Department of Gastroenterology, Clinic for Internal Medicine, University Hospital of Split, Spinciceva 1, 21000 Split, Croatia.
Department of Maxillofacial Surgery, University Hospital of Split, Spinciceva 1, 21000 Split, Croatia.
Medicina (Kaunas). 2023 Aug 16;59(8):1466. doi: 10.3390/medicina59081466.
: 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. : 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 (C or trough serum concentration (C) 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 C, there were 34 (37.8%), and according to C, 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 C ( = 0.048) and C ( < 0.001), with the highest rate in the group treated with dabigatran (55.6% for C and 59.3% for C). Multivariate logistic regression showed that age (OR 1.177, = 0.049) is a significant positive and glomerular filtration rate (OR 0.909, = 0.016) is a negative predictive factor for excess plasma drug values. A total of six (6.7%) patients had fatal outcomes. : 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.
抗凝剂是胃肠道出血 (GIB) 的已知危险因素。近年来，直接口服抗凝剂 (DOAC) 在血栓栓塞事件的治疗和预防中占据主导地位。本研究旨在调查 DOAC 治疗的 GIB 患者中，血浆药物浓度超过文献报道的截止值的患者的患病率，并评估其临床特征。
在 2020 年 2 月至 2022 年 3 月期间，因 GIB 入住重症监护病房的患者前瞻性纳入本研究，并根据处方 DOAC 类型（阿哌沙班、利伐沙班和达比加群）分为三组。对于所有参与者，确定测量的血浆药物水平是否超过从现有数据获得的最大血清浓度 (C) 或谷值血清浓度 (C)。比较了药物浓度超过正常值患者和药物浓度未超过正常值患者的临床参数。
本研究共纳入 90 例患者（54.4%为男性），其中 27 例接受达比加群治疗，24 例接受阿哌沙班治疗，39 例接受利伐沙班治疗。根据 C ，有 34 例（37.8%），根据 C ，有 28 例（31.1%）患者的血浆药物浓度超过正常值。根据 C 和 C ，达比加群组的药物浓度超过正常值的比例均明显高于其他两组（= 0.048 和 < 0.001），且达比加群组的药物浓度超过正常值的比例最高（C 为 55.6%，C 为 59.3%）。多变量逻辑回归显示，年龄（OR 1.177，= 0.049）是血浆药物浓度超过正常值的显著正预测因子，肾小球滤过率（OR 0.909，= 0.016）是负预测因子。共有 6 例（6.7%）患者死亡。
超过三分之一的 GIB 患者服用 DOAC 后，其血浆药物浓度超过文献报道的截止值，达比加群组的药物浓度超过正常值的比例最高。临床医生在给老年人和肾衰竭患者开达比加群时应更加谨慎。在这些患者中，应考虑调整剂量、监测血浆药物浓度或改用其他更合适的 DOAC。
