利伐沙班治疗老年血栓性疾病患者的疗效和安全性

目的探讨利伐沙班治疗老年人血栓性疾病的有效性和安全性。方法回顾性研究,连续入选解放军总医院第二医学中心2012年10月至2017年11月服用利伐沙班的老年住院患者301例,年龄60~102岁(86.5±8.4)岁。根据患者适应证、肌酐清除率、缺血和出血风险等综合评估制定抗凝方案,分为利伐沙班2.5~5.0 mg/d组72例、10.0 mg/d组205例、15.0~20.0 mg/d组24例。检测应用利伐沙班前后的肝、肾功能及凝血指标,记录观察期间的致死性出血、心源性死亡、全因死亡及非致死性出血和缺血事件。结果纳入患者利伐沙班剂量(9.3±3.0)mg/d,最小剂量2.5 mg/d。随访(14.9±13.9)个月,最长随访48个月。利伐沙班治疗后发生颅内出血1例、心源性死亡3例(1.0%)、全因死亡20例(6.6%)。累积发生率为25.2%,其中55.0%(11例)因肺炎、多脏器功能衰竭死亡;非致死性出血事件40例(13.3%),累积发生率为42.4%;缺血事件7例(2.3%),累积发生率为16.0%,其中非致死性心肌梗死2例,脑梗死3例,下肢静脉血栓栓塞2例。与用药前比较,凝血指标中凝血酶原时间延长、纤维蛋白原(FIB)升高,D-二聚体降低(P<0.05)。结论与既往文献报道比较,高龄老年血栓性疾病患者应用偏低剂量利伐沙班抗凝治疗安全有效,但需综合评估患者出血缺血风险,选择合适剂量的利伐沙班,个体化用药。

The efficacy and safety of Rivaroxaban for elderly patients with thrombotic diseases

Objective To investigate the efficacy and safety of Rivaroxaban for elderly patients with thrombotic diseases.Methods This was a retrospective study.A total of 301 elderly patients taking Rivaroxaban from October 2012 to November 2017 at the Second Medical Center of the Chinese PLA General Hospital were consecutively selected.The ages ranged from 60 to 102 years,with an average age of(86.5±8.4)years.Anticoagulation regimens were developed based on comprehensive evaluation of indications,creatinine clearance,ischemia and bleeding risk.Patients were divided into a Rivaroxaban 2.5-5.0 mg/d group(n=72),a 10.0 mg/d group(n=205),and a 15.0-20.0 mg/d group(n=24).Hepatic function,renal function,and coagulation indexes were measured before and after the administration of Rivaroxaban.Fatal bleeding,cardiovascular deaths,all-cause deaths,non-fatal bleeding and thromboembolic events were recorded during the follow-up period.Results The average dose of Rivaroxaban was(9.3±3.0)mg/d,and the minimum dose was 2.5 mg/d.The average follow-up time was(14.9±13.9)months and the longest follow-up time was 48 months.One patient had intracranial bleeding.Twenty patients(6.6%)died with a cumulative incidence of 25.2%,three(1.0%)died of cardiac events,and 55.0%died of pneumonia and multiple organ failure.Forty patients(13.3%)had non-fatal hemorrhagic events with a cumulative incidence of 42.4%.Seven patients(2.3%)had thromboembolic events with a cumulative incidence of 16.0%,including 2 cases of non-fatal myocardial infarction,3 cases of cerebral infarction and 2 cases of deep vein thrombosis.After treatment,levels of prothrombin time and fibrinogen significantly increased while levels of D-dimer significantly deceased(P<0.05).Conclusions Compared with previous reports,low-dose Rivaroxaban is safe and effective for elderly patients with thrombotic diseases.However,the risk of bleeding and ischemia should be comprehensively evaluated,and appropriate doses of Rivaroxaban should be selected individually.