目的 分析艾沙康唑所致药品不良反应的临床特点，为临床安全应用该药提供参考。方法 检索中国知网、万方、维普、PubMed和Embase数据库截至2024年8月收录的艾沙康唑相关不良反应案例报道和病例系列分析，对涉及患者的一般资料、用药情况、不良反应发生时间、主要临床表现、治疗及转归等信息进行描述性统计分析。结果 共纳入文献15篇，涉及患者26例，男女比例2.25∶1，患者中位年龄60（39，69）岁，以肺部侵袭性真菌病治疗性用药为主。不良反应发生中位时间为10（4.8，17.5）d，20例（76.92%）患者的不良反应发生在用药1个月以内。26例患者共发生39例次不良反应，严重不良反应占比26.92%，主要为用药所致的各种程度肝损伤；不良反应共累及11个系统器官（SOC），排名前3位的为神经系统、肝胆系统和各类实验室检查异常。新的不良反应（28.21%）分布于各SOC，暂未见明显特征。24例患者经治疗后好转/痊愈，中位转归时间为7（2，10.25）d。结论 临床在用药时需掌握艾沙康唑致各系统不良反应的特点，根据其可能机制或流行病学信息，关注易发生不良反应的高危人群，以便及时处理用药时遇到的风险。

Objective To analyze the clinical characteristics of adverse drug reactions caused by isavuconazole, and provide reference for the safe use of the drug in clinical practice. Methods Retrieve adverse drug reactions case reports and case series analysis related to isavuconazole from databases such as CNKI, Wanfang, VIP, PubMed, and Embase as of August 2024. Descriptive statistical analysis was conducted on patient general information, medication use, adverse drug reactions occurrence time, main clinical manifestations, treatment, and outcomes. Results A total of 15 articles were included in the study, involving 26 patients with a male to female ratio of 2.25∶1. The median age of the patients was 60 (39, 69) years old, and they mainly used therapeutic drugs for invasive fungal diseases of the lungs. The median time for adverse drug reactions occurrence was 10 (4.8, 17.5) d, and adverse reactions occurred within one month of medication in 20 patients (76.92%). A total of 39 adverse drug reactions occurred in 26 patients, with severe adverse reactions accounting for 26.92%, mainly due to various degrees of liver damage caused by medication. Adverse drug reactions affects a total of 11 systemic organs (SOC), with the top three being the nervous system, hepatobiliary system, and various laboratory abnormalities. The new adverse drug reactions (28.21%) is distributed among various SOC, and no obvious characteristics have been observed yet. 24 patients recovering/recovered after treatment, with a median transition time of 7 (2, 10.25) d. Conclusion In clinical practice, it is necessary to understand the characteristics of adverse drug reactions caused by isavuconazole in various systems, and based on its possible mechanisms or epidemiological information, pay attention to high-risk populations that are prone to adverse drug reactions, in order to timely handle the risks encountered during medication.

R978.5