体外引发冲击碎石机临床可疑不良事件的分析研究

Analysis of Clinical Suspicious Adverse Events Caused by in Vitro Shock Stone Crusher

近年来,国内各类结石患病人数呈现不断上升趋势,作为临床医学结石碎石的主要手段之一的体外引发冲击波碎石机在临床使用的需求越来越高,但随之出现出现的该设备的各类可疑不良事件也显著增多。通过对本院近三年该设备可疑不良事件的汇总分析,及文献资料的检索,现将临床使用该产品常见的可疑不良事件表现、原因分析等内容进行综述,以期为医疗机构同仁正确认识该类产品的可疑不良事件、降低该类产品临床可疑不良事件发生率提供循证支持。

In recent years,the number of patients with various kinds of stones in China is on the rise.As one of the main means of clinical stone lithotripsy,the demand of extracorporeal shock wave lithotriptor in clinical use is increasing.However,the number of suspicious adverse events of this equipment is also increasing.Through the summary and analysis of suspicious adverse events of the equipment in our hospital in recent three years,and the retrieval of literature,this paper summarizes the performance and cause analysis of common suspicious adverse events of this product in clinical use,in order to correctly understand the suspicious adverse events of such products and reduce the number of such products To provide evidence-based support for the incidence of clinically suspected adverse events.