Klöcker N, Hanschke W, Toussaint S, Verse T
AUDIT Institute for Medical Services and Quality Assurance, Mühlfeldstr. 22, 65232, Taunusstein, Germany.
Eur J Pharm Sci. 2001 May;13(2):227-32. doi: 10.1016/s0928-0987(01)00107-5.
Scopolamine has been used successfully for treatment of motion sickness for almost a century and the nasal administration was first studied 50 years ago. However, there never appeared a nasal dosage form. Finally, after finding a stable and suitable formulation for scopolamine, a study to investigate efficacy, safety, and tolerability was conducted, with a randomised, double-blind, double-dummy, crossover, Latin square design including placebo control and a placebo/placebo control for internal validity at the German Air Force Institute of Aviation Medicine. To assess the efficacy of a new, stable and well-tolerated formulation of scopolamine nasal spray the reproducible induction of whole body vibrations by a rotating chair was chosen and a validated seasickness score (SKS). The reduction of SKS showed that scopolamine nasal spray at a concentration of 0.2% was statistically superior to both placebo and dimenhydrinate (P=0.003 and 0.004, respectively). There were no signs for a nasal or epipharyngeal irritation of the mucous membrane. Scopolamine nasal spray was found to be an effective and safe treatment in motion sickness, with a fast onset of action within 30 min after administration.
东莨菪碱成功用于治疗晕动病已近一个世纪，鼻腔给药的研究始于50年前。然而，一直没有出现鼻腔剂型。最终，在找到一种稳定且合适的东莨菪碱制剂后，德国空军航空医学研究所进行了一项研究，以调查其疗效、安全性和耐受性，采用随机、双盲、双模拟、交叉、拉丁方设计，包括安慰剂对照和用于内部效度的安慰剂/安慰剂对照。为评估一种新的、稳定且耐受性良好的东莨菪碱鼻喷雾剂的疗效，选择了通过转椅可重复诱发的全身振动以及经过验证的晕船评分（SKS）。SKS的降低表明，浓度为0.2%的东莨菪碱鼻喷雾剂在统计学上优于安慰剂和茶苯海明（P分别为0.003和0.004）。没有迹象表明鼻黏膜或咽上黏膜有刺激。东莨菪碱鼻喷雾剂被发现是一种治疗晕动病的有效且安全的方法，给药后30分钟内起效迅速。
