摘要
目的通过对肺炎球菌疫苗的不良反应信号进行挖掘与研究,为肺炎疫苗的临床安全合理使用提供参考。方法采用报告比值比法(ROR)和比例报告比值比法(PRR)对美国疫苗不良事件报告系统(VAERS)2010年1月1日至2019年12月31日收集的药品不良反应(adverse drug reaction,ADR)报告进行分析,挖掘其中有关肺炎球菌疫苗(23价和13价)的ADR信号。结果23价肺炎疫苗经ROR和PRR法检测得到36个信号,其中7个未在说明书中提及,信号强度最高的ADR是白细胞增多症。13价肺炎疫苗ROR和PRR分别得到103和102个ADR信号,其中36个信号未在说明书中提及,信号强度较高的ADR多为胃肠系统疾病、感染及侵袭类疾病、全身性疾病及给药部位各种反应等。结论临床使用肺炎疫苗时应密切监测患者的ADR,特别是说明书未提及的,应及时做出干预。
Objective To provide reference for rational and safe use of pneumonia vaccines by mining and studying the adverse reaction signals of pneumonia vaccines.Methods The reporting odds ratio(ROR)and the proportional reporting ratio(PRR)were used to analyze the adverse reaction reports collected by the American Vaccine Adverse Reaction Event Reporting System(VAERS)between January 1,2010 and December 31,2019,while adverse reaction signals related to pneumonia vaccines were mined.Results Thirty-six ADR signals associated with 23-valent pneumonia polysaccharide vaccines were obtained using both the ROR and PRR method,seven of which were not mentioned in specifications before,and ADR with the highest signal intensity were related to leukocytosis.A total of 103 ADR signals of 13-valent pneumococcal polysaccharide conjugate vaccines were obtained using ROR,compared with 102 signals by PRR.Thirty-six of the ADR signals were not mentioned in any specifications before,and ADR with relatively high signal intensity centered on gastrointestinal diseases,infections and invasive diseases,systemic diseases,and various reactions at the administration site.Conclusion It is suggested that patients should be closely monitored for adverse reactions,especially new ADR that are not mentioned in specifications,and immediate interventions should be enforced when pneumonia vaccines are used.
作者
刘砚韬
张伶俐
林芸竹
陈力
王丽
LIU Yantao;ZHANG Lingli;LIN Yunzhu;CHEN Li;WANG Li(Department of Pharmacy,West China Second University Hospital,Sichuan University,Chengdu Sichuan 610041,China;Evidence-Based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu Sichuan 610041,China;Key Laboratory of Birth Defects and Related Diseases of Women and Children,Sichuan University,Ministry of Education,Chengdu Sichuan 610041,China)
出处
《中国药物警戒》
2023年第1期96-100,116,共6页
Chinese Journal of Pharmacovigilance
基金
四川省科技计划项目重点研发项目(2020YFS0035)。
