Ashrafi Farzaneh, Rezaie Najmeh, Mousavi Sarah
Department of Hematology and Oncology, Isfahan University of Medical Sciences, Isfahan, Iran.
Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.
J Res Pharm Pract. 2017 Oct-Dec;6(4):211-216. doi: 10.4103/jrpp.JRPP_17_54.
Dabigatran etexilate is a novel oral anticoagulant with several advantages over warfarin such as no need for routine monitoring and fewer drug interactions. This drug was added to our hospital's formulary in 2012. The objective of this study was to assess the rational drug use of dabigatran at a large teaching hospital.
A prospective cross-sectional study was performed from November to June 2015 at Alzahra teaching hospital, Isfahan, Iran. All patients who received at least one dose of dabigatran were eligible for inclusion. Data were collected on patient demographics, indication, dosing regimen, adverse events, concurrent anticoagulant therapy, and laboratory data (including renal function).
A total of sixty patients were included in our study. The majority of patients ( = 40, 66.7%) was prescribed dabigatran for deep vein thrombosis prophylaxis. Only one patient received dabigatran with appropriate indication, dose, and duration. Thirty-six (60%) of our patients had thrombocytopenia at the time of dabigatran initiation. We also detected that ten patients (16.7%) received this drug for heparin-induced thrombocytopenia (HIT). In 32 patients, platelet levels increased after dabigatran initiation. Only seven patients received the appropriate dose of dabigatran (regarding both indication and renal function).
Unlabeled use and incorrect dosing of dabigatran in this study emphasize the need to develop a hospital protocol for dabigatran use within our facility. We suggest proper education of clinicians about novel drugs, pharmacist interventions, and further studies about the safety and efficacy of dabigatran for the new indication (such as HIT).
达比加群酯是一种新型口服抗凝剂，与华法林相比具有多项优势，如无需常规监测且药物相互作用较少。该药物于2012年被列入我院药品目录。本研究的目的是评估一家大型教学医院中达比加群的合理用药情况。
2015年11月至6月在伊朗伊斯法罕的阿尔扎赫拉教学医院进行了一项前瞻性横断面研究。所有接受至少一剂达比加群的患者均符合纳入标准。收集了患者的人口统计学数据、适应证、给药方案、不良事件、同时进行的抗凝治疗以及实验室数据（包括肾功能）。
我们的研究共纳入了60例患者。大多数患者（n = 40，66.7%）被处方使用达比加群预防深静脉血栓形成。只有1例患者接受达比加群的适应证、剂量和疗程合适。36例（60%）患者在开始使用达比加群时出现血小板减少。我们还发现10例患者（16.7%）因肝素诱导的血小板减少症（HIT）接受该药物治疗。32例患者在开始使用达比加群后血小板水平升高。只有7例患者接受了合适剂量的达比加群（在适应证和肾功能方面均合适）。
本研究中达比加群的未标注使用和用药错误强调了在我们机构制定达比加群使用医院方案的必要性。我们建议对临床医生进行关于新药的适当教育、药剂师进行干预，并进一步研究达比加群用于新适应证（如HIT）的安全性和有效性。
