早期乳腺癌患者均在手术前注射MHI和核素作为SLN示踪剂。分别统计MHI和核素的SLN检出数量和SLN检出率,分析两种示踪剂示踪效果的差异。结果:MHI的SLN检出率为96.9%(370/382),核素的SLN检出率为97.4%(372/382),两者检出率差异无统计学意义(P>0.05)。两种示踪剂共同检测到362例(94.7%)受试者的SLN;16例(4.1%)发生可能与试验药物相关的不良事件。结论:本研究发现MHI示踪效果不劣于核素。且MHI的使用无需特殊仪器/设备辅助。

Background and purpose:Both domestic and foreign guidelines recommend the use of radionuclide as sentinel lymph node(SLN)biopsy(SLNB)tracer,however this technique has not been popularized in China for a variety of reasons.Mitoxantrone hydrochloride injection for tracing(MHI),a new strategy to identify lymph nodes,has not been tested for axillary node staging in breast cancer.This multicenter,self-controlled,non-inferiority trial aimed to evaluate the differences between MHI and radionuclide in SLNB tracing.Methods:The trial was conducted across 7 hospitals from December 2019 to December 2020.Patients with early-stage breast cancer received MHI and radionuclide(technetium 99 labeled sulfur colloid,99mTc-Sc)as SLN tracers during the surgery.The number of SLNs detected and sentinel node detection rates of MHI and radionuclide were counted to evaluate differences in the tracing effects between the two tracers.Results:SLN detection rates of MHI and radionuclide were 96.9%(370/382)and 97.4%(372/382),respectively,with no significant difference(P>0.05).SLNs were co-detected by both tracers in 362(94.7%)patients;16(4.1%)had adverse events possibly related to the trial drugs.Conclusion:In this study,it was found that the lymphatic tracing ability of MHI was not inferior to that of radionuclide.Meanwhile,the use of MHI does not require special instrument/equipment assistance.