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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 standard or conventional treatment modality for breast cancer axillary lymph node staging in a few hospitals in Europe and the United States. Currently, however, the most commonly used sulfur colloidal (SC) targeting sentinel lymph node (SLN) belongs to non-Chinese medicine quasi-size reagent in China, which poses great difficulties and impediments to the routine clinical practice of SLNB. This study was aimed to investigate the tracing effect and safety of sodium phytate and stannous chioride for injection (SLP) on axillary lymph node metastasis of breast cancer using SC as a radionuclide carrier. Methods Gansu Provincial Tumor Hospital breast cancer 2013-02-01-2014-12-30 Totally 120 patients with early stage breast cancer who were clinically diagnosed as cTis-3N0-1M0 by pathology were treated with ultrasound contrast guided SLN and lymphopexy The lymph node metastases or disappeared were sent to cytology examination. The patients with axillary lymph node metastasis were initially excluded. According to the random number table, they were randomly divided into experimental group and control group. 99 Tcm-PHY and 99 Tcm-SC were injected Surrounding the tumor and the surface of subcutaneous, ipsilateral sore SLN subcutaneous SLN tracer. Intraoperative combination of methylene blue dye dual tracing, SLN was detected and sent to cytology alone, intraoperative frozen, and then further axillary lymph node clearance, postoperative SLN and non sentinel lymph node (nSLN) sent pathology. To the United States Louisville University of SLNB technology computing rate as the evaluation criteria, non-inferiority standard threshold. Results The detection rate of SLN was 100.0%, the SLN blue staining rate was 99.5%, the SLN detection sensitivity was 88.9%, the specificity was 94.1%, the accuracy rate was 93.3%, the false negative rate was 11.1% and the false positive rate was 5.9% The positive rate was 66.7%, the negative rate was 92.3%, the positive rate was 72.7%, the negative rate was 97.9%. The SLN detection rate was 100.0%, the SLN blue dye rate was 98.9%, the sensitivity was 85.7% and the specificity was 92.5% , The accuracy rate was 91.7%, the false negative rate was 14.3%, the false positive rate was 7.5%, the positive rate was 54.5%, the negative rate was 90.7%, the positive rate was 60.0%, and the negative rate was 98.0%. The non-inferiority test statistical analysis suggested that the test group and control group specificity, accuracy, false positive rate were P value <0.05. All patients after 14 to 36 months of follow-up, did not appear local axillary lymph node recurrence and distant metastasis. Conclusion PHY can be used as a safe and effective radionuclide carrier for axillary SLNB in early stage breast cancer, which can achieve good SLN tracing effect.