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骨科植入物不良事件发生原因及处置方式系统综述
引用本文:陶庆梅,孙凤,郁凯,翟伟,詹思延. 骨科植入物不良事件发生原因及处置方式系统综述[J]. 中国药物警戒, 2012, 9(2): 104-109
作者姓名:陶庆梅  孙凤  郁凯  翟伟  詹思延
作者单位:1. 北京大学公卫学院流行病与卫生统计学系,北京,100191
2. 北京大学药学院,北京,100191
3. 天津市第五中心医院骨科,天津,300450
4. 北京市药品不良反应监测中心,北京,100024
摘    要:目的 了解我国骨科植入物不良事件发生原因及处置方式的情况.方法 于2010年11月,采用系统综述的方法,以“骨科植入物+不良事件”为关键检索词,在CMCC、CBMDISC 、CNKI、VIP、万方数据等系统检索国内已公开发表的文献,综合分析骨科植入物的各种不良事件的发生原因及处置方式等.结果 依据纳入、排除标准,对检索结果进行筛选,最终45篇研究满足入选标准.综合文献报告的骨科植入物不良事件发生原因可分为四类:医疗技术因素、患者自身因素、医疗器械因素、综合因素.其中医疗技术性因素为主要原因,为46.8%,综合因素占31.8%.按不同骨科植入物分层分析,均显示医疗技术性因素及综合因素为主要原因.处置方式更多地依据每个病例的综合情况进行操作,但多通过手术方式.结论 目前我国骨科植入物不良事件发生的主要原因是医疗技术因素及综合因素,发生不良事件后多通过再手术方式进行处置,提示亟需采取相关措施应对主要的发生原因,同时进一步开展更权威的研究确定每一种不良事件的发生原因,从而有针对性的最大程度地降低不良事件的发生.

关 键 词:骨科植入物  不良事件  原因  处置方式  系统综述

Causation and Treatment Of Orthopedic Implants Adverse Events Systematic Review
TAO Qing-mei , SUN Feng , YU Kai , ZHAI Wei , ZHAN Si-yan. Causation and Treatment Of Orthopedic Implants Adverse Events Systematic Review[J]. Chinese JOurnal of Pharmacovigilance, 2012, 9(2): 104-109
Authors:TAO Qing-mei    SUN Feng    YU Kai    ZHAI Wei    ZHAN Si-yan
Affiliation:TAO Qing-mei SUN Feng YU Kai ZHAI Wei ZHAN Si-yan (1Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China; 2School of Pharmacy, Peking University, Beijing 100191, China; 3Tianjin Fifth Central Hospital; Tianjin 300450, China; Beijing Center for ADR Monitoring, Beijing 100024, China)
Abstract:Objective To study the causation and treatment of orthopedic implants adverse events in China. Methods Articles about orthopedic implants adverse events published by Nov. 2010 in China were searched. The causes and treatment of the adverse events were analyzed. Results According to our searching strategy and including criteria, 45 studies were included. The overall adverse events were caused by medical techniques, patient factors, medical implants and the comprehensive factors, the medical techniques covered 46.8%, was the main cause, and the comprehensive factors covered 31.8% among these four factors, different kinds of orthopedic implants showed the same way. The main treatment was operation which may be suitable to different cases. Conclusion The main causes of orthopedic implants adverse events in China were medical techniques and the comprehensive factors, operation was most likely to apply when the adverse events happened, relative measures to control the main causes and researches to make sure the causes of the adverse events are needed to reduce the orthopedic implants adverse events incidence.
Keywords:orthopedic implants  adverse events  causation  treatment  systematic review
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