^(99)Tc^m标记的亚锡植酸钠在乳腺癌腋窝前哨淋巴结活检术中的应用

Application of ^(99)Tc^m labeled sodium phytate and stannous chloride injection to sentinel lymph node biopsy in axillary of early breast cancer

目的早期乳腺癌前哨淋巴结活检术(sentinel lymph node biopsy,SLNB)已成为欧美国家和我国少部分医院乳腺癌腋窝淋巴结分期的标准或常规治疗模式。但目前定位前哨淋巴结(sentinel lymph node,SLN)最常用的核素载体硫胶体(sulfur colloidal,SC)在国内属于非国药准字号试剂,对临床常规开展SLNB造成巨大的困难和阻碍。本研究探讨亚锡植酸钠(sodium phytate and stannous chioride for injection,PHY)替代SC作为核素载体对乳腺癌腋窝SLN的示踪效果及其安全性。方法甘肃省肿瘤医院乳腺科2013-02-01-2014-12-30收治的经病理确诊临床分期为cTis-3N0-1M0的120例早期乳腺癌患者,术前行超声造影引导穿刺SLN及淋巴门结构偏移或消失的淋巴结送细胞学检查,初步排除腋淋巴结转移的患者,根据随机数字表法随机分为试验组和对照组,在术前分别使用99 Tcm-PHY及99 Tcm-SC注射于肿物四周及表面皮下、患侧乳晕皮下进行SLN示踪。术中联合亚甲蓝染料双示踪,检出SLN并单独送细胞学、术中冷冻,遂进一步行腋窝淋巴结清除,术后将SLN和非前哨淋巴结(nSLN)送病理检查。以美国Louisville大学对SLNB技术的计算率为评价标准,非劣效标准界值。结果试验组SLN检出率为100.0%,SLN蓝染率为99.5%,SLN检出灵敏度88.9%,特异度94.1%,准确率93.3%,假阴性率11.1%,假阳性率5.9%,阳性准确率66.7%,阴性准确率92.3%,阳性结果预测率72.7%,阴性结果预测率97.9%;对照组SLN检出率为100.0%,SLN蓝染率为98.9%,灵敏度85.7%,特异度92.5%,准确率91.7%,假阴性率14.3%,假阳性率7.5%,阳性准确率54.5%,阴性准确率90.7%,阳性结果预测率60.0%,阴性结果预测率98.0%。经非劣效性检验统计学分析提示,试验组与对照组特异度、准确率、假阳性率均P值<0.05。所有患者经14~36个月的随访,均未出现局部腋窝淋巴结复发及远处转移。结论 PHY可作为安全、有效的核素载体进行早期乳腺癌腋窝SLNB,可达到良好的SLN示踪效果。

OBJECTIVE Sentinel lymph node biopsy（SLNB）has become the European and American countries and a small number of hospitals in our country for early breast cancer of axillary lymph node staging criteria or conventional treatment mode.As a result of intraoperative nuclide looking for SLNS carrier of the most commonly used sulfur colloidal（SC）detected in China belong to the national medicine kind reagent,the clinical routine in SLNB caused great difficulties and obstacles.Sodium phytate and stannous chioride for injection（PHY）is often used for the preparation of clinical technetium^99Tc^m phytic acid salt injection nuclide carrier,this study explore alternative SC PHY as nuclide carrier in early breast cancer axillary SLNS tracer effect detected and its safety.METHODS This study collected on 2013-02-01-2014-12-30 in Gansu Province Tumor Hospital treated by pathological diagnosis of mammary gland of clinical staging for cT_（is-3）N_0M_0,120 cases of early breast cancer patients,preoperative line contrast-enhanced ultrasound guided puncture SLN and hilus structure deviation detected or disappear of lymph nodes send cytology,preliminary excluded patients with axillary lymph node metastasis,were randomly divided into experimental group and control group according to random number table,using ^99Tc^m-PHY and ^99Tc^m-SC,respectively,in preoperative SC surface subcutaneous injection in the neoplasm,with lateral areola subcutaneous SLN tracer detected.Intraoperative joint methylene blue dye double tracer,check out the SLN and separate the cytology detected,intraoperative frozen,hence further lines of axillary lymph node cleaning,after sending SLN,the nSLN detected pathologic examination.At the university of Louisville the computing rate of SLNB technology as evaluation standard,the bad effect standard value（delta）was set to 5%.RESULTS Experimental group sentinel lymph node detection rate was 100.0%,the sentinel aizen rate was 99.5%,the sentinel lymph node detection sensitivity was 88.9%,specific degree 94.1%,93.3% accuracy,false negative rate was 11.1%,false positive rate of 5.9%,positive rate 66.7%,negative 92.3% accuracy rate,positive rate 72.7% prediction results,negative results predict the rate of 97.9%.Control group sentinel lymph node detection rate was 100.0%,the sentinel aizen rate was 98.9%,sensitivity 85.7%,specific degree 92.5%,91.7% accuracy,false negative rate was 14.3%,false positive rate of 7.5%,positive rate 54.5%,negative 90.7% accuracy rate,positive rate 60.0% prediction results,negative result prediction rate was 98.0%.Not bad effect by statistical analysis：the experimental group and control group specific degrees,accuracy and false positive rate all P values 0.05,the experimental group was not inferior to the control group.All of the patients after 14-36 months of outpatient service and telephone follow-up,no local recurrence of axillary lymph node and distant metastasis occurred.CONCLUSIONS PHY can serve as a safe and effective carrier of nuclide axillary SLNB for early breast cancer,can achieve good effect of SLNS tracer detected,but the false negative rate and sensitivity are not inferior to SC,still need to be constantly added the number of cases,it is concluded that a more scientific and reliable data support.