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354 例三叉神经痛患者中卡马西平和奥卡西平的真实世界疗效和耐受性。

Real-world effectiveness and tolerability of carbamazepine and oxcarbazepine in 354 patients with trigeminal neuralgia.

机构信息

Department of Human Neuroscience, Sapienza University, Rome, Italy.

Dipartimento di Metodi e Modelli per l'Economia, il Territorio e la Finanza, Sapienza University, Rome, Italy.

出版信息

Eur J Pain. 2021 May;25(5):1064-1071. doi: 10.1002/ejp.1727. Epub 2021 Feb 2.

Abstract

BACKGROUND

It is widely agreed that carbamazepine and oxcarbazepine are highly effective in the long-term treatment of trigeminal neuralgia. However, the tolerability of these drugs across the different aetiologies of trigeminal neuralgia is still undetermined.

METHODS

In this retrospective, real-world study, we assessed the effectiveness and tolerability of carbamazepine and oxcarbazepine in a large cohort of patients with classical (254 patients), secondary (60 patients) and idiopathic (40 patients) trigeminal neuralgia. We analysed data using a propensity score analysis to account for selection bias; frequencies of side effects associated with carbamazepine and oxcarbazepine were calculated by adjusting data with the inverse probability of treatment weighting.

RESULTS

The initial proportion of responders was 88.3% with carbamazepine, and 90.9% with oxcarbazepine. The number of refractory patients was significantly higher in idiopathic (15%) and secondary forms (27%) than in classical trigeminal neuralgia (6%; p < .05). In 53 patients treated with carbamazepine (29.6%) and in 22 treated with oxcarbazepine (12.6%), major side effects caused treatment interruption or dosage reduction to an unsatisfactory level. Side effects occurred more frequently in patients treated with carbamazepine (43.6%) than with oxcarbazepine (30.3%, p < .0001). The frequency of treatment discontinuation was higher in patients with secondary and idiopathic forms than in those with classical trigeminal neuralgia (p < .05).

CONCLUSIONS

Our real-world study shows that carbamazepine and oxcarbazepine are effective in most patients with trigeminal neuralgia; nevertheless, side effects are still a major issue, particularly in patients with secondary and idiopathic trigeminal neuralgia.

SIGNIFICANCE

Although carbamazepine and oxcarbazepine are effective in most patients with trigeminal neuralgia, their side effects are still a major issue, thus necessitating the development of better-tolerated drugs.

摘要

背景

卡马西平与奥卡西平在三叉神经痛的长期治疗中均具有显著疗效,这一观点已得到广泛认同。然而,这两种药物对于不同病因三叉神经痛的耐受性仍未确定。

方法

本回顾性真实世界研究纳入了 254 例经典型、60 例继发性和 40 例特发性三叉神经痛患者,评估了卡马西平与奥卡西平的有效性和耐受性。采用倾向评分分析以校正选择偏倚,通过逆概率治疗加权法校正数据以计算卡马西平与奥卡西平相关副作用的频率。

结果

卡马西平初始应答率为 88.3%,奥卡西平为 90.9%。特发性(15%)和继发性(27%)三叉神经痛患者中难治性患者的比例明显高于经典型(6%;p<0.05)。卡马西平治疗的 53 例(29.6%)和奥卡西平治疗的 22 例(12.6%)患者因严重不良反应而中断或降低剂量治疗。卡马西平治疗组(43.6%)不良反应发生率高于奥卡西平治疗组(30.3%;p<0.0001)。继发性和特发性三叉神经痛患者的停药率高于经典型三叉神经痛患者(p<0.05)。

结论

本真实世界研究表明卡马西平与奥卡西平治疗三叉神经痛多数患者有效;然而,不良反应仍是一个主要问题,尤其是在继发性和特发性三叉神经痛患者中。

意义

尽管卡马西平与奥卡西平治疗三叉神经痛多数患者有效,但不良反应仍是一个主要问题,因此需要开发耐受性更好的药物。

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