Special Needs Department, School of Medicine and Dentistry, Santiago de Compostela University, Santiago de Compostela, Spain.
Br J Clin Pharmacol. 2010 Jun;69(6):684-8. doi: 10.1111/j.1365-2125.2010.03659.x.
To evaluate the efficacy of scopolamine administered transdermally for the treatment of drooling in severely disabled patients.
A prospective, randomized, double-blind, crossover, placebo-controlled clinical trial was designed. The study group consisted of 30 handicapped patients with persistent drooling. The exclusion criteria were the specific contra-indications of scopolamine. Severity of drooling was quantified using a modified Thomas-Stonell and Greenberg visual scale simplified into three grades: 1 = dry; 2 = mild/moderate; 3 = severe/fulsome. The frequency of drooling was estimated using the number of bibs used each day. The baseline observational phase was followed by the application of a 1.5 mg scopolamine (Scopoderm TTS; Novartis Consumer Healthcare, UK) or placebo patch every 72 h for a fortnight. This was followed by a 1 week washout period and then crossover of assignments for 2 weeks.
At baseline, 77% of patients showed grade 3 of drooling. The placebo administration showed no significant reduction in drooling. We found a significant drooling reduction (P < 0.005) in the scopolamine group in the 1 and 2 week controls (69% and 80% respectively <or= grade 3). The mean number of bibs/day decreased during the scopolamine phase from 6/day at baseline to 3/day at the 2 week control. Four patients (13.3%) dropped out because of scopolamine side effects and minor adverse reactions were observed in three other patients. No blood alterations were found during the study period.
Scopolamine can be useful to control drooling in severely disabled patients although it requires appropriate patient selection and is not free from adverse effects.
评估透皮东莨菪碱治疗严重残疾患者流涎的疗效。
设计了一项前瞻性、随机、双盲、交叉、安慰剂对照的临床试验。研究组由 30 名持续性流涎的残疾患者组成。排除标准为东莨菪碱的特定禁忌证。使用改良的 Thomas-Stonell 和 Greenberg 视觉量表简化为 3 个等级来量化流涎的严重程度：1 = 干燥；2 = 轻度/中度；3 = 重度/大量。使用每天使用的围嘴数量来估计流涎的频率。基线观察阶段后，每 72 小时应用 1.5 毫克东莨菪碱（Scopoderm TTS；诺华消费者保健，英国）或安慰剂贴剂 2 周。随后进行 1 周洗脱期，然后交叉分配 2 周。
基线时，77%的患者流涎程度为 3 级。安慰剂治疗对流涎无明显减少。我们发现东莨菪碱组在第 1 和第 2 周的对照中流涎明显减少（P < 0.005）（分别为 69%和 80%<或= 3 级）。在东莨菪碱组，在第 2 周的对照中，每天使用围嘴的数量从基线时的 6 个减少到 3 个。由于东莨菪碱的副作用，有 4 名患者（13.3%）退出，另外 3 名患者出现轻微不良反应。在研究期间未发现血液改变。
尽管东莨菪碱需要适当的患者选择且并非没有不良反应，但它可以用于控制严重残疾患者的流涎。
