Eleonor Carvajal-Alegria, Nathalie Girault, Gianluca Donatini, Denis Frasca, Denis Tonnerre, Tom Cosset, Anne Rullière, Jean-Pascal Lebreton, Xavier Dufour, Florent Carsuzaa
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The findings suggest that corticosteroids may have a beneficial effect in managing this phenomenon.</p><p><strong>Objective: </strong>To evaluate the efficacy of a 7-day oral corticosteroid treatment on vocal cord remobilization in patients with unilateral VFP after thyroidectomy or parathyroid surgery.</p><p><strong>Design, setting, and participants: </strong>This prospective randomized double-blind placebo-controlled trial was conducted between September 2018 and May 2023 at a tertiary referral hospital. Patients who underwent partial or total thyroidectomy or parathyroid surgery were included. Exclusion criteria included corticosteroid intolerance, prior cervical surgery or radiotherapy, surgery performed for a malignant tumor and multinodular intrathoracic goiters.</p><p><strong>Interventions: </strong>At baseline, an inclusion visit assessed vocal cord mobility via nasofibroscopy and voice quality using the GRBAS (grade, roughness, breathiness, asthenia, strain) scale. Postoperative assessments were performed the day after surgery to identify unilateral VFP. Patients with unilateral VFP were randomized to receive either a 7-day course of oral corticosteroids or a placebo.</p><p><strong>Main outcomes and measures: </strong>At 7 days, 1 month, and 3 months, nasofibroscopic evaluation and GRBAS scale assessment were performed to monitor vocal fold remobilization and voice quality. All analyses were intention to treat.</p><p><strong>Results: </strong>Of the 468 patients included, 26 (5.6%) developed unilateral VFP and were randomized (19.2% male; 80.8% female; median age, 68 [IQR, 62.5-73.0] years in corticosteroid group and 59 [IQR, 52.5-73.0] years in placebo group). By day 7, vocal cord remobilization occurred in 42.8% (6 of 14) of the corticosteroid group and 41.6% (5 of 12) of the placebo group (proportion difference, 1.2%; 95% CI -32.8% to 34.4%). GRBAS results showed no meaningful difference in pathological items between groups at any time point.</p><p><strong>Conclusion and relevance: </strong>Results of this randomized clinical trial suggest that oral corticosteroids do not enhance vocal cord remobilization or improve voice quality in patients with postoperative unilateral VFP. 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引用次数: 0
摘要
重要性:对于甲状腺切除术后单侧声带麻痹(VFP)的治疗尚无共识。在没有喉返神经横断的情况下,局部炎症过程被认为是VFP的原因。研究结果表明,皮质类固醇可能对控制这种现象有有益的作用。目的:评价单侧VFP患者甲状腺切除术或甲状旁腺手术后口服糖皮质激素治疗7天对声带恢复的疗效。设计、环境和参与者:该前瞻性随机双盲安慰剂对照试验于2018年9月至2023年5月在一家三级转诊医院进行。接受部分或全部甲状腺切除术或甲状旁腺手术的患者也包括在内。排除标准包括皮质类固醇不耐受、既往宫颈手术或放疗、恶性肿瘤手术和多结节性胸内甲状腺肿。干预措施:在基线时,纳入访问通过鼻纤维镜评估声带活动度,并使用GRBAS(分级、粗糙度、呼吸、乏力、张力)量表评估语音质量。术后第二天进行评估以确定单侧VFP。单侧VFP患者随机接受7天疗程的口服皮质类固醇或安慰剂。主要观察指标:分别于术后第7天、第1个月和第3个月进行鼻纤维镜评估和GRBAS量表评估,监测声带活动和语音质量。所有分析均为意向治疗。结果:纳入的468例患者中,26例(5.6%)发生单侧VFP,随机分组(19.2%男性;80.8%的女性;中位年龄:皮质类固醇组68岁[IQR, 62.5-73.0]岁,安慰剂组59岁[IQR, 52.5-73.0]岁)。到第7天,皮质类固醇组42.8%(14人中的6人)和安慰剂组41.6%(12人中的5人)出现声带恢复(比例差异为1.2%;95% CI -32.8%至34.4%)。GRBAS结果显示,各组各时间点病理项目无显著差异。结论及相关性:这项随机临床试验的结果表明,口服皮质类固醇不能增强术后单侧VFP患者的声带恢复或改善语音质量。言语治疗在术后VFP的治疗中仍然是必不可少的。试验注册:ClinicalTrials.gov标识符:NCT03553342。
Oral Corticosteroids in Vocal Fold Paralysis After Thyroid Surgery: A Randomized Clinical Trial.
Importance: There is no consensus in the field for the management of postthyroidectomy unilateral vocal fold paralysis (VFP). In cases where recurrent laryngeal nerve transection is not present, a local inflammatory process is thought to cause VFP. The findings suggest that corticosteroids may have a beneficial effect in managing this phenomenon.
Objective: To evaluate the efficacy of a 7-day oral corticosteroid treatment on vocal cord remobilization in patients with unilateral VFP after thyroidectomy or parathyroid surgery.
Design, setting, and participants: This prospective randomized double-blind placebo-controlled trial was conducted between September 2018 and May 2023 at a tertiary referral hospital. Patients who underwent partial or total thyroidectomy or parathyroid surgery were included. Exclusion criteria included corticosteroid intolerance, prior cervical surgery or radiotherapy, surgery performed for a malignant tumor and multinodular intrathoracic goiters.
Interventions: At baseline, an inclusion visit assessed vocal cord mobility via nasofibroscopy and voice quality using the GRBAS (grade, roughness, breathiness, asthenia, strain) scale. Postoperative assessments were performed the day after surgery to identify unilateral VFP. Patients with unilateral VFP were randomized to receive either a 7-day course of oral corticosteroids or a placebo.
Main outcomes and measures: At 7 days, 1 month, and 3 months, nasofibroscopic evaluation and GRBAS scale assessment were performed to monitor vocal fold remobilization and voice quality. All analyses were intention to treat.
Results: Of the 468 patients included, 26 (5.6%) developed unilateral VFP and were randomized (19.2% male; 80.8% female; median age, 68 [IQR, 62.5-73.0] years in corticosteroid group and 59 [IQR, 52.5-73.0] years in placebo group). By day 7, vocal cord remobilization occurred in 42.8% (6 of 14) of the corticosteroid group and 41.6% (5 of 12) of the placebo group (proportion difference, 1.2%; 95% CI -32.8% to 34.4%). GRBAS results showed no meaningful difference in pathological items between groups at any time point.
Conclusion and relevance: Results of this randomized clinical trial suggest that oral corticosteroids do not enhance vocal cord remobilization or improve voice quality in patients with postoperative unilateral VFP. Speech therapy remains essential in the management of postoperative VFP.
期刊介绍:
JAMA Otolaryngology–Head & Neck Surgery is a globally recognized and peer-reviewed medical journal dedicated to providing up-to-date information on diseases affecting the head and neck. It originated in 1925 as Archives of Otolaryngology and currently serves as the official publication for the American Head and Neck Society. As part of the prestigious JAMA Network, a collection of reputable general medical and specialty publications, it ensures the highest standards of research and expertise. Physicians and scientists worldwide rely on JAMA Otolaryngology–Head & Neck Surgery for invaluable insights in this specialized field.