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ENGLISH ABSTRACT
新型示踪剂盐酸米托蒽醌在甲状腺癌根治术中淋巴结显影的应用探究
程宇
张爽
刘智伟
刘莉莉
王毅
顾建华
作者及单位信息
·
DOI: 10.3760/cma.j.cn115330-20240518-00287
Application of mitoxantrone hydrochloride in lymph node imaging during radical thyroidectomy
Cheng Yu
Zhang Shuang
Liu Zhiwei
Liu Lili
Wang Yi
Gu Jianhua
Authors Info & Affiliations
Cheng Yu
Department of Thyroid, Breast and Hernia Surgery, Tianjin First Central Hospital, Tianjin 300192, China
Zhang Shuang
Department of Pediatrics, Tianjin Dongli Hospital, Tianjin 300399, China
Liu Zhiwei
Department of Plastic and Burn Surgery, Tianjin First Central Hospital, Tianjin 300192, China
Liu Lili
Department of Thyroid, Breast and Hernia Surgery, Tianjin First Central Hospital, Tianjin 300192, China
Wang Yi
Department of Thyroid, Breast and Hernia Surgery, Tianjin First Central Hospital, Tianjin 300192, China
Gu Jianhua
Department of Thyroid, Breast and Hernia Surgery, Tianjin First Central Hospital, Tianjin 300192, China
·
DOI: 10.3760/cma.j.cn115330-20240518-00287
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摘要

目的探讨新型示踪剂盐酸米托蒽醌(mitoxantrone hydrochloride injection for tracing,MHI)在甲状腺癌根治术中颈部淋巴结的显影效果以及辅助甲状旁腺、喉返神经识别中的临床价值。

方法采用前瞻性对照研究的方法于2022年1月至2024年4月间在天津市第一中心医院招募甲状腺癌病例180例,男性54例,女性126例,年龄26~69岁。随机分为盐酸米托蒽醌淋巴结示踪组(MHI组)、纳米炭淋巴结示踪组(纳米炭组)、无淋巴结示踪剂组(空白组),每组60例。3组患者均行全甲状腺切除及区域淋巴清扫,记录一般临床指标,对比淋巴结的检出数目、阳性转移情况、术野清晰度、甲状旁腺识别率及误切情况,分析不同时间点血清钙、甲状旁腺素(PTH)以及并发症情况。采用单因素方差分析、卡方检验和两独立样本非参数检验等统计学方法,分析3组病例的评估指标。

结果MHI组和纳米炭组手术时间、颈部引流量、住院时间显著低于空白组( P值均˂0.05)。MHI组染色程度评分、示踪成功率、术野清晰度评分均显著高于纳米炭组( P值均˂0.05)。MHI组淋巴结清扫数目、阳性转移数目、甲状旁腺识别率均显著高于纳米炭组和空白组;MHI组和纳米炭组甲状旁腺误切率均显著低于空白组( P值均˂0.05)。术后1 d、5 d,MHI组血钙、PTH水平均显著高于纳米炭组和空白组;但术后1 d纳米炭组与空白组血钙水平无差异( P>0.05),纳米炭组PTH水平高于空白组,术后5 d纳米炭组上述两指标水平均高于空白组( P值均˂0.05);术后30 d,MHI组血钙、PTH水平与纳米炭组比较无差异( P值均>0.05)。MHI组和纳米炭组颜面部麻木、手足搐搦、饮水呛咳风险均低于空白组( P值均˂0.05)。

结论MHI在甲状腺癌根治术区域淋巴清扫中可发挥快速靶向递送、染色术野清晰的优势,可有效降低喉返神经及甲状旁腺副损伤风险。

甲状腺肿瘤;颈淋巴结清扫术;盐酸米托蒽醌;淋巴结示踪剂;甲状旁腺损伤
ABSTRACT

ObjectiveTo investigate the clinical application value of the new tracer mitoxantrone hydrochloride in imaging of cervical lymph nodes and identifying of parathyroid, recurrent laryngeal nerve during thyroid cancer radical surgery.

MethodsA prospective controlled study was conducted between January 2022 and April 2024 at Tianjin First Central Hospital, recruiting 180 patients with thyroid cancer, including 54 males and 126 females, aged from 26 to 69 years. The patients were randomly divided into three groups: the mitoxantrone hydrochloride lymph node tracing group (MHI group), the nanocarbon lymph node tracing group (nanocarbon group), and the control group without lymph node tracers, with 60 cases in each group. All patients underwent total thyroid resection and regional lymph node dissection. The number of detected lymph nodes and positive metastatic lymph nodes and surgical field clarity scores and the identification rate of parathyroid glands and the instances of inadvertent excision were compared between the groups. Serum calcium and parathyroid hormone (PTH) levels at different perioperative time points and treatment-related complications were analyzed. One-way ANOVA, chi-square test and two independent sample non-parametric tests, were employed for statistical analyses.

