Meng Xiao, Wu Yaozhou, Liu Zixuan, Chen Yifan, Dou Zhizhou, Wei Li
Department of Pharmacy, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Front Pharmacol. 2024 Jun 28;15:1322587. doi: 10.3389/fphar.2024.1322587. eCollection 2024.
The increasing prevalence of fungal infections necessitates broader use of antifungal medications. However, the prevalence of adverse drug events (ADEs) restricts their clinical application. This study aimed to develop a reliable ADEs trigger for antifungals to enable proactive ADEs monitoring, serving as a reference for ADEs prevention and control.
This investigation comprises two phases. Initially, the trigger was established via a literature review, extraction of relevant items, and refinement through Delphi expert consultation. Subsequently, the validity of the trigger was assessed by analyzing hospital records of antifungal drug users from 1 January 2019 to 31 December 2020. The correlation between each trigger signal and ADEs occurrence was examined, and the sensitivity and specificity of the trigger were evaluated through the spontaneous reporting system (SRS) and Global Trigger Tool (GTT). Additionally, risk factors contributing to adverse drug events (ADEs) resulting from antifungal use were analyzed. Results: Twenty-one preliminary triggers were refined into 21 final triggers after one expert round. In the retrospective analysis, the positive trigger rate was 65.83%, with a positive predictive value (PPV) of 28.75%. The incidence of ADEs in inpatients was 28.75%, equating to 44.58 ADEs per 100 admissions and 33.04 ADEs per 1,000 patient days. Predominant ADEs categories included metabolic disturbances, gastrointestinal damage, and skin rashes. ADEs severity was classified into 36 cases at grade 1, 160 at grade 2, and 18 at grade 3. The likelihood of ADEs increased with longer stays, more positive triggers, and greater comorbidity counts.
This study underscores the effectiveness of the GTT in enhancing ADEs detection during antifungal medication use, thereby confirming its value as a monitoring tool.
真菌感染患病率的上升使得抗真菌药物的使用更为广泛。然而，药物不良事件（ADEs）的发生率限制了它们的临床应用。本研究旨在开发一种可靠的抗真菌药物ADEs触发工具，以实现对ADEs的主动监测，为ADEs的预防和控制提供参考。
本调查包括两个阶段。首先，通过文献回顾、提取相关项目并经德尔菲专家咨询进行完善来建立触发工具。随后，通过分析2019年1月1日至2020年12月31日期间抗真菌药物使用者的医院记录来评估触发工具的有效性。检查每个触发信号与ADEs发生之间的相关性，并通过自发报告系统（SRS）和全球触发工具（GTT）评估触发工具的敏感性和特异性。此外，还分析了抗真菌药物使用导致的药物不良事件（ADEs）的危险因素。结果：经过一轮专家咨询，21个初步触发工具被提炼为21个最终触发工具。在回顾性分析中，阳性触发率为65.83%，阳性预测值（PPV）为28.75%。住院患者中ADEs的发生率为28.75%，相当于每100次入院发生44.58例ADEs，每1000个患者日发生33.04例ADEs。主要的ADEs类别包括代谢紊乱、胃肠道损伤和皮疹。ADEs严重程度分为1级36例、2级160例和3级18例。住院时间越长、阳性触发工具越多、合并症数量越多，发生ADEs的可能性就越大。
本研究强调了GTT在提高抗真菌药物使用期间ADEs检测方面的有效性，从而证实了其作为监测工具的价值。
