therapeutic drug monitoring (TDM)

治疗药物监测 ( TDM )
  • 文章类型: Journal Article
    在这项研究中,我们评估新生儿医疗服务提供者对庆大霉素治疗药物监测(TDM)指南的依从性.在麦加妇幼医院进行,沙特阿拉伯,从2020年7月至2022年7月,本研究回顾性分析了医护人员管理庆大霉素治疗新生儿的依从性.覆盖410名新生儿,主要诊断为呼吸窘迫(56%)和败血症(32%),研究表明,虽然大多数波谷和峰值水平符合指导方针,在呼吸窘迫的病例中发现了实质性的偏差。这强调了有针对性的TDM策略的必要性,特别是在新生儿呼吸窘迫的管理,以确保最佳的治疗疗效和安全性。调查结果敦促严格遵守TDM指南,强调新生儿庆大霉素治疗的个性化方法,以改善医疗保健结果。
    In this study, we assess healthcare providers\' adherence to therapeutic drug monitoring (TDM) guidelines for gentamicin in neonates. Conducted at the Maternity and Children\'s Hospital in Makkah, Saudi Arabia, from July 2020 to July 2022, it retrospectively analyzed the compliance of healthcare workers in managing neonates treated with gentamicin. Covering 410 neonates, primarily diagnosed with respiratory distress (56%) and sepsis (32%), the study revealed that while a majority of trough and peak levels conformed to guidelines, substantial deviations were noted in cases of respiratory distress. This underlines the necessity for targeted TDM strategies, particularly in managing respiratory distress in neonates, to ensure optimal treatment efficacy and safety. The findings urge stringent compliance with TDM guidelines, emphasizing personalized approaches in neonatal gentamicin therapy for improved healthcare outcomes.
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  • 文章类型: Journal Article
    Polymyxin B, which is a last-line antibiotic for extensively drug-resistant Gram-negative bacterial infections, became available in China in Dec. 2017. As dose adjustments are based solely on clinical experience of risk toxicity, treatment failure, and emergence of resistance, there is an urgent clinical need to perform therapeutic drug monitoring (TDM) to optimize the use of polymyxin B. It is thus necessary to standardize operating procedures to ensure the accuracy of TDM and provide evidence for their rational use. We report a consensus on TDM guidelines for polymyxin B, as endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society. The consensus panel was composed of clinicians, pharmacists, and microbiologists from different provinces in China and Australia who made recommendations regarding target concentrations, sample collection, reporting, and explanation of TDM results. The guidelines provide the first-ever consensus on conducting TDM of polymyxin B, and are intended to guide optimal clinical use.
    多黏菌素B是治疗广泛耐药革兰氏阴性细菌感染的最后“一道防线”,但因剂量限制性肾毒性及低剂量可能出现治疗失败和耐药性,临床上迫切需要通过治疗药物监测(TDM)优化其使用。多黏菌素B TDM专家共识以及规范操作程序的制定将有助于确保TDM的准确性并为其合理使用提供依据。中国药理学学会治疗药物监测研究专业委员会及上海医学会感染与化疗专科分会共同发起制定多黏菌素B的TDM专家共识。共识小组由来自中国不同省份的临床药学、临床医学和临床微生物学专家,及两位澳大利亚莫纳什大学专家组成,就多黏菌素B进行TDM的目标浓度、样本采集、测定、报告和TDM结果解释提出了建议。该指南共识的制定旨在指导多黏菌素B的个体化精准治疗。.
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  • 文章类型: Journal Article
    背景:炎症性肠病(IBD)是慢性的,复发缓解性炎症性疾病对健康相关生活质量和工作效率有重大负面影响。生物疗法的出现彻底改变了IBD的治疗方法,最初使用抗TNF药物,最近使用多种替代靶标,还有更多正在开发中。
    目的:大约三分之一的患者对生物治疗没有反应,更重要的是,在治疗期间有相当一部分患者出现部分反应或反应丧失。后者是常见的临床情况,矛盾的是,在商业药物标签和可用指南中没有解决。因此,临床上需要医生了解何时以及如何最终优化生物治疗。
    方法:阿联酋胃肠病学和肝病学会促进和支持了使用德尔菲方法的共识,以缩小这一差距。
    方法:在对超过60,000项研究进行了广泛的系统回顾之后,选择了81项剂量递增研究和5项解决药物监测的研究,此外还有5项系统评价和3项指南。
    结论:经过三轮投票,选择了18个声明,同意范围从80%到100%。
    BACKGROUND: Inflammatory bowel diseases (IBD) are chronic, relapsing-remitting inflammatory conditions with a substantial negative impact on health-related quality of life and work productivity. Treatment of IBD has been revolutionized by the advent of biologic therapies, initially with anti-TNF agents and more recently with multiple alternatives targets, and yet more under development.
    OBJECTIVE: Approximatively one third of patients do not respond to biologic therapy and more importantly a significant proportion experiences partial response or loss of response during treatment. The latter are common clinical situations and paradoxically are not addressed in the commercial drug labels and available guidelines. There is therefore a clinical need for physicians to understand when and how eventually to optimize the biologic therapy.
    METHODS: This consensus using a Delphi methodology was promoted and supported by the Emirates Society of Gastroenterology and Hepatology to close this gap.
    METHODS: Following an extensive systematic review of over 60,000 studies, 81 studies with dose escalation and five addressing drug monitoring were selected and in addition five systematic reviews and three guidelines.
    CONCLUSIONS: after three rounds of voting 18 statements were selected with agreement ranging from of 80% to 100.
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  • 文章类型: Journal Article
    Although therapeutic drug monitoring (TDM) guidelines are available, systematic evaluations of their methodological quality are scarce. This study aimed to assess the quality of current TDM guidelines using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument.
    We performed a systematic search to identify the relevant TDM guidelines in PubMed, EMBASE, CNKI, Wan Fang Database, CBM, VIP, four main guideline databases (NICE, NGC, GIN, and WHO guideline databases), and official websites of the governments and societies associated with TDM from the inception date to May 2018. Four independent appraisers rated the quality of each TDM guideline using the AGREE II instrument, and the mean score of each AGREE II item was calculated. The overall agreement among the appraisers was evaluated using the intraclass correlation coefficient (ICC).
    Twenty-eight TDM guidelines satisfied the eligibility criteria from among 12,235 references. The overall agreement among the appraisers was substantial (0.700-0.880). The mean scores for the six AGREE II domains were scope and purpose, 67.7% (95% CI, 64.0-71.4%); stakeholder involvement, 39.8% (95% CI, 33.3-46.3%); rigor of development, 36.0% (95% CI, 28.1-43.9%); clarity and presentation, 61.6% (95% CI, 55.7-67.4%); applicability, 30.6% (95% CI, 26.4-34.8%); and editorial independence, 49.2% (95% CI, 40.0-58.6%). The reviewers recommended only four guidelines, and most of the TDM guidelines were rated as \"recommended with modifications.\"
    Overall, the quality of TDM guidelines is suboptimal according to the evaluation using the AGREE II instrument. The domains of applicability, rigor of development, stakeholder involvement, and editorial independence of the guidelines need to be reported. In addition, guideline developers closely adhering to the AGREE II instrument and the Grading of Recommendations Assessment Development and Evaluation system are required to draft high-quality and reliable TDM guidelines.
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