氟喹诺酮类药物致血小板减少症的临床特点及危险因素分析

Clinical characteristics and risk factors of thrombocytopenia induced by fluoroquinolones

目的探讨氟喹诺酮类药物致血小板减少症的临床特点,并进行相关危险因素分析,为临床的合理安全用药提供依据。方法采用回顾性研究方法,选取衡水市人民医院和衡水市第四人民医院药品不良反应(ADR)监测系统2015年1月1日至2019年12月31日上报的氟喹诺酮类药物致ADR病例596例,根据是否发生血小板减少症分为血小板减少症组(44例)和非血小板减少症组(552例),应用单因素和多因素逐步Logistic回归分析其相关危险因素。结果氟喹诺酮类药物致血小板减少症占总ADR的7.38%,血小板计数低于正常值75%的有26例(59.09%)、低于正常值50%~75%的有12例(27.27%)、低于正常值50%的有6例(13.64%),停药后逐渐恢复正常。单因素及多因素分析显示,APACHE-Ⅱ评分≥20分(OR=2.09,95%CI=1.10~3.99,P=0.022)、肌酐清除率≤30 mL·min^(-1)(OR=2.01,95%CI=1.08~3.75,P=0.031)、大剂量用药(OR=2.02,95%CI=1.08~3.72,P=0.028)和用药时间≥14 d(OR=1.95,95%CI=1.04~3.64,P=0.043)是氟喹诺酮类药物致血小板减少症的独立危险因素。结论对于使用氟喹诺酮类药物的患者,需要警惕血小板减少症的发生,尤其是重症(APACHE-Ⅱ评分≥20)、肾功能不全(肌酐清除率≤30 mL·min^(-1))、大剂量用药和长时间用药(≥14 d)的患者。

Objective To investigate the prevalence of and risk factors for thrombocytopenia caused by fluoroquinolones in order to provide reference for rational use of fluoroquinolones.Methods A retrospective study was made of 596 cases of adverse drug reactions(ADR)in two hospitals between Jan 1,2015 and Dec 31,2019.According to the diagnostic criteria for thrombocytopenia,these patients were divided into the thrombocytopenia group(44 patients)and non-thrombocytopenia group(552 patients).Univariate and multiple logistic regression analysis was used to identify risk factors related to thrombocytopenia.Results Thrombocytopenia caused by fluoroquinolones accounted for 7.38%of the total ADR.There were 26 cases(59.09%)with platelet counts below 75%of the normal level,12 cases(27.27%)below 50%~75%of the normal level,and 6 cases(13.64%)below 50%of the normal level.After discontinuation of medication,those symptoms gradually returned to normal.Univariate and multivariate logistic analysis showed that APACHE-Ⅱ score≥20 points(OR=2.09,95%CI=1.10 to 3.99,P=0.022),creatinine clearance rate≤30 mL·min^(-1)(OR=2.01,95%CI=1.08 to 3.75,P=0.031),overdose medication(OR=2.02,95%CI=1.08 to3.72,P=0.028)and duration of medication≥14 days(OR=1.95,95%CI=1.04 to 3.64,P=0.043)were independent risk factors for thrombocytopenia caused by fluoroquinolones.Conclusion When patients are using fluoroquinolones,clinicians should be alert to the occurrence of thrombocytopenia,especially among severe cases(APACHE-Ⅱ score≥20)or cases with renal insufficiency(creatinine clearance≤30 mL·min^(-1)),overdose medication and long-term medication(≥14 days).