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新型自体高浓度纤维蛋白作为冠状动脉手术的先进止血剂。

Novel autologous, high concentrated fibrin as advanced hemostatic agent for coronary surgery.

机构信息

Cardiovascular Institute Dedinje, Milana Tepića 1, 11000, Belgrade, Serbia.

Gulf Coasts Biologics Inc, 4331 Veronica S Shoemaker Blvd, Fort Myers, FL, 33916, United States.

出版信息

Transfus Apher Sci. 2021 Aug;60(4):103171. doi: 10.1016/j.transci.2021.103171. Epub 2021 May 27.

DOI:10.1016/j.transci.2021.103171
PMID:34099403
Abstract

BACKGROUND

Variability in transfusion outcomes and excessive postoperative bleeding represents a significant problem in cardiac surgery. The effort to reduce bleeding complications and transfusion outcomes is desirable. Our study investigated the feasibility of reducing bleeding complications and transfusion requirements by applying perioperatively prepared autologous bio-regenerative fibrin sealant.

METHODS

A prospective, case-control study enrolled 74 patients undergoing coronary artery bypass grafting by a single surgeon. Patients in the control group (N = 43), received traditional methods of hemostasis, while patients in the experimental group (N = 31) were treated additionally with autologous bio-regenerative fibrin.

RESULTS

Patients were well-matched with regard to basic demographic, laboratory and procedural data. Allogeneic blood transfusion requirement in control group was 39.5 % (17 of 43 patients), compared to 6.5 % (2 of 31 patients) in treated group (p < 0,001). The lower infection rate in the experimental group was also noted. No safety issues were identified during the preparation and application process.

CONCLUSION

Autologous bio-regenerative fibrin can be safely prepared, with no time consuming, and was demonstrated to be a useful tool to decrease allogeneic blood transfusion requirements following elective coronary artery bypass grafting surgery. A prospective randomized trial is needed to confirm these findings.

摘要

背景

心脏手术中,输血效果的差异和术后过度出血是一个重大问题。减少出血并发症和输血需求的努力是可取的。我们的研究调查了通过应用围手术期制备的自体生物再生纤维蛋白密封剂来减少出血并发症和输血需求的可行性。

方法

一项前瞻性病例对照研究纳入了由一位外科医生进行冠状动脉旁路移植术的 74 名患者。对照组(N=43)患者接受传统的止血方法,而实验组(N=31)患者则另外使用自体生物再生纤维蛋白进行治疗。

结果

患者在基本人口统计学、实验室和手术数据方面匹配良好。对照组的异体输血需求为 39.5%(43 例患者中的 17 例),而治疗组为 6.5%(31 例患者中的 2 例)(p<0.001)。实验组的感染率也较低。在制备和应用过程中未发现安全问题。

结论

自体生物再生纤维蛋白可以安全制备,不需要耗时,并且已被证明是减少择期冠状动脉旁路移植术后异体输血需求的有用工具。需要进行前瞻性随机试验来证实这些发现。

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