住院患者华法林应用合理性调查

Investigation of rationale of warfarin use in inpatients

目的:了解华法林临床应用中存在的问题,为提高其用药合理水平提供参考。方法:收集北京安贞医院2010年1至5月期间住院时间超过7 d、应用华法林并进行国际标准化比值(INR)监测患者的病历,记录患者年龄、性别、华法林用药剂量及时间I、NR监测次数及达标情况以及不良反应等。按原发疾病将患者分为人工机械心脏瓣膜置换术组(AMH组)、心房颤动组(AF组)和其他疾病组(OD组)进行比较。结果:共收集到住院患者339例,AMH组252例(男性142例,女性110例,年龄11～78岁),AF组33例(男性23例,女性10例,年龄20～84岁),OD组54例(男性38例,女性16例,年龄12～77岁)。AMH组、AF组、OD组用药剂量中位数分别为3.0(1.5,6.0)、3.0(1.5,3.0)、3.0(1.5,6.0)mg,用药时间中位数分别为9(2,61)、5(2,15)和10(2,42)d,AMH组用药剂量高于AF组(P<0.01),AMH组和OD组用药时间长于AF组(P<0.01);INR监测次数中位数分别为5(2,21)、1(1,2)和6(1,20)次;华法林最终INR达标率分别为40.9%(103/252)、12.1%(4/33)和46.3%(25/54),未达标率分别为10.7%(27/252),84.8%(28/33),和38.9%(21/54),超范围率分别为48.4%(122/252)、3.1%(1/33)和14.8%(85/54),AMH组与AF组患者之间,AF组与OD组患者之间,华法林INR达标率差异均有统计学意义;3组患者之间两两比较未达标率差异均有统计学意义(均P<0.01);AMH组与AF组患者之间,AMH组与OD组患者之间超范围率差异有统计学意义(均P<0.01)。用药期间出现转氨酶可逆性升高者71例(20.9%),胃纳不佳或恶心呕吐8例(2.4%),腹泻5例(1.5%),鼻出血2例(0.6%),凝血时间延长1例(0.3%)。结论:我院住院患者华法林INR总体达标率不高,尤其是AF组患者;而AMH组患者华法林INR超范围率较高。提示应用华法林时要注意监测INR以提高用药的合理性,应定期监测患者肝功能和出凝血指标以减少不良反应的发生。

Objective：To understand the problems of warfarin use in clinical practice and to provide reference for its rational use.Methods： The medical records of patients who stayed in the hospital for more than 7 days and received warfarin with international normalized ratio（INR） monitoring in Beijing Anzhen Hospital from January to May 2010 were collected.The data of the patients＇age,gender,dosage and duration of warfarin therapy,INR monitoring frequency,INR values and adverse reactions were collected.According to the primary diseases,the patients were divided into 3 groups： artificial mechanical heart valve replacement group（AMH group）,atrial fibrillation group（AF group）,and other diseases group（OD group）.All results were compared and analyzed among the 3 groups.Results： A total of 339 inpatients were collected.Of them,252 patients（142 males and 110 females with age from 11 to 78 years） were in the AMH group,33 patients（23 males and 10 females with age from 20 to 84 years） in the AF group and 54（38 males and 16 females with age from 12 to 77 years） in the OD group.The medians of warfarin dosage in the AMH,AF and OD groups were 3.0（1.5,6.0）,3.0（1.5,3.0） and 3.0（1.5,6.0）mg,respectively.The medians of warfarin treatment duration in the 3 groups were 9（2,61）,5（2,15）,and 10（2,42）d,respectively.The warfarin dosage was higher in the AMH group than in the AF group（P0.01）.The warfarin treatment duration was longer in the AMH and OD groups than in the AF group（P0.01）.The medians of INR monitoring frequency were 5（2,21）,1（1,2） and 6（1,20） in the 3 groups,respectively.The percentage of patients who had an INR within safe range in the 3 groups were 40.9%（103/252）,12.1%（4/33） and 46.3%（25/54）,respectively;the percentage of patients who had an INR below safe range were 10.7%（27/252）,84.8%（28/33） and 38.9%（21/54）,respectively;the percentage of patients who had an INR above safe range were 48.4%（122/252）,3.1%（1/33）and 14.8%（85/54）,respectively.The differences in the percentage of patients who had an INR within the safe range between the AMH and AF groups,as well as AF and OD groups were significant;the differences in the percentage of patients who had an INR below the safe range among the 3 groups were significant;the differences in the percentage of patients who had an INR above the safe range between the AMH and AF groups,as well as AMH and OD groups were significant（P0.01 for all comparisons）.Seventy-one（20.9%） patients had a reversible increase in serum transaminase level,8（2.4%） had nausea and vomiting,5（1.5%） had diarrhea,2（0.6%） had nasal hemorrhage and 1（0.3%） prothrombin time prolongation during warfarin treatment.Conclusion： The percentage of inpatients who had an INR within the safe range was lower,especially in patients with atrial fibrillation,and the percentage of patients who underwent artificial mechanical heart valve replacement and had an INR above safe range was higher.This suggests that INR monitoring should be enhanced to improve the rational use of warfarin,and liver function and coagulation indexes should be monitored regularly to reduce occurrence of adverse reactions.