流涎减少干预随机试验 (DRI)：比较氢溴酸东莨菪碱贴片和格隆溴铵液对神经发育障碍儿童流涎的疗效和可接受性。
Drooling Reduction Intervention randomised trial (DRI): comparing the efficacy and acceptability of hyoscine patches and glycopyrronium liquid on drooling in children with neurodisability.
机构信息
Institute of Neuroscience, Newcastle University, Newcastle Upon Tyne, UK.
The Great North Children's Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.
出版信息
Arch Dis Child. 2018 Apr;103(4):371-376. doi: 10.1136/archdischild-2017-313763. Epub 2017 Nov 30.
OBJECTIVE
Investigate whether hyoscine patch or glycopyrronium liquid is more effective and acceptable to treat drooling in children with neurodisability.
DESIGN
Multicentre, single-blind, randomised controlled trial.
SETTING
Recruitment through neurodisability teams; treatment by parents.
PARTICIPANTS
Ninety children with neurodisability who had never received medication for drooling (55 boys, 35 girls; median age 4 years).
EXCLUSION CRITERIA
medication contraindicated; in a trial that could affect drooling or management.
INTERVENTION
Children were randomised to receive a hyoscine skin patch or glycopyrronium liquid. Dose was increased over 4 weeks to achieve optimum symptom control with minimal side-effects; steady dose then continued to 12 weeks.
PRIMARY AND SECONDARY OUTCOMES
Primary outcome: Drooling Impact Scale (DIS) score at week-4.
SECONDARY OUTCOMES
change in DIS scores over 12 weeks, Drooling Severity and Frequency Scale and Treatment Satisfaction Questionnaire for Medication; adverse events; children's perception about treatment.
RESULTS
Both medications yielded clinically and statistically significant reductions in mean DIS at week-4 (25.0 (SD 22.2) for hyoscine and 26.6 (SD 16) for glycopyrronium). There was no significant difference in change in DIS scores between treatment groups. By week-12, 26/47 (55%) children starting treatment were receiving hyoscine compared with 31/38 (82%) on glycopyrronium. There was a 42% increased chance of being on treatment at week-12 for children randomised to glycopyrronium relative to hyoscine (1.42, 95% CI 1.04 to 1.95).
CONCLUSIONS
Hyoscine and glycopyrronium are clinically effective in treating drooling in children with neurodisability. Hyoscine produced more problematic side effects leading to a greater chance of treatment cessation.
TRIAL REGISTRATION NUMBERS
ISRCTN 75287237; EUDRACT: 2013-000863-94; Medicines and Healthcare Products Regulatory Agency: 17136/0264/001-0003.
目的
探究氢溴酸东莨菪碱贴剂或格隆溴铵溶液治疗神经发育障碍儿童流涎的有效性和可接受性。
设计
多中心、单盲、随机对照试验。
地点
通过神经发育障碍团队招募；由家长进行治疗。
参与者
90 名从未接受过流涎药物治疗的神经发育障碍儿童（55 名男孩，35 名女孩；中位年龄 4 岁）。
排除标准
药物禁忌；正在参加可能影响流涎或治疗的试验。
干预措施
将儿童随机分配接受氢溴酸东莨菪碱贴剂或格隆溴铵溶液。4 周内逐渐增加剂量，以达到最佳症状控制和最小副作用；然后继续使用稳定剂量 12 周。
主要和次要结局
主要结局：第 4 周的流涎影响量表（DIS）评分。
次要结局
12 周内 DIS 评分的变化、流涎严重程度和频率量表以及药物治疗满意度问卷；不良事件；儿童对治疗的看法。
结果
两种药物在第 4 周时均使平均 DIS 显著降低（氢溴酸东莨菪碱为 25.0（22.2 标准差），格隆溴铵为 26.6（16 标准差））。治疗组之间 DIS 评分的变化无显著差异。到第 12 周时，开始接受治疗的 47 名儿童中有 26 名（55%）接受了氢溴酸东莨菪碱治疗，而 38 名儿童中有 31 名（82%）接受了格隆溴铵治疗。与氢溴酸东莨菪碱相比，随机接受格隆溴铵治疗的儿童在第 12 周时继续治疗的可能性增加了 42%（1.42，95%CI 1.04 至 1.95）。
结论
氢溴酸东莨菪碱和格隆溴铵在治疗神经发育障碍儿童流涎方面均具有临床疗效。氢溴酸东莨菪碱产生了更多的问题，导致停药的可能性更大。
试验注册
ISRCTN 75287237；EUDRACT：2013-000863-94；药品和保健品管理局：17136/0264/001-0003。
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