Brotto Davide, Greggio Marco
Department of Neuroscience DNS, Otolaryngology Section, Padova University, Padova, Italy.
Department of Neuroscience DNS, Degree Course in Audiometric Techniques, Padova University, Padova, Italy.
Otolaryngol Head Neck Surg. 2024 Jun;170(6):1613-1629. doi: 10.1002/ohn.656. Epub 2024 Feb 3.
Intratympanic injections are a safe, well tolerated procedure routinely performed by ENT's specialists. Intratympanic injections of gels have the potential to deliver therapeutics into the cochlea through the round window membrane prolonging the release of drugs in the inner ear compartment. Aim of the present review is to summarize clinical trials testing pharmacological treatments for inner ear pathologies through intratympanic gel formulations.
Online databases (Google scholar and PubMed) and registers (Clinicaltrials.gov and Euclinicaltrial) were used to identify clinical trials performed between 1990 and 2022.
PRISMA criteria have been followed. Clinical trials testing gel formulations administered through local intratympanic injections and targeting inner ear disorders were included. All the reports were identified by the authors working in pairs sequentially selecting only studies respecting the inclusion criteria.
A total of 45 clinical studies have been noticed; the gels for intratympanic injection are in the form of poloxamers or hyaluronic acid combinations; the trials found target different kind of inner ear disorders: acquired-stable SNHL, tinnitus, acute sudden SNHL, Meniere disease, cisplatin induced ototoxicity and hearing preservation in patients undergoing cochlear implant surgery.
Few studies listed do not provide the specific kind of gel formulation used but only report the intratympanic delivery vehicle as "gel" or "thermogel". Multiple clinical studies have been targeting several forms of inner ear disorders by injecting different compounds through poloxamer and hyaluronic acid formulations. Larger and more advanced clinical stages are necessary to confirm the efficacy of these chemical compounds.
鼓室内注射是一种安全且耐受性良好的操作,通常由耳鼻喉科专家进行。鼓室内注射凝胶有可能通过圆窗膜将治疗药物输送到耳蜗,延长药物在内耳腔室中的释放时间。本综述的目的是总结通过鼓室内凝胶制剂测试内耳疾病药物治疗的临床试验。
使用在线数据库(谷歌学术和PubMed)以及注册库(Clinicaltrials.gov和Euclinicaltrial)来识别1990年至2022年间进行的临床试验。
遵循PRISMA标准。纳入测试通过局部鼓室内注射给药且针对内耳疾病的凝胶制剂的临床试验。所有报告均由成对工作的作者识别,依次仅选择符合纳入标准的研究。
共注意到45项临床研究;鼓室内注射用凝胶为泊洛沙姆或透明质酸组合形式;这些试验发现针对不同类型的内耳疾病:获得性稳定感音神经性听力损失、耳鸣、急性突发感音神经性听力损失、梅尼埃病、顺铂诱导的耳毒性以及人工耳蜗植入手术患者的听力保留。
列出的少数研究未提供所使用的具体凝胶制剂类型,仅将鼓室内给药载体报告为“凝胶”或“热凝胶”。多项临床研究通过泊洛沙姆和透明质酸制剂注射不同化合物,针对多种形式的内耳疾病。需要更大规模和更高级别的临床阶段来证实这些化合物的疗效。