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韩国机械心脏瓣膜患者华法林治疗的适宜强度。

Adequate intensity of warfarin therapy for Korean patients with mechanical cardiac valves.

作者信息

Yoon In Kyung, Lee Kyung Eun, Lee Jin Koo, Chang Byung Chul, Gwak Hye Sun

机构信息

College of Pharmacy & Division of Life and Pharmaceutical Sciences, Ewha Woman's University, Seoul, Korea.

出版信息

J Heart Valve Dis. 2013 Jan;22(1):102-9.

Abstract

BACKGROUND AND AIM OF THE STUDY

The study aim was to identify adequate therapeutic ranges of the International Normalized Ratio (INR) in Korean patients receiving warfarin after prosthetic mechanical heart valve replacement.

METHODS

Retrospective chart reviews were conducted of 818 patients for a total follow up period of 8,100 patient-years; all details of major complication events of thromboembolism and bleeding were recorded. The INR-incidence of complication curve was plotted, and an adequate INR determined from the intersections of 95% confidence interval (CI) curves of complication rates to ensure the lowest incidences of both thromboembolic and bleeding complications. An analysis of a subgroup of patients with atrial fibrillation (AF) was performed to evaluate the complication occurrence.

RESULTS

A total of 69 complications occurred, of which 36 were thromboembolic events and 33 were bleeding. The adequate ranges of INR were determined as: 2.0-2.5 for patients with aortic or mitral valve replacement; 2.1-2.6 for those with aortic plus mitral valve replacement; and 2.3-2.8 for those with tricuspid valve replacement with or without other valves. It has been shown that, by keeping the INR levels within these therapeutic ranges, complication risks could be significantly reduced by up to 51%. The overall incidence of complications was increased if the patients had AF (hazards risk (HR) = 1.27, 95% CI = 1.05-1.52).

CONCLUSION

The study results may provide evidence for the application of low-intensity warfarin therapies in Asian patients, including Koreans. In addition, the method of determining adequate INR levels by using INR-incidence of complications curves might be employed in many clinical settings.

摘要

研究背景与目的

本研究旨在确定韩国人工机械心脏瓣膜置换术后接受华法林治疗患者的国际标准化比值(INR)的合适治疗范围。

方法

对818例患者进行回顾性病历审查,总随访期为8100患者年;记录血栓栓塞和出血等主要并发症事件的所有细节。绘制INR-并发症发生率曲线,并根据并发症发生率的95%置信区间(CI)曲线的交点确定合适的INR,以确保血栓栓塞和出血并发症的发生率最低。对房颤(AF)患者亚组进行分析以评估并发症的发生情况。

结果

共发生69例并发症,其中36例为血栓栓塞事件,33例为出血事件。确定的INR合适范围为:主动脉瓣或二尖瓣置换患者为2.0 - 2.5;主动脉瓣加二尖瓣置换患者为2.1 - 2.6;三尖瓣置换伴或不伴其他瓣膜置换患者为2.3 - 2.8。结果表明,将INR水平保持在这些治疗范围内,并发症风险可显著降低多达51%。如果患者患有房颤,并发症的总体发生率会增加(风险比(HR)= 1.27,95% CI = 1.05 - 1.52)。

结论

研究结果可为包括韩国人在内的亚洲患者应用低强度华法林治疗提供依据。此外,利用INR-并发症发生率曲线确定合适INR水平的方法可能在许多临床环境中得到应用。

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