吲哚菁绿在乳腺癌手术切缘评估和范围定位中的有效性、安全性探索：一项单中心、观察性队列研究

吕刚; 王光庆; 郑炎; 唐琴; 陈飞; 俞旭东; 许盛琪; 汤发扬; 朱际飚

doi:10.19401/j.cnki.1007-3639.2025.08.006

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吲哚菁绿在乳腺癌手术切缘评估和范围定位中的有效性、安全性探索：一项单中心、观察性队列研究

论著 | 更新时间：2025-12-31

- 吲哚菁绿在乳腺癌手术切缘评估和范围定位中的有效性、安全性探索：一项单中心、观察性队列研究
- Exploration of the efficacy and safety of indocyanine green in the evaluation and localization of breast cancer surgical margins: a single-center, observational cohort study
- 中国癌症杂志 2025年35卷第8期页码：776-783
- 作者机构：
  
  1. 安徽医科大学第四附属医院（附属巢湖医院）甲乳外科，安徽合肥 238000
  2. 安徽医科大学第四附属医院（附属巢湖医院）病理科，安徽合肥 238000
  3. 合肥市第一人民医院全科医学科，安徽合肥 230092
- 作者简介：
  
  [ "吕刚（ORCID：0009-0006-8218-6874），硕士，主治医师，安徽医科大学第四附属医院（附属巢湖医院）甲乳外科科助理。" ]
  朱际飚（ORCID：0009-0007-4277-9074），主任医师，安徽医科大学第四附属医院（附属巢湖医院）甲乳外科主任。
- 基金信息：
  
  安徽医科大学校科研基金(2020xkj054)
- DOI：10.19401/j.cnki.1007-3639.2025.08.006
  中图分类号： R737.9
- 收稿：2024-12-01，
  
  修回：2025-07-19，
  
  纸质出版：2025-08-30
- 稿件说明：
移动端阅览
吕刚, 王光庆, 郑炎, 等. 吲哚菁绿在乳腺癌手术切缘评估和范围定位中的有效性、安全性探索：一项单中心、观察性队列研究[J]. 中国癌症杂志, 2025,35(8):776-783.

Gang LÜ, Guangqing WANG, Yan ZHENG, et al. Exploration of the efficacy and safety of indocyanine green in the evaluation and localization of breast cancer surgical margins: a single-center, observational cohort study[J]. China Oncology, 2025, 35(8): 776-783.
吕刚, 王光庆, 郑炎, 等. 吲哚菁绿在乳腺癌手术切缘评估和范围定位中的有效性、安全性探索：一项单中心、观察性队列研究[J]. 中国癌症杂志, 2025,35(8):776-783. DOI： 10.19401/j.cnki.1007-3639.2025.08.006.

Gang LÜ, Guangqing WANG, Yan ZHENG, et al. Exploration of the efficacy and safety of indocyanine green in the evaluation and localization of breast cancer surgical margins: a single-center, observational cohort study[J]. China Oncology, 2025, 35(8): 776-783. DOI： 10.19401/j.cnki.1007-3639.2025.08.006.

摘要

背景与目的：

乳腺癌手术治疗中，切缘状态的评估对于患者的预后具有重要影响，其中切缘阳性意味着较高的复发及转移风险，确保肿瘤的彻底切除成为手术成功的核心要素。在此背景下，吲哚菁绿（indocyanine green，ICG）在近红外光照射下能够实时成像乳腺癌病灶的潜力引起了研究者的关注。据此，本研究采用ICG进行术中乳腺癌病灶切缘状态的评估，并进一步探讨优化乳腺癌病灶周围正常乳腺组织切缘安全距离的可能性。

方法：

回顾性分析2021年12月—2022年9月安徽医科大学第四附属医院（附属巢湖医院）甲状腺乳腺外科收治的接受保乳手术的乳腺癌患者的临床资料并根据是否采用了ICG和常规手术进行分组。ICG组患者在开始前2~3 h，按照0.5 mg/kg的剂量通过外周静脉注射ICG。手术过程中，对标本切除前后以及残腔进行术中荧光影像拍摄。同时，利用近红外线荧光成像设备对切除的病灶在12、3、6、9点共4个方向进行荧

光强度定量取值，以及对病灶切除后残腔的荧光探测。接着，将标本及时进行病理学检查，并记录标本4个方向正常乳腺组织的安全范围。本研究严格遵循《加强流行病学中观察性研究报告质量》指南中的各项条目。本研究获得安徽医科大学第四附属医院（附属巢湖医院）伦理委员会批准（伦理批件编号：KYXM-202310-46）。

