■真菌感染患病率的增加需要更广泛地使用抗真菌药物。然而,药物不良事件(ADEs)的发生率限制了其临床应用。这项研究旨在开发一种可靠的抗真菌药物ADE触发剂,以实现主动ADE监测,作为ADE预防和控制的参考。
■这项调查包括两个阶段。最初,触发因素是通过文献综述确定的,提取相关项目,并通过Delphi专家咨询进行细化。随后,触发因素的有效性是通过分析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的.检查了每个触发信号与ADE发生之间的相关性,通过自发报告系统(SRS)和全局触发工具(GTT)评估触发因素的敏感性和特异性.此外,分析了导致抗真菌药物不良事件(ADE)的危险因素.结果:经过一轮专家回合后,将21个初步触发因素细化为21个最终触发因素。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ADE的发生率为28.75%,相当于每100个入院者44.58个ADE和每1,000个患者日33.04个ADE。主要的ADE类别包括代谢紊乱,胃肠道损伤,还有皮疹.ADE的严重程度分为1级36例,2级160例和3级18例。ADE的可能性随着停留时间的延长而增加,更多积极的触发因素,和更大的合并症计数。
■这项研究强调了GTT在抗真菌药物使用期间增强ADE检测的有效性,从而确认其作为监测工具的价值。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: This study underscores the effectiveness of the GTT in enhancing ADEs detection during antifungal medication use, thereby confirming its value as a monitoring tool.