ObjectiveTo 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. MethodsGuidelines concerning TDM were electronically retrieved in PubMed, Ovid-EMbase, CNKI, VIP, CBM, WanFang 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. ResultsA 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. ConclusionThere 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.
ObjectiveThe guideline is formulated to standardize the principles, procedures and methods of developing therapeutic drug monitoring (TDM) guidelines and to promote open, transparent, scientific and credibility of the TDM guidelines.MethodsDivision of Therapeutic Drug Monitoring, Chinese Pharmacological Society established guideline working groups, declared and managed conflict of interest. The guideline working groups used the Delphi method to formulate the purpose and scope of the guideline and questions in PICO format, searched and synthesized evidence, integrated with Chinese actual situation and TDM characteristics to preliminarily develop recommendations for the guideline for TDM guideline development in China. Through internal discussion of the guideline working groups and external peer review, the content has been improved, and we eventually formulated the guideline suitable for guiding TDM related guidelines development.ResultsThe guideline provide suggestions for problems to be identified and solved in the planning, development, publishing and updating stages of TDM guidelines including forming guideline wording groups, planning guidelines, declaration and management of interests, formulating questions and selecting outcomes, preparing the planning proposal, retrieval and synthesis evidence, evaluating evidence, developing recommendations, drafting guidelines, external review, publishing and spreading guidelines, evaluating guidelines, and updating guidelines.ConclusionsThis guideline can provide methodological guidance and reference for the development of TDM guidelines.
ObjectiveTo systematically review the research status of therapeutic drug monitoring (TDM) for traditional Chinese medicine. MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, CBM, VIP databases, official websites of governments and societies associated with TDM were electronically searched to collect studies on TDM for traditional Chinese medicine from inception to January, 2022. Two reviewers independently screened literature and extracted data. Then, a qualitative systematic review was conducted. ResultsA total of 13 studies were included, all of which came from China and were small sample size studies. The studied population consisted mainly of healthy volunteers (85%), followed by patients of coronary artery disease with blood stasis pattern (31%), patients of rheumatoid arthritis (8%), and patients of acquired immune deficiency syndrome (8%). There were two types of medicine, including proprietary Chinese medicine (69%) and Chinese herbal pieces (31%). The research topics were all theoretical research of TDM, mainly concentration detection methods (77%), followed by influence factors of blood drug concentration (15%), the selection of specimen (15%), the selection of monitoring object (8%) and the concentration reference range (8%). There was no clinical practice study on TDM of traditional Chinese medicine. ConclusionTDM of traditional Chinese medicine is still in the exploratory stage in China. Published studies are mainly on the theoretical research of TDM, and no relevant studies is on clinical practice of TDM of traditional Chinese medicine.
Therapeutic drug monitoring (TDM) has been more widely used in small molecule agents, such as immuno-suppressants, antiepileptic drugs and antibiotics, with less attention in the field of therapeutic biological agents. Monoclonal drugs represented by tumor necrosis factor alpha (TNF-α) inhibitors have shown a good relationship between exposure and efficacy in clinical studies. There are corresponding guidelines and consensus for the recommendations of TDM based on current research evidence. Therefore, this paper introduced the current evidence, strategies and considerations for TDM in the optimal treatment of adalimumab from the perspective of adalimumab TDM to provide references for the clinical practice of adalimumab TDM.