不同剂量利伐沙班在老年血栓栓塞性疾病患者中的疗效和安全性系统评价

Systematic Review of Efficacy and Safety of Different Doses of Rivaroxaban in Elderly Patients with Thromboembolic Diseases

目的:系统评价不同剂量利伐沙班在我国老年血栓栓塞性疾病患者中的疗效和安全性。方法:检索中国知网、万方数据库和维普数据库中,检索时限为建库至2021年3月23日,纳入不同剂量利伐沙班在老年患者中疗效和安全性比较的临床随机对照研究,提取相关数据,进行荟萃分析(Meta分析)。结果:纳入16项研究,共2581例老年血栓栓塞性疾病患者。各项研究中,利伐沙班的剂量范围为2.5~30 mg/d。其中,8项研究比较了不同剂量利伐沙班与血栓栓塞性事件的风险关系,结果显示,小剂量利伐沙班(≤10 mg/d)的血栓栓塞性事件发生率高于大剂量利伐沙班,但差异无统计学意义(RR=1.33,95%CI=0.77~2.32,P=0.305);9项研究比较了不同剂量利伐沙班与出血事件的风险关系,结果显示,小剂量利伐沙班(≤10 mg/d)的出血事件发生率明显低于大剂量利伐沙班,差异有统计学意义(RR=0.48,95%CI=0.26~0.91,P=0.025)。结论:小剂量利伐沙班可能更适合我国老年血栓栓塞性疾病患者;对于高龄患者,临床需综合评估出血及血栓风险,选择适宜的剂量。

OBJECTIVE:To systematically evaluate the efficacy and safety of different doses of rivaroxaban in elderly patients with thromboembolic diseases.METHODS:CNKI,Wanfang Data and VIP database were retrieved to collect the randomized controlled trial of different doses of rivaroxaban in elderly patients with thromboembolic diseases.The retrieval time was from the establishment of the database to Mar.23rd,2021.Relevant data were extracted and Meta-analysis was conducted.RESULTS:Totally 16 literature were collected,including 2581 elderly patients with thromboembolic diseases.The doses of rivaroxaban in various studies ranged from 2.5 mg/d to 30 mg/d.Eight studies compared the risk relationship between different doses of rivaroxaban and thromboembolic events,and the results showed that the incidence of thromboembolic events of low-dose rivaroxaban(≤10 mg/d)was higher than that of high-dose rivaroxaban,but the difference was not statistically significant(RR=1.33,95%CI=0.77-2.32,P=0.305).Nine studies compared the risk relationship between different doses of rivaroxaban and bleeding,and the results showed that the incidence of bleeding of low-dose rivaroxaban(≤10 mg/d)was significantly lower than that of high-dose rivaroxaban,the difference was statistically significant(RR=0.48,95%CI=0.26-0.91,P=0.025).CONCLUSIONS:Low-dose rivaroxaban is more suitable for elderly patients with thromboembolic diseases in China.For elderly patients,comprehensive clinical assessment of bleeding and thrombotic risk is required to select the appropriate dose.