国内外治疗药物监测指南现状的循证研究
发布时间：2019-01-07 18:03
【摘要】：目的系统评价现有治疗药物监测(TDM)指南的类型、时间、区域分布、制订方法、结构内容,为循证制订我国TDM指南提供参考。方法计算机检索PubMed、Ovid-EMbase、CNKI、VIP、WanFang Data、CBM、NGC、GIN、WHO指南数据库和TDM相应协会的官方网站及各国政府及学术组织网站,搜索TDM相关指南,检索时间均从建库至2015年10月。由2位研究者独立筛选文献和提取TDM指南发布机构、年份、时间、国家或地区、类型、制订方法、篇章结构、适用范围等资料后,进行描述性分析。结果共纳入TDM指南37篇,其中管理指南4篇,技术指南32篇和综合指南1篇;管理指南篇章结构涉及12个条目,A级3篇占75%;技术指南涉及14个条目,A级1篇占3.13%。指南中TDM管理规范包括:标准术语、流程规范、质量控制和人员资质4方面内容;对具体药物TDM技术方法的推荐内容包括:TDM依据、标准与流程、人员资质3部分,具体内容的纳入情况指南间存在差异。结论国内外TDM指南发展迅速,地域分布不均,以技术指南为主。我国指南起步晚,循证方法运用不足,建议循证制订中国TDM指南,并将临床常用尚无技术指南的药物及技术环节纳入指南制订规划。
[Abstract]:Objective to systematically evaluate the types, time, regional distribution, formulation methods and structure of the existing (TDM) guidelines for monitoring therapeutic drugs, and to provide a reference for the evidence-based development of TDM guidelines in China. Methods the PubMed,Ovid-EMbase,CNKI,VIP,WanFang Data,CBM,NGC,GIN,WHO guide database, the official website of the TDM association and the websites of governments and academic organizations were searched by computer, and the relevant TDM guidelines were searched. The retrieval time is from the construction of the database to October 2015. After the two researchers independently sifted through the literature and extracted the TDM guidelines for publication, year, time, country or region, type, method of formulation, text structure, scope of application and so on, descriptive analysis was carried out. Results A total of 37 TDM guidelines were included, of which 4 were management guidelines, 32 were technical guidelines and 1 was comprehensive guidelines. The Technical Guide covers 14 entries, A 1 for 3.13. The TDM management specification in the guide includes four aspects: standard terminology, process specification, quality control and personnel qualification; The recommended content of technical methods for specific drug TDM includes: TDM basis, standard and process, personnel qualification, and there are differences among the guidelines on the inclusion of specific content. Conclusion the TDM guidelines at home and abroad are developing rapidly, with uneven regional distribution and technical guidelines. The guidelines of our country started late and the evidence-based methods were not used well. It is suggested that the evidence-based guidelines for TDM in China should be formulated and the drugs and technical links which are commonly used in clinical practice without technical guidelines should be included in the planning of the guidelines.
【作者单位】： 四川大学华西第二医院药学部/循证药学中心;出生缺陷与相关妇儿疾病教育部重点实验室;四川大学华西医院中国循证医学中心;四川大学华西药学院;
【基金】：国家自然科学基金项目(编号:81373381)
【分类号】：R95;R-03
本文编号：2403965
[Abstract]:Objective to systematically evaluate the types, time, regional distribution, formulation methods and structure of the existing (TDM) guidelines for monitoring therapeutic drugs, and to provide a reference for the evidence-based development of TDM guidelines in China. Methods the PubMed,Ovid-EMbase,CNKI,VIP,WanFang Data,CBM,NGC,GIN,WHO guide database, the official website of the TDM association and the websites of governments and academic organizations were searched by computer, and the relevant TDM guidelines were searched. The retrieval time is from the construction of the database to October 2015. After the two researchers independently sifted through the literature and extracted the TDM guidelines for publication, year, time, country or region, type, method of formulation, text structure, scope of application and so on, descriptive analysis was carried out. Results A total of 37 TDM guidelines were included, of which 4 were management guidelines, 32 were technical guidelines and 1 was comprehensive guidelines. The Technical Guide covers 14 entries, A 1 for 3.13. The TDM management specification in the guide includes four aspects: standard terminology, process specification, quality control and personnel qualification; The recommended content of technical methods for specific drug TDM includes: TDM basis, standard and process, personnel qualification, and there are differences among the guidelines on the inclusion of specific content. Conclusion the TDM guidelines at home and abroad are developing rapidly, with uneven regional distribution and technical guidelines. The guidelines of our country started late and the evidence-based methods were not used well. It is suggested that the evidence-based guidelines for TDM in China should be formulated and the drugs and technical links which are commonly used in clinical practice without technical guidelines should be included in the planning of the guidelines.
【作者单位】： 四川大学华西第二医院药学部/循证药学中心;出生缺陷与相关妇儿疾病教育部重点实验室;四川大学华西医院中国循证医学中心;四川大学华西药学院;
【基金】：国家自然科学基金项目(编号:81373381)
【分类号】：R95;R-03
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