与Z类药物相关的嗅觉和味觉障碍信号检测：FAERS数据库的不比例分析

文献信息

中文摘要

目的： 本研究旨在检测并描述美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）中与Z类药物相关的嗅觉和味觉障碍的不比例报告信号。
方法： 使用标准化MedDRA查询（SMQ）“味觉和嗅觉障碍”识别涉及Z类药物和嗅觉/味觉障碍的报告。采用报告比值比（ROR）、比例报告比（PRR）、经验贝叶斯几何均值（EBGM）和信息成分（IC）进行不比例分析。还进行了性别分层、年龄分层和发病时间（TTO）分析。
结果： 在32,853份涉及Z类药物的报告中，3,480份被归类为嗅觉或味觉相关不良事件。艾司佐匹克隆占这些报告的97.6%，并显示出强烈的不比例信号。味觉障碍是主要的不良事件，而嗅觉倒错和首选术语“味觉障碍”产生了额外的阳性信号。信号强度在18至45岁的成年人中最大，且嗅觉倒错在女性中显示出更强的不比例。大多数事件在治疗开始后30天内报告。
结论： FAERS数据表明艾司佐匹克隆与嗅觉/味觉障碍之间存在强烈关联，尤其是味觉障碍。嗅觉倒错作为额外信号出现，值得临床关注。需要进一步的流行病学和机制研究来阐明这些发现的潜在机制和临床意义。

英文摘要

OBJECTIVE: This study aimed to detect and characterise signals of disproportionate reporting for smell and taste disorders associated with Z-drugs in the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).
METHODS: Reports involving Z-drugs and smell/taste disorders were identified using the Standardised MedDRA Query (SMQ) 'Taste and smell disorders'. Disproportionality analyses were performed using the reporting odds ratio (ROR), proportional reporting ratio (PRR), empirical Bayes geometric mean (EBGM), and information component (IC). Sex-stratified, age-stratified, and time-to-onset (TTO) analyses were also conducted.
RESULTS: Among 32,853 reports involving Z-drugs, 3,480 were classified as smell- or taste-related adverse events. Eszopiclone accounted for 97.6% of these reports and demonstrated a strong disproportionality signal. Dysgeusia was the predominant adverse event, whereas parosmia and the preferred term 'taste disorder' generated additional positive signals. Signal strength was greatest among adults aged 18 to 45 years, and parosmia showed stronger disproportionality among women. Most events were reported within 30 days after treatment initiation.
CONCLUSIONS: FAERS data indicate a strong association between eszopiclone and smell/taste disorders, particularly dysgeusia. Parosmia emerged as an additional signal warranting clinical attention. Further epidemiological and mechanistic studies are needed to clarify the underlying mechanisms and clinical significance of these findings.