中国口腔颌面外科杂志

中国口腔颌面外科杂志 ›› 2025, Vol. 23 ›› Issue (5): 508-516.doi: 10.19438/j.cjoms.2025.05.013

• 循证医学 • 上一篇    下一篇

氨甲环酸减少正颌外科患者围术期失血疗效的循证评价

刘洋1, 李晨曦2,3,*, 龚忠诚2,*, 丁明超4, 孙家琳5   

  1. 1.新疆维吾尔自治区人民医院 中心手术室,新疆 乌鲁木齐 830001;
    2.新疆医科大学第一附属医院（附属口腔医院） 口腔颌面肿瘤外科,新疆维吾尔自治区口腔医学研究所,新疆 乌鲁木齐 830054;
    3.华中科技大学同济医学院附属协和医院 口腔医学中心,口腔颌面发育与再生湖北省重点实验室,湖北 武汉 430022;
    4.中国人民解放军空军军医大学第三附属医院（口腔医院） 颌面创伤与正颌外科,军事口腔医学国家重点实验室,口腔疾病国家临床医学研究中心,陕西省口腔疾病临床医学研究中心,陕西 西安 710032;
    5.华中科技大学同济医学院 公共卫生学院,湖北 武汉 430030
  • 收稿日期:2024-11-07 修回日期:2025-01-07 发布日期:2025-10-10
  • 通讯作者: 李晨曦,E-mail: lichenximed@163.com;龚忠诚,E-mail: gzc740904@xjmu.edu.cn。*共同通信作者
  • 作者简介:刘洋（1987-）,女,本科,E-mail: 290944046@qq.com
  • 基金资助:
    新疆维吾尔自治区自然科学基金面上项目; 口腔颌面发育与再生湖北省重点实验室开放课题基金（2022kqhm008）

Evidence-based evaluation of the efficacy of tranexamic acid in reducing perioperative blood loss in orthognathic surgery patients

Liu Yang1, Li Chenxi2,3, Gong Zhongcheng2, Ding Mingchao4, Sun Jialin5   

  1. 1. Central Operation Division, People's Hospital of Xinjiang Uygur Autonomous Region. Urumqi 830001, Xinjiang Uygur Autonomous Region;
    2. 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, Xinjiang Uygur Autonomous Region;
    3. Center of Stomatology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Hubei Province Key Laboratory of Oral and Maxillofacial Development and Regeneration. Wuhan 430022, Hubei Province;
    4. Department of Oral and Maxillofacial Traumatology & Orthognathic Surgery, the Third Affiliated Hospital of Air Force Medical University (Hospital of Stomatology); State Key Laboratory of Military Stomatology; National Clinical Research Center for Oral Diseases; Shaanxi Clinical Research Center for Oral Diseases. Xi'an 710032, Shaanxi Province;
    5. School of Public Health, Tongji Medical College, Huazhong University of Science and Technology. Wuhan 430030, Hubei Province, China
  • Received:2024-11-07 Revised:2025-01-07 Published:2025-10-10

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摘要： 目的: 基于meta回归及试验序贯分析（trial sequential analysis,TSA）,系统评价氨甲环酸（tranexamic acid,TXA）对降低正颌外科患者围术期失血的临床疗效。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,汇集评估正颌手术患者围术期使用TXA减少失血疗效的临床研究。应用Cochrane评价工具对随机对照试验（randomized controlled trial,RCT）进行质量评价,采用纽卡斯尔-渥太华量表对前瞻性队列研究进行风险评估。通过R语言编程软件,根据异质性检验,进行相应效应模型统计推断的meta分析,通过试验序贯分析对结果进行可靠性验证。结果: 配对meta分析随机效应模型（I2=81%）合并结果显示,与对照组相比,使用TXA能显著降低患者出血量[SMD：-1.26;95%CI（-1.81,-0.71）,P<0.01]。亚组分析显示,TXA对不同手术类型的患者降低术中出血均有显著作用,有效排名为单颌正颌手术[SMD：-1.58;95%CI（-2.41,-0.76）,P<0.01],以及双颌正颌手术[SMD：-0.97;95%CI（-1.69,-0.25）,P<0.01]。Meta回归分析结果表明,随着使用剂量增加（5、10、15、20 mg/kg）,TXA对患者的止血作用并无显著差别（P>0.05）。敏感性分析验证合并结果稳定可靠。Egger检验结果提示存在一定的发表偏倚（Z=-3.10,P=0.002）。TSA低偏倚风险试验表明,在足够有效的样本量中使用氨甲环酸是有益的。结论: 现有证据表明,TXA可有效降低正颌外科患者围术期出血量,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信息,力求全面评价静脉输注单一剂量TXA对正颌外科围术期患者的有效性及安全性。

关键词: 正颌外科, 氨甲环酸, 围术期失血, 循证医学

Abstract: PURPOSE: Based on meta-regression and trial sequential analysis, this study aimed to comprehensively evaluate the clinical efficacy with respect to tranexamic acid(TXA) for blood loss control in perioperative patients underwent orthognathic surgery. METHODS: Embase, PubMed, WanFang Data, VIP, China National Knowledge Infrastructure(CNKI), Chinese Clinical Trial Registry(ChiCTR) and Cochrane Central Register of Controlled Trials (CENTRAL) were electronically retrieved to collect clinical studies related to appraise the effectiveness in perioperative orthognathic surgery patients intravenously used TXA from inception to August, 2024. Quality assessment of the risk of bias for randomized controlled trials (RCTs) was performed using Cochrane Collaboration's Risk of Bias Tool (2.0), whereas the Newcastle-Ottawa Scale was used for assessment of the prospective cohort studies. Based on the results of methodological heterogeneity, corresponding meta-analyses were carried out with a random-effects or fixed-effects model applying R programming software. A trial sequential analysis of outcomes was carried out to investigate the reliability and conclusiveness of findings. RESULTS: The paired meta-analysis random-effects model (I2=81%) showed that compared with the control group, the use of TXA significantly reduced the amount of bleeding in perioperative patients [standardized mean difference(SMD) = -1.26; 95%CI (-1.81, -0.71), P<0.01]. Subgroup analysis revealed that TXA had a significant effect on reducing intraoperative bleeding in patients with different surgeries, with monomaxillary orthognathic surgery ranking as the most effective [SMD = -1.58; 95%CI (-2.41, -0.76), P<0.01], followed by bimaxillary orthognathic surgery [SMD = -0.97; 95%CI(-1.69, -0.25), P<0.01]. The result of meta regression showed there was no significant difference in the hemostatic effect of TXA on patients with increasing doses(5, 10, 15, 20 mg/kg) (P>0.05). Sensitivity analysis verified that the pooled values were stable and reliable. Egger's test indicated a certain degree of publication bias(Z=-3.10, P= 0.002). Low risk-of-bias trials showed benefit of tranexamic acid use with a sufficiently powered sample, through trial sequential analysis. CONCLUSIONS: Taken as a whole, existing evidence suggests that TXA can effectively reduce perioperative bleeding in patients undergoing orthognathic surgery, regardless of its dosage administered. However, further clinical researches are still needed to provide more baseline 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 intravenous TXA for perioperative blood loss control in patients treated with orthognathic surgery.

Key words: Orthognathic surgery, Tranexamic acid, Perioperative blood loss, Evidence-based medicine

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