College of Pharmacy, Chungnam National University, Daejeon, Republic of Korea.
College of Pharmacy, Ewha Womans University, Seoul, Republic of Korea.
J Dig Dis. 2022 Feb;23(2):118-123. doi: 10.1111/1751-2980.13075. Epub 2022 Feb 9.
The objective of this case/non-case study was to detect rebamipide-related pulmonary adverse events (AE) compared with other drugs for acid-related disorders based on population-level data.
From 2009 to 2018, AE reports on drugs for acid-related disorders, which are anatomical therapeutic chemical code A02B drugs, in the Korea Adverse Events Reporting System (KAERS) database were examined. The reporting odds ratio (ROR) was calculated, and the odds of reporting pulmonary AE for rebamipide and all other A02B drugs were compared. Furthermore, a stratified analysis according to patients' age and sex was conducted.
Altogether 13 (0.05%) and 157 (0.11%) cases of pulmonary AE were reported for rebamipide and all other A02B drugs, respectively. The risk of reporting pulmonary AE was significantly lower for rebamipide than for all other A02B drugs (ROR 0.49, 95% confidence interval [CI] 0.28-0.87). The number of reports of pulmonary AE for rebamipide was significantly higher among patients aged ≥65 years than those aged <65 years (ROR 19.36, 95% CI 2.50-149.97).
Rebamipide was less often reported for pulmonary AE. However, healthcare professionals need to be aware of the risk of pulmonary AE in elderly patients.
本病例对照研究旨在基于人群水平数据，与其他酸相关疾病药物相比，检测瑞巴派特相关的肺部不良事件（AE）。
在 2009 年至 2018 年期间，检查了韩国不良事件报告系统（KAERS）数据库中酸相关疾病药物（解剖治疗化学代码 A02B 药物）的 AE 报告。计算了报告比值比（ROR），并比较了瑞巴派特和所有其他 A02B 药物报告肺部 AE 的可能性。此外，还根据患者的年龄和性别进行了分层分析。
共报告了 13 例（0.05%）和 157 例（0.11%）瑞巴派特和所有其他 A02B 药物的肺部 AE 病例。与所有其他 A02B 药物相比，报告肺部 AE 的风险明显更低（ROR 0.49，95%置信区间[CI]0.28-0.87）。≥65 岁患者报告的瑞巴派特肺部 AE 数量明显高于<65 岁患者（ROR 19.36，95%CI 2.50-149.97）。
瑞巴派特报告的肺部 AE 较少。然而，医护人员需要意识到老年患者肺部 AE 的风险。
