术前卢戈液在 Graves 病全甲状腺切除术中的作用：随机临床试验。

Role of Lugol solution before total thyroidectomy for Graves' disease: randomized clinical trial.

机构信息

Department of Surgery, Oncology and Gastroenterology, Endocrine Surgery Unit, University of Padua, Padua, Italy.

Department of Medicine, Institute of Radiology, University of Padua, Padua, Italy.

出版信息

Br J Surg. 2024 Aug 2;111(8). doi: 10.1093/bjs/znae196.

DOI:10.1093/bjs/znae196

PMID:39129619

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11977759/

Abstract

BACKGROUND

Lugol solution is often administered to patients with Graves' disease before surgery. The aim is to reduce thyroid vascularization and surgical morbidity, but its real effectiveness remains controversial. The present study was designed to evaluate the effects of preoperative Lugol solution on thyroid vascularization and surgical morbidity in patients with Graves' disease undergoing total thyroidectomy.

METHODS

Fifty-six patients undergoing total thyroidectomy for Graves' disease were randomly assigned to receive 7 days of Lugol treatment (Lugol+ group, 29) or no Lugol treatment (LS- group, 27) before surgery in this single-centre and single-blinded trial. Preoperative hormone and colour Doppler ultrasonographic data for assessing thyroid vascularization were collected 8 days before surgery (T0) and on the day of surgery (T1). The primary outcome was intraoperative and postoperative blood loss. Secondary outcomes included duration of surgery, thyroid function, morbidity, vascularization, and microvessel density at final pathology.

RESULTS

No differences in demographic, preoperative hormone or ultrasonographic data were found between LS+ and LS- groups at T0. At T1, free tri-iodothyronine (FT3) and free thyroxine (FT4) levels were significantly reduced compared with T0 values in the LS+ group, whereas no such variation was observed in the LS- group. No differences between T0 and T1 were found for ultrasonographic vascularization in either group, nor did the histological findings differ. There were no significant differences between the LS+ and LS- groups concerning intraoperative/postoperative blood loss (median 80.5 versus 94 ml respectively), duration of surgery (75 min in both groups) or postoperative morbidity.

CONCLUSION

Lugol solution significantly reduces FT3 and FT4 levels in patients undergoing surgery for Graves' disease, but does not decrease intraoperative/postoperative blood loss, thyroid vascularization, duration of surgery or postoperative morbidity.

REGISTRATION NUMBER

NCT05784792 (https://www.clinicaltrials.gov).

摘要

背景

术前常给格雷夫斯病患者使用卢戈液。目的是减少甲状腺血管化和手术发病率，但其实效仍存在争议。本研究旨在评估术前卢戈液对格雷夫斯病患者行甲状腺全切除术的甲状腺血管化和手术发病率的影响。

方法

56 例行甲状腺全切除术的格雷夫斯病患者在这项单中心、单盲试验中随机分为术前 7 天接受卢戈液治疗（卢戈液+组，29 例）或不接受卢戈液治疗（LS-组，27 例）。术前激素和彩色多普勒超声数据用于评估甲状腺血管化，在术前 8 天（T0）和手术当天（T1）收集。主要结局为术中及术后出血量。次要结局包括手术时间、甲状腺功能、发病率、最终病理的血管化和微血管密度。

结果

在 T0 时，LS+和 LS-组在人口统计学、术前激素或超声数据方面无差异。在 T1 时，LS+组游离三碘甲状腺原氨酸（FT3）和游离甲状腺素（FT4）水平与 T0 时相比显著降低，而 LS-组则没有这种变化。两组在 T0 和 T1 时的超声血管化均无差异，组织学结果也无差异。LS+和 LS-组在术中/术后出血量（中位数分别为 80.5 和 94ml）、手术时间（两组均为 75min）或术后发病率方面均无显著差异。