Department of Practical Pharmacy, Faculty of Pharmaceutical Sciences, Toho University, Chiba, Japan.
Center for Experiential Pharmacy Practice, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan.
Drug Discov Ther. 2021;15(3):150-155. doi: 10.5582/ddt.2021.01053.
We aimed to investigate the association between anaphylaxis and anti-influenza drug use using the Japanese Adverse Drug Event Report (JADER) database, a national spontaneous reporting database in Japan. We surveyed registered cases from the JADER database between April 2004 and November 2019. The target drugs were five anti-influenza drugs, namely oseltamivir, zanamivir, peramivir, laninamivir, and baloxavir. Adverse events associated with anaphylaxis, "anaphylactic reaction," "anaphylactic shock," "anaphylactoid reaction," and "anaphylactoid shock," were evaluated. The association between anaphylaxis and anti-influenza drug use was assessed by calculating the reporting odds ratio (ROR) and information component (IC) as a measure of disproportionality. Signals were considered positive if the lower limit of the 95% confidence interval (CI) of ROR was > 1, and that of IC was > 0. The number of anaphylaxis cases associated with anti-influenza drug use was 199 (0.9%). Signals were detected for inhaled laninamivir (ROR: 4.24 [95% CI: 3.06-5.88], IC: 1.83 [1.35-2.30]), intravenous peramivir (ROR: 2.97 [2.11-4.17], IC: 1.40 [0.90-1.89]), and oral baloxavir (ROR: 3.05 [2.22-4.18], IC: 1.44 [0.98-1.90]). Conversely, signals were not detected for oral oseltamivir or inhaled zanamivir. Although zanamivir and laninamivir were used as dry powder inhalers containing lactose as an additive, they differed in terms of signal detection. Our analysis indicated that the signal of anaphylaxis may varies based on the main component or dosage form of each anti-influenza drug. Appropriate use of these drugs is essential to prevent anaphylaxis and improve health status.
我们旨在使用日本不良反应事件报告（JADER）数据库，这是日本的一个全国性自发报告数据库，研究过敏反应与抗流感药物使用之间的关联。我们调查了 2004 年 4 月至 2019 年 11 月期间 JADER 数据库中登记的病例。目标药物为五种抗流感药物，即奥司他韦、扎那米韦、帕拉米韦、拉尼米韦和巴洛沙韦。评估了与过敏反应相关的不良反应事件，包括“过敏反应”、“过敏性休克”、“类过敏反应”和“类过敏反应性休克”。通过计算报告比值比（ROR）和信息分量（IC）来评估过敏反应与抗流感药物使用之间的关联，作为不成比例性的度量。如果 ROR 的 95%置信区间（CI）下限>1，并且 IC 的下限>0，则认为信号为阳性。与抗流感药物使用相关的过敏反应病例数为 199 例（0.9%）。检测到吸入用拉尼米韦（ROR：4.24 [95% CI：3.06-5.88]，IC：1.83 [1.35-2.30]）、静脉用帕拉米韦（ROR：2.97 [2.11-4.17]，IC：1.40 [0.90-1.89]）和口服巴洛沙韦（ROR：3.05 [2.22-4.18]，IC：1.44 [0.98-1.90]）的信号。相反，口服奥司他韦或吸入用扎那米韦未检测到信号。尽管扎那米韦和拉尼米韦都作为含有乳糖作为添加剂的干粉吸入剂使用，但它们在信号检测方面存在差异。我们的分析表明，过敏反应的信号可能因每种抗流感药物的主要成分或剂型而异。这些药物的合理使用对于预防过敏反应和改善健康状况至关重要。
