示踪剂米托蒽醌和纳米炭在机器人甲状腺癌手术中的应用效果比较
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作者单位:

1.锦州医科大学研究生学院,辽宁 锦州 121001;2.中国人民解放军联勤保障部队第九六〇医院 甲状腺乳腺外科, 山东 济南 250031

作者简介:

张为良,锦州医科大学研究生学院/中国人民解放军联勤保障部队第九六〇医院硕士研究生,主要从事甲状腺、甲状旁腺及乳腺外科临床方面的研究。

基金项目:

山东省医药卫生科技发展计划基金资助项目(202204011069)。


Comparison of the application effects of mitoxantrone versus carbon nanoparticles as tracers in robotic thyroid cancer surgery
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Affiliation:

1.Graduate School of Jinzhou Medical University, Jinzhou, Liaoning 121001, China;2.Department of Thyroid and Breast Surgery, the 960th Hospital of Joint Logistics Support Force of the People's Liberation Army, Jinan 250031, China

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    摘要:

    背景与目的 示踪用盐酸米托蒽醌注射液(MHI)作为一种新型获国家药监局批准应用于甲状腺癌的示踪剂,目前相关报道较少,尚存在较大研究空白。因此,本研究比较MHI和纳米炭两种示踪剂在机器人甲状腺癌根治术中对淋巴结清扫及甲状旁腺保护的效果,以期为临床工作提供新的示踪剂选择。方法 采用前瞻性、随机对照设计,纳入2022年6月—2023年6月于中国人民解放军联勤保障部队第九六〇医院甲状腺乳腺外科行达芬奇机器人甲状腺癌根治术的患者,按照随机数字表法进行分组,将应用MHI的患者纳入研究组,应用纳米炭的患者纳入对照组。统计两组患者Ⅵ区淋巴结示踪数和示踪率,比较两组患者Ⅵ区(±颈侧区)淋巴结清扫总数及阳性数目、手术前后血钙和甲状旁腺激素(PTH)水平、甲状旁腺误切率、甲状旁腺功能减退发生率和暂时性低钙血症发生率以及术后体表注射点是否遗留印记,分析两种示踪剂效果的差异。结果 本研究共纳入99例患者,失访7例,最终92例完成试验,研究组与对照组各46例,两组患者在一般情况方面差异无统计学意义(均P>0.05)。研究组与对照组Ⅵ区淋巴结示踪率分别为97.1%(95% CI=95.7~98.5)和96.4%(95% CI=94.9~97.8),差异无统计学意义(P>0.05)。两组间Ⅵ区淋巴结示踪率差值为0.7%(95% CI=1.2%~2.8%),研究组的Ⅵ区淋巴结示踪率非劣于对照组(95% CI下限≥-10%);研究组和对照组Ⅵ区总淋巴结检出数分别为557枚和630枚(Z=-0.388,P=0.698),阳性淋巴结检出数分别为125枚和92枚(Z=-1.443,P=0.149);两组患者术前与术后1 d、6个月PTH和血钙水平差异均无统计学意义(均P>0.05)。研究组甲状旁腺误切1例,对照组甲状旁腺误切4例,差异无统计学意义(P>0.05);两组患者术后暂时性甲状旁腺功能减退发生率差异无统计学意义(P>0.05),但研究组术后暂时性低钙血症发生率低于对照组(P<0.05);研究组未出现永久性甲状旁腺功能减退,对照组出现永久性甲状旁腺功能减退1例;术后两组均有1例患者遗留体表印记,在术后6个月随访时,研究组患者表示印记已消失,对照组患者仍存留,随访期间无复发病例。结论 在达芬奇机器人甲状腺癌手术中使用MHI可取得和纳米炭混悬注射液相近的淋巴示踪和甲状旁腺保护效果。

    Abstract:

