Agapurin Retard Used in Patients With Smell Disorder- A Post-marketing Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- TDI-score
研究概览
简要总结
Signal processing in the olfactory neuron could be influenced by inhibition of enzymes like phosphodiesterase. Pentoxifylline is a unspecific phosphodiesterase inhibitor. The hypothesis is that pentoxifylline could lead to increased sensitivity to odors.
详细描述
Olfactory signal processing is conducted by a G-protein linked increase of intracellular concentration of adenosine 3´,5´-cyclic monophosphate (cAMP). In the cilia of olfactory sensory neurons (OSN) cAMP is degraded by phosphodiesterase 1C2 (PDE1C2). Inhibition of PDE1C2 could result in an increased response of OSN to chemical stimuli. Aim of the present prospective post-marketing surveillance study was to investigate the impact of pentoxifylline, an unspecific phosphodieasterase inhibitor, on olfactory function.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hyposmic or functionally anosmic patients TDI-score <31
- •age: 18-50 years
- •odor threshold: better than 1
- •cause of smell loss: post traumatic, postinflammatory, idiopathic
排除标准
- •normosmic patients,
- •patients with contraindications for application of pentoxifylline
- •patients that cannot give written agreement to the study
- •patients under 18 years and over 50 years of age
研究组 & 干预措施
1
Patients with posttraumatic, idiopathic, and postinflammatory cause of smell loss; patients age between 18 and 50 years. Odor threshold better than 1.
干预措施: Pentoxifylline retard 400mg (Drug)
结局指标
主要结局
TDI-score
时间窗: at day 0 and follow up after 3 weeks
次要结局
- odor threshold odor discrimination odor identification(at day 0 and at follow up after 3 weeks)