亚甲蓝联合吲哚菁绿示踪乳腺癌前哨淋巴结活检的临床研究
发布时间：2018-08-13 16:17
【摘要】：目的对照亚甲蓝联合吲哚菁绿染色示踪前哨淋巴结活检与传统亚甲蓝示踪前哨淋巴结活检在早期乳腺癌病患中的临床效果,探讨更为合理的先于腋窝外科处理的前哨淋巴结示踪方法,从而为临床应用提供依据。方法临床对照研究,入组2013-12至2016-12因早期乳腺癌须要手术且行前哨淋巴结活检的病患224例。术前诊断基于B超引导下弹针穿刺活检,常规病理及免疫组化证实。入组标准:(1)第六版美国癌症委员会(AJCC)临床Ⅰ期或Ⅱa期的早期乳腺癌女性病患;(2)乳腺单侧单发灶;(3)腋淋巴结术前无临床上可疑转移;(4)患侧腋窝未行过放疗或手术治疗;(6)术前未行局部放疗或(和)新辅助化学药物治疗;(7)患者及家属知情同意协商一致,自愿签署相关术前文件。排除标准:(1)继发性乳腺癌,Ⅱa期(不含)以后,多发病灶,男性乳腺癌;(2)术前临床上或病理诊断存有转移阳性腋淋巴结者;(3)术前曾行乳腺或(和)腋淋巴结局部放疗者(或)和接受新辅助化疗者;(4)既往有诸如隆胸、缩胸等乳腺重大手术史或腋窝手术史。术前15分钟将4ml亚甲蓝溶液皮下注射于乳晕区或原发恶性癌肿周围,在常规消毒铺巾后于乳晕区外上象限皮下注射1mL 10倍稀释后的吲哚菁绿,1-3 min后,关手术灯,开荧光脉管系统成像仪,找寻从注射部位至腋窝荧光显影的淋巴管,将荧光显影淋巴管消失处皮肤标记,于标记点切开皮肤、分离皮下脂肪组织,荧光脉管显影仪再次探测到的亮染荧光剂汇聚处即为吲哚菁绿示踪SLNs,定位并取出。而后取出亚甲蓝示踪蓝染的SLNs。定义全数吲哚菁绿亮染及亚甲蓝蓝染淋巴结为联合染色示踪组的前哨淋巴结(sentinel lymphnode,SLNs)。经典亚甲蓝示踪组,亚甲蓝注射方式同上,术中循蓝染淋巴管仔细分离,示踪剂汇聚所至蓝染淋巴结为亚甲蓝示踪组的前哨淋巴结(sentinel lymph node,SLNs)。纵然所有淋巴结快速病理证实阴性都清扫了至少levelⅡ水平的腋窝淋巴结。如若其中任何一个淋巴结癌转移改行腋窝淋巴结清扫术。术中腋窝淋巴结清除以胸小肌为界,分为三组:Ⅰ水平组(胸小肌外侧组);Ⅱ水平组(胸小肌后组);Ⅲ水平组(胸小肌内侧组)。根据患者术前病情评估与术前谈话知情意愿行全乳切除或保乳手术,术后根据患者一般情况及基本病理情况选取诸如全身静脉化疗、局部放疗、口服药物内分泌治疗、曲妥珠单抗生物靶向治疗等个体化综合性辅助治疗。根据前哨淋巴结以及腋窝补充清扫腋淋巴结的各自术后常规病理结果,对照分析联合示踪法和传统蓝染示踪前哨淋巴结活检准确性、假阴性率、检出个数、检出率的差别,同时探讨前哨淋巴结检出枚数与假阴性率之间的关系。结果1.106名病患亚甲蓝联合吲哚菁绿示踪前哨淋巴结活检而118名病患传统蓝染示踪前哨淋巴结活检,术后未发现与吲哚菁绿及亚甲蓝有关的诸如皮瓣坏死,过敏,感染等不良反应,两组病患一般情况及术后病理情况差异统计学上均无意义(P0.05)。2.传统亚甲蓝组检出率90.68%(107/118),检出SLNs1～4枚不等。联合吲哚菁绿示踪前哨淋巴结检出率为98.11%(104/106),检出SLNs 1～7枚不等,其中亚甲蓝示踪SLNs99例成功,检出率93.40%(99/106),同时荧光剂示踪SLNs 101例成功,检出率95.28%(101/106)。3.术后病理证实亚甲蓝组6人前哨淋巴结假阴性,灵敏度88.24%,准确度85.98%,假阴性率11.76%。联合组则为4人,灵敏度92.30%,准确度86.54%,假阴性率7.69%。4.成功完成SLNB的211例早期乳腺癌病患中,前哨淋巴结取出数≤2枚共104人,有8人假阴性,假阴性率17.78%。取出数≥3枚者107人,假阴性病例2人,假阴性率3.45%。结论1、亚甲蓝及联合示踪法均能稳定进行SLNB,较准确评估腋窝淋巴结乳腺癌累积侵蚀状态。2、联合吲哚菁绿示踪前哨淋巴结活检与传统亚甲蓝组相较检出率及检出个数较高而假阴性率有降低趋势,评估腋窝淋巴结状态可选取联合吲哚菁绿示踪SLNs。3、联合染色示踪法简单易掌握,术后与之相关的不良事件少,具有较好的安全稳定性和临床适用前景
[Abstract]:Objective To compare the clinical effect of methylene blue combined with indocyanine green staining in sentinel lymph node biopsy and traditional methylene blue staining in early breast cancer, and to explore a more reasonable method of sentinel lymph node tracing prior to axillary surgery, so as to provide a basis for clinical application. From December 2013 to December 2016, 224 women with early stage breast cancer underwent surgery and sentinel lymph node biopsy. Preoperative diagnosis was based on ultrasound-guided bullet needle biopsy, routine pathological and immunohistochemical confirmation. Single lesion; (3) no clinically suspicious metastasis of axillary lymph node before operation; (4) no radiotherapy or surgical treatment of the affected axillary; (6) no local radiotherapy or (and) neoadjuvant chemotherapy before operation; (7) patients and their families informed consent consensus, voluntary signing of relevant preoperative documents. Male breast cancer; (2) preoperative clinical or pathological diagnosis of positive axillary lymph node metastasis; (3) preoperative breast or (and) axillary lymph node local radiotherapy (or) and receiving neoadjuvant chemotherapy; (4) previous major breast surgery or axillary surgery such as breast augmentation, thymectomy history. 15 minutes before surgery 4 ml methylene blue solution subcutaneous Injected into the areola area or around the primary malignant tumor, injected 1 mL 10 times diluted indocyanine green subcutaneously in the upper quadrant of the areola area after routine disinfection and toweling. After 1-3 minutes, turn off the operation light, open the fluorescent angiography system, look for the lymphatic vessels from the injection site to the axillary fluorescence imaging, and mark the lymphatic vessels where the lymphatic vessels disappear. The SLNs stained with indocyanine green were located and removed at the confluence of brightly stained fluorescent agents detected by fluorescence angiography, and then the SLNs stained with methylene blue were removed. All the SLNs stained with indocyanine green and methylene blue were defined as sentinel lymph nodes (sen lymph nodes) in the combined staining group. Tinel lymph node, SLNs. classical methylene blue tracer group, methylene blue injection method the same, intraoperative careful separation of blue-stained lymphatic vessels, tracer convergence to blue-stained lymph nodes as methylene blue tracer Group sentinel lymph nodes (SLNs). Although all lymph nodes quickly pathologically proved