氨甲环酸在儿童颅缝闭锁手术中安全性和有效性的Meta分析  

Meta-Analysis on Efficacy and Safety of Tranexamic Acid in Children with Craniosynostosis Surgery

作　　者：任丹阳[1] 沈建玲 涂彩霞 杨琰茗 谢睿 李云巍[1] 李琳 李惠英[1] Ren Danyang;Shen Jianling;Tu Caixia;Yang Yanming;Xie Rui;Li Yunwei;Li Lin;Li Huiying(Kunming Children’s Hospital,Kunming 650228,China;Kunming Medical University,Kunming 650500,China)

机构地区：[1]昆明市儿童医院,昆明650228 [2]昆明医科大学,昆明650500

出　　处：《儿科药学杂志》2025年第4期39-44,共6页Journal of Pediatric Pharmacy

基　　金：昆明市卫生科技人才培养项目,编号2023-SW(技)-19。

摘　　要：目的:系统评价氨甲环酸(TXA)在儿童颅缝闭锁手术中的有效性和安全性,为临床用药提供循证依据。方法:计算机检索PubMed、EMBase、the Cochrane Library、Web of Science、中国知网、维普和万方数据库,收集关于氨甲环酸在儿童颅缝闭锁手术中的随机对照试验(RCT)。检索时限为建库至2023年12月31日。筛选文献、提取资料并采用Cochrane协作偏倚风险评价工具对纳入的RCT进行质量评价,采用RevMan 5.3软件进行Meta分析。结果:纳入研究5项,共计220例患儿。Meta分析结果显示,与对照组相比,试验组能够降低术中失血量(MD=-18.64,95%CI-31.50~-5.78,P=0.004)、围手术期总失血量(MD=-25.55,95%CI-43.16~-7.94,P=0.004)、术中输血量(红细胞,MD=-7.70,95%CI-10.74~-4.66,P<0.01)、围手术期总输血量(红细胞,MD=-14.24,95%CI-27.00~-1.48,P=0.03);试验组与对照组术后失血量、术后输血量(红细胞)及手术持续时间比较差异无统计学意义。有1项研究有不良事件报道。结论:在儿童颅缝闭锁手术中,与安慰剂或无干预相比,TXA可减少失血量和输血需求。同时,10 mg/kg的负荷剂量及5 mg/(kg·h)的维持剂量方案可推荐应用于临床。Objective:To systematically review the efficacy and safety of tranexamic acid in children with craniosynostosis surgery,and to provide evidence-based reference for clinical drug use.Methods:PubMed,EMBase,the Cochrane Library,Web of Science,CNKI,VIP and Wanfang databases were retrieved to collect randomized controlled trials(RCT)of tranexamic acid in children with craniosynostosis surgery.The retrieval time was from the database establishment to Dec.31st,2023.Literature screening and data extraction were performed,the quality of included RCT were evaluated by bias risk assessment tool recommended by Cochrane system evaluator manual,RevMan 5.3 software was used for Meta-analysis.Results:A total of 5 articles were enrolled,including 220 patients.Meta-analysis showed that compared with control group,TXA could significantly reduce intraoperative blood loss(MD=-18.64,95%CI-31.50 to-5.78,P=0.004),perioperative total blood loss(MD=-25.55,95%CI-43.16 to-7.94,P=0.004),intraoperative blood transfusion(red blood cells,MD=-7.70,95%CI-10.74 to-4.66,P<0.01),perioperative total blood transfusion(red blood cells,MD=-14.24,95%CI-27.00 to-1.48,P=0.03).There was no statistical significance between two groups in the postoperative blood loss,postoperative blood transfusion(red blood cells)and surgical time.Adverse events were reported in 1 study.Conclusion:In pediatric craniosynostosis surgery,TXA can reduce blood loss and blood transfusion compared with placebo or no intervention.Meanwhile,10 mg/kg load dose and 5 mg/(kg∙h)continuous infusion dose regimen can be recommended for clinical use.

关 键 词：氨甲环酸 颅缝闭锁手术 儿童 META分析 

分 类 号：R726.1[医药卫生—儿科]