手术机器人技术的安全性和有效性评估

Safety and Effectiveness Assessment of Surgical Robot Technology

目的对手术机器人技术的安全性和有效性进行评价,提出符合我国国情的手术机器人配置建议。方法采取快速评估手段,以国外集成的技术评估为主,辅以最近4年的英文文献综述。结果手术机器人诞生至今,已经呈现出部分优势。但与传统腹腔镜手术对照研究,结论并不十分明确。截至目前,尚无足够的证据区分手术机器人与传统的开放性手术、腹腔镜手术在安全性和有效性方面的差异。结论手术机器人应定位于临床高端技术,按科研临床型设备进行配置。坚持从严控制、适度发展原则。加强过程监管,并建立不良事件报告系统。

Objective To evaluate the safety and effectiveness of surgical robotics to provide recommendations for the allocation of surgical robot according to our country＇s conditions. Method We used rapid assessment tools to evaluate foreign - based technology, conbining with English literature review of recent 4 years. Result Since the inception of surgical robot, it has shown some advantages. However, compared with controlled studies on conventional laparoscopie surgery, the conclusion was not very sure. To data, there was insufficient evidence on the safety and efficacy to distinguish surgical robot from the traditional open surgery and laparoscopic surgery. Conclusion Surgical robot should be classified as the clinical high - technology, which belongs to scientific clinical equipments. It should be strict controlled, and be moderate developed. Furthermore, the process of supervision should be strengthened and adverse event reporting system should be established.