Glycopyrronium 320 μg/mL in children and adolescents with severe sialorrhoea and neurodisabilities: An open-label study extension of the SALIVA trial

IF 4.3 2区医学 Q1 CLINICAL NEUROLOGY Developmental Medicine and Child Neurology Pub Date : 2025-02-09 DOI:10.1111/dmcn.16268

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Abstract

Drooling (sialorrhoea) is common in children with neurodisabilities, such as cerebral palsy. Severe drooling can cause irritated skin, dehydration, retention of urine, and chest infections. Drooling may also affect the child's quality of life, self-esteem, and social interactions. In addition, it can add to the burden of parents and caregivers, for example, leading to frequent changes of bibs and clothing. The SALIVA (Sialanar plus orAl rehabiLitation against placebo plus oral rehabilitation for chIldren and adolescents with seVere sialorrhoeA and neurodisabilities) trial investigated 320 μg/mL glycopyrronium, a medicine that has been specifically designed to meet the needs of children.

An open label (or non-blinded) study is one in which both the healthcare providers and the patients are aware of the drug or treatment being given.

In the first part of the trial, 87 children (aged 3–17 years) with neurodisabilities and severe drooling were randomly allocated to receive either 320 μg/mL glycopyrronium or placebo for 12 weeks. Treatment with 320 μg/mL glycopyrronium significantly reduced drooling versus placebo and the impact of drooling on quality of life was decreased, with no unexpected side effects.

In the second part of the trial, all children received 320 μg/mL glycopyrronium for 24 weeks. Improvements in drooling seen in the first part were sustained with continued 320 μg/mL glycopyrronium. Around 80% of children responded to treatment and 70% showed a good response. In addition, reductions in drooling's impact on quality of life were sustained with continued 320 μg/mL glycopyrronium.

Overall, the side effects seen with 320 μg/mL glycopyrronium were typical of this type of medicine, most commonly constipation and dry mouth. Side effects were more frequent during the first 4 weeks, when the dose was being adjusted, with the frequency of side effects subsequently reducing.

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glycopyronium 320 μg/mL用于患有严重唾液和神经功能障碍的儿童和青少年：一项扩展了唾液试验的开放标签研究。

流口水（唾液）在患有神经障碍的儿童中很常见，比如脑瘫。严重的流口水会引起皮肤过敏、脱水、尿潴留和胸部感染。流口水也可能影响孩子的生活质量、自尊和社会交往。此外，它可能会增加父母和照顾者的负担，例如，导致频繁更换围兜和衣服。唾液（Sialanar +口腔康复对照安慰剂+口腔康复治疗患有严重唾液和神经功能障碍的儿童和青少年）试验研究了320 μg/mL的glycopyronium，这是一种专门为满足儿童需求而设计的药物。开放标签（或非盲法）研究是指医疗保健提供者和患者都知道正在使用的药物或治疗。在试验的第一部分中，87名患有神经功能障碍和严重流口水的儿童（3-17岁）被随机分配到320 μg/mL的glycopyronium或安慰剂组，为期12周。与安慰剂相比，320 μg/mL glycopyronium治疗显著减少了流口水，并降低了流口水对生活质量的影响，无意外副作用。在试验的第二部分，所有儿童接受320 μg/mL的吡氯硝铵治疗24周。在第一部分中观察到的流口水的改善持续使用320 μg/mL的甘普罗铵。大约80%的儿童对治疗有反应，70%表现出良好的反应。此外，使用320 μg/mL的甘普罗铵后，流口水对生活质量的影响持续降低。总的来说，320 μg/mL甘氯硝铵的副作用是这类药物的典型副作用，最常见的是便秘和口干。在前4周，当剂量调整时，副作用更频繁，随后副作用频率减少。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Developmental Medicine and Child Neurology 医学-临床神经学

CiteScore

7.80

自引率

13.20%

发文量

338

审稿时长

3-6 weeks

期刊介绍： Wiley-Blackwell is pleased to publish Developmental Medicine & Child Neurology (DMCN), a Mac Keith Press publication and official journal of the American Academy for Cerebral Palsy and Developmental Medicine (AACPDM) and the British Paediatric Neurology Association (BPNA). For over 50 years, DMCN has defined the field of paediatric neurology and neurodisability and is one of the world’s leading journals in the whole field of paediatrics. DMCN disseminates a range of information worldwide to improve the lives of disabled children and their families. The high quality of published articles is maintained by expert review, including independent statistical assessment, before acceptance.