人工髋关节置换可疑不良事件的报告分析

Analysis of the reports of suspected adverse events in total hip arthroplasty

目的通过对人工髋关节不良事件的报告进行分析,发现不良事件监测存在的问题,探讨解决问题的对策。方法采用前瞻性研究方法,跟踪随访2014年1月至2015年6月北京市药品不良反应监测中心收集的行人工髋关节置换术的874例患者(878髋),并将其中的127髋可疑不良事件报告情况进行综合分析。结果 878髋中,127髋发生可疑不良事件,总可疑不良事件发生率为14.46%,平均随访时间为5.28个月。在不良事件信息收集过程中有5例患者未填写随访表(即在数据库中有不良事件信息,但未填写随访表),共发现不良事件122例,其中疼痛发生率最高,为112例,下肢肌力弱、纠正步态、弹响、假体周围骨折、伤口脂肪液化和血栓各发生1例,红肿及下肢不等长各发生2例。112例疼痛患者中,轻微疼痛所占比例最高(73.8%)。重度疼痛占比例最低(0.8%)。结论疼痛原因是一个较为复杂的问题,因此要做好术前准备工作,术中要谨慎操作,严格遵循无菌操作的原则,有效预防疼痛,术后做好康复训练及健康指导,有效减少术后不良事件的发生。另外,应加强临床医生的培训,提高其对医疗器械不良事件的认知,及时发现医疗器械的使用风险,提高医疗产品的安全性。

Objective By analyzing the suspected adverse events reports for total hip arthroplasty, to find the supervise problem of adverse events and to provide the way to solve the problem. Methods With pro-spective analysis, collected basic information for 874 patients （878 hips）who had reported to the Beijing Center for Adverse Drug Reaction Monitoring during January 2014 to June 2015 and all the patients have been fol-lowed. There were 127 cases of suspected adverse reports and all were aggregated analysis. Results All the 878 prospective collected patients who underwent total hip arthroplasty, 127 cases had suspected adverse e- vents, the incidence was 1 4 .46% , average follow-up time was 5 .2 8 months. There were 5 cases didn91 com-plete the follow-up during the prospective information collection （ only had basic information but had no specific follow-up information）. For all the 122 adverse events, pain had the highest incidence for 112 cases. There was 1 case for muscle weakness, abnormal gait, hip snapping, periprosthetic fracture, wound fat liquefaction and thrombosis respectively. There were 2 cases for swelling and limb length discrepancy respectively. A total of 112 cases of pain, mild pain had highest incidence for 73. 8% while severe pain were least for only 0. 8%. Conclusion With analysis for the reasons of adverse events after total hip arthroplasty, pain is a complicated problem. Fully preoperative preparation, careful operation and strict aseptic rules are useful to prevent pain. Postoperative rehabilitation and education can help to decrease the incidence of adverse events. Additionally, training of surgeons, increase ability for awareness of adverse events could help to detect r isk, and increase the safety of medical devicesusage in time.