摘要
目的 探讨不同时机启动利伐沙班抗凝治疗对心房颤动合并脑卒中患者疗效及出血风险的影响.方法 连续纳入2021年1月至2023年12月在郑州人民医院神经内科诊疗的心房颤动合并脑卒中患者336例,采用随机数字表法将患者分为试验组165例,对照组171例,试验组患者于发病48 h内给予利伐沙班治疗,对照组患者按照轻度脑卒中、中度脑卒中、重度脑卒中分别在发病后第3、第6、第12天口服利伐沙班治疗.收集患者的基线临床资料并随访至90 d,观察2组患者复发性缺血性脑卒中、症状性颅内出血、颅外出血、死亡、改良的Rankin量表(modi-fied Rankin scale,mRS)≤2分比例及mRS评分分布情况.结果 随访90 d,试验组中度脑卒中患者主要终点事件复发性缺血性脑卒中比例显著低于对照组(5.4％vs 15.9％,P=0.037);试验组与对照组轻度脑卒中、重度脑卒中患者主要终点事件复发性缺血性脑卒中(3.0％vs 3.2％、12.5％vs 14.8％)比较,差异无统计学意义(P＞0.05).试验组轻度脑卒中、中度脑卒中患者症状性颅内出血(1.5％vs 3.2％、5.4％vs 9.8％)、颅外出血(9.0％vs 14.5％、12.2％vs 15.9％)、mRS评分[1(0,2)分vs 1(1,2)分、3(1,4)分vs 3(2,4)分]低于对照组,但差异无统计学意义(P＞0.05);试验组与对照组重度脑卒中患者颅外出血(20.8％vs 22.2％)、症状性颅内出血(20.8％vs 7.4％)、死亡(8.3％vs 3.7％)、mRS评分[4(3,4)分vs 3(3,4)分]比较,差异无统计学意义(P＞0.05).试验组患者死亡2例,其中1例继发肺部感染,1例脑干出血;对照组患者死亡1例(脑干出血).结论 心房颤动合并脑卒中患者48 h内给予利伐沙班抗凝治疗未明显增加出血风险,显著降低中度脑卒中患者复发性缺血性脑卒中的比例,可能改善患者预后.
Abstract
Objective To investigate the effects of different timing of initiation of rivaroxaban anti-coagulation therapy on the efficacy and bleeding risk of atrial fibrillation patients after stroke.Methods A total of 336 patients with atrial fibrillation and stroke admitted in our hospital be-tween January 2021 and December 2023 were consecutively enrolled,and randomly divided into an experimental group(165 cases)and a control group(171 cases).The experimental group received rivaroxaban treatment within 48 h of symptom onset,whereas the control group initiated oral ri-varoxaban treatment on the 3rd,6th,and 12th day post-stroke onset,respectively,depending on stroke severity(mild,moderate,and severe).Their baseline clinical data were collected,and all of them were followed up till 90 d after stroke.The incidences of recurrent ischemic stroke,symp-tomatic intracranial hemorrhage and extracranial hemorrhage,mortality,and proportion of pa-tients with mRS score≤ 2 and distribution of the score were observed and analyzed in the two groups.Results During a 90-day follow-up period,the patients with moderate stroke from the ex-perimental group of patients exhibited a significantly lower rate of recurrent ischemic stroke than those in the control group(5.4％vs 15.9％,P=0.037).However,for patients with mild and se-vere stroke,no obvious difference was observed in the primary endpoint of recurrent ischemic stroke between the experimental and control groups(3.0％vs 3.2％,12.5％vs 14.8％,P＞0.05).Though no statistical differences were observed,lower rates of symptomatic intracranial hemor-rhage(1.5％vs 3.2％,5.4％vs 9.8％),reduced incidence of extracranial hemorrhage(9.0％vs 14.5％,12.2％vs 15.9％),and lower mRS score[1(0,2)vs 1(1,2),3(1,4)vs 3(2,4)]were seen in the patients with mild and moderate stroke from the experimental group when compared with the control group(P＞0.05).Similarly,there were no statistically differences for the severe stroke patients between the experimental and control groups(P＞0.05)in the incidence of extracranial hemorrhage(20.8％vs 22.2％),rate of symptomatic intracranial hemorrhage(20.8％vs 7.4％),mortality(8.3％vs 3.7％),and mRS score[4(3,4)vs 3(3,4)].Two patients from the experimen-tal group died,with one case due to secondary pulmonary infection and the other due to brainstem hemorrhage.In the control group,only one death occurred due to brainstem hemorrhage.Conclu-sion For atrial fibrillation patients,anticoagulation with rivaroxaban within 48 h after stroke has no significant increase in the risk of bleeding,reduces the proportion of recurrent ischemic stroke in patients with moderate stroke,and may improve the prognosis of patients.
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