利伐沙班治疗儿童静脉血栓栓塞症安全性和有效性的Meta分析

Meta-analysis of safety and efficacy of rivaroxaban in the treatment of children with venous thromboembolism

目的评价利伐沙班相较于标准抗凝治疗在儿童静脉血栓栓塞症中的安全性和有效性。方法系统检索PubMed、Embase、中国国家知识基础设施、Cochrane图书馆、SinoMed和ClinicalTrials.gov等数据库2000年9月至2022年9月相关的随机对照临床试验研究,使用RevMan 5.3对使用利伐沙班和标准抗凝治疗患儿再栓塞、大出血以及血栓负荷改变等情况进行Meta分析。结果共纳入6项随机对照临床试验共905例患者,其中利伐沙班组621例,标准抗凝治疗组284例。Meta分析结果显示,利伐沙班可有效降低患儿血栓负荷(OR=4.24,95%CI=3.04~5.91,P<0.01),但临床相关非大出血发生率较高[相对危险度(relative risk),(RR=3.53,95%CI=1.14~10.94,P=0.03)];此外,静脉血栓栓塞症复发率(RR=0.34,95%CI=0.10~1.11,P=0.07)和大出血发生率(RR=0.13,95%CI=0.12~1.16,P=0.07)方面二者差异无统计学意义。结论利伐沙班可有效降低静脉血栓栓塞症患儿的血栓负荷,主要安全性和有效性与标准抗凝治疗相似,是儿童抗凝治疗的良好选择。

Objective To evaluate the safety and efficacy of rivaroxaban compared with standard anticoagulant therapy in children with venous thromboembolism.Methods A systematic search of related randomized controlled clinical trial studies from September 2000 to September 2022 at databases such as PubMed,Embase,China National Knowledge Infrastructure,Cochrane Library,SinoMed and ClinicalTrials.gov was performed.Meta-analysis was performed with RevMan 5.3 to compare rivaroxaban and standard anticoagulant therapy on re-embolization,major bleeding and thrombus burden changes.Results Six randomised controlled clinical trials with 905 patients were included,including 621 in the rivaroxaban group and 284 in the standard anticoagulation group.The meta-analysis showed that rivaroxaban was effective in reducing thrombotic load in children(OR=4.24,95%CI=3.04-5.91,P<0.01),but the incidence of clinically relevant non-major bleeding was higher[relative risk(RR)=3.53,95%CI=1.14-10.94,P=0.03].The incidences of recurrent venous thromboembolism(RR=0.34,95%CI=0.10-1.11,P=0.07)and major bleeding(RR=0.13,95%CI=0.12-1.16,P=0.07)were not statistically different between the two groups.Conclusion Rivaroxaban can effectively reduce the thrombus burden in children with venous thromboembolism,and its main safety and efficacy are similar to standard anticoagulant therapy.It is a good choice for anticoagulant therapy in children.