Abstract：
OBJECTIVE: 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.
METHODS: Online databases (Google scholar and PubMed) and registers (Clinicaltrials.gov and Euclinicaltrial) were used to identify clinical trials performed between 1990 and 2022.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: Online databases (Google scholar and PubMed) and registers (Clinicaltrials.gov and Euclinicaltrial) were used to identify clinical trials performed between 1990 and 2022.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
目的：鼓室内注射是安全的，由耳鼻喉科专家常规进行的耐受性良好的手术。鼓室内注射凝胶具有通过圆窗膜将治疗剂递送到耳蜗中的潜力,延长药物在内耳室中的释放。本综述的目的是总结通过鼓室内凝胶制剂测试内耳病变的药理学治疗的临床试验。
方法：在线数据库（谷歌学者和PubMed）和寄存器（Clinicaltrials.gov和Euclinicaltrial）用于确定1990年至2022年进行的临床试验。
方法：遵循PRISMA标准。包括测试通过局部鼓室内注射和靶向内耳疾病施用的凝胶制剂的临床试验。所有报告均由成对工作的作者确定，依次选择仅符合纳入标准的研究。
结果：总共发现了45项临床研究；用于鼓内注射的凝胶是泊洛沙姆或透明质酸组合的形式；试验发现针对不同类型的内耳疾病：获得性稳定的SNHL，耳鸣,急性突发性SNHL，梅尼埃病,顺铂对人工耳蜗植入手术患者的耳毒性和听力保护。
结论：列出的少数研究没有提供所使用的特定类型的凝胶制剂，而仅将鼓内给药载体报告为“凝胶”或“热凝胶”。多个临床研究已经通过通过泊洛沙姆和透明质酸制剂注射不同的化合物来靶向几种形式的内耳病症。需要更大和更高级的临床阶段来确认这些化合物的功效。
方法：在线数据库（谷歌学者和PubMed）和寄存器（Clinicaltrials.gov和Euclinicaltrial）用于确定1990年至2022年进行的临床试验。
方法：遵循PRISMA标准。包括测试通过局部鼓室内注射和靶向内耳疾病施用的凝胶制剂的临床试验。所有报告均由成对工作的作者确定，依次选择仅符合纳入标准的研究。
结果：总共发现了45项临床研究；用于鼓内注射的凝胶是泊洛沙姆或透明质酸组合的形式；试验发现针对不同类型的内耳疾病：获得性稳定的SNHL，耳鸣,急性突发性SNHL，梅尼埃病,顺铂对人工耳蜗植入手术患者的耳毒性和听力保护。
结论：列出的少数研究没有提供所使用的特定类型的凝胶制剂，而仅将鼓内给药载体报告为“凝胶”或“热凝胶”。多个临床研究已经通过通过泊洛沙姆和透明质酸制剂注射不同的化合物来靶向几种形式的内耳病症。需要更大和更高级的临床阶段来确认这些化合物的功效。
