PDF(Pubmed)
Abstract：
BACKGROUND: Acute venous thromboembolism (VTE) in children presents unique challenges due to the limitations of standard anticoagulation therapies. Herein, we aimed to systematically review randomized controlled trials (RCTs) evaluating the efficacy and safety of direct oral anticoagulants (DOACs) in pediatric patients with acute VTE.
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.
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.
摘要：
背景：由于标准抗凝治疗的局限性，儿童急性静脉血栓栓塞症（VTE）面临着独特的挑战。在这里，我们旨在系统回顾评价直接口服抗凝药(DOACs)在急性VTE儿科患者中的疗效和安全性的随机对照试验(RCTs).
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。
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。
