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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
任丹阳1,沈建玲1,涂彩霞1,杨琰茗1,谢睿2,李云巍1,李琳1,李惠英1
0
((1. 昆明市儿童医院,昆明 650228;2. 昆明医科 大学,昆明 650500))
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。
关键词:  氨甲环酸  颅缝闭锁手术  儿童  Meta 分析
DOI:doi:10.13407/j.cnki.jpp.1672-108X.2025.04.009
基金项目:昆明市卫生科技人才培养项目,编号2023-SW(技)-19。
Meta-Analysis on Efficacy and Safety of Tranexamic Acid in Children with Craniosynostosis Surgery
Ren Danyang1, Shen Jianling1, Tu Caixia1, Yang Yanming1, Xie Rui2, Li Yunwei1, Li Lin1, Li Huiying1
((1. Kunming Children’s Hospital, Kunming 650228, China; 2. Kunming Medical University, Kunming 650500, China))
Abstract:
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.
Key words:  tranexamic acid  craniosynostosis surgery  children  Meta-analysis

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