Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.
Am J Ther. 2012 Sep;19(5):330-7. doi: 10.1097/MJT.0b013e3182546840.
Compared with usual practice, clinical trials often exclude patients with relative contraindications. A study of real-world warfarin use could help inform trials of new medications that could potentially replace warfarin. The objective of this study was to describe potential barriers to warfarin use among patients with atrial fibrillation. This was a retrospective study of electronic medical records (1998-2007) from an inner-city public hospital and affiliated primary care clinics and included adults aged 18 years or more with atrial fibrillation. Exclusions included mitral or aortic valve replacement, hyperthyroidism, or no clinical encounter within 1 year after first diagnosis. Warfarin exposure was defined by electronic pharmacy or physician order data or, in a second definition, international normalized ratio > 1.3. A history of potential barriers to warfarin was defined by International Classification of Diagnoses, 9th revision codes or electronic medical record "dictionary" terms. Among 3329 patients, CHADS2 scores were 0 (17%), 1 (26%), 2-6 (57%). Among 1276 patients with CHADS2 scores >0 who were prescribed warfarin, rates of potential barriers to warfarin were gastrointestinal or genitourinary hemorrhage (20%), alcohol abuse (16%), renal insufficiency (15%), predisposition to falls (8%), cirrhosis/hepatitis (5%), intracranial hemorrhage (1%), other hemorrhage (6%), and age 75 years or more (23%). Among 1475 patients with CHADS2 scores >0 who were not prescribed warfarin, these rates differed by not >3% except for predisposition to falls (16%) and age 75 years or more (43%). In real-world practice, many patients given warfarin have contraindications that would exclude them from clinical trials, and many patients apparently eligible for warfarin do not receive it.
与常规实践相比,临床试验通常排除有相对禁忌症的患者。对真实世界中使用华法林的研究可以为潜在替代华法林的新药试验提供信息。本研究旨在描述房颤患者使用华法林的潜在障碍。这是一项回顾性电子病历研究(1998-2007 年),来自市区公立医院及其附属初级保健诊所,纳入年龄在 18 岁及以上的房颤患者。排除标准包括二尖瓣或主动脉瓣置换术、甲状腺功能亢进症,或首次诊断后 1 年内无临床接触。华法林暴露通过电子药房或医生医嘱数据定义,或者通过第二个定义,国际标准化比值(INR)>1.3 定义。潜在的华法林使用障碍史通过国际疾病分类,第 9 版(ICD-9)代码或电子病历“字典”术语定义。在 3329 名患者中,CHA2DS2-VASc 评分为 0(17%)、1(26%)、2-6(57%)。在 1276 名 CHA2DS2-VASc 评分>0 并接受华法林治疗的患者中,华法林使用的潜在障碍发生率为胃肠道或泌尿生殖道出血(20%)、酒精滥用(16%)、肾功能不全(15%)、易跌倒倾向(8%)、肝硬化/肝炎(5%)、颅内出血(1%)、其他出血(6%)和年龄 75 岁或以上(23%)。在 1475 名 CHA2DS2-VASc 评分>0 且未接受华法林治疗的患者中,除易跌倒倾向(16%)和年龄 75 岁或以上(43%)外,这些比率均<3%。在真实世界的实践中,许多接受华法林治疗的患者有临床试验排除的禁忌症,许多显然适合使用华法林的患者并未使用。