中国药物警戒 ›› 2012, Vol. 9 ›› Issue (2): 104-109.

• 综述 • 上一篇    下一篇

骨科植入物不良事件发生原因及处置方式系统综述

陶庆梅1，孙凤2，郁凯3，翟伟4，詹思延1，*   

  1. 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
  • 收稿日期:2011-06-23 出版日期:2012-02-10 发布日期:2015-08-10
  • 通讯作者: 詹思延,女,教授,博导,药物流行病学。E-mail：siyan-zhan@bjmu.edu.cn
  • 作者简介:陶庆梅，女，在读硕士，药物流行病学。

Causation and Treatment Of Orthopedic Implants Adverse Events Systematic Review

TAO Qing-mei1, SUN Feng2, YU Kai3, ZHAI Wei4, ZHAN Si-yan1, *   

  1. 1 Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China;
    2 School of Pharmacy, Peking University, Beijing 100191, China;
    3 Tianjin Fifth Central Hospital; Tianjin 300450, China; Beijing Center for ADR Monitoring, Beijing 100024, China
  • Received:2011-06-23 Online:2012-02-10 Published:2015-08-10

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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

Abstract: Objective To study the causation and treatment of orthopedic implants adverse events in China. MethodsArticles about orthopedic implants adverse events published by Nov. 2010 in China were searched. The causes and treatment of the adverse events were analyzed. ResultsAccording 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. ConclusionThe 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.

Key words: orthopedic implants, adverse events, causation, treatment, systematic review