摘要
目的:分析达芬奇机器人手术系统(DVSS)辅助子宫切除术的不良事件记录数据,评估其在子宫切除术中的安全性。方法:采用R软件对FDA MAUDE数据库2005~2023年DVSS辅助子宫切除术的不良事件记录数据进行合并、转换和筛选,并对整合后的数据及死亡类不良事件信息进行纵向比较和可视化分析。结果:共筛选出2005—2023年DVSS辅助子宫切除术不良事件报告2138例,该手术不良事件发生率于2013年出现显著高峰。在所有不良事件中,技术故障与患者受伤类占比高达88.97%。死亡类不良事件共88例,占所有不良事件的4.12%,术后并发症是造成该类事件的主要原因。结论:为进一步提升DVSS辅助子宫切除术的安全性,可通过持续加强操作标准化、设备维护、术后监测和报告系统完善等策略,构建全方位保障体系。
Objective:To analyze adverse event records associated with Da Vinci Surgical System(DVSS)assisted hysterectomies and evaluate its safety during hysterectomy procedures.Methods:Using R software to merge,transform,and filter adverse event records from the FDA MAUDE database between 2005 and 2023 associated with DVSS-assisted hysterectomy,and conducting longitudinal comparison and visualization analysis on the integrated data and fatality-related adverse events.Results:A total of 2138 adverse event reports associated with DVSS-assisted hysterectomies from 2005 to 2023 were screened,with a significant peak in adverse event incidence observed in 2013.In all adverse events,malfunctions and injuries accounted for as high as 88.97%.There were 88 deathrelated adverse events,accounting for 4.12%of all adverse events,among which postoperative complications were the primary cause.Conclusion:To further enhance the safety of DVSS-assisted hysterectomy,a comprehensive safety assurance system should be established through continuous enhancement in standardization of procedures,equipment maintenance,postoperative monitoring,and improvement of reporting systems.
作者
陈楠
马晓汇
张心荷
张朦
武颂文
CHEN Nan;MA Xiaohui;ZHANG Xinhe;ZHANG Meng;WU Songwen(School of Public Health,Xi’an Medical University,Xi’an 710021,China)
基金
2024年陕西省大学生创新训练计划项目(S202411840110)。