negative were cleared at least level of level of level II axillary lymph nodes. If one of the lymph nodes metastases, axillary lymph node dissection should be performed. The axillary lymph node dissection should be done by the pectoralis minor muscles. The patients were divided into three groups: level I group (lateral pectoralis minor muscle group), level II group (posterior pectoralis minor muscle group), and level III group (medial pectoralis minor muscle group). Total mastectomy or breast-conserving surgery is performed. Individualized comprehensive adjuvant therapies such as systemic intravenous chemotherapy, local radiotherapy, oral drug endocrine therapy, and trastuzumab targeted biotherapy are selected according to the patient's general condition and basic pathological conditions. Routine postoperative clearance of axillary lymph nodes is performed according to sentinel lymph nodes and axillary complement. The accuracy, false negative rate, number and detection rate of sentinel lymph node biopsy with combined tracing and traditional blue staining were compared and analyzed. The relationship between the number of sentinel lymph node detection and false negative rate was also discussed. Results 1 106 patients were biopsy with methylene blue combined with indocyanine green tracing and 118 patients were transmitted. No adverse reactions related to indocyanine green and methylene blue, such as flap necrosis, allergy, infection, etc. were found after sentinel lymph node biopsy. There was no significant difference in general condition and postoperative pathological condition between the two groups (P 0.05). 2. The detection rate of SLNs in the traditional methylene blue group was 90.68% (107/118). The detection rate of SLNs was 98.11%(104/106), and 1-7 SLNs were detected. 99 SLNs were successfully detected with methylene blue (93.40%(99/106), and 101 SLNs were successfully detected with fluorescent agent (95.28%(101/106). 3. Postoperative pathology confirmed that the false negative rate of SLNs was 88.24%, and the accuracy was 85.9%. In the combined group, the sensitivity, accuracy and false negative rate were 92.30%, 86.54% and 7.69%. 4. Among 211 patients with early breast cancer who successfully completed SLNB, 104 had less than 2 sentinel lymph nodes removed, 8 had false negative, and the false negative rate was 17.78%. 107 patients had more than 3 lymph nodes removed, 2 had false negative cases, and the false negative rate was 3.45%. SLNB could be performed stably with blue and combined tracing methods, which could accurately assess the aggregation of axillary lymph node breast cancer. 2. Compared with traditional methylene blue group, SLNB with indocyanine green tracing had a higher detection rate and a lower false negative rate. Ns.3, combined staining tracer method is easy to master, less adverse events associated with it after surgery, with good safety and stability and clinical application prospects.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R737.9
[Abstract]:Objective To compare the clinical effect of methylene blue combined with indocyanine green staining in sentinel lymph node biopsy and traditional methylene blue staining in early breast cancer, and to explore a more reasonable method of sentinel lymph node tracing prior to axillary surgery, so as to provide a basis for clinical application. From December 2013 to December 2016, 224 women with early stage breast cancer underwent surgery and sentinel lymph node biopsy. Preoperative diagnosis was based on ultrasound-guided bullet needle biopsy, routine pathological and immunohistochemical confirmation. Single lesion; (3) no clinically suspicious metastasis of axillary lymph node before operation; (4) no radiotherapy or surgical treatment of the affected axillary; (6) no local radiotherapy or (and) neoadjuvant chemotherapy before operation; (7) patients and their families informed consent consensus, voluntary signing of relevant preoperative documents. Male breast cancer; (2) preoperative clinical or pathological diagnosis of positive axillary lymph node metastasis; (3) preoperative breast or (and) axillary lymph node local radiotherapy (or) and receiving neoadjuvant chemotherapy; (4) previous major breast surgery or axillary surgery such as breast augmentation, thymectomy history. 