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甲磺酸倍他司汀片作为奥卡西平和卡马西平辅助药物治疗前庭性阵发性眩晕的随机试验

Randomized trial of betahistine mesilate tablets as augmentation for oxcarbazepine and carbamazepine in treating vestibular paroxysmia.

作者信息

Xue Hui, Xiang Wenping, Yu Yichuan, Liu Guorong, Chong Yi, Zhou Jiying

机构信息

Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.

Department of Neurology, Baotou Central Hospital, Inner Mongolia, Baotou, China.

出版信息

Drug Des Devel Ther. 2018 Apr 12;12:837-843. doi: 10.2147/DDDT.S158888. eCollection 2018.

DOI:10.2147/DDDT.S158888
PMID:29695895
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5905823/
Abstract

BACKGROUND

Vestibular paroxysmia (VP) is a rare episodic peripheral vestibular disorder. This study was conducted to compare the efficacy and acceptability of carbamazepine (CBZ) plus betahistine mesilate tablets (BMT) (CBZ+BMT) and oxcarbazepine (OXC) plus BMT (OXC+BMT) in treating VP, and investigated whether the synergistic effect could be increased along with the increased dose of BMT.

METHODS

VP patients were recruited and randomly assigned to receive CBZ+BMT or OXC+BMT. The doses of CBZ and OXC were set to 200 and 300 mg/time, twice daily, respectively. The doses of BMT were set to 12 and 18 mg/time, twice daily. Half of the patients in each group received BMT 12 mg/time and the other half received BMT 18 mg/time. The treatment was continued for 12 weeks. The vertigo frequency, vertigo score, vertigo duration, response rate, and drug-related side effects were analyzed.

RESULTS

In total, 92 patients in the CBZ+BMT group and 93 patients in the OXC+BMT group completed this trial. After 12 weeks of treatment, the two groups had similar average vertigo frequency, average vertigo score, average vertigo duration, and response rate. But the incidence of side effects was significantly higher in the CBZ+BMT group than in the OXC+BMT group (=0.04). Subgroup analysis found that patients receiving BMT (18 mg) had greater reductions in average vertigo frequency, average vertigo duration, and average vertigo score, and higher response rates than patients receiving BMT (12 mg).

CONCLUSION

These results demonstrated that OXC+BMT may be suitable as an alternative method in VP patients with CBZ hypersensitivity, and the synergistic effect could be increased along with the increased dose of BMT.

摘要

背景

前庭性阵发性眩晕(VP)是一种罕见的发作性外周前庭疾病。本研究旨在比较卡马西平(CBZ)联合甲磺酸倍他司汀片(BMT)(CBZ+BMT)与奥卡西平(OXC)联合BMT(OXC+BMT)治疗VP的疗效和可接受性,并探讨BMT剂量增加时协同效应是否会增强。

方法

招募VP患者并随机分配接受CBZ+BMT或OXC+BMT治疗。CBZ和OXC的剂量分别设定为每次200和300mg,每日两次。BMT的剂量设定为每次12和18mg,每日两次。每组一半患者接受每次12mg的BMT,另一半接受每次18mg的BMT。治疗持续12周。分析眩晕频率、眩晕评分、眩晕持续时间、缓解率和药物相关副作用。

结果

CBZ+BMT组共92例患者和OXC+BMT组共93例患者完成了本试验。治疗12周后,两组的平均眩晕频率、平均眩晕评分、平均眩晕持续时间和缓解率相似。但CBZ+BMT组的副作用发生率显著高于OXC+BMT组(=0.04)。亚组分析发现,接受BMT(18mg)的患者在平均眩晕频率、平均眩晕持续时间和平均眩晕评分方面的降低幅度更大,缓解率也高于接受BMT(12mg)的患者。

结论

这些结果表明,OXC+BMT可能适合作为对CBZ过敏的VP患者的替代治疗方法,且BMT剂量增加时协同效应会增强。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2d7/5905823/f1e468033952/dddt-12-837Fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2d7/5905823/dbab36cce210/dddt-12-837Fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2d7/5905823/ebe48dc4b271/dddt-12-837Fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2d7/5905823/f1e468033952/dddt-12-837Fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2d7/5905823/dbab36cce210/dddt-12-837Fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2d7/5905823/ebe48dc4b271/dddt-12-837Fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2d7/5905823/f1e468033952/dddt-12-837Fig3.jpg

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