基于上海市临床药事质量控制中心数据库的药物致血小板减少回顾性分析  

Drug-induced Thrombocytopenia:a Descriptive Survey in Adverse Drug Reaction Spontaneous Reporting Database of Shanghai in China

作　　者：赵晖[1] 张千 颜明明[1] 邱晓燕[1] 钟明康[1] Zhao Hui;Zhang Qian;Yan Mingming;QiuXiaoyan;Zhong Mingkang(Huashan Hospital Affiliated to Fudan University,Shanghai 200040.China)

机构地区：[1]复旦大学附属华山医院,上海200040

出　　处：《药物流行病学杂志》2022年第7期454-462,共9页Chinese Journal of Pharmacoepidemiology

基　　金：上海市2019年度“科技创新行动计划”软科学研究领域重点项目(编号:19692107000);上海市优秀青年临床药师培养计划(编号:201801-202012);上海市“医苑新星”青年医学人才培养资助计划-临床药师项目[编号:沪卫人事(2021)99]。

摘　　要：目的:基于上海市临床药事质量控制中心数据库,采用比例失衡法对药物致血小板减少症(DITP)相关药品不良反应(ADR)信号进行监测,并对DITP相关ADR报告进行描述。方法:利用2017~2019年上海市临床药事质量控制中心收集的下属44家医疗机构报告的21679条ADR数据,运用报告比例比法(ROR)对DITP相关ADR报告进行数据挖掘,并对其进行统计分析。结果:110种可疑药物中,利奈唑胺(ROR:110.37,95%CI:72.07,169.03)、替罗非班(ROR:57.33,95%CI:18.99,173.01)、硼替佐米(ROR:38.68,95%CI:11.58,129.16),奥希替尼(ROR:37.99,95%CI:15.91,90.73)等26种药物与血小板降低可能相关。194份DITP报告中,男110例(56.70%),女82例(42.27%),2例性别不详;68例(35.05%)患者接受抗肿瘤治疗,93例(47.94%)患者接受抗感染治疗,抗凝治疗患者34例(17.01%);103例(53.09%)患者年龄大于66岁。患者在接触可疑药物后出现血小板减少,平均延迟7 d出现症状。94例(48.45%)患者Plt低于75×10^(9)·L^(-1),其中18例(9.28%)出现出血症状。45例(23.20%)患者接受了特殊治疗。其他药物也可能引起血小板减少,如氯法齐明、西妥昔单抗、乌苯美司、氨甲环酸、注射用凝血酶、亚叶酸钙、蔗糖铁,以及5种从未被报道为DITP诱导药物的中成药。结论:医务工作者应熟悉可能引起血小板减少的药物,并利用ADR数据库中药物-DITP潜在的因果关系,关注未经报道风险药物的用药安全。Objective:To describe adverse drug reaction(ADR)reports of drug-induced thrombocytopenia(DITP)in the database of Shanghai Quality Control Center of Hospital Pharmaceutical Administration,and to detect signal of potential drug-ADR combinations using report odds ratio(ROR)method.Methods:44 medical organizations’reports were retrieved from a total of 21679 ADR reports dating from 2017 to 2019 and was subject to data mining procedure using ROR method.Results:Among the 110 suspected drugs,26 drugs was associated to thrombocytopenia including:linezolid(ROR=110.37,95%CI 72.07 to 169.03),tirofiban(ROR=57.33,95%CI 18.99 to 173.01),bortezomib(ROR=38.68,95%CI 11.58 to 129.16),osimertinib(ROR=37.99,95%CI 15.91 to 90.73).Among the 194 DITP patients,110 cases(56.70%)were male,as well as 82 cases(42.27%)female,the gender of 2 cases was unknown.68 cases(35.05%)received anti-cancer treatment,while 34 cases(17.53%)were with anti-cogulant therapy,and 93 cases(47.94%)were with anti-biotic treatment.103 cases(53.09%)was the elderly above 66 years old.Patients presented thrombocytopenia with a median delay of 7 days after exposure of suspected drugs,platelet count nadirs less than 75×10^(9)·L^(-1)·Lwere seen in 94(48.45%)patients,while 18(9.28%)cases documented hemorrhage symptoms.Specific treatment was indroduced in 45(23.20%)patierts.Some other drugs might also associated to DITP like clofazimine,cetuximab,ubenimex,tranexamic acid,hemocoagulase for injection,calcium folinate,iron sucrose,and five Chinese patent medications that were never reported as DITP inducers.Conclusion:Chinese healthcare workers should pay more attention to ADR databases,and with data mining method,to investigate the association between interested drug and ADR as pharmacovigilance,especially for those rare and severe ADR which is not reported such as DITP.

关 键 词：药物性血小板减少症 药品不良反应 报告比值比法 数据挖掘 药物警戒 

分 类 号：R181.35[医药卫生—流行病学]