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比较三种局部止血剂用于慢性抗凝治疗患者拔牙的随机临床试验——一项比较研究

Randomized Clinical Trial Comparing Three Local Hemostatic Agents for Dental Extractions in Patients under Chronic Anticoagulant Therapy - A Comparative Study.

作者信息

Puia Sebastian Ariel, Hilber Ezequiel Matias, Garcia-Blanco Matias

机构信息

Department of Oral and Maxillofacial Surgery, School of Dentistry, University of Buenos Aires, Buenos Aires, Argentina.

出版信息

Ann Maxillofac Surg. 2020 Jul-Dec;10(2):292-296. doi: 10.4103/ams.ams_276_20. Epub 2020 Dec 23.

Abstract

INTRODUCTION

Oral anticoagulants are widely used worldwide for many systemic diseases. Recent oral surgical protocols suggest that therapeutic levels of the anticoagulant drug should be maintained for simple dental extractions because bleeding complications could be managed with proper local hemostasis. The aim of the present study was to compare bleeding complication of three different local hemostatic agents for dental extractions without interrupting drug administration in patients undergoing oral Vitamin K antagonist chronic anticoagulant therapy.

MATERIAL AND METHODS

Randomized control trial of three hemostatic agents for dental extractions, in patients under oral anticoagulant therapy without drug interruption. The present study included 240 patients with international normalized ratio between 1.5 and 3.5. Patients took their anticoagulation drug normally. A single surgeon performed calibrated simple dental extractions and applied a plug of bismuth subgallate (BS), fibrin tissue adhesive (FTA) or microfibrillar collagen (MC), assigned randomly. Statistical analysis of bleeding between the groups was performed using the Chi-square test.

RESULTS

There was no hemorrhagic complication in the BS group, and only one in the FTA group. However, in the MC group, 10 patients (12.5%) suffered postoperative bleeding. Data analysis showed statistical differences between the MC group and the other two groups ( < 0.05).

DISCUSSION

BS and FTA showed similar clinical effectiveness and were more effective than MC for the control of postoperative bleeding in oral anticoagulated patients.

摘要

引言

口服抗凝剂在全球范围内被广泛用于多种全身性疾病。近期的口腔外科手术方案表明,对于简单的拔牙手术,应维持抗凝药物的治疗水平,因为通过适当的局部止血措施可以控制出血并发症。本研究的目的是比较三种不同局部止血剂在接受口服维生素K拮抗剂慢性抗凝治疗的患者拔牙时不中断药物给药情况下的出血并发症情况。

材料与方法

对三种拔牙止血剂进行随机对照试验,研究对象为接受口服抗凝治疗且不中断药物的患者。本研究纳入了240名国际标准化比值在1.5至3.5之间的患者。患者正常服用抗凝药物。由一名外科医生进行标准化的简单拔牙手术,并随机应用次没食子酸铋(BS)、纤维蛋白组织粘合剂(FTA)或微纤维胶原(MC)栓塞。使用卡方检验对组间出血情况进行统计分析。

结果

BS组未出现出血并发症,FTA组仅出现一例。然而,MC组有10名患者(12.5%)术后出血。数据分析显示MC组与其他两组之间存在统计学差异(<0.05)。

讨论

BS和FTA在控制口服抗凝患者术后出血方面显示出相似的临床效果,且比MC更有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/608f/7943974/4b1c3e2afd33/AMS-10-292-g001.jpg

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