DOAC在泰国肾损害患者和老年人各种肾脏方程式中的剂量评价

IF 3.1 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Sayamon Sukkha, Supatat Chumnumwat, Pattaranun Thongsoi, Rawiphon Sonsiri, Apisara Lohachatinante, Nuttanun Kittikunkanyakit, Rattana Chawanasuntharapot, Junporn Kongwatcharapong
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引用次数: 0

摘要

泰国食品和药物管理局(TFDA)已经批准了基于估计肌酐清除率eCrCl (Cockcroft-Gault方程)的直接口服抗凝剂(DOAC)剂量。然而,在肾脏疾病患者的实践中经常使用其他肾功能方程,导致DOAC剂量推荐的潜在差异。在资源有限的国家,DOAC的实际给药模式仍然报告不足。本横断面研究纳入了在泰国玛希隆大学Siriraj医院门诊部接受治疗的肾功能损害患者。患者在2019年1月至2022年12月期间接受了第一次房颤DOAC治疗。主要目的是评估使用eCrCl符合TFDA指南的DOAC处方的百分比。我们还检查了用估计的肾小球滤过率、eGFR (CKD-EPI)代替eCrCl时的剂量一致性。在一年的随访中,还评估了患者因素以及中风和出血的发生率。共分析326例患者和1587张DOAC处方。患者平均年龄为79.1±9.2岁,平均eGFR为45.6±9.9 mL/min/1.73 m2。68.2%的处方符合tfda给药要求。eGFR和eCrCl的剂量差异为45%,有过量使用eGFR的趋势。eGFR小于45 mL/min/1.73 m2与剂量差异有关。卒中和出血发生率较低,不同DOAC类型间无差异。虽然大多数泰国患者接受了适当的DOAC剂量,但三分之一的患者不符合TFDA的指导方针。使用eGFR代替eCrCl可能会导致剂量差异,特别是在中度至重度肾损害中。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Evaluation of DOAC Dosing Among Various Renal Equations in Patients With Kidney Impairment and Elderly in Thailand

Evaluation of DOAC Dosing Among Various Renal Equations in Patients With Kidney Impairment and Elderly in Thailand

The Thai Food and Drug Administration (TFDA) has approved direct oral anticoagulant (DOAC) dosing based on estimated creatinine clearance, eCrCl (Cockcroft-Gault equation). However, other renal function equations are often used in practice for patients with kidney disease, leading to potential discrepancies in DOAC dosing recommendations. The actual DOAC dosing patterns in resource-limited countries remain underreported. This cross-sectional study included patients with renal impairment who were treated at the outpatient department of Siriraj Hospital, Mahidol University, Thailand. Patients received their first DOAC for atrial fibrillation from January 2019 to December 2022. The primary objective was to evaluate the percentage of DOAC prescriptions compliant with TFDA guidelines using eCrCl. We also examined dosing agreement when substituting estimated glomerular filtration rate, eGFR (CKD-EPI) for eCrCl. Patient factors and the incidence of stroke and bleeding over a one-year follow-up were also assessed. A total of 326 patients and 1587 DOAC prescriptions were analyzed. The mean patient age was 79.1 ± 9.2 years, with a mean eGFR of 45.6 ± 9.9 mL/min/1.73 m2. TFDA-compliant dosing was observed in 68.2% of prescriptions. Dose disagreement between eGFR and eCrCl was 45%, with a trend toward overdosing using eGFR. An eGFR of less than 45 mL/min/1.73 m2 was associated with dose discrepancies. Stroke and bleeding incidences were low, with no differences across DOAC types. While most Thai patients received appropriate DOAC dosing, one-third did not comply with TFDA guidelines. Using eGFR instead of eCrCl may result in dosing differences, particularly in moderate to severe renal impairment.

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来源期刊
Cts-Clinical and Translational Science
Cts-Clinical and Translational Science 医学-医学:研究与实验
CiteScore
6.70
自引率
2.60%
发文量
234
审稿时长
6-12 weeks
期刊介绍: Clinical and Translational Science (CTS), an official journal of the American Society for Clinical Pharmacology and Therapeutics, highlights original translational medicine research that helps bridge laboratory discoveries with the diagnosis and treatment of human disease. Translational medicine is a multi-faceted discipline with a focus on translational therapeutics. In a broad sense, translational medicine bridges across the discovery, development, regulation, and utilization spectrum. Research may appear as Full Articles, Brief Reports, Commentaries, Phase Forwards (clinical trials), Reviews, or Tutorials. CTS also includes invited didactic content that covers the connections between clinical pharmacology and translational medicine. Best-in-class methodologies and best practices are also welcomed as Tutorials. These additional features provide context for research articles and facilitate understanding for a wide array of individuals interested in clinical and translational science. CTS welcomes high quality, scientifically sound, original manuscripts focused on clinical pharmacology and translational science, including animal, in vitro, in silico, and clinical studies supporting the breadth of drug discovery, development, regulation and clinical use of both traditional drugs and innovative modalities.
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