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肾功能不全对中国患者华法林抗凝效果及安全性的影响:一项随机对照研究的分析。

Influence of renal insufficiency on anticoagulant effects and safety of warfarin in Chinese patients: analysis from a randomized controlled trial.

机构信息

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, 138 TongZiPo Road, Changsha, 410013, Hunan, China.

Research Center for Drug Clinical Evaluation of Central South University, Changsha, 410013, Hunan, China.

出版信息

Naunyn Schmiedebergs Arch Pharmacol. 2021 Jun;394(6):1275-1283. doi: 10.1007/s00210-020-02037-3. Epub 2021 Jan 6.

Abstract

This study aimed to analyze the influence of renal insufficiency on the anticoagulant effects and safety of warfarin in Chinese patients. Data on the creatinine levels of participants enrolled in a randomized controlled study were screened and divided into the non-renal insufficiency group, mild renal insufficiency group, and moderate renal insufficiency group, according to the creatinine clearance rate. The primary outcome measures were stable dose and average daily dose of warfarin. Secondary outcome measures were percentage of time in the therapeutic international normalized ratio (INR) (%TTR), and the first time to reach the therapeutic INR. Adverse events included bleeding events, thromboembolic events, and mortality. All participants with renal function test results and a baseline INR of less than 1.5 were included in the primary and secondary outcome analysis. The SPSS Statistics 21.0 software was used for statistical analysis. The randomized controlled trial was registered in Clinicaltrials.gov (NCT02211326). A total of 571 patients were included in this analysis. Multiple regression analysis showed that the renal function was correlated with stable dose, average daily dose, and the first time to reach therapeutic INR after adjusting for confounding factors. However, no correlation was noted between kidney function and %TTR. No significant differences were observed across the various safety parameters among the three groups. Renal function is an important consideration in patients using warfarin.

摘要

本研究旨在分析肾功能不全对中国患者华法林抗凝效果和安全性的影响。对一项随机对照研究中纳入患者的肌酐水平数据进行筛选,并根据肌酐清除率将其分为肾功能正常组、轻度肾功能不全组和中度肾功能不全组。主要观察指标为华法林稳定剂量和平均日剂量。次要观察指标为治疗国际标准化比值(INR)时间百分比(%TTR)和达到治疗 INR 的首次时间。不良事件包括出血事件、血栓栓塞事件和死亡率。所有具有肾功能检测结果和基线 INR<1.5 的患者均纳入主要和次要结局分析。采用 SPSS Statistics 21.0 软件进行统计分析。该随机对照试验已在 Clinicaltrials.gov(NCT02211326)注册。共有 571 例患者纳入本分析。多因素回归分析显示,在调整混杂因素后,肾功能与稳定剂量、平均日剂量和达到治疗 INR 的首次时间相关,但与%TTR 无相关性。三组间各安全性参数无显著差异。肾功能是华法林使用者的重要考虑因素。

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