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三叉神经痛患者蝶腭神经节注射A型肉毒毒素的疗效和安全性:一项前瞻性观察研究

Efficacy and safety profile of Onabotulinum toxin-A injection at sphenopalatine ganglion in trigeminal neuralgia: a prospective observational study.

作者信息

Thepsoparn Marvin, Anukoolwittaya Prakit, Toeypromthong Patcharapol, Thanaboriboon Chanon

机构信息

Department of Anesthesiology, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Bangkok, Thailand.

Department of Anesthesiology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

出版信息

J Headache Pain. 2024 Dec 2;25(1):210. doi: 10.1186/s10194-024-01926-9.

DOI:10.1186/s10194-024-01926-9
PMID:39623300
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11613643/
Abstract

INTRODUCTION

The sphenopalatine ganglion (SPG) plays a role in orofacial pain and headaches and is a target for pain modulation. Onabotulinum toxin-A injections have been described as a treatment for several neuropathic pain conditions. However, there is limited evidence for using this medication at the sphenopalatine ganglion for orofacial pain. The goal of this study was to investigate the effectiveness, in terms of pain intensity and frequency of pain attacks, as well as the safety of fluoroscopy-guided Onabotulinum toxin-A injection administered directly to the sphenopalatine ganglion in patients with trigeminal neuralgia.

METHOD

Fourteen patients diagnosed with trigeminal neuralgia who either could not tolerate the side effects of oral medication or did not respond to oral medication. Onabotulinum toxin-A 40 units was injected through the sphenopalatine ganglion under fluoroscopy guidance. The primary outcome was a reduction in pain intensity (using the Numerical Rating Scale). The secondary outcome was a reduction in the frequency of pain attack and safety profile of the procedure.

RESULTS

The average pain scores and frequency of pain decreased significantly (p-value < 0.001). The mean baseline pain score before the injection was 8.15 ± 1.91. The mean pain score reduction 60 days after the procedure was 4.15 (95% CI: 2.72, 5.59; p < 0.001). The frequency of pain attacks also decreased significantly from 12.15 ± 8.61 times per day to 3.38 ± 2.53 times per day at 60 days after the procedure (p < 0.001). Complications directly associated with the procedure included hemifacial palsy (76.9%) and diplopia (7.7%). These symptoms resolved within three months after the procedure.

CONCLUSION

Onabotulinum toxin-A injection at the SPG is effective in reducing pain symptoms in trigeminal neuralgia patients who cannot tolerate the side effects of medication or are refractory to oral medication.

TRIAL REGISTRATION

This study was retrospectively registered in the Thai Clinical Trial Registry under registration number TCTR20240908004 on 3 September 2024.

摘要

引言

蝶腭神经节(SPG)在口面部疼痛和头痛中起作用,是疼痛调节的一个靶点。A型肉毒毒素注射已被描述为几种神经性疼痛病症的一种治疗方法。然而,在蝶腭神经节使用这种药物治疗口面部疼痛的证据有限。本研究的目的是在疼痛强度和疼痛发作频率方面,以及在三叉神经痛患者中,研究在荧光镜引导下直接向蝶腭神经节注射A型肉毒毒素的有效性和安全性。

方法

14名被诊断为三叉神经痛的患者,他们要么无法耐受口服药物的副作用,要么对口服药物无反应。在荧光镜引导下,通过蝶腭神经节注射40单位A型肉毒毒素。主要结果是疼痛强度的降低(使用数字评分量表)。次要结果是疼痛发作频率的降低和该操作的安全性。

结果

平均疼痛评分和疼痛频率显著降低(p值<0.001)。注射前的平均基线疼痛评分为8.15±1.91。术后60天平均疼痛评分降低4.15(95%置信区间:2.72,5.59;p<0.001)。术后60天,疼痛发作频率也从每天12.15±8.61次显著降低至每天3.38±2.53次(p<0.001)。与该操作直接相关的并发症包括面瘫(76.9%)和复视(7.7%)。这些症状在术后三个月内消失。

结论

在SPG注射A型肉毒毒素可有效减轻无法耐受药物副作用或对口服药物难治的三叉神经痛患者的疼痛症状。

试验注册

本研究于2024年9月3日在泰国临床试验注册中心进行回顾性注册,注册号为TCTR20240908004。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46c1/11613643/fb20a12bcc4d/10194_2024_1926_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46c1/11613643/678204ecc1e8/10194_2024_1926_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46c1/11613643/fb20a12bcc4d/10194_2024_1926_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46c1/11613643/678204ecc1e8/10194_2024_1926_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46c1/11613643/fb20a12bcc4d/10194_2024_1926_Fig2_HTML.jpg

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