目的 挖掘阿糖苷酶α的不良反應(yīng)風(fēng)險信號，為該藥的臨床安全使用提供參考。方法 采用報告比值比法與英國藥品和保健品管理局綜合標(biāo)準(zhǔn)法對2006年6月-2022年12月美國FDA不良事件報告系統(tǒng)（FAERS）數(shù)據(jù)庫收到的阿糖苷酶α相關(guān)藥品不良事件（ADE）報告進行數(shù)據(jù)挖掘與分析。結(jié)果 共獲得阿糖苷酶α相關(guān)ADE報告3 255份，一半以上（1 695份，52.1%）為嚴(yán)重ADE。女性略多于男性（1 461份，44.88%vs 1 369份，42.06%）；報告主要來自歐美，其中美國報告數(shù)最多（1 683份，51.7%）。共檢測到相關(guān)風(fēng)險信號298個，發(fā)生頻次位居首位的是發(fā)熱，其次是呼吸衰竭、肺炎、呼吸困難以及輸液反應(yīng)等；信號強度排名第1位的是藥物特異性抗體缺失。ADE風(fēng)險信號共涉及22個系統(tǒng)器官分類（SOC），排名前10位的依次是呼吸系統(tǒng)、胸及縱隔疾病，各類檢查，全身性疾病及給藥部位各種反應(yīng)，感染及侵染類疾病，心臟器官疾病，各種肌肉骨骼及結(jié)締組織疾病，各類損傷、中毒及操作并發(fā)癥，各類神經(jīng)系統(tǒng)疾病，免疫系統(tǒng)疾病和胃腸系統(tǒng)疾病。結(jié)論 阿糖苷酶α ADE信號及其累及系統(tǒng)器官與說明書基本一致，包括過敏反應(yīng)、免疫介導(dǎo)反應(yīng)、急性心肺衰竭風(fēng)險、抗體形成風(fēng)險等，但仍需警惕其說明書中未提及的安全風(fēng)險，如可能存在的相關(guān)感染風(fēng)險。

Objective To mine the risk signals of alglucosidase α, so as to provide evidence for clinically safe drug use. Methods Data mining and analysis of risperidone-related ADE reports from rom June 2006 to December 2022 in the FAERS database were carried out using reported odds ratio and composite criteria methods from Medicines and Healthcare Products Regulatory Agency. Results A total of 3 255 reports of ADE associated with alglucosidase α were obtained, and more than half (1 695, 52.1%) were severe ADE. Slightly more women than men (1 461, 44.88% vs 1 369, 42.06%). Reports were mainly from Europe and the United States, with the largest number of reports from the United States (1 683, 51.7%). A total of 298 risk signals were detected, with fever being the most frequent, followed by respiratory failure, pneumonia, dyspnea, and infusion reactions, drug-specific antibody deficiency was the top signal intensity. The top 10 are respiratory, thoracic and mediastinal diseases, various tests, systemic diseases and various reactions at the drug administration site, infectious and infectious diseases, cardiac diseases, various musculoskeletal and connective tissue diseases, various injuries, toxicities and operational complications, various neurological diseases, immune system diseases and gastrointestinal diseases. Conclusion The alglucosidase α ADE signal and its involvement in systemic organs are generally consistent with the instructions, including the risk of allergic reactions, immune-mediated reactions, acute cardiopulmonary failure, and the risk of antibody formation, but it is still necessary to be alert to safety risks not mentioned in its instructions, such as the possible risk of associated infections.

R977.3

上海市臨床藥學(xué)重點專科建設(shè)項目（滬衛(wèi)計藥政[2018]8號）