Objective: To 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. Methods: A 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. Results: The 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). Conclusion: MHI 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.
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。.