Stellate Ganglion Block for the Treatment of COVID-19-Induced Parosmia: A Randomized Clinical Trial.

IF 6 1区医学 Q1 OTORHINOLARYNGOLOGY

JAMA otolaryngology-- head & neck surgery Pub Date : 2025-06-12 DOI:10.1001/jamaoto.2025.1304

Nyssa Fox Farrell, Lara W Crock, Aseeyah Islam, Dean Adkins, Andrew M Peterson, Dorina Kallogjeri, Jay F Piccirillo

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引用次数: 0

Abstract

Importance: Smell distortion (parosmia) is a symptom of post-COVID-19 condition that persists and has immeasurable detriments on quality of life. To date, a standard criterion for treatment of this bothersome condition has not been identified.

Objective: To determine whether stellate ganglion block (SGB) is effective and safe in improving olfactory dysfunction in patients with persistent COVID-19-induced parosmia.

Design, setting, and participants: This was a randomized, double-blinded, placebo-controlled clinical trial conducted from October 2023 to September 2024 at a single center study (the Washington University in St Louis/Barnes Jewish Hospital). A volunteer sample of 192 individuals were screened; 57 were enrolled after meeting eligibility criteria (age 18-70 years with self-reported parosmia of ≥6 months since COVID-19 infection, and a screening score of ≥40 on the Parosmia Olfactory Dysfunction Outcomes Rating [DisODOR] scale). Of 135 excluded, the most common reasons were prior SGB (n = 42) and parosmia resolution or non-COVID-19-induced parosmia (n = 28). Data were analyzed from September to October 2024.

Intervention: Ultrasonography-guided injection of 6 to 8 mL of active mepivacaine, 1%, or saline, 0.9%, at the right or left (randomized 1:1) stellate ganglion was performed by a board-certified anesthesiologist and pain medicine specialist.

Main outcome and measure: Between-subject difference of 25% in proportion of responders (defined by a 15-point decrease in DisODOR score) from baseline.

Results: The study evaluated 48 participants, 32 randomized to SGB (median [range] age, 45 [19-64] y; 25 [81%] female), and 16 to placebo (median [SD] age, 45 [26-64] y; 13 [81%] female). Time since COVID-19 infection was similar between groups (SGB, 35.3 vs placebo, 30.6 months; MD = -3.1 months; 95% CI, -10.9 to 3.7). Three-month response rate was 43% (n = 13) for SGB and 38% (n = 6) for placebo (difference, -5%; 95% CI, -32% to 33%). There was no between-group difference in clinical global impression of improvement.

Conclusions and relevance: This randomized clinical trial found that SGB is not superior to placebo in treating COVID-19-induced parosmia, and thus, should not be recommended as treatment.

Trial registration: ClinicalTrials.gov Identifier: NCT06253806.

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星状神经节阻滞治疗新冠肺炎致腮腺炎的随机临床试验

重要性：嗅觉扭曲（嗅觉缺失）是covid -19后症状的一种症状，会持续存在，对生活质量造成不可估量的损害。迄今为止，尚未确定治疗这种令人烦恼的病症的标准标准。目的：探讨星状神经节阻滞（SGB）治疗新冠肺炎持续性嗅觉障碍患者嗅觉功能障碍的有效性和安全性。设计、环境和参与者：这是一项随机、双盲、安慰剂对照的临床试验，于2023年10月至2024年9月在单中心研究（圣路易斯华盛顿大学/巴恩斯犹太医院）进行。对192名志愿者进行了筛选；57例符合入选标准（年龄18-70岁，自COVID-19感染后自我报告嗅觉缺陷≥6个月，嗅觉缺陷嗅觉功能障碍结局评分[DisODOR]量表筛查得分≥40分）。在被排除的135例患者中，最常见的原因是既往SGB （n = 42）和阴唇消退或非covid -19诱导的阴唇（n = 28）。数据分析时间为2024年9月至10月。干预措施：超声引导下在右侧或左侧（随机1:1）星状神经节处注射6 ~ 8ml 1%活性甲哌卡因或0.9%生理盐水（随机1:1）。主要结局和测量：受试者间应答者比例的差异为25%（由DisODOR评分下降15分定义）。结果：该研究评估了48名参与者，其中32名随机分为SGB组(年龄中位数[范围]45岁[19-64]岁；25名（81%）女性)，安慰剂组16名(中位[SD]年龄45岁[26-64]岁；13[81%]女性)。两组之间的COVID-19感染时间相似(SGB， 35.3个月vs安慰剂，30.6个月；MD = -3.1个月；95% CI, -10.9 ~ 3.7)。SGB组的三个月缓解率为43% (n = 13)，安慰剂组为38% (n = 6)(差异为-5%；95% CI， -32%至33%)。两组间临床总体印象改善无差异。结论及相关性：本随机临床试验发现，SGB治疗新冠肺炎引起的腮腺炎并不优于安慰剂，因此不应推荐作为治疗方法。试验注册：ClinicalTrials.gov标识符：NCT06253806。

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来源期刊

JAMA otolaryngology-- head & neck surgery OTORHINOLARYNGOLOGY-

CiteScore

9.10

自引率

5.10%

发文量

230

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.