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伴有扭曲性抽搐/震颤的颈肌张力障碍的艾司西酞普兰随机对照试验。

Randomised controlled trial of escitalopram for cervical dystonia with dystonic jerks/tremor.

机构信息

Department of Neurology, Academic Medical Center, Amsterdam, The Netherlands.

Department of Radiology and Nuclear Medicine, Academic Medical Center, Amsterdam, The Netherlands.

出版信息

J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):579-585. doi: 10.1136/jnnp-2017-317352. Epub 2018 Jan 11.

Abstract

OBJECTIVE

Trials for additional or alternative treatments for cervical dystonia (CD) are scarce since the introduction of botulinum neurotoxin (BoNT). We performed the first trial to investigate whether dystonic jerks/tremor in patients with CD respond to the selective serotonin reuptake inhibitor (SSRI) escitalopram.

METHODS

In a randomised, double-blind, crossover trial, patients with CD received escitalopram and placebo for 6 weeks. Treatment with BoNT was continued, and scores on rating scales regarding dystonia, psychiatric symptoms and quality of life (QoL) were compared. Primary endpoint was the proportion of patients that improved at least one point on the Clinical Global Impression Scale for jerks/tremor scored by independent physicians with experience in movement disorders.

RESULTS

Fifty-threepatients were included. In the escitalopram period, 14/49 patients (29%) improved on severity of jerks/tremor versus 11/48 patients (23%) in the placebo period (P=0.77). There were no significant differences between baseline and after treatment with escitalopram or placebo on severity of dystonia or jerks/tremor. Psychiatric symptoms and QoL improved significantly in both periods compared with baseline. There were no significant differences between treatment with escitalopram and placebo for dystonia, psychiatric or QoL rating scales. During treatment with escitalopram, patients experienced slightly more adverse events, but no serious adverse events occurred.

CONCLUSION

In this innovative trial, no add-on effect of escitalopram for treatment of CD with jerks was found on motor or psychiatric symptoms. However, we also did not find a reason to withhold patients treatment with SSRIs for depression and anxiety, which are common in dystonia.

TRIAL REGISTRATION NUMBER

NTR2178.

摘要

目的

自从肉毒毒素(BoNT)问世以来,针对颈部肌张力障碍(CD)的额外或替代治疗的试验很少。我们进行了第一项试验,以研究 CD 患者的扭曲性抽搐/震颤是否对选择性 5-羟色胺再摄取抑制剂(SSRI)依地普仑有反应。

方法

在一项随机、双盲、交叉试验中,CD 患者接受依地普仑和安慰剂治疗 6 周。继续使用 BoNT 治疗,并比较关于肌张力障碍、精神症状和生活质量(QoL)的评分量表上的评分。主要终点是在由具有运动障碍经验的独立医生对抽搐/震颤进行评分的临床总体印象量表上,至少有一位患者的抽搐/震颤改善至少一个点的比例。

结果

共纳入 53 名患者。在依地普仑治疗期间,49 名患者中有 14 名(29%)在抽搐/震颤严重程度上有所改善,而 48 名患者中有 11 名(23%)在安慰剂治疗期间有所改善(P=0.77)。与基线相比,依地普仑或安慰剂治疗后,肌张力障碍或抽搐/震颤的严重程度均无显著差异。与基线相比,两个时期的精神症状和 QoL 均显著改善。依地普仑与安慰剂治疗在肌张力障碍、精神或 QoL 评分量表上均无显著差异。依地普仑治疗期间,患者经历了更多的不良反应,但没有发生严重的不良反应。

结论

在这项创新性试验中,依地普仑并未发现对 CD 伴抽搐的运动或精神症状有额外的治疗作用。然而,我们也没有发现拒绝为伴有抑郁和焦虑的患者使用 SSRIs 治疗的理由,这些在肌张力障碍患者中很常见。

试验注册号

NTR2178。

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