Evans Alison, Roy Debabrata, Dhanda Sandeep, Lane Samantha, Coutinho Graça, Kulasekaran Anuradha, Miller-Shakesby David, Ramamoorthi Nagalakshmi, Shakir Saad
Drug Safety Research Unit, Southampton, United Kingdom.
University of Portsmouth, Portsmouth, United Kingdom.
Front Pharmacol. 2024 Mar 6;15:1107185. doi: 10.3389/fphar.2024.1107185. eCollection 2024.
Flurbiprofen 8.75 mg lozenges and oromucosal sprays are used for symptomatic relief of sore throat in patients aged 12 years and over. The documented adverse events of flurbiprofen use include those related to its pharmacological actions, namely, increased risk of haemorrhagic events, however other adverse events (such as nephrotoxicity and cardiac failure) have been known to occur. The likelihood of occurrence of adverse events increases when flurbiprofen is used concomitantly with some other medications. Therefore, the objective of this systematic review was to collate the current evidence on adverse events which occur with flurbiprofen 8.75 mg dose (any formulation), in particular as a result of interaction with other medicinal products, with a focus on non-haemorrhagic events. Systematic searches of the literature were conducted to identify literature on any formulation of flurbiprofen 8.75 mg up to the date of the electronic database search (data lock: 28 April 2020). Publications were screened to identify studies reporting non-haemorrhagic adverse events with flurbiprofen 8.75 mg and/or non-haemorrhagic adverse events in the comparator arm. Data extraction was performed for eligible studies according to pre-defined criteria and summarised in narratives, tables and figures. Risk of bias and certainty of evidence assessments were planned for each included study where results relating to the primary objective of the systematic review were available. Of 1,528 publications identified by systematic literature searches, 26 met the inclusion criteria and were included in this review. None of these 26 studies contained information on non-haemorrhagic adverse events occurring as a result of a drug-drug interaction (interaction with concomitant medication used with flurbiprofen 8.75 mg), as per the primary objective and secondary objectives of the systematic review. Results from this systematic review on the risk of non-haemorrhagic events did not provide evidence for these events occurring as a result of interaction with other medicinal products. Additional appropriately designed studies would be required to confirm whether these findings suggest a true absence of risk or limitations in reporting.
氟比洛芬8.75毫克含片和口腔黏膜喷雾剂用于缓解12岁及以上患者的咽痛症状。已记录的使用氟比洛芬的不良事件包括与其药理作用相关的事件，即出血事件风险增加，然而，已知还会发生其他不良事件（如肾毒性和心力衰竭）。当氟比洛芬与其他一些药物同时使用时，发生不良事件的可能性会增加。因此，本系统评价的目的是整理关于8.75毫克剂量氟比洛芬（任何剂型）发生的不良事件的现有证据，特别是由于与其他药品相互作用导致的不良事件，重点是非出血性事件。对文献进行了系统检索，以识别截至电子数据库检索日期（数据锁定：2020年4月28日）的任何8.75毫克氟比洛芬剂型的文献。对出版物进行筛选，以识别报告8.75毫克氟比洛芬非出血性不良事件和/或对照臂中非出血性不良事件的研究。根据预先定义的标准对符合条件的研究进行数据提取，并以叙述性、表格和图表形式进行总结。对于每个纳入研究，如果有与系统评价主要目标相关的结果，则计划进行偏倚风险和证据确定性评估。在通过系统文献检索确定的1528篇出版物中，26篇符合纳入标准并被纳入本评价。根据系统评价的主要目标和次要目标，这26项研究中没有一项包含因药物相互作用（与8.75毫克氟比洛芬同时使用的伴随药物相互作用）而发生的非出血性不良事件的信息。关于非出血性事件风险的本系统评价结果未提供这些事件因与其他药品相互作用而发生的证据。需要进行更多设计合理的研究，以确认这些发现是表明真正不存在风险还是报告存在局限性。
