摘要
目的对150例骨科植入物可疑不良事件报告进行分析,发现骨科植入物不良事件监测存在的问题,探讨解决问题的对策。方法采用回顾性研究方法,对近五年北京市药品不良反应监测中心收到的150例骨科植入物可疑不良事件报告进行综合分析。结果骨科植入物可疑不良事件报告数量占同期收到报告总数的10.6%,但远少于骨科植入物不良事件实际发生数量;不良事件关联性难以评价;报告质量有待提高。结论目前骨科植入物不良事件监测现状无法满足提取预警信号的要求。应在完善法律法规的基础上,不断提高报告的数量和质量,以加强信息利用度。
Objective By event monitoring, and to analyzing 150 reports to find the problems of orthopedic implants adverse explore countermeasures to solve the problem. Methods With retrospective study, analyze 150 reports of orthopedic implants suspicious adverse events received from the Beijing Center ADR Monitoring in the past five years. Results The number of reports accounted for 10.6% of the total number of the reports received in the same period, but is less than the actual number of orthopedic implants adverse events The relevance of adverse events is difficult to evaluate, and the quality of the report needs to be raised. Conclusion At present, the monitoring of orthopedic im- plants medical device adverse events is unable to meet the detection of early warning signal. On the basis of the perfection of laws and regulations, the quantity and quality of reports should be improved continuously in order to enhance the availability of information.
出处
《中国药物警戒》
2009年第5期291-294,共4页
Chinese Journal of Pharmacovigilance
关键词
骨科植入物
不良事件
分析
orthopedic implants
adverse events
analysis
