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孤立性Le Fort I型截骨术中翼上颌分离与结节分离的比较:一项前瞻性、多中心、三盲、随机对照试验

Comparison of pterygomaxillary dysjunction with tuberosity separation in isolated Le Fort I osteotomies: a prospective, multi-centre, triple-blind, randomized controlled trial.

作者信息

Christabel A, Anantanarayanan P, Subash P, Soh C L, Ramanathan M, Muthusekhar M R, Narayanan V

机构信息

Department of Oral and Maxillofacial Surgery, Meenakshi Ammal Dental College and Hospital, Chennai, India.

Department of Oral and Maxillofacial Surgery, Meenakshi Ammal Dental College and Hospital, Chennai, India.

出版信息

Int J Oral Maxillofac Surg. 2016 Feb;45(2):180-5. doi: 10.1016/j.ijom.2015.07.021. Epub 2015 Sep 1.

DOI:10.1016/j.ijom.2015.07.021
PMID:26338075
Abstract

The aim of this trial was to compare two techniques of maxillary dysjunction, with 10mg/kg tranexamic acid as an adjuvant, in isolated non-segmented Le Fort I procedures. Two hundred patients were randomized to one of four groups: group A, pterygomaxillary dysjunction+saline; group B, tuberosity separation+saline; group C, pterygomaxillary dysjunction+tranexamic acid; and group D, tuberosity separation+tranexamic acid. Primary outcome measures were intraoperative blood loss and operating time, while the secondary outcome measures were surgical field assessment, need for blood transfusion, and duration of hospitalization. The data were analyzed using one-way analysis of variance (SPSS v. 17.0), and the level of significance was set at P<0.05. Results revealed that group D (tuberosity separation+tranexamic acid) had the least blood loss (mean 172 ml) and shortest operating times (mean 49 min), with the best surgical field. This group also exhibited the lowest drop in postoperative haemoglobin concentration (Hbgm/dl) and packed cell volume (PCV). Five patients, all in group A, required a blood transfusion and had an extra 24h of hospitalization. This trial revealed that the tuberosity separation technique with the use of tranexamic acid was the best protocol in producing the least blood loss, minimizing the operating time, and providing the best surgical field.

摘要

本试验旨在比较两种上颌骨离断技术,并以10mg/kg氨甲环酸作为辅助药物,用于孤立性非节段性Le Fort I手术。200例患者被随机分为四组之一:A组,翼上颌离断+生理盐水;B组,结节分离+生理盐水;C组,翼上颌离断+氨甲环酸;D组,结节分离+氨甲环酸。主要观察指标为术中失血量和手术时间,次要观察指标为手术视野评估、输血需求和住院时间。数据采用单因素方差分析(SPSS v. 17.0)进行分析,显著性水平设定为P<0.05。结果显示,D组(结节分离+氨甲环酸)失血量最少(平均172ml),手术时间最短(平均49分钟),手术视野最佳。该组术后血红蛋白浓度(Hbgm/dl)和红细胞压积(PCV)下降幅度也最低。所有5例需要输血并额外住院24小时的患者均在A组。本试验表明,使用氨甲环酸的结节分离技术是减少失血量、缩短手术时间和提供最佳手术视野的最佳方案。

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