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拉科酰胺治疗三叉神经痛患者的疗效与安全性:一项为期8周的剂量递增试验性研究。

Efficacy and safety of lacosamide in patients with trigeminal neuralgia: an 8-week pilot dose-escalation study.

作者信息

Lappichetpaiboon Pramot, Tiamkao Somsak, Ruangsri Supanigar, Paphangkorakit Jarin, Pitiphat Waranuch, Jorns Teekayu P

机构信息

Department of Oral Biomedical Science, Faculty of Dentistry, Khon Kaen University, 40002 Khon Kaen, Thailand.

Department of Medicine, Faculty of Medicine, Khon Kaen University, 40002 Khon Kaen, Thailand.

出版信息

J Oral Facial Pain Headache. 2025 Mar;39(1):119-127. doi: 10.22514/jofph.2025.011. Epub 2025 Mar 12.

DOI:10.22514/jofph.2025.011
PMID:40129429
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11934738/
Abstract

BACKGROUND

Trigeminal neuralgia (TN) is a severe neuropathic pain condition in the orofacial region, with carbamazepine recommended as the first-line treatment. Nonetheless, its application is constrained by unfavorable drug responses and side effects. The objective of this research was to assess the effectiveness and safety of lacosamide, a third-generation anticonvulsant, in individuals with TN, and to juxtapose the findings with observational records from recently diagnosed TN patients who underwent carbamazepine monotherapy within the corresponding timeframe.

METHODS

An 8-week flexible dose titration of lacosamide was performed on newly diagnosed 12 TN patients who were divided into two groups: 200 mg/day (n = 5), and 400 mg/day (n = 7). Outcome measures included average pain score, Brief Pain Inventory-facial scores, and side effects. Patients were followed-up at 2, 4 and 8 weeks after baseline.

RESULTS

The percentage change of pain score at 4-week visit was compared between both lacosamide groups and patients receiving carbamazepine (n = 6) for four weeks during concurrent period. Both lacosamide groups experienced a decrease in pain score at 2-week follow-up, and differences in average pain score reduction were not observed between the two groups across all visits ( > 0.05). The mean Brief Pain Inventory-facial score in the lacosamide 200 mg/day group was higher than that in the 400 mg/day group at the 2-week follow-up ( = 0.03). Interestingly, the 4-week follow-up revealed that there were no significant variances in pain intensity between the lacosamide and the contemporaneous carbamazepine cohorts ( > 0.05). Frequently noted adverse events were mild somnolence (n = 9), slight vertigo (n = 5), and emotional lability (n = 2) without instances of severe adverse drug responses.

CONCLUSIONS

Lacosamide demonstrates potential as a therapeutic option for patients suffering from trigeminal neuralgia.

CLINICAL TRIAL REGISTRATION

TCTR20210811002.

摘要

背景

三叉神经痛(TN)是一种严重的口面部神经性疼痛疾病,卡马西平被推荐作为一线治疗药物。尽管如此,其应用受到不良药物反应和副作用的限制。本研究的目的是评估第三代抗惊厥药物拉科酰胺对TN患者的有效性和安全性,并将研究结果与同期接受卡马西平单药治疗的新诊断TN患者的观察记录进行对比。

方法

对12例新诊断的TN患者进行为期8周的拉科酰胺灵活剂量滴定,患者分为两组:200毫克/天(n = 5)和400毫克/天(n = 7)。观察指标包括平均疼痛评分、简明疼痛量表面部评分和副作用。在基线后的第2、4和8周对患者进行随访。

结果

比较了拉科酰胺两组与同期接受卡马西平治疗4周的患者(n = 6)在第4周就诊时疼痛评分的百分比变化。拉科酰胺两组在2周随访时疼痛评分均有所下降,在所有就诊期间两组平均疼痛评分降低幅度无差异(> 0.05)。在2周随访时,拉科酰胺200毫克/天组的简明疼痛量表面部平均评分高于400毫克/天组(= 0.03)。有趣的是,4周随访显示,拉科酰胺组和同期卡马西平组之间的疼痛强度无显著差异(> 0.05)。常见的不良事件为轻度嗜睡(n = 9)、轻微眩晕(n = 5)和情绪不稳定(n = 2),无严重药物不良反应发生。

结论

拉科酰胺对三叉神经痛患者显示出作为一种治疗选择的潜力。

临床试验注册

TCTR20210811002。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed78/11934738/8df274e43dac/fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed78/11934738/c9edd8a977cc/fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed78/11934738/a156b70a0668/fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed78/11934738/a30d2509999e/fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed78/11934738/8df274e43dac/fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed78/11934738/c9edd8a977cc/fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed78/11934738/a156b70a0668/fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed78/11934738/a30d2509999e/fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed78/11934738/8df274e43dac/fig4.jpg

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本文引用的文献

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Trigeminal neuralgia: therapeutic strategies to restore quality of life.三叉神经痛:恢复生活质量的治疗策略。
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Trigeminal neuralgia.三叉神经痛
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Intravenous lacosamide and phenytoin for the treatment of acute exacerbations of trigeminal neuralgia: A retrospective analysis of 144 cases.静脉注射拉考沙胺和苯妥英钠治疗三叉神经痛急性发作:144 例回顾性分析。
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