基于CHPS的替加环素致低纤维蛋白原血症的主动监测研究

CHPS-Based Active Surveillance of Tigecycline-Induced Hypofibrinogenemia

目的:利用中国医院药物警戒系统(CHPS)对替加环素致低纤维蛋白原血症(HF)开展主动监测,为临床安全使用替加环素和医疗机构利用CHPS开展药品不良反应主动监测提供参考。方法:利用CHPS建立替加环素致HF的主动监测方案,对2019年1月1日~2021年6月30日期间于某院使用替加环素的住院患者发生HF的相关情况开展主动监测,分析替加环素致HF的发生率、临床特点和相关危险因素。结果:共纳入186例患者,发生HF者95例,HF发生率为51.08%。多因素Logistic回归分析显示,日维持量超出药品说明书推荐量是替加环素致HF的独立危险因素(OR=2.726,95%CI:1.112~6.685,P=0.028),替加环素使用疗程与HF的发生呈正相关,纤维蛋白原(FIB)和血尿素氮(BUN)基线值与HF的发生呈负相关。结论:临床在使用替加环素前应关注患者FIB和BUN基线值,评估患者发生HF的风险,根据患者的感染程度合理控制替加环素使用疗程和使用剂量,并密切监测其FIB水平的变化。

Objective:To conduct active surveillance of tigecycline-induced hypofibrinogenemia(HF)using China Hospital Pharmacovigilance System(CHPS),so as to provide reference for clinical safe use of tigecycline and active surveillance of adverse drug reactions(ADR)using CHPS at medical institutions.Methods:An active surveillance program of tigecycline-induced HF was established based on CHPS.Active surveillance of HF reported for inpatients treated with tigecycline in a hospital between January 1,2019 and June 30,2021 was conducted to analyze the incidence,clinical characteristics and relevant risk factors of tigecycline-induced HF.Results:A total of 186 patients were included,95 of whom were reported with HF,and the incidence of HF was 51.08%.Multi-variate logistic regression analysis showed that a daily maintenance dose exceeding the label-recommended dose was an independent risk factor for tigecyclineinduced HF(OR=2.726,95%CI:1.112~6.685,P=0.028).The duration of tigecycline treatment was positively correlated with the occurrence of HF,and was negatively correlated with the baseline values of fibrinogen(FIB)and blood urea nitrogen(BUN).Conclusion:Before clinical use of tigecycline,assessment of HF risk should be performed for the patient by considering the patient's values of FIB and BUN.The duration and dosage of tigecycline should be reasonably controlled depending on the patient's degree of infection,and variation of FIB level should be closely monitored.