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首页> 外文期刊>Journal of Clinical and Diagnostic Research >Comparative Study of Two Different Intravenous Doses of Tranexamic Acid with Placebo on Surgical Field Quality in Functional Endoscopic Sinus Surgery- A Randomised Clinical Trial
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Comparative Study of Two Different Intravenous Doses of Tranexamic Acid with Placebo on Surgical Field Quality in Functional Endoscopic Sinus Surgery- A Randomised Clinical Trial

机译：两种不同剂量的氨甲环酸与安慰剂在功能性内窥镜鼻窦手术中对手术视野质量的比较研究（一项随机临床试验）

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Intraoperative haemorrhage, which disrupts surgical patency, is a major obstacle for surgeons, especially in endoscopic sinus surgeries. Tranexamic acid is synthetic antifibrinolytic agent that binds competitively at lysine binding site on plasminogen prevents fibrinolysis, improves blood clot formation and reduces bleeding. The role of tranexamic acid by topical adminstration during Functional Endoscopic Sinus Surgeries (FESS) had contrasting reports and limited number of studies are available with systemic adminstration of tranexamic acid in FESS surgeries.Aim: To compare two different intravenous doses of tranexamic acid with placebo on surgical field quality, surgical time and blood loss in FESS surgeries.Materials and Methods: Eighty four ASA physical status I and II patients from January 2013 to December 2013 aged 18-60 years, who underwent FESS surgery, were included in the study. Patients were randomised to Group A receiving 15 mg.kg~(-1) tranexamic acid Group B receiving 5 mg.kg~(-1) tranexamic acid and Group C as placebo receiving normal saline. Heart rate, systolic, diastolic blood pressure, oxygen saturation, blood loss and surgical site quality were recorded. Statistical analysis between treatment groups was performed using repeated measures of ANOVA and intergroup analysis was performed where appropriate. The primary outcome was surgical field quality; secondary outcome was blood loss and surgical time.Results: Intravenous administration of tranexamic acid was found to reduce the total blood loss in FESS surgery by 64% in group A (15 mg.kg~(-1)) and 31% in group B (5 mg.kg~(-1)) compared to placebo (p=0.0001). Reduction in bleeding by administration of tranexamic acid also led to an improved surgical field quality. There was partial surgical field clearance at a low dose of tranexamic acid while 15 mg.kg~(-1) of the drug achieved about 100% surgical site clearance as measured with Wormald Grading Scale of surgical field quality (p=0.0001). This was also validated by a surgeon satisfaction score after FESS procedure using Likert scale and the fraction of patients for whom surgery was affected by bleeding. The surgical field improvement by use of tranexamic acid has also been found to have a prominent reduction in the total time taken to complete the surgery. Administration of 5 mg.kg~(-1) drug led to a 7% reduction and 15 mg.kg~(-1) of tranexamic acid led to about 15% reduction in time taken for FESS surgery (p=0.0001).Conclusion: Tranexamic acid 15 mg/kg dose effectively reduces blood loss, improves surgical field quality and reduces surgical time.
机译：术中出血会破坏外科手术的通畅性，这是外科医生的主要障碍，尤其是在内窥镜鼻窦手术中。氨甲环酸是一种合成的抗纤维蛋白溶解剂，可在纤溶酶原的赖氨酸结合位点竞争性结合，从而防止纤维蛋白溶解，改善血凝块形成并减少出血。在功能性内窥镜鼻窦手术（FESS）期间局部给药氨甲环酸的作用有相反的报道，在FESS手术中全身给药氨甲环酸的研究还很有限。目的：比较两种静脉内不同剂量的氨甲环酸材料与方法：2013年1月至2013年12月，年龄18-60岁的84例ASA身体状况I和II患者，他们接受了FESS手术，其手术视野质量，手术时间和失血量分别为18-60岁。包括在研究中。患者被随机分为A组，接受15 mg.kg〜（-1）氨甲环酸; B组接受5 mg.kg〜（-1）氨甲环酸; C组作为安慰剂，接受生理盐水。记录心率，收缩压，舒张压，氧饱和度，失血量和手术部位质量。使用重复测量的方差分析进行治疗组之间的统计分析，并在适当的情况下进行组间分析。主要结果是手术现场质量。次要结果是失血和手术时间。结果：A组（15 mg.kg〜（-1））静脉给药氨甲环酸可减少FESS手术的总失血64％和31％ B组（5 mg.kg〜（-1））与安慰剂相比（p = 0.0001）。通过施用氨甲环酸来减少出血也导致改善的手术视野质量。低剂量的氨甲环酸有部分手术视野清除率，而用15mg.kg〜（-1）的药物可达到手术视野质量的Wormald分级量表（p = 0.0001），则达到约100％的手术视野清除率。这也通过使用李克特量表的FESS手术后的外科医生满意度评分以及因出血而影响手术的患者比例来验证。还发现通过使用氨甲环酸来改善外科手术领域显着减少了完成外科手术所需的总时间。给予5 mg.kg〜（-1）药物可使FEX手术时间减少7％，而氨甲环酸15 mg.kg〜（-1）可使FESS手术时间减少约15％（p = 0.0001）。 b>结论：氨甲环酸15 mg / kg剂量可有效减少失血，改善手术视野质量并减少手术时间。

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