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中国西部地区华法林治疗期间目标国际标准化比值(INR)达标情况、出血并发症发生率及影响因素研究

Study of target INR achievement, incidence of hemorrhagic complications and affecting factors after during warfarin treatment in western area of China.

作者信息

Shi Rui, Wei Wei, Yang Yanbiao, Yang Shouyuan, Yan Liping, Zhu Zongjie

机构信息

The First People's Hospital of Lanzhou, Lanzhou, China.

出版信息

Sci Rep. 2025 May 25;15(1):18200. doi: 10.1038/s41598-025-03434-5.

DOI:10.1038/s41598-025-03434-5
PMID:40415097
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12104477/
Abstract

This study aimed to assess the clinical management of warfarin therapy in Western China by investigating: the rate of international normalized ratio (INR) target achievement and its influencing factors, and the incidence and risk factors for hemorrhagic complications. The primary goal was to identify high-risk patient populations requiring intensified monitoring in this resource-limited region with distinct demographic challenges including multi-ethnic populations and limited healthcare access. We conducted a retrospective cohort analysis of 154 consecutive inpatients prescribed warfarin at a tertiary care center in Western China. Data were systematically collected from: baseline demographics, detailed medication histories, INR monitoring results, and documentation of bleeding events. Statistical analysis employed Pearson chi-square tests to evaluate associations between clinical variables and primary outcomes: achievement of target INR ranges (2.0-3.0 for most indications; 1.8-2.5 for mechanical valves) and development of hemorrhagic complications. Secondary analysis examined factors influencing bleeding severity. The study revealed several critical findings regarding INR control: the overall therapeutic achievement rate was 32.3% for the 2.0-3.0 range (n = 130) and 50.0% for the 1.8-2.5 range (n = 24). Notably, we observed universal therapeutic failure (0% achievement) in three high-risk subgroups: octogenarians (≥ 81 years), underweight patients (BMI < 18.5 kg/m), and amiodarone users. In contrast, structured physician education demonstrated substantial benefit (72.13% achievement rate vs 27.87% without instruction). Regarding safety outcomes, Bleeding complications were strongly associated with heart failure (16.07% vs 83.93% without), pulmonary infections (20.72% vs 79.28% without), and PPI use (42.86% vs 57.14%). A striking disparity emerged in bleeding severity: cardiothoracic surgery patients experienced minor bleeding at markedly higher rates (66.7%) compared to other departments (≤ 6.7%). This study identifies three high-risk populations in Western China requiring prioritized monitoring: vulnerable patients (advanced age, low BMI), individuals with cardiopulmonary comorbidities, and those prescribed interacting medications (amiodarone, PPIs). These findings have important clinical implications, particularly for resource-limited settings, we propose: implementation of Structured Medication Education Programs, intensive medication monitoring for high-risk patients, development of specialty-specific monitoring protocols in cardiothoracic departments, and establishment of multidisciplinary anticoagulation management teams. These findings underscore the need for context-specific strategies to optimize warfarin therapy in ethnically diverse, under-resourced regions, while highlighting critical areas for future research.

摘要

本研究旨在通过调查以下方面来评估中国西部华法林治疗的临床管理情况

国际标准化比值(INR)目标达成率及其影响因素,以及出血并发症的发生率和危险因素。主要目标是确定在这个资源有限、面临包括多民族人群和医疗服务可及性有限等独特人口统计学挑战的地区,需要加强监测的高危患者群体。我们对中国西部一家三级医疗中心连续收治的154例接受华法林治疗的住院患者进行了回顾性队列分析。数据从以下方面系统收集:基线人口统计学资料、详细用药史、INR监测结果以及出血事件记录。统计分析采用Pearson卡方检验来评估临床变量与主要结局之间的关联:目标INR范围的达成情况(大多数适应证为2.0 - 3.0;机械瓣膜为1.8 - 2.5)以及出血并发症的发生情况。二次分析研究了影响出血严重程度的因素。该研究揭示了关于INR控制的几个关键发现:2.0 - 3.0范围的总体治疗成功率为32.3%(n = 130),1.8 - 2.5范围的为50.0%(n = 24)。值得注意的是,我们在三个高危亚组中观察到普遍的治疗失败(达成率为0%):八旬老人(≥81岁)、体重过轻患者(BMI < 18.5 kg/m²)以及使用胺碘酮的患者。相比之下,结构化的医师教育显示出显著益处(达成率为72.13%,未接受指导的为27.87%)。关于安全性结局,出血并发症与心力衰竭(16.07% vs未发生心力衰竭的为83.93%)、肺部感染(20.72% vs未发生的为79.28%)以及使用质子泵抑制剂(PPI)(42.86% vs 57.14%)密切相关。出血严重程度出现了显著差异:心胸外科手术患者轻微出血的发生率明显更高(66.7%),高于其他科室(≤6.7%)。本研究确定了中国西部需要优先监测的三个高危人群:脆弱患者(高龄、低BMI)、患有心肺合并症的个体以及使用相互作用药物(胺碘酮、PPI)的患者。这些发现具有重要的临床意义,特别是对于资源有限的环境,我们建议:实施结构化药物教育计划、对高危患者进行强化药物监测、制定心胸外科专科特定的监测方案以及建立多学科抗凝管理团队。这些发现强调了在种族多样、资源匮乏的地区需要因地制宜的策略来优化华法林治疗,同时突出了未来研究的关键领域。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84f2/12104477/a29365818a22/41598_2025_3434_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84f2/12104477/a29365818a22/41598_2025_3434_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84f2/12104477/a29365818a22/41598_2025_3434_Fig1_HTML.jpg

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