【摘要】 目的 前瞻性探讨低剂量利伐沙班用于肾功能不全的高龄心房颤动患者的安全性和有效性。方法 收集2022年10月-2023年10月75岁以上合并肾功能不全的非瓣膜性心房颤动(NVAF)患者79例，随机分为低剂量组(10 mg/d)和常规剂量组(15 mg/d)。随访6个月，观察药物治疗的安全性及有效性。有效性终点：缺血性脑卒中和外周动脉栓塞；安全性终点：大出血和有临床意义的小出血，包括皮下瘀斑、牙龈出血、血尿、便潜血、眼结膜出血。结果 (1)两组基线比较CHA2DS2-VASc评分和HASBLED评分差异无统计学意义(P>0.05),但年龄和合并脑梗死或TIA例数低剂量组略高于常规剂量组，肌酐清除率低剂量组要略低于常规剂量组，两组间差异均有统计学意义(P<0.05)。(2)两组治疗前凝血指标水平比较差异无统计学意义(P>0.05)。(3)随访6个月，低剂量组及常规剂量组均未见到新发缺血性脑卒中和外周栓塞事件。常规剂量组便潜血3例，牙龈出血2例，皮下瘀斑2例。结论 合并肾功能不全的高龄NVAF患者应用低剂量利伐沙班抗凝治疗有效性不劣于常规剂量，出血风险低，安全性高，为该类患者优化抗凝治疗提供理论依据。更多还原

【Abstract】 Objective To prospectively explore the safety and efficacy of low-dose rivaroxaban in elderly patients with atrial fibrillation(AF) and renal insufficiency. Methods A total of 79 elderly patients(aged ≥75 years) with non-valvular AF(NVAF) and renal insufficiency admitted from October 2022 to October 2023 were prospectively enrolled. Participants were randomly assigned to the low-dose group(10 mg/day) and the standard-dose group(15 mg/day). Safety and efficacy were evaluated over 6 months of follow-up. Efficacy endpoints consisted of ischemic stroke and peripheral arterial embolism. Safety endpoints included major bleeding and clinically relevant non-major bleeding(e.g., subcutaneous ecchymosis, gingival bleeding, hematuria, fecal occult blood, and conjunctival hemorrhage). Results(1)Baseline characteristics showed no significant difference in the CHA2DS2-VASc Score for Atrial Fibrillation Stroke Risk and the HAS-BLED Score for Major Bleeding Risk between groups(P>0.05). However, patients in the low-dose group had a significantly older mean age, fewer cases of prior cerebral infarction/transient ischemic attack(TIA), and lower creatinine clearance compared to the standard-dose group(P<0.05).(2)Coagulation parameters were analyzed. Pretreatment coagulation index levels were similar between groups(P>0.05).(3)Follow-up outcomes did not show new ischemic strokes or peripheral embolisms in either group. Three cases of fecal occult blood, 2 cases of gingival bleeding, and 2 cases of subcutaneous ecchymosis were reported in the standard-dose group. Conclusion Low-dose rivaroxaban demonstrated non-inferior efficacy and a lower bleeding risk compared to standard-dose rivaroxaban in elderly patients with NVAF and renal insufficiency, offering a potential optimization strategy for anticoagulation therapy.更多还原