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依库珠单抗毒素 A 治疗肌萎缩侧索硬化症患者的唾液分泌过多:一项开放标签单中心研究。

IncobotulinumtoxinA for hypersalivation in patients with amyotrophic lateral sclerosis: an open-label single-centre study.

机构信息

Movement Disorders Section, Department of Neurology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.

Department of Neurology, Hannover Medical School, Hannover, Germany.

出版信息

J Neural Transm (Vienna). 2019 Oct;126(10):1341-1345. doi: 10.1007/s00702-019-02044-6. Epub 2019 Jul 17.

Abstract

The objective of this study is to discover whether incobotulinumtoxinA (inco) can reduce relative hypersalivation in patients with amyotrophic lateral sclerosis (ALS). 14 patients with ALS (8 males and 6 females, age 55.4 ± 16.3 years) received ultrasound-guided injection of inco 100 MU in both parotid glands and inco 50 MU in both submandibular glands. Saliva production was gravimetrically measured with three cotton rolls placed in the mouth. Weight increase after 5 min was measured on an electronic scale. Subjective saliva production was registered with drooling frequency scale (DFS) and drooling severity scale (DSS). Saliva production was gravimetrically reduced at week 4 (p = 0.04), week 8 (p = 0.01) but not after week 12 after BT application. DFS was reduced at week 4 (p = 0.04), week 8 (p = 0.02), but not after week 12. DSS was reduced at week 4 (p = 0.03), week 8 (p = 0.04) and week 12 (p = 0.04). Patients in our study did not experience changes in their swallowing patterns or any other safety-relevant events. Inco is effective and well tolerated for saliva reduction in patients with ALS for 8-12 weeks.

摘要

本研究旨在探讨 IncobotulinumtoxinA(inco)是否可减少肌萎缩侧索硬化症(ALS)患者的相对唾液分泌过多。14 例 ALS 患者(8 名男性,6 名女性,年龄 55.4±16.3 岁)接受了超声引导下双侧腮腺注射 100 MU inco 和双侧颌下腺注射 50 MU inco。通过将三个棉卷置于口腔中,用称重法测量唾液产生量。使用电子秤测量 5 分钟后的重量增加。用流涎频率量表(DFS)和流涎严重程度量表(DSS)记录主观唾液产生情况。BT 应用后第 4 周(p=0.04)、第 8 周(p=0.01)唾液产生量显著减少,但第 12 周后无明显变化。DFS 在第 4 周(p=0.04)、第 8 周(p=0.02),但第 12 周后无明显变化。DSS 在第 4 周(p=0.03)、第 8 周(p=0.04)和第 12 周(p=0.04)均显著减少。本研究中患者未出现吞咽模式改变或任何其他与安全性相关的事件。Inco 可有效减轻 ALS 患者的唾液分泌过多,且 8-12 周内耐受性良好。

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