Ehrenberger Klaus
Department of Otorhinolaryngology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria.
Int Tinnitus J. 2005;11(1):34-7.
This prospective study, which conformed with good clinical practice (GCP-conform), tested the concept that the topical transtympanic administration of the quinoxaline derivative Caroverine promises a new approach to the treatment of tinnitus. The rationale for the study is the hypothesis that tinnitus reflects sequelae of auditory neurotoxicity that can prevented and repaired by the neuroprotective and neuroregenerative activities of quinoxaline derivatives exhibited in previous preclinical tests. In a representative patient cohort, the probability of a long-lasting tinnitolytic effect of lipophilic eardrops containing 1% Caroverine as their active ingredient gained in significance, crossing from low-intensity levels to high-intensity levels of individual tinnitus sensations. These results encouraged us to design consequential GCP-conform phase 2 and phase 3 studies.
这项符合良好临床实践规范（GCP规范）的前瞻性研究，验证了喹喔啉衍生物卡维林经鼓膜局部给药有望成为治疗耳鸣新方法的概念。该研究的理论依据是一种假设，即耳鸣反映了听觉神经毒性的后遗症，而先前临床前试验中显示的喹喔啉衍生物的神经保护和神经再生活性可以预防和修复这些后遗症。在一个具有代表性的患者队列中，含有1%卡维林作为活性成分的亲脂性耳滴剂产生持久耳鸣缓解效果的可能性显著增加，从个体耳鸣感觉的低强度水平转变为高强度水平。这些结果促使我们设计后续符合GCP规范的2期和3期研究。
