亞甲藍聯(lián)合吲哚菁綠示蹤乳腺癌前哨淋巴結(jié)活檢的臨床研究
發(fā)布時間：2018-08-13 16:17
【摘要】：目的對照亞甲藍聯(lián)合吲哚菁綠染色示蹤前哨淋巴結(jié)活檢與傳統(tǒng)亞甲藍示蹤前哨淋巴結(jié)活檢在早期乳腺癌病患中的臨床效果,探討更為合理的先于腋窩外科處理的前哨淋巴結(jié)示蹤方法,從而為臨床應(yīng)用提供依據(jù)。方法臨床對照研究,入組2013-12至2016-12因早期乳腺癌須要手術(shù)且行前哨淋巴結(jié)活檢的病患224例。術(shù)前診斷基于B超引導(dǎo)下彈針穿刺活檢,常規(guī)病理及免疫組化證實。入組標準:(1)第六版美國癌癥委員會(AJCC)臨床Ⅰ期或Ⅱa期的早期乳腺癌女性病患;(2)乳腺單側(cè)單發(fā)灶;(3)腋淋巴結(jié)術(shù)前無臨床上可疑轉(zhuǎn)移;(4)患側(cè)腋窩未行過放療或手術(shù)治療;(6)術(shù)前未行局部放療或(和)新輔助化學藥物治療;(7)患者及家屬知情同意協(xié)商一致,自愿簽署相關(guān)術(shù)前文件。排除標準:(1)繼發(fā)性乳腺癌,Ⅱa期(不含)以后,多發(fā)病灶,男性乳腺癌;(2)術(shù)前臨床上或病理診斷存有轉(zhuǎn)移陽性腋淋巴結(jié)者;(3)術(shù)前曾行乳腺或(和)腋淋巴結(jié)局部放療者(或)和接受新輔助化療者;(4)既往有諸如隆胸、縮胸等乳腺重大手術(shù)史或腋窩手術(shù)史。術(shù)前15分鐘將4ml亞甲藍溶液皮下注射于乳暈區(qū)或原發(fā)惡性癌腫周圍,在常規(guī)消毒鋪巾后于乳暈區(qū)外上象限皮下注射1mL 10倍稀釋后的吲哚菁綠,1-3 min后,關(guān)手術(shù)燈,開熒光脈管系統(tǒng)成像儀,找尋從注射部位至腋窩熒光顯影的淋巴管,將熒光顯影淋巴管消失處皮膚標記,于標記點切開皮膚、分離皮下脂肪組織,熒光脈管顯影儀再次探測到的亮染熒光劑匯聚處即為吲哚菁綠示蹤SLNs,定位并取出。而后取出亞甲藍示蹤藍染的SLNs。定義全數(shù)吲哚菁綠亮染及亞甲藍藍染淋巴結(jié)為聯(lián)合染色示蹤組的前哨淋巴結(jié)(sentinel lymphnode,SLNs)。經(jīng)典亞甲藍示蹤組,亞甲藍注射方式同上,術(shù)中循藍染淋巴管仔細分離,示蹤劑匯聚所至藍染淋巴結(jié)為亞甲藍示蹤組的前哨淋巴結(jié)(sentinel lymph node,SLNs)�？v然所有淋巴結(jié)快速病理證實陰性都清掃了至少levelⅡ水平的腋窩淋巴結(jié)。如若其中任何一個淋巴結(jié)癌轉(zhuǎn)移改行腋窩淋巴結(jié)清掃術(shù)。術(shù)中腋窩淋巴結(jié)清除以胸小肌為界,分為三組:Ⅰ水平組(胸小肌外側(cè)組);Ⅱ水平組(胸小肌后組);Ⅲ水平組(胸小肌內(nèi)側(cè)組)。根據(jù)患者術(shù)前病情評估與術(shù)前談話知情意愿行全乳切除或保乳手術(shù),術(shù)后根據(jù)患者一般情況及基本病理情況選取諸如全身靜脈化療、局部放療、口服藥物內(nèi)分泌治療、曲妥珠單抗生物靶向治療等個體化綜合性輔助治療。根據(jù)前哨淋巴結(jié)以及腋窩補充清掃腋淋巴結(jié)的各自術(shù)后常規(guī)病理結(jié)果,對照分析聯(lián)合示蹤法和傳統(tǒng)藍染示蹤前哨淋巴結(jié)活檢準確性、假陰性率、檢出個數(shù)、檢出率的差別,同時探討前哨淋巴結(jié)檢出枚數(shù)與假陰性率之間的關(guān)系。結(jié)果1.106名病患亞甲藍聯(lián)合吲哚菁綠示蹤前哨淋巴結(jié)活檢而118名病患傳統(tǒng)藍染示蹤前哨淋巴結(jié)活檢,術(shù)后未發(fā)現(xiàn)與吲哚菁綠及亞甲藍有關(guān)的諸如皮瓣壞死,過敏,感染等不良反應(yīng),兩組病患一般情況及術(shù)后病理情況差異統(tǒng)計學上均無意義(P0.05)。2.傳統(tǒng)亞甲藍組檢出率90.68%(107/118),檢出SLNs1～4枚不等。聯(lián)合吲哚菁綠示蹤前哨淋巴結(jié)檢出率為98.11%(104/106),檢出SLNs 1～7枚不等,其中亞甲藍示蹤SLNs99例成功,檢出率93.40%(99/106),同時熒光劑示蹤SLNs 101例成功,檢出率95.28%(101/106)。3.術(shù)后病理證實亞甲藍組6人前哨淋巴結(jié)假陰性,靈敏度88.24%,準確度85.98%,假陰性率11.76%。聯(lián)合組則為4人,靈敏度92.30%,準確度86.54%,假陰性率7.69%。4.成功完成SLNB的211例早期乳腺癌病患中,前哨淋巴結(jié)取出數(shù)≤2枚共104人,有8人假陰性,假陰性率17.78%。取出數(shù)≥3枚者107人,假陰性病例2人,假陰性率3.45%。結(jié)論1、亞甲藍及聯(lián)合示蹤法均能穩(wěn)定進行SLNB,較準確評估腋窩淋巴結(jié)乳腺癌累積侵蝕狀態(tài)。2、聯(lián)合吲哚菁綠示蹤前哨淋巴結(jié)活檢與傳統(tǒng)亞甲藍組相較檢出率及檢出個數(shù)較高而假陰性率有降低趨勢,評估腋窩淋巴結(jié)狀態(tài)可選取聯(lián)合吲哚菁綠示蹤SLNs。3、聯(lián)合染色示蹤法簡單易掌握,術(shù)后與之相關(guān)的不良事件少,具有較好的安全穩(wěn)定性和臨床適用前景
[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.
【學位授予單位】：山東大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：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.
【學位授予單位】：山東大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R737.9
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