Gorzelak-Pabiś Paulina, Duraj Iwona, Szlagowska Liliana, Ciastkowska Agnieszka, Broncel Marlena
Pol Merkur Lekarski. 2014 Nov;37(221):261-4.
For 60 years, vitamin K antagonists have been used in prevention of thromboembolic complications in the course of atrial fibrillation (AF), however such therapy is associated with many inconveniences. New oral anticoagulants (NOAC), rivaroxaban and dabigatran, represent an attractive alternative to VKA.
Yo evaluate the safety of a 6-month therapy with rivaroxaban and dabigatran in patients (pts) with persistent AF.
The analysis included 24 pts (14 females, 10 males) with nonvalvular AF and indications for oral anticoagulant therapy (CHA2DS2-VASc > or = 2, HAS-BLED < 3), hospitalized in the Clinic of Internal Diseases and Clinical Pharmacology of the Medical University of Lodz between July 2012 and September 2013. In the group of patients treated chronically with VKA, laboratory tests (GFR, creatinine, ALT AST, coagulation) were performed during their stay in the clinic. The patients were randomly assigned to the treatment with one of the new NOACs, rivaroxaban or dabigatran. After a 6-month period, the patients completed a questionnaire on their general health condition and follow-up laboratory tests were performed.
In the group of pts. receiving dabigatran INR increased by 23% (p = 0.0002) and APTT prolongation by 91% was noted (p = 0.0004) whereas in the group of pts receiving rivaroxaban an INR increase by 17% (p = 0.04) and APTT prolongation by 32% (p = 0.0043) were observed. After a 6-month therapy, dabigatran prolongs APTT significantly more, as compared to rivaroxaban (p=0.0002). Among patients using dabigatran, 16.7% experienced the following symptoms: abdominal pain, gastritis, nausea. 8.3% patients experienced bleeding from haemorrhoids, easier bruising. In the group of patients receiving rivaroxaban, 16.7% experienced the following symptoms: nosebleeds and easier bruising; 8.3%: bleeding from gums, haematuria. 25%: pruritus, rash: 8.3%. The hazard ratio (HR) for occurrence of dyspeptic symptoms was 1.13 for dabigatran. Minor bleeding is 3.6 times more common when using rivaroxaban.
Significant increase of INR and prolongation of APTT are observed after a 6-month therapy with rivaroxaban or dabigatran. Additionally, dabigatran significantly prolongs the prothrombin time. Despite the fact that dabigatran caused larger prolongation of APTT minor bleeding episodes occurred more frequently in patients treated with rivaroxaban. No worsening of kidney or liver function was observed during the 6-month therapy with rivaroxaban or dabigatran. Rywaroxaban more frequently causes minor bleeding, whereas treatment with dabigatran is associated with more frequent gastrointestinal adverse symptoms.
60年来，维生素K拮抗剂一直用于预防心房颤动（AF）过程中的血栓栓塞并发症，然而这种治疗存在诸多不便。新型口服抗凝药（NOAC）利伐沙班和达比加群是维生素K拮抗剂颇具吸引力的替代药物。
评估利伐沙班和达比加群对持续性房颤患者进行6个月治疗的安全性。
分析纳入2012年7月至2013年9月在罗兹医科大学内科与临床药理诊所住院的24例患者（14例女性，10例男性），这些患者患有非瓣膜性房颤且有口服抗凝治疗指征（CHA2DS2-VASc≥2，HAS-BLED＜3）。长期接受维生素K拮抗剂治疗的患者组在住院期间进行了实验室检查（肾小球滤过率、肌酐、谷丙转氨酶、谷草转氨酶、凝血功能）。患者被随机分配接受新型NOAC之一利伐沙班或达比加群治疗。6个月后，患者完成了关于其总体健康状况的问卷调查，并进行了随访实验室检查。
接受达比加群治疗的患者组国际标准化比值（INR）升高23%（p = 0.0002），活化部分凝血活酶时间（APTT）延长91%（p = 0.0004）；而接受利伐沙班治疗的患者组INR升高17%（p = 0.04），APTT延长32%（p = 0.0043）。6个月治疗后，与利伐沙班相比，达比加群使APTT延长更显著（p = 0.0002）。使用达比加群的患者中，16.7%出现以下症状：腹痛、胃炎、恶心。8.3%的患者出现痔疮出血、更容易出现瘀伤。接受利伐沙班治疗的患者组中，16.7%出现以下症状：鼻出血和更容易出现瘀伤；8.3%：牙龈出血、血尿；25%：瘙痒、皮疹；8.3%。达比加群出现消化不良症状的风险比（HR）为1.13。使用利伐沙班时轻微出血的发生率高3.6倍。
利伐沙班或达比加群治疗6个月后可观察到INR显著升高和APTT延长。此外达比加群显著延长凝血酶原时间。尽管达比加群使APTT延长幅度更大，但利伐沙班治疗的患者轻微出血事件更频繁发生。利伐沙班或达比加群治疗6个月期间未观察到肾功能或肝功能恶化。利伐沙班更频繁地引起轻微出血，而达比加群治疗与更频繁的胃肠道不良症状相关。
Zotero 插件