摘要
目的系统评价单剂量氨甲环酸(TXA)对降低颅颌面整形患者围手术期出血量的有效性。方法计算机检索Embase、PubMed、万方、维普、中国知网、中国临床试验注册中心和Cochrane临床对照试验中心注册数据库,检索时限从建库至2024年8月,汇集评估颅颌面整形手术患者使用TXA减少围手术期出血疗效的随机对照试验(RCT)研究。采用R 4.0.4软件根据各研究间异质性情况进行固定效应模型或随机效应模型统计推断的配对meta分析,并根据手术类型、患者年龄、患者地区分布、纳入研究的样本量进行亚组分析。对报道了不同剂量TXA降低围手术期出血疗效的研究进行meta回归分析。通过敏感性分析验证合并结果的稳定性。Egger’s检验用于分析潜在发表偏倚。结果共纳入31篇RCT研究,包含2072例患者,其中TXA组1051例,安慰剂对照组1021例。配对meta分析随机效应模型(I^(2)=90%)合并结果显示,与安慰剂对照组相比,使用TXA能显著降低患者出血量[标准化平均差(SMD)为-1.13,95%CI为-1.47~-0.80,P<0.01]。亚组分析显示,TXA对不同手术类型、年龄、分布地区的患者以及在不同样本量的研究中均显示对降低术中出血量有显著作用。其中,降低出血量最有效的亚组分别是正颌手术组(SMD为-1.44,95%CI为-2.07~-0.80,P<0.01)、<30岁组(SMD为-1.32,95%CI为-1.68~-0.96,P<0.01)、亚洲患者(SMD为-1.29,95%CI为-1.72~-0.86,P<0.01)、样本量<30例组(SMD为-1.16,95%CI为-1.50~-0.82,P<0.01)。meta回归分析结果表明,不同剂量的TXA(5、10、15、20、25 mg/kg)对患者的止血作用并无明显差别(P>0.05)。敏感性分析验证了合并结果具有稳定性。Egger’s检验结果提示存在一定的发表偏倚(P<0.01)。结论现有证据表明TXA可有效降低颅颌面整形患者的围手术期出血量,且与给药剂量无关。然而,后期临床研究仍需提供更多的患者基线数据、输血相关指标和血管栓塞等不良事件的信息,以求全面评价单剂量TXA对颅颌面整形围手术期患者的有效性及安全性。
ObjectiveTo comprehensively evaluate the clinical effectiveness with respect to a single dose of tranexamic acid(TXA)given preoperatively for blood loss control in perioperative patients accepted craniomaxillofacial plastic and cosmetic surgery.MethodsEmbase,PubMed,WanFang Data,VIP,China National Knowledge Infrastructure(CNKI),the Chinese Clinical Trial Registry(ChiCTR)and Cochrane Central Register of Controlled Trials(CENTRAL)were electronically retrieved to collect randomized controlled trials(RCTs)related to appraise the efficacy in perioperative craniomaxillofacial plastic and cosmetic surgery patients used TXA from inception to August 2024.Based on the result of methodological heterogeneity,corresponding paired meta-analyses were carried out with a random-effects or fixed-effects model applying R 4.0.4 software.Subgroup analysis was performed based on type of surgery,patient age,regional distribution of patients,and sample size included in the studies.A meta-regression analysis was performed on studies that reported the effect of different doses of TXA on reducing perioperative bleeding.Sensitivity analysis was performed to verify the stability of the meta result.Egger’s test was used to analyze potential publication bias.ResultsA total of 31 RCTs were included,involving 2072 patients,with 1051 in the TXA group and 1021 in the placebo group.The paired meta-analysis random-effects model(I^(2)=90%)showed that compared with the control group,the use of TXA significantly reduced the amount of bleeding in perioperative patients[standardized mean difference(SMD)=-1.13,95%CI-1.47 to-0.80,P<0.01].Subgroup analysis revealed that TXA had a significant effect on reducing intraoperative bleeding in patients with different surgeries,ages,regions,and sample sizes.The most effective subgroups were cases in orthognathic surgery(SMD=-1.44,95%CI-2.07 to-0.80,P<0.01),less than 30 year-old(SMD=-1.32,95%CI-1.68 to-0.96,P<0.01),Asian patients(SMD=-1.29,95%CI-1.72 to-0.86,P<0.01),less than 30 individuals(SMD=-1.16,95%CI-1.50 to-0.82,P<0.01).The result of the meta regression showed there was no significant difference in the hemostatic effect of TXA on patients with increasing doses(5,10,15,20,25 mg/kg)(P>0.05).Sensitivity analysis verified that the pooled values were stable and reliable.The Egger’s test indicated a certain degree of publication bias(P<0.01).ConclusionTaken as a whole,existing evidence suggests that TXA can effectively reduce perioperative bleeding in patients undergoing craniofacial plastic surgery,regardless of its dosage administered.However,further clinical researches are still needed to provide more baselined data,transfusion-related indicators,and information on adverse events such as vascular embolism,in order to comprehensively evaluate and analyze the efficacy and safety of a single dose of TXA for perioperative blood loss control in patients treated with craniomaxillofacial plastic and cosmetic surgery.
作者
李晨曦
马红梅
刘瑶
韩静霏
丁明超
孙家琳
Li Chenxi;Ma Hongmei;Liu Yao;Han Jingfei;Ding Mingchao;Sun Jialin(Department of Oral and Maxillofacial Oncology&Surgery,School/Hospital of Stomatology,the First Affiliated Hospital of Xinjiang Medical University,Stomatological Research Institute of Xinjiang Uygur Autonomous Region,Urumqi 830054,China;Hubei Province Key Laboratory of Oral and Maxillofacial Development and Regeneration,School of Stomatology,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430022,China;Intensive Care Unit,People’s Hospital of Xinjiang Uygur Autonomous Region,Urumqi 830001,China;Division of Blood Transfusion,the First Affiliated Hospital of Xinjiang Medical University,Urumqi 830054,China;Department of Anesthesiology,the First Affiliated Hospital of Xinjiang Medical University,Urumqi 830054,China;State Key Laboratory of Military Stomatology,National Clinical Research Center for Oral Diseases,Shaanxi Clinical Research Center for Oral Diseases,Department of Oral and Maxillofacial Traumatology&Orthognathic Surgery,the Third Affiliated Hospital of Air Force Medical University(Hospital of Stomatology),Xi’an 710032,China;School of Public Health,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430022,China)
出处
《中华整形外科杂志》
北大核心
2025年第1期52-68,共17页
Chinese Journal of Plastic Surgery
关键词
氨甲环酸
颅颌面外科
整形外科
围手术期出血
Tranexamic acid
Craniomaxillofacial surgery
Plastic and cosmetic surgery
Perioperative blood loss
