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.
CONCLUSIONS: 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.
BACKGROUND: NCT05784792 (https://www.clinicaltrials.gov).
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.
CONCLUSIONS: 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.
BACKGROUND: NCT05784792 (https://www.clinicaltrials.gov).
摘要：
背景：经常在手术前给Graves病患者服用Lugol溶液。目的是减少甲状腺血管化和手术发病率，但是它的真正有效性仍然存在争议。本研究旨在评估术前Lugol溶液对接受全甲状腺切除术的Graves病患者甲状腺血管形成和手术发病率的影响。
方法：56例接受Graves病甲状腺全切除术的患者被随机分配接受7天的Lugol治疗（Lugol组，29）或不使用Lugol治疗（LS-组，27）在这项单中心和单盲试验中的手术前。术前（T0）和手术当天（T1）收集术前激素和彩色多普勒超声检查数据，以评估甲状腺血管形成。主要结果是术中和术后失血。次要结果包括手术持续时间，甲状腺功能,发病率，血管化,和最终病理时的微血管密度。
结果：人口统计学上没有差异，在T0时，LS+和LS-组之间发现了术前激素或超声检查数据。T1时,LS+组游离三碘甲状腺原氨酸(FT3)和游离甲状腺素(FT4)水平较T0值明显降低,而在LS-组中没有观察到这种变化。两组超声血管形成的T0和T1之间均无差异，组织学发现也没有差异。LS+和LS-组之间术中/术后失血量无显著差异（中位数分别为80.5和94ml），手术时间（两组75分钟）或术后发病率。
结论：Lugol溶液可显著降低Graves病手术患者的FT3和FT4水平，但不能减少术中/术后失血，甲状腺血管化，手术持续时间或术后发病率。
背景：NCT05784792(https://www.clinicaltrials.gov）。
方法：56例接受Graves病甲状腺全切除术的患者被随机分配接受7天的Lugol治疗（Lugol组，29）或不使用Lugol治疗（LS-组，27）在这项单中心和单盲试验中的手术前。术前（T0）和手术当天（T1）收集术前激素和彩色多普勒超声检查数据，以评估甲状腺血管形成。主要结果是术中和术后失血。次要结果包括手术持续时间，甲状腺功能,发病率，血管化,和最终病理时的微血管密度。
结果：人口统计学上没有差异，在T0时，LS+和LS-组之间发现了术前激素或超声检查数据。T1时,LS+组游离三碘甲状腺原氨酸(FT3)和游离甲状腺素(FT4)水平较T0值明显降低,而在LS-组中没有观察到这种变化。两组超声血管形成的T0和T1之间均无差异，组织学发现也没有差异。LS+和LS-组之间术中/术后失血量无显著差异（中位数分别为80.5和94ml），手术时间（两组75分钟）或术后发病率。
结论：Lugol溶液可显著降低Graves病手术患者的FT3和FT4水平，但不能减少术中/术后失血，甲状腺血管化，手术持续时间或术后发病率。
背景：NCT05784792(https://www.clinicaltrials.gov）。
