国内外治疗药物监测指南现状的循证研究

Current Status of Guidelines for Therapeutic Drug Monitoring:An Evidence-based Evaluation

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。

Objective To investigate the type, development time, regional distribution, development methods, structure and contents of therapeutic drug monitoring（TDM） guidelines, so as to provide references for the development of TDM guidelines in China. Methods Guidelines concerning TDM were electronically retrieved in Pub Med, OvidEMbase, CNKI, VIP, CBM, Wan Fang Data, NGC（National Guideline Clearinghouse）, GIN（Guidelines International Network）, World Health Organization（WHO） guideline database, official websites of governments and societies associated with TDM from inception to October 2015. Two reviewers independently screened literature, extracted data including basic characteristics, formulation methods and text structure, etc.. Then a descriptive analysis was conducted. Results A total of 37 guidelines concerning TDM were included, which involved 4 guidelines for management of TDM, 32 for technical practice and 1 for both of them. The results of analysis showed that： for the integrity of reporting items of guidelines, three（75%） management guidelines ranked grade A, but only 1（3.13%） technical guidelines ranked grade A. The management specifications of TDM included four aspects as follows： standard terminology, the process specification, quality control and personnel qualification. The recommendations to TDM technology of specific drugs included evidence of TDM, standards and procedures, and personnel qualification. Conclusion There is a rapid but unbalanced development for abroad TDM guidelines. Most of them are TDM technical guidelines. Evidence-based methods are suggested to be used to develop local TDM guidelines, especially for commonly used medicines and technologies without supporting of existed guidelines.