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示踪用盐酸米托蒽醌注射液在经口腔前庭入路机器人甲状腺切除术中应用：一项前瞻性随机对照研究
罗府, 张刚, 郭翎佶, 姜燕, 于帆, 徐静, 黄煜舒, 汪玲俐, 严洁, 徐琰
中国实用外科杂志 ›› 2026, Vol. 46 ›› Issue (6) : 804-809.
PDF(1840 KB)
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示踪用盐酸米托蒽醌注射液在经口腔前庭入路机器人甲状腺切除术中应用：一项前瞻性随机对照研究
Application of mitoxantrone hydrochloride injection for tracing in transoral robotic thyroid cancer surgery: a prospective randomized controlled study
目的 评价示踪用盐酸米托蒽醌注射液（MHI）在经口腔前庭入路机器人甲状腺切除术中辅助中央区淋巴结清扫及甲状旁腺保护的有效性与安全性。方法 采用前瞻性、单中心、随机对照临床试验设计，纳入2024年2月至2025年11月陆军军医大学大坪医院乳腺甲状腺外科接受经口腔前庭入路机器人甲状腺切除术的病人114例，按1∶1随机分为试验组和对照组，每组57例。试验组术中向甲状腺腺体多点注射MHI，对照组不使用淋巴示踪剂。比较两组中央区淋巴结清扫数目、阳性淋巴结检出数、甲状旁腺误切率、术后甲状旁腺激素（PTH）及血钙水平变化、术后并发症和不良反应发生情况。结果 两组基线资料差异均无统计学意义。试验组中央区淋巴结清扫数目多于对照组[6.0（4.0，9.0 ） vs. 5.0（3.0，7.0）枚，P=0.022]；阳性淋巴结检出数[1.0（0.0,2.0）vs. 0.0（0.0,2.0）枚， P=0.518]差异无统计学意义。试验组中央区淋巴结染色率为88.6%，阳性淋巴结示踪率为91.6%。试验组甲状旁腺误切率低于对照组[3.5%（2/57）vs.10.5%（6/57）]，但差异无统计学意义（P=0.271）。两组术后第1天、第7天PTH及血钙水平差异均无统计学意义，暂时性甲状旁腺功能减退、暂时性低钙血症、感染及喉返神经损伤发生率差异均无统计学意义（均P>0.05）。结论 MHI用于经口腔前庭入路机器人甲状腺切除术具有较好的中央区淋巴结示踪效果，可增加中央区淋巴结清扫数目，且未增加术后并发症；其可减少甲状旁腺误切的临床增益尚未达到统计学意义，仍需多中心、大样本研究进一步验证。
Objective To evaluate the efficacy and safety of mitoxantrone hydrochloride injection for tracing (MHI) in assisting central lymph node dissection and parathyroid gland protection during transoral robotic thyroidectomy. Methods A prospective, single-center, and randomized controlled clinical trial was conducted. A total of 114 patients who underwent transoral robotic thyroidectomy at the Department of Breast and Thyroid Surgery, Daping Hospital, Army Medical University, between February 2024 and November 2025 were enrolled and randomly assigned at a 1∶1 ratio to the experimental group and the control group, with 57 patients in each group. MHI was injected intraoperatively into the thyroid gland at multiple sites in the experimental group, whereas no lymphatic tracer was used in the control group. The number of dissected central lymph nodes, number of positive lymph nodes detected, rate of inadvertent parathyroidectomy, postoperative changes in parathyroid hormone (PTH) and serum calcium levels, postoperative complications, and adverse reactions were compared between the two groups. Results There were no statistically significant differences in the baseline characteristics between the two groups. The number of dissected central lymph nodes was higher in the experimental group than in the control group [6.0 (4.0, 9.0) vs. 5.0 (3.0, 7.0), P=0.022]. The number of detected positive lymph nodes [1.0 (0.0, 2.0) vs. 0.0 (0.0, 2.0), P=0.518] was not statistically significant. In the experimental group, the staining rate of central lymph nodes was 88.6%, and the tracing rate of positive lymph nodes was 91.6%. The rate of inadvertent parathyroidectomy was lower in the experimental group than in the control group [3.5% (2/57) vs.10.5% (6/57)], but the difference was not statistically significant (P=0.271). No statistically significant differences were observed between the two groups in PTH or serum calcium levels on postoperative days 1 and 7, or in the incidence of transient hypoparathyroidism, transient hypocalcemia, infection, and recurrent laryngeal nerve injury (all P>0.05). Conclusion MHI has a favorable central lymph node tracing effect in transoral robotic thyroidectomy, increases the number of dissected central lymph nodes, and does not increase postoperative complications. Its clinical benefit in inadvertent parathyroid excision has not reached statistical significance and needs to be further validated in multicenter studies with larger sample sizes.
甲状腺癌 / 示踪用盐酸米托蒽醌注射液 / 经口腔前庭入路机器人甲状腺切除术 / 淋巴结清扫 / 甲状旁腺
thyroid cancer / mitoxantrone hydrochloride injection for tracing / transoral robotic thyroidectomy / lymph node dissection / parathyroid gland
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The long-term survival of patients with thyroid cancer and the possibility of tumour recurrence up to 30-40 years after the achievement of a disease-free status illustrate the importance of lifelong follow-up in these individuals. This Review discusses the most innovative aspects of follow-up protocols for patients with differentiated thyroid cancer, that is, of papillary or follicular hystotype, and those with medullary thyroid cancer. Particular focus is placed on the relevance of new ultrasensitive assays for thyroglobulin measurement and the option of using recombinant human TSH to stimulate thyroglobulin secretion. Methods to compensate for the loss of diagnostic significance of serum thyroglobulin levels in patients with differentiated thyroid cancer and circulating anti-thyroglobulin antibodies are highlighted, as well as the role of the postoperative calcitonin stimulation test and the clinical relevance of determining the doubling time of calcitonin and carcinoembryonic antigen in patients with medullary thyroid cancer. Moreover, this Review gives some insights into the role of molecular thyroid cancer testing, both for prognostic and for therapeutic purposes. Finally, a general overview of traditional imaging procedures, such as neck ultrasonography, CT, MRI and bone scintigraphy, is provided alongside a comparison with new nuclear imaging tests such as PET.
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The identification and preservation of parathyroid glands (PGs) during thyroid surgery can be challenging. Many techniques have been developed to help surgeons find PGs. We have developed a novel mitoxantrone hydrochloride injection that can be used for lymphatic targeting. After local application during surgery, mitoxantrone hydrochloride injection for tracing (MHI) helps surgeons better identify and preserve PGs and helps pathologists find more lymph nodes. We conducted an open-label, multicenter, randomized clinical trial (CTR20171137) in six centers in China from 08/2017 to 12/2018. Patients with thyroid carcinoma were randomized to the MHI group or the control group. All patients received total thyroidectomy and bilateral central compartment lymph node dissection. The primary outcomes were the PG resection rate and lymph node staining rate. The full analysis set (FAS) included 461 patients, of which 228 were assigned to the MHI group, and 233 were assigned to the control group. The PG resection rates of the MHI group and the control group were 6.6% (15/228) and 26.6% (62/233), respectively, with a significant difference (P < 0.001). No PGs were stained blue with MHI. The central lymph nodes were stained blue with MHI, and the staining rate was 90.5%±12.0%. More lymph nodes were detected in the MHI group than in the control group (13.0±7.3 vs. 10.1±6.4 nodes/patient, P < 0.001). No adverse events related to MHI were observed. MHI is a safe and effective tracer that may help to preserve PGs and identify more central lymph nodes in patients with thyroid cancer.AJCR Copyright © 2022.
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