    Background and Aims Methylene blue hydrochloride injection (MHI) for tracing is a new type of tracer approved by the National Medical Products Administration for use in thyroid cancer. There are few related reports at present, leaving significant research gap. Therefore, this study compared the effects of MHI and carbon nanoparticles as tracers on lymph node dissection and parathyroid protection in robot-assisted thyroid cancer surgery, so as to provide new tracer options for clinical work.Methods Using a prospective, randomized controlled design, patients undergoing da Vinci robot-assisted total thyroidectomy in the Department of Thyroid and Breast Surgery, the 960th Hospital of the People's Liberation Army were enrolled between June 2022 to June 2023. Grouping was done using a random number table. Patients receiving MHI were included in the study group, and patients receiving carbon nanoparticles were included in the control group. The number and tracing rate of level Ⅵ lymph nodes in the two groups were recorded and compared. The total number and positive number of level Ⅵ (± lateral neck) lymph node dissections, preoperative and postoperative 1-d and 6-month levels of blood calcium and parathyroid hormone (PTH), rate of inadvertent parathyroidectomy, incidence of hypoparathyroidism, incidence of temporary hypocalcemia after surgery, and whether there were residual marks at the injection site on the skin after surgery were analyzed to compare the differences in the effects of the two tracers.Results A total of 99 patients were included in this study, with 7 lost to follow-up. Finally, 92 patients completed the trial, with 46 in each group. There were no significant differences in general conditions between the two groups (all P>0.05). The lymph node tracing rates in the Ⅵ region were 97.1% (95% CI=95.7-98.5) in the study group and 96.4% (95% CI=94.9-97.8) in the control group, with no significant difference between the groups (P>0.05). The difference in the lymph node tracing rate in the Ⅵ region between the two groups was 0.7% (95% CI=1.2%-2.8%), and the Ⅵ region lymph node tracing rate in the study group was non-inferior to that in the control group (95% CI lower limit ≥-10%). The total number of lymph nodes detected in the Ⅵ region was 557 and 630 in the study and control groups, respectively (Z=-0.388, P=0.698), and the number of positive lymph nodes detected was 125 and 92, respectively (Z=-1.443, P=0.149). There were no statistically significant differences in preoperative and postoperative 1-d and 6-month PTH and blood calcium levels between the two groups (all P>0.05). Inadvertent parathyroidectomy occurred in one case in the study group and 4 cases in the control group, with no significant difference between the groups (P>0.05). There was no significant difference in the incidence of transient hypoparathyroidism after surgery between the two groups (P>0.05), but the incidence of transient hypocalcemia in the study group was lower than that in the control group (P<0.05). There was no permanent hypoparathyroidism in the study group, while one case occurred in the control group. One patient in each group had residual marks on the skin after surgery. During the 6-month follow-up, the marks had disappeared in the study group patient but remained in the control group patient. There were no cases of recurrence during the follow-up period.Conclusion In da Vinci robot-assisted thyroid cancer surgery, the use of MHI for tracing can achieve lymphatic tracing and parathyroid protection effects similar to those of carbon nanoparticles suspension injection.

    表 2 两组患者术后病理情况Table 2 Postoperative pathology of the two groups of patients
    表 4 两组患者术后并发症情况[n(%)]Table 4 Postoperative complications in two groups [n (%)]
    图1 对照组纳米炭注射后体表及术区黑染情况 A:皮肤表面黑染;B:术区黑染Fig.1 Black staining of the skin and operative area after injection of carbon nanoparticles in the control group A: Skin surface staining; B: Operative area staining
    图2 研究组注射MHI情况 A:术中注射MHI;B:蓝染的淋巴结Fig.2 Injection of MHI in the study group A: Intraoperative injection of MHI; B: Blue-stained lymph nodes
    图3 显露的甲状旁腺和喉返神经Fig.3 Exposure of parathyroid glands and recurrent laryngeal nerve
    图4 患者入组与随访情况Fig.4 Enrollment and follow-up of patients
    图1 对照组纳米炭注射后体表及术区黑染情况 A:皮肤表面黑染;B:术区黑染Fig.1 Black staining of the skin and operative area after injection of carbon nanoparticles in the control group A: Skin surface staining; B: Operative area staining
    图2 研究组注射MHI情况 A:术中注射MHI;B:蓝染的淋巴结Fig.2 Injection of MHI in the study group A: Intraoperative injection of MHI; B: Blue-stained lymph nodes
    图3 显露的甲状旁腺和喉返神经Fig.3 Exposure of parathyroid glands and recurrent laryngeal nerve
    图4 患者入组与随访情况Fig.4 Enrollment and follow-up of patients
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张为良,周鹏,李小磊,朱见,庄大勇,岳涛,徐婧,贺青卿.示踪剂米托蒽醌和纳米炭在机器人甲状腺癌手术中的应用效果比较[J].中国普通外科杂志,2024,33(5):762-771.
DOI:10.7659/j. issn.1005-6947.2024.05.009

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  • 收稿日期:2024-02-02
  • 最后修改日期:2024-05-08
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  • 在线发布日期: 2024-06-06