PDF(Pubmed)
Abstract：
Background and Objectives: Anticoagulants are a well-known risk factor for gastrointestinal bleeding (GIB). In recent years, direct oral anticoagulants (DOACs) have taken a leading role in the treatment and prevention of thromboembolic incidents. The aim of this study was to investigate the prevalence of DOAC-treated patients with GIB whose plasma drug concentrations exceeded the cut-off values reported in the literature and to evaluate their clinical characteristics. Materials and Methods: Patients who were admitted to the Intensive Care Unit in the period 2/2020-3/2022 due to GIB were prospectively included in the study and classified into three groups according to the prescribed type of DOAC (apixaban, rivaroxaban, and dabigatran). For all participants, it was determined if the measured plasma drug levels exceeded the maximum serum concentration (Cmax) or trough serum concentration (Ctrough) obtained from the available data. A comparison of clinical parameters between the patients with and without excess drug values was performed. Results: There were 90 patients (54.4% men) included in the study, of whom 27 were treated with dabigatran, 24 with apixaban, and 39 with rivaroxaban. According to Cmax, there were 34 (37.8%), and according to Ctrough, there were 28 (31.1%) patients with excess plasma drug values. A statistically significant difference regarding excess plasma drug values was demonstrated between DOACs according to both Cmax (p = 0.048) and Ctrough (p < 0.001), with the highest rate in the group treated with dabigatran (55.6% for Cmax and 59.3% for Ctrough). Multivariate logistic regression showed that age (OR 1.177, p = 0.049) is a significant positive and glomerular filtration rate (OR 0.909, p = 0.016) is a negative predictive factor for excess plasma drug values. A total of six (6.7%) patients had fatal outcomes. Conclusions: Plasma drug concentrations exceed cut-off values reported in the literature in more than one-third of patients with GIB taking DOAC, with the highest rate in the dabigatran group. Clinicians should be more judicious when prescribing dabigatran to the elderly and patients with renal failure. In these patients, dose adjustment, plasma drug monitoring, or substitution with other, more appropriate DOACs should be considered.
摘要：
背景和目的：抗凝剂是胃肠道出血（GIB）的一个众所周知的危险因素。近年来,直接口服抗凝剂(DOAC)在治疗和预防血栓栓塞事件方面发挥了主导作用.这项研究的目的是调查DOAC治疗的GIB患者的患病率，其血浆药物浓度超过文献报道的临界值，并评估其临床特征。材料和方法：在2/2020-3/2022期间因GIB入院的重症监护病房患者被前瞻性地纳入研究，并根据DOAC的规定类型分为三组（阿哌沙班，利伐沙班,和达比加群)。对于所有参与者，确定测量的血浆药物水平是否超过从可用数据获得的最大血清浓度(Cmax)或谷值血清浓度(Ctoor).对有和没有过量药物值的患者之间的临床参数进行了比较。结果：有90例患者（54.4%为男性）纳入研究，其中27人接受了达比加群的治疗，24与阿哌沙班，和39利伐沙班。根据Cmax,有34人(37.8%)，根据Cfoot的说法，有28例（31.1％）患者的血浆药物超值。根据Cmax（p=0.048）和Ctooth（p<0.001），DOAC之间的血浆药物过量值具有统计学上的显着差异，达比加群治疗组中的发生率最高（Cmax为55.6％，Ctugh为59.3％）。多因素logistic回归分析显示,年龄(OR1.177,p=0.049)为阳性,肾小球滤过率(OR0.909,p=0.016)为阴性预测因子。共有6例（6.7％）患者出现致命结局。结论：超过三分之一服用DOAC的GIB患者的血浆药物浓度超过文献报道的临界值，达比加群的比率最高。临床医生在给老年人和肾功能衰竭患者开达比加群时应更加谨慎。在这些患者中,剂量调整,血浆药物监测，或与其他替代，应该考虑更合适的DOAC。