15 minutes before surgery 4 ml methylene blue solution subcutaneous Injected into the areola area or around the primary malignant tumor, injected 1 mL 10 times diluted indocyanine green subcutaneously in the upper quadrant of the areola area after routine disinfection and toweling. After 1-3 minutes, turn off the operation light, open the fluorescent angiography system, look for the lymphatic vessels from the injection site to the axillary fluorescence imaging, and mark the lymphatic vessels where the lymphatic vessels disappear. The SLNs stained with indocyanine green were located and removed at the confluence of brightly stained fluorescent agents detected by fluorescence angiography, and then the SLNs stained with methylene blue were removed. All the SLNs stained with indocyanine green and methylene blue were defined as sentinel lymph nodes (sen lymph nodes) in the combined staining group. Tinel lymph node, SLNs. classical methylene blue tracer group, methylene blue injection method the same, intraoperative careful separation of blue-stained lymphatic vessels, tracer convergence to blue-stained lymph nodes as methylene blue tracer Group sentinel lymph nodes (SLNs). Although all lymph nodes quickly pathologically proved negative were cleared at least level of level of level II axillary lymph nodes. If one of the lymph nodes metastases, axillary lymph node dissection should be performed. The axillary lymph node dissection should be done by the pectoralis minor muscles. The patients were divided into three groups: level I group (lateral pectoralis minor muscle group), level II group (posterior pectoralis minor muscle group), and level III group (medial pectoralis minor muscle group). Total mastectomy or breast-conserving surgery is performed. Individualized comprehensive adjuvant therapies such as systemic intravenous chemotherapy, local radiotherapy, oral drug endocrine therapy, and trastuzumab targeted biotherapy are selected according to the patient's general condition and basic pathological conditions. Routine postoperative clearance of axillary lymph nodes is performed according to sentinel lymph nodes and axillary complement. The accuracy, false negative rate, number and detection rate of sentinel lymph node biopsy with combined tracing and traditional blue staining were compared and analyzed. The relationship between the number of sentinel lymph node detection and false negative rate was also discussed. Results 1 106 patients were biopsy with methylene blue combined with indocyanine green tracing and 118 patients were transmitted. No adverse reactions related to indocyanine green and methylene blue, such as flap necrosis, allergy, infection, etc. were found after sentinel lymph node biopsy. There was no significant difference in general condition and postoperative pathological condition between the two groups (P 0.05). 2. The detection rate of SLNs in the traditional methylene blue group was 90.68% (107/118). The detection rate of SLNs was 98.11%(104/106), and 1-7 SLNs were detected. 99 SLNs were successfully detected with methylene blue (93.40%(99/106), and 101 SLNs were successfully detected with fluorescent agent (95.28%(101/106). 3. Postoperative pathology confirmed that the false negative rate of SLNs was 88.24%, and the accuracy was 85.9%. In the combined group, the sensitivity, accuracy and false negative rate were 92.30%, 86.54% and 7.69%. 4. Among 211 patients with early breast cancer who successfully completed SLNB, 104 had less than 2 sentinel lymph nodes removed, 8 had false negative, and the false negative rate was 17.78%. 107 patients had more than 3 lymph nodes removed, 2 had false negative cases, and the false negative rate was 3.45%. SLNB could be performed stably with blue and combined tracing methods, which could accurately assess the aggregation of axillary lymph node breast cancer. 2. Compared with traditional methylene blue group, SLNB with indocyanine green tracing had a higher detection rate and a lower false negative rate. Ns.3, combined staining tracer method is easy to master, less adverse events associated with it after surgery, with good safety and stability and clinical application prospects.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R737.9
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