不同剂量利伐沙班对高龄非瓣膜性心房颤动患者卒中预防效果及安全性评价

Effect and safety evaluation of different doses of rivaroxaban on stroke prevention in elderly patients with non-valvular atrial fibrillation

摘要:

目的 探讨不同剂量利伐沙班对高龄非瓣膜性心房颤动患者卒中预防效果及安全性。方法 选取2018年3月—2021年1月萍乡矿业集团有限责任公司总医院收治的174例高龄非瓣膜性心房颤动患者为研究对象，以随机数字表法分为利伐沙班高剂量组、中剂量组、低剂量组，每组58例。利伐沙班高剂量组口服利伐沙班20 mg/d，中剂量组口服利伐沙班15 mg/d，低剂量组口服利伐沙班10 mg/d，自治疗起随访12个月观察效果。记录随访期间3组的栓塞、出血发生情况，比较3组治疗前后凝血功能及肝肾功能变化，统计治疗期间不良反应发生情况。结果 3组总栓塞发生率比较，差异无统计学意义（P >0.05）；3组总出血发生率比较，差异无统计学意义（P >0.05）；3组治疗前、治疗3个月、治疗后的凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、凝血酶时间（TT）、国际标准化比值（INR）比较，不同时间点间的PT、APTT、TT、INR有差异（P <0.05），3组的PT、APTT、TT、INR无差异（P >0.05），3组的PT、APTT、TT、INR变化趋势有差异（P <0.05）。3组治疗前、治疗3个月、治疗后的丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）、肌酐、尿素氮、尿酸比较，不同时间点间的ALT、AST、肌酐、尿素氮、尿酸无差异（P >0.05），3组的ALT、AST、肌酐、尿素氮、尿酸无差异（P >0.05），3组的ALT、AST、肌酐、尿素氮、尿酸变化趋势无差异（P >0.05）。3组总不良反应发生率比较，差异无统计学意义（P >0.05）。结论 利伐沙班20 mg/d、15 mg/d、10 mg/d在高龄非瓣膜性心房颤动患者的治疗中总栓塞发生率及总出血发生率相当，均具有良好的抗凝疗效，对肝肾功能影响小，安全性良好，推荐低剂量利伐沙班用于高龄非瓣膜性心房颤动患者。

Abstract:

Objective To investigate the effect and safety of different doses of rivaroxaban on stroke prevention in elderly patients with non-valvular atrial fibrillation.Methods A total of 174 elderly patients with nonvalvular atrial fibrillation admitted to our hospital from March 2018 to January 2021 were selected as the research objects, and were divided into rivaroxaban high-dose group, medium-dose group and low-dose group by random number table method, with 58 cases in each group. Rivaroxaban high-dose group received rivaroxaban 20 mg/d, medium-dose group received rivaroxaban 15 mg/d, and low-dose group received rivaroxaban 10 mg/d. The results were observed after 12 months of follow-up. The occurrence of embolism events and bleeding events in the 3 groups were recorded during follow-up, and the changes of coagulation function and liver and kidney function in the 3 groups were compared before and after treatment, and the occurrence of adverse reactions during treatment was counted.Result There was no significant difference in the incidence of total embolism events among the three groups (P > 0.05). There was no significant difference in the incidence of total bleeding events among the 3 groups (P > 0.05). The prothrombin time (PT), activated partial thrombin time (APTT), thrombin time (TT) and international standardized ratio (INR) of the 3 groups were compared before treatment, 3 months after treatment and after treatment, showing differences in PT, APTT, TT and INR between different time points (P < 0.05). There were no differences in PT, APTT, TT and INR among the three groups (P > 0.05), but there were differences in the trend of PT, APTT, TT and INR among the three groups (P < 0.05). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, urea nitrogen and uric acid in 3 groups were compared before, 3 months and after treatment, showing no difference in ALT, AST, creatinine, urea nitrogen and uric acid at different time points (P > 0.05). There were no differences in ALT, AST, creatinine, urea nitrogen and uric acid among the three groups (P > 0.05), and there were no differences in the trend of ALT, AST, creatinine, urea nitrogen and uric acid among the three groups (P > 0.05). There was no significant difference in the incidence of total adverse reactions among the three groups (P > 0.05).Conclusion Rivaroxaban 20 mg/d, 15 mg/d, and 10 mg/d have similar clinical thromboembolic and hemorrhagic events in the treatment of elderly patients with non-valvular atrial fibrillation, all have good anticoagulant efficacy, and have little effect on liver and kidney function , with good safety, and low-dose rivaroxaban is recommended for elderly patients with non-valvular atrial fibrillation.