Faculdade de Farmácia, Hospital das Clínicas, Universidade Federal de Minas Gerais, Av. Antônio Carlos, 6627, Belo Horizonte, MG, CEP 31270-901, Brazil.
Eur J Clin Pharmacol. 2013 Apr;69(4):919-28. doi: 10.1007/s00228-012-1411-6. Epub 2012 Sep 28.
The aim of this study was to assess the agreement of four renowned interaction lists on potentially severe warfarin drug interactions (DI) in outpatients at a university hospital in Brazil, specifically in subgroups of Trypanosoma cruzi-infected and non-infected patients and those with previous bleeding episodes.
This was a cross-sectional study in which adult outpatients with heart disease and indications for chronic warfarin use were enrolled. The occurrence of potentially severe warfarin DI was evaluated based on the lists provided by three compendia, i.e., Drug Interaction Facts (DIF), Drug Interactions: Analysis and Management (DIAM) and DRUG-REAX, and by the World Health Organization (WHO) Model Formulary. A kappa coefficient was used to calculate the agreement among the sources.
A total of 280 patients were studied. Most patients were female (54.6 %) with an average age of 56.8 (standard deviation 13.1) years. The agreement among the four sources was fair (Fleiss' kappa coefficient = 0.295). T. cruzi-infected individuals were less likely to have severe warfarin DI than non-infected patients (p < 0.05 for DIAM, DRUG-REAX and the WHO Model Formulary). Potentially severe DI were more frequent in patients with previous bleeding episodes, based on the DIF compendia (p = 0.007).
This evaluation of warfarin DI revealed that the disagreement between compendia is also observed in clinical practice. T. cruzi infection is associated with a lower prevalence of potentially severe warfarin DI, but with a wider variation in its detection. Our results suggest a wide spectrum of discrepancies in detecting heart disease patients at higher risk for severe warfarin DI and a possible heterogeneity in clinical guidance.
本研究旨在评估在巴西一所大学医院的门诊患者中，四种著名的相互作用列表在潜在严重华法林药物相互作用（DI）方面的一致性，特别是在克氏锥虫感染和非感染患者以及有既往出血事件的患者亚组中。
这是一项横断面研究，纳入了患有心脏病且有慢性华法林使用指征的成年门诊患者。根据 Drug Interaction Facts（DIF）、Drug Interactions: Analysis and Management（DIAM）和 DRUG-REAX 三种药物相互作用手册以及世界卫生组织（WHO）处方集提供的列表，评估潜在严重华法林 DI 的发生情况。使用 Kappa 系数计算各来源之间的一致性。
共纳入 280 例患者。大多数患者为女性（54.6%），平均年龄为 56.8（标准差 13.1）岁。四种来源之间的一致性为中等（Fleiss' kappa 系数=0.295）。与非感染患者相比，克氏锥虫感染患者发生严重华法林 DI 的可能性较低（DIAM、DRUG-REAX 和 WHO 处方集差异有统计学意义，p<0.05）。根据 DIF 手册，有既往出血事件的患者发生潜在严重 DI 的可能性更高（p=0.007）。
本对华法林 DI 的评估表明，在临床实践中也观察到了手册之间的不一致。克氏锥虫感染与潜在严重华法林 DI 的发生率较低相关，但在其检测方面存在更大的差异。我们的研究结果表明，在检测发生严重华法林 DI 风险较高的心脏病患者方面存在广泛的差异，并且在临床指导方面可能存在异质性。
