Abstract:
Sudden sensorineural hearing loss (SSNHL), a rare audiological condition that accounts for 1% of all cases of sensorineural hearing loss, can cause permanent hearing damage. Soon after the launch of global COVID-19 vaccination campaigns, the World Health Organization released a signal detection about SSNHL cases following administration of various COVID-19 vaccines. Post-marketing studies have been conducted in different countries using either pharmacovigilance or medico-administrative databases to investigate SSNHL as a potential adverse effect of COVID-19 vaccines. Here, we examine the advantages and limitations of each type of post-marketing study available. While pharmacoepidemiological studies highlight the potential association between drug exposure and the event, pharmacovigilance approaches enable causality assessment. The latter objective can only be achieved if an expert evaluation is provided using internationally validated diagnostic criteria. For a rare adverse event such as SSNHL, case information and quantification of hearing loss are mandatory for assessing seriousness, severity, delay onset, differential diagnoses, corrective treatment, recovery, as well as functional sequelae. Appropriate methodology should be adopted depending on whether the target objective is to assess a global or individual risk.
摘要:
突发性感觉神经性听力损失(SSNHL),一种罕见的听力学状况,占所有感音神经性听力损失病例的1%,会造成永久性听力损伤。在全球COVID-19疫苗接种运动启动后不久,世界卫生组织在服用各种COVID-19疫苗后发布了有关SSNHL病例的信号检测。已在不同国家/地区使用药物警戒或医学管理数据库进行了上市后研究,以调查SSNHL作为COVID-19疫苗的潜在不良反应。这里,我们研究了每种类型的上市后研究的优点和局限性.虽然药物流行病学研究强调了药物暴露与事件之间的潜在关联,药物警戒方法可以进行因果关系评估。只有使用国际认可的诊断标准提供专家评估,才能实现后一个目标。对于罕见的不良事件,如SSNHL,病例信息和听力损失的量化对于评估严重性是强制性的,严重程度,延迟发作,鉴别诊断,纠正治疗,recovery,以及功能性后遗症。根据目标目标是评估全球风险还是个人风险,应采用适当的方法。