止血粉的安全性与性能

Safety and Performance of Hemostatic Powders.

作者信息

Szymanski Lukasz, Gołaszewska Kamila, Małkowska Justyna, Kaczyńska Judyta, Gołębiewska Małgorzata, Gromadka Bartosz, Matak Damian

机构信息

Department of Molecular Biology, Institute of Genetics and Animal Biotechnology, Polish Academy of Science, Magdalenka, 05-552, Poland.

European Biomedical Institute, Jozefow, 05-410, Poland.

出版信息

Med Devices (Auckl). 2023 Jun 8;16:133-144. doi: 10.2147/MDER.S407838. eCollection 2023.

DOI:10.2147/MDER.S407838

PMID:37313450

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10259579/

Abstract

BACKGROUND

Hemorrhage, a sudden and severe leakage of blood due to the disruption of blood vessels, is one of the most common causes of death from injuries worldwide. Severe bleeding accounts for more than 35% of pre-hospital deaths and about 40% of deaths recorded within 24 hours of injury. One of the methods for achieving homeostasis is the use of hemostatic powders. This study compares the basic safety and performance of the most popular hemostatic powders.

METHODS

Basic safety of commercially available products were evaluated using MTT, MEM elution assay, and endotoxin testing. The in vitro performance was evaluated using water absorption capacity, water absorption rate, and adhesion strength assays.

RESULTS

4Seal, Starsil, and 4DryField extracts did not cause cytotoxicity in MTT and MEM elution assays. PerClot and SuperClot extracts demonstrated cytotoxic potential in MTT assay, while Arista extract was cytotoxic in both MEM elution and MTT assays. 4Seal has the lowest endotoxin contamination, followed by PerClot, 4DryField, SuperClot, Arista, and Starsil. 4Seal and Starsil showed significantly highest WAR among the tested samples, followed by 4DryField, Arista, PerClot, and SuperClot. Adhesion force is highest for 4Seal, followed by Starsil, PerClot, 4DryField Arista, and SuperClot.

CONCLUSION

4Seal is the most versatile in terms of safety and functional properties compared to 4DryField, Arista, PerClot, Starsil, and SuperClot.

摘要

背景

出血是血管破裂导致的血液突然大量泄漏，是全球范围内因伤致死的最常见原因之一。严重出血占院前死亡的35%以上，约占受伤后24小时内记录死亡人数的40%。实现体内平衡的方法之一是使用止血粉。本研究比较了最常用止血粉的基本安全性和性能。

方法

使用MTT、MEM洗脱试验和内毒素检测评估市售产品的基本安全性。使用吸水能力、吸水速率和粘附强度试验评估体外性能。

结果

在MTT和MEM洗脱试验中，4Seal、Starsil和4DryField提取物未引起细胞毒性。PerClot和SuperClot提取物在MTT试验中显示出细胞毒性潜力，而Arista提取物在MEM洗脱试验和MTT试验中均具有细胞毒性。4Seal的内毒素污染最低，其次是PerClot、4DryField、SuperClot、Arista和Starsil。在测试样品中，4Seal和Starsil的吸水速率显著最高，其次是4DryField、Arista、PerClot和SuperClot。4Seal的粘附力最高，其次是Starsil、PerClot、4DryField、Arista和SuperClot。