Effect observation on elderly patients with non-valvular atrial fibrillation treated with dabigatran etexilate

doi:10.3760/cma.j.issn.1007-1245.2024.10.005

Abstract

Abstract:

Objective　To investigate the effects of dabigatran etexilate treatment on the coagulation function, cardiac function, adverse reactions, and prognosis in elderly patients with non-valvular atrial fibrillation. Methods　This study was a randomized controlled trial. A total of 130 elderly patients with non-valvular atrial fibrillation admitted to the Second Hospital of Tianjin Medical University from January 2020 to September 2023 were included. The patients were divided into group A (warfarin treatment, 43 cases), group B (rivaroxaban treatment, 43 cases), and group C (dabigatran etexilate treatment, 44 cases) by the random number table method. Group A included 22 males and 21 females, aged (74.56±6.43) years; there were 23 cases of grade I and 20 cases of grade II cardiac function. Group B included 24 males and 19 females, aged (73.89±6.21) years; there were 22 cases of grade I and 21 cases of grade II cardiac function. Group C included 20 males and 24 females, aged (74.12±6.38) years; there were 23 cases of grade I and 21 cases of grade II cardiac function. Group A was treated with warfarin sodium tablets, once a day, starting at 2.5 mg and then adjusting the dose according to the international normalized ratio (INR) by 0.5 mg each time, keeping the INR between 2.0 and 3.0. Group B was treated with rivaroxaban tablets, 15 mg each time, once a day. Group C was treated with dabigatran etexilate capsules, 110 mg each time, twice a day. The course of treatment was 2 months. The levels of liver and kidney function indicators [creatinine (Cr), urea nitrogen (BUN), alanine aminotransferase (ALT), and aspartate aminotransferase (AST)], coagulation function indicators [thrombin time (TT), fibrinogen (FIB), activated partial thromboplastin time (APTT), and plasma prothrombin time (PT)], CHA2DS2-VASc scores of atrial fibrillation thromboembolic risk, HAS-BLED scores of atrial fibrillation anticoagulant bleeding risk, and adverse reactions (skin ecchymosis, nausea and vomiting, stroke, and hematuria) of the three groups were compared. The patients were followed up for 3 months to record the incidences of thromboembolic formation and bleeding. Repeated measure ANOVA, χ² test, and Fisher exact probability method were used. Results　After 2 months of treatment, the levels of Cr, BUN, ALT, and AST in group B and C were lower than those in group A, with statistically significant differences (all P<0.05). The levels of TT, APTT, and PT in group B and C were higher than those in group A, and the levels of FIB in group B and C were lower than that in group A, with statistically significant differences (all P<0.05). The CHA2DS2-VASc and HAS-BLED scores in group A, B, and C after treatment were slightly higher than those before treatment, but the differences were not statistically significant (all P>0.05). The incidences of adverse reactions in group A, B, and C were 16.28% (7/43), 4.65% (2/43), and 2.27% (1/44); the incidence of adverse reactions in group C was lower than that in group A, with a statistically significant difference (P<0.05). After 3 months of follow-up, the rates of thromboembolic formation and minor bleeding in group B and C were slightly lower than those in group A, but the differences were not statistically significant (all P>0.05). Conclusion　In treating elderly patients with non-valvular atrial fibrillation, dabigatran etexilate and rivaroxaban demonstrate better therapeutic effects and safety compared to warfarin, improving the liver and kidney functions and coagulation function, and reducing the adverse reactions and thromboembolic and bleeding events.

Key words:

Dabigatran etexilate, Rivaroxaban, Warfarin, Non-valvular atrial fibrillation, Elderly, Prognosis

摘要：

目的　探讨达比加群酯治疗老年非瓣膜性房颤患者对凝血功能、心功能的影响及不良反应和预后。方法　本研究为随机对照试验，共纳入2020年1月至2023年9月期间天津医科大学第二医院130例老年非瓣膜性房颤患者。通过随机数字表法将患者分为A组（华法林治疗，43例）、B组（利伐沙班治疗，43例）和C组（达比加群酯治疗，44例）。A组男性22例，女性21例，年龄为（74.56±6.43）岁；心功能分级Ⅰ级23例、Ⅱ级20例。B组男性24例，女性19例，年龄为（73.89±6.21）岁；心功能分级Ⅰ级22例、Ⅱ级21例。C组男性20例，女性24例，年龄为（74.12±6.38）岁；心功能分级Ⅰ级23例、Ⅱ级21例。A组接受华法林钠片治疗，每日一次，起始剂量为2.5 mg，后根据国际标准化比值（INR）调整剂量，每次调整0.5 mg，保持INR在2.0～3.0之间；B组接受利伐沙班片治疗，每次15 mg，每日一次；C组接受达比加群酯胶囊治疗，每次110 mg，每日两次。疗程为2个月。对比3组患者肝肾功能指标［肌酐（Cr）、尿素氮（BUN）、丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）］的水平、凝血功能［凝血酶时间（TT）、纤维蛋白原（FIB）、活化部分凝血活酶时间（APTT）、血浆凝血酶原时间（PT）］、心房颤动栓塞风险CHA2DS2-VASc评分、心房颤动抗凝出血风险HAS-BLED评分和不良反应（皮肤瘀斑、恶心呕吐、脑卒中、血尿）的发生情况，并随访3个月，统计3组的血栓栓塞形成率和出血情况。采用重复测量方差分析、χ²检验、Fisher确切概率法。结果　治疗2个月后，B组和C组Cr、BUN、ALT和AST水平低于A组，差异均有统计学意义（均P<0.05）。B组和C组TT、APTT、PT高于A组，FIB低于A组，差异均有统计学意义（均P<0.05）。A组、B组和C组CHA2DS2-VASc和HAS-BLED评分较治疗前略升高，但差异均无统计学意义（均P>0.05）。A组、B组和C组的不良反应发生率为16.28%（7/43）、4.65%（2/43）、2.27%（1/44）；C组的不良反应发生率低于A组，差异有统计学意义（P<0.05）。随访3个月后，B组和C组的血栓栓塞形成率和轻微出血率略低于A组，但差异均无统计学意义（均P>0.05）。结论　相比华法林，达比加群酯和利伐沙班在治疗老年非瓣膜性房颤患者中能改善肝肾功能和凝血功能，降低不良反应发生率，减少血栓栓塞和出血事件，显示出更好的治疗效果和安全性。

关键词:

达比加群酯, 利伐沙班, 华法林, 非瓣膜性房颤, 老年, 预后

Wang Xuewen, Li Guangping, Bi Xiaoxue, Zhang Zizhao, Xu Yanmin, Liu Tong.

Effect observation on elderly patients with non-valvular atrial fibrillation treated with dabigatran etexilate [J]. International Medicine and Health Guidance News, 2024, 30(10): 1604-1608.

王学文李广平毕晓雪张子钊徐延敏刘彤.

达比加群酯治疗老年非瓣膜性房颤患者的效果观察 [J]. 国际医药卫生导报, 2024, 30(10): 1604-1608.

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