基于真实世界证据的人工髋关节假体临床使用研究  

Clinical use of artificial hip prosthesis based on real world evidence

作　　者：张晓燕 刘雨田 李岳飞 王学军 周媛媛 朱丹丹 Zhang Xiaoyan;Liu Yutian;Li Yuefei;Wang Xuejun;Zhou Yuanyuan;Zhu Dandan(Department of Biomedical Engineering,Inner Mongolia People’s Hospital,Hohhot 010020,China;Department of Orthopedics,Hohhol First Hospital,Hohhol 010030,China;College of Computer and Information,Inner Mongolia Medical University,Hohhot 010110,China)

机构地区：[1]内蒙古自治区人民医院医学工程处,呼和浩特010020 [2]呼和浩特市第一医院骨科,呼和浩特010030 [3]内蒙古医科大学计算机信息学院,呼和浩特010110

出　　处：《现代仪器与医疗》2022年第2期1-4,12,共5页Modern Instruments & Medical Treatment

基　　金：内蒙古自治区科技计划项目,项目名称:基于3D打印的膝关节置换数据采集和方案决策系统研究,项目编号:2021GG0135。

摘　　要：目的探讨真实世界中不同材质人工髋关节假体在治疗严重髋关节疾病中的应用,为临床髋关节假体选择提供数据支持。方法回顾性分析2017年1月至2020年12月行髋关节置换术且有完整随访信息的62例患者,依据人工髋关节假体生产厂家及材质的不同,分为国产A组、B组、C组及进口组,其中国产A组和B组使用陶瓷材质球头及内衬,国产C组与进口组使用高交联超高分子量聚乙烯球头及内衬。对术中出血量、手术用时、Harris评分、并发症、总住院日、术后住院日及费用等多项指标进行统计学分析。结果国产A组、C组和进口组手术用时存在明显差异,其中国产A组最短,且差异有统计学意义(P<0.05)。四组术中出血量存在明显差异,其中国产C组最少,且差异有统计学意义(P<0.05)。四组总住院日及术后住院日差异无统计学意义(P>0.05)。国产A组、B组和C组术后6个月及术后12个月的Harris评分存在明显差异,其中国产C组最低,且差异有统计学意义(P<0.05)。所有患者均未发现假体松动、脱位等术后并发症。结论陶瓷材质较高分子材质球头及内衬的人工髋关节假体的临床治疗有效性更为显著,更多医用耗材的临床使用评价指标有待确定。Objective To study the application of different materials of artificial hip joint prosthesis in the treatment of severe hip joint diseases in the real world,so as to provide data support for the selection of hip joint prostheses in actual clinical work.Methods A retrospective study was done on 62 patients who underwent hip arthroplasty from January 2017 to December 2020 and completed follow-up information.According to the different manufacturers and materials of artificial hip joint prosthesis,they were divided into domestic A,B,C and the imported group,with the domestic A and B groups used ceramic ball heads and linings,and the domestic C and imported groups used high cross-linked ultra-high molecular weight polyethylene ball heads and linings.Statistical analysis was performed on multiple indicators such as intraoperative blood loss,operation time,Harris score,complications,total hospital stay,postoperative hospital stay and expenses.Results There was a significant difference in the operation time between the domestic A group,the C group and the imported group.The domestic A group was the lowest,and the difference was statistically significant(P<0.05).There was a significant differences in intraoperative blood loss among the four groups,of which the domestic C group was the least,and the difference was statistically significant(P<0.05).There was no significant difference in total hospital stay and postoperative hospital stay in the four groups(P>0.05).There were significant differences in Harris scores between the domestic A,B,and C groups at 6 months and 12 months after the operation.The domestic C group was the lowest,and the difference was statistically significant(P<0.05).No postoperative complications such as prosthesis loosening or dislocation were found.Conclusion The artificial hip joint prosthesis with ceramic material is more effective in clinical treatment.The clinical use evaluation index of more medical consumables needs to be determined.

关 键 词：人工髋关节假体 临床使用 评价 真实世界证据 

分 类 号：R197.39[医药卫生—卫生事业管理]