结果：

本研究共纳入50例乳腺癌患者，其中ICG组24例，传统手术组26例。在纳入研究的ICG组患者中，均在病灶部位检测到了荧光信号的存在。具体而言，病灶中心、病灶边缘以及病灶周围正常乳腺组织的荧光强度值分别测定为251.08±10.73、208.08±19.74以及156.76±16.47，呈现出由内向外逐渐减弱的趋势，差异有统计学意义（

0.05）。除此之外，在病灶中心与病灶边界、以及病灶中心与病灶周围正常组织之间的荧光比值分别为1.22±0.13和1.62±0.19。病灶切除后，残腔中发现异常荧光的比例为2/24，分别为浸润性癌伴导管内癌和正常乳腺组织。本研究结果示，ICG在切缘判断方面的灵敏度为95.9%，特异度为97.9%。在标本切除后，通过对病灶周围正常腺体组织的安全范围进行测量，ICG组与同期乳腺癌手术组的安全宽度分别为（8.36±6.42）mm和（15.08±4.75）mm，差异有统计学意义（

0.05）。

结论：

ICG作为一种实时、高效且具有经济效益的示踪剂，能够应用于乳腺癌手术切缘的确定，其具备出色的敏感性和特异性。对于符合乳腺保留手术条件的早期乳腺癌患者，该示踪剂有助于缩小病灶周围正常乳腺组织的切除范围。

Abstract

Background and purpose:

In breast cancer surgery

margin status assessment significantly impacts patient prognosis

with positive margins indicating higher recurrence and metastasis risks. Ensuring complete tumor resection is thus critical for surgical success. Indocyanine green (ICG) has garnered attention for its potential real-time imaging of breast cancer lesions under near-infrared light. This study employed ICG for intraoperative assessment of breast cancer lesion margin status and further explored the possibility of optimizing the safe margin distance surround the lesion in normal breast tissue.

Methods:

Clinical data of patients admitted to the Department of Thyroid and Breast Surgery

the Fourth Affiliated Hospital of Anhui Medical University (Affiliated Chaohu Hospital)

from December 2021 to September 2022 were collected. A retrospective clinical study was conducted on breast cancer patients who were randomly assigned to either the ICG group or the conventional surgery group. Two to three hours before surgery

patients in the ICG group received a peripheral intravenous injection of 0.5 mg/kg ICG. Intraoperative fluorescence imaging was performed on the specimen b

efore and after resection

as well as on the residual cavity. Near-infrared fluorescence imaging equipment was used to quantitatively measure fluorescence intensity of resected lesions at 4 directions (12

and 9 o'clock) and detect fluorescence in the residual cavity after lesion removal. Specimens were promptly sent to the pathology department for pathological examination

and safety margins of normal breast tissue in the 4 directions were recorded. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist was followed for this study. This study was approved by the Ethics Committee of the Fourth Affiliated Hospital of Anhui Medical University (Affiliated Chaohu Hospital) (No. KYXM-202310-46).

Results:

This study included 50 breast cancer patients

with 24 in the ICG group and 26 in the traditional surgery group. In the ICG group

fluorescence signals were detected at all lesion sites. Specifically

fluorescence density values at the lesion center

margin

and surrounding normal breast tissue were measured as 251.08±10.73

208.08±19.74

and 156.76±16.47

respectively

showing a gradual decrease from center outward with statistically significant differences (

0.05). Additionally

fluorescence ratios between the lesion center and margin

and center and surrounding normal tissue

were 1.22±0.13 and 1.62±0.19

respectively. After resection

abnormal fluorescence was observed in 2 of 24 cases in the residual cavity

with 1 case being invasive carcinoma with ductal carcinoma

in situ

and the other normal breast tissue. Ultimately

this study demonstrated that ICG achieved a sensitivity of 95.9% and a specificity of 97.9% in margin assessment. After specimen resection

the safety margins of normal glandular tissue surrounding the lesion were measured. The safety widths for the ICG group and the concurrent breast cancer surgery group were (8.36±6.42) mm and (15.08±4.75) mm

respectively. This difference was statistically significant

(

0.05).

Conclusion:

ICG is a real-time

efficient

and cost-effective tracer that can be used to determine breast cancer margins

with excellent sensitivity and specificity. For early-stage breast cancer patients who are eligible for breast-conserving surgery

this tracer helps to reduce the amount of healthy breast tissue that is removed around the lesion.

关键词

Keywords

references

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