ResultsThe mean operation time, neck drainage volume and hospital stay in the MHI group and the nanocarbon group were respectively significantly lower than those in the control group ( P<0.05). The mean staining intensity score, tracer success rate and surgical field clarity score in MHI group were respectively significantly higher than those in nanocarbon group ( P<0.05). The mean numbers of dissected lymph nodes positive metastatic nodes and identification rates of parathyroid glands in MHI group were respectively significantly higher than those in both the nanocarbon and control groups ( P<0.05). The rates of inadvertent parathyroid excision in both MHI group and nanocarbon group were significantly lower than those in control group ( P<0.05). On postoperative day 1 and day 5, mean serum calcium and PTH levels in MHI group were respectively significantly higher than those in nanocarbon group and control groups. However, on postoperative day 1, there was no difference in mean serum calcium levels between the nanocarbon group and the control group ( P>0.05), though PTH level in the nanocarbon group was higher than that in the control group. By postoperative day 5, both serum calcium and PTH levels were higher in the nanocarbon group compared to the control group ( P<0.05). On postoperative days 30, there were no differences in serum calcium and PTH levels between the MHI group and the nanocarbon group ( P>0.05). The risks of facial numbness, hand and foot tetany and choking during drinking were lower in both the MHI and nanocarbon groups compared to the control group ( P<0.05).

ConclusionMHI demonstrates advantages in rapid targeted delivery and clear staining of the surgical field during regional lymph node dissection in radical thyroidectomy for thyroid cancer, effectively reducing the risk of collateral damage to the recurrent laryngeal nerve and parathyroid glands.

Thyroid neoplasms;Neck dissection;Mitoxantrone hydrochloride;Lymph node tracer;Parathyroid injury
Gu Jianhua, Email: mocdef.3ab61021auhnaijug
引用本文

程宇,张爽,刘智伟,等. 新型示踪剂盐酸米托蒽醌在甲状腺癌根治术中淋巴结显影的应用探究[J]. 中华耳鼻咽喉头颈外科杂志,2024,59(10):1064-1071.

DOI:10.3760/cma.j.cn115330-20240518-00287

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甲状腺癌(thyroid carcinoma,TC)是一种常见的内分泌系统恶性肿瘤,其病理类型以甲状腺乳头状癌(papillary thyroid carcinoma,PTC)为主,尽管恶性程度较低,但早期易发生区域性淋巴结转移 1。美国国立综合癌症网络(NCCN)指南表明,PTC患者初诊时颈部淋巴结转移率为20%~30%,其中28%~33%无法在术前影像学检查或术中检查发现,仅在术后病理中才得到证实,因此区域性淋巴结彻底清扫在TC外科治疗中至关重要 2。如何提高区域性淋巴结清扫的彻底性,同时避免副损伤成为改善TC治疗现状、提高患者预后的关键问题。
2021年,示踪剂盐酸米托蒽醌(mitoxantrone hydrochloride injection for tracing,MHI)作为一种新型生物自组装纳米晶示踪剂首次经国家药品监督管理局(National Medical Products Administration,NMPA)批准用于甲状腺术区淋巴结显影,在提高甲状旁腺和喉返神经辨识方面提供一种临床新方案 3;但作为新型淋巴结示踪剂,国内外对其临床应用报道均较少。因此,本研究拟探讨MHI在TC根治术中的应用价值及临床优势,旨在为临床推广提供循证依据。
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备注信息
A
顾建华,Email: mocdef.3ab61021auhnaijug
B

程宇:论文撰写、病例资料收集、外科手术操作、统计分析;张爽:病例资料收集及数据整理、统计学分析;刘智伟:数据采集、统计学分析、数据结果解释、论文修改;刘莉莉:围手术期护理指导、病例资料收集;王毅:外科手术指导;顾建华:论文构思、外科手术操作、论文修改

C
程宇, 张爽, 刘智伟, 等. 新型示踪剂盐酸米托蒽醌在甲状腺癌根治术中淋巴结显影的应用探究[J]. 中华耳鼻咽喉头颈外科杂志, 2024, 59(10): 1064-1071. DOI: 10.3760/cma.j.cn115330-20240518-00287.
D
所有作者声明无利益冲突
E
北京健康促进会甲状腺中青年医生研究项目 (BJHPA-2022-JZHXZHQNYJ-LCH-12)
天津市科技计划项目 (23JCYBJC01730)
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