【摘要】：目的系統(tǒng)評價現(xiàn)有治療藥物監(jiān)測(TDM)指南的類型、時間、區(qū)域分布、制訂方法、結(jié)構(gòu)內(nèi)容,為循證制訂我國TDM指南提供參考。方法計算機(jī)檢索PubMed、Ovid-EMbase、CNKI、VIP、WanFang Data、CBM、NGC、GIN、WHO指南數(shù)據(jù)庫和TDM相應(yīng)協(xié)會的官方網(wǎng)站及各國政府及學(xué)術(shù)組織網(wǎng)站,搜索TDM相關(guān)指南,檢索時間均從建庫至2015年10月。由2位研究者獨(dú)立篩選文獻(xiàn)和提取TDM指南發(fā)布機(jī)構(gòu)、年份、時間、國家或地區(qū)、類型、制訂方法、篇章結(jié)構(gòu)、適用范圍等資料后,進(jìn)行描述性分析。結(jié)果共納入TDM指南37篇,其中管理指南4篇,技術(shù)指南32篇和綜合指南1篇;管理指南篇章結(jié)構(gòu)涉及12個條目,A級3篇占75%;技術(shù)指南涉及14個條目,A級1篇占3.13%。指南中TDM管理規(guī)范包括:標(biāo)準(zhǔn)術(shù)語、流程規(guī)范、質(zhì)量控制和人員資質(zhì)4方面內(nèi)容;對具體藥物TDM技術(shù)方法的推薦內(nèi)容包括:TDM依據(jù)、標(biāo)準(zhǔn)與流程、人員資質(zhì)3部分,具體內(nèi)容的納入情況指南間存在差異。結(jié)論國內(nèi)外TDM指南發(fā)展迅速,地域分布不均,以技術(shù)指南為主。我國指南起步晚,循證方法運(yùn)用不足,建議循證制訂中國TDM指南,并將臨床常用尚無技術(shù)指南的藥物及技術(shù)環(huán)節(jié)納入指南制訂規(guī)劃。
[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.
【作者單位】： 四川大學(xué)華西第二醫(yī)院藥學(xué)部/循證藥學(xué)中心;出生缺陷與相關(guān)婦兒疾病教育部重點(diǎn)實(shí)驗室;四川大學(xué)華西醫(yī)院中國循證醫(yī)學(xué)中心;四川大學(xué)華西藥學(xué)院;
【基金】：國家自然科學(xué)基金項目(編號:81373381)
【分類號】：R95;R-03

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