METHODS: PubMed and Embase databases were searched for RCTs comparing DOACs to standard anticoagulation in pediatric VTE patients. Efficacy outcomes included VTE recurrence and all-cause mortality, while safety outcomes comprised major bleeding and other adverse events.
RESULTS: Three RCTs with 790 participants were included. When compared with standard anticoagulation, DOACs demonstrated a reduced risk of VTE recurrence (risk difference[RD] = -3%, 95% confidence interval[CI]: -6% to 0%, P = 0.04) and an increased risk of any adverse event (RD = 8%, 95% CI: 1% to 14%, P = 0.02). No significant differences were found in all-cause mortality, major bleeding, clinically relevant non-major bleeding, or total bleeding between the DOAC and control groups.
CONCLUSIONS: DOACs, primarily dabigatran and rivaroxaban, are non-inferior to standard anticoagulants in reducing VTE recurrence in pediatric patients, with comparable safety profiles. Further research is essential to confirm these findings.
方法:搜索PubMed和Embase数据库,以比较DOAC与标准抗凝治疗在小儿VTE患者中的RCT。疗效结果包括VTE复发和全因死亡率,而安全性结局包括大出血和其他不良事件.
结果:纳入了三个RCT,790名参与者。与标准抗凝相比,DOACs显示VTE复发风险降低(风险差异[RD]=-3%,95%置信区间[CI]:-6%至0%,P=0.04)和任何不良事件的风险增加(RD=8%,95%CI:1%至14%,P=0.02)。全因死亡率没有发现显著差异,大出血,临床相关非大出血,或DOAC组和对照组之间的总出血。
结论:DOAC,主要是达比加群和利伐沙班,在减少儿科患者的VTE复发方面不劣于标准抗凝剂,具有可比的安全性。进一步的研究对于证实这些发现至关重要。