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新型可流动止血剂ActiClot：大鼠和猪模型中的疗效与安全性评估

Novel Flowable Hemostatic Agent ActiClot: Efficacy and Safety Assessment in Rat and Porcine Models.

作者信息

Kim Hee-Jung, Lee Su-Kyoung, Ko Yun-Jeh, Jeon Soo-Hyeon, Kim Eun-Jin, Kwon Oh-Hyeong, Cho Yang-Hyun

机构信息

Department of Thoracic and Cardiovascular Surgery, Korea University Anam Hospital, Seoul 02841, Republic of Korea.

Korea Artificial Organ Center, Korea University, Seoul 02841, Republic of Korea.

出版信息

J Clin Med. 2024 Aug 14;13(16):4770. doi: 10.3390/jcm13164770.

DOI:10.3390/jcm13164770
PMID:39200912
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11355466/
Abstract

: This study evaluated the hemostatic performance and safety of ActiClot (ATC), a new flowable hemostatic agent, through in vivo tests. : ATC was compared with the commercially available FLOSEAL. ATC consists of carboxymethyl starch, thrombin, and sorbitol powders in Syringe I, and a calcium chloride solution in Syringe II. In vivo evaluation used rat liver bleeding and porcine heart bleeding models. Safety was assessed using a rat subcutaneous implantation model. : ATC significantly reduced hemostasis time (70.00 ± 7.35 s) compared to gauze control (240.63 ± 32.31 s) in the rat liver model, showing a 70% reduction. There was no significant difference between ATC and FLOSEAL (58.75 ± 13.42 s). In the porcine heart model, both agents achieved 100% hemostasis within 3 min, with no significant difference in success rates within 2 min (ATC 87.5%, FLOSEAL 75%). The gauze control group failed in all tests. The rat subcutaneous implantation model showed no visual ATC observation after 48 h, indicating biocompatibility, with no inflammation observed. : ATC demonstrated effective hemostatic performance similar to FLOSEAL in two in vivo models, with faster hemostasis in the rat liver model. It also showed excellent safety and biocompatibility, indicating its potential for surgical and emergency bleeding control.

摘要

本研究通过体内试验评估了新型可流动止血剂ActiClot（ATC）的止血性能和安全性。将ATC与市售的FLOSEAL进行比较。ATC由注射器I中的羧甲基淀粉、凝血酶和山梨醇粉末以及注射器II中的氯化钙溶液组成。体内评估采用大鼠肝脏出血模型和猪心脏出血模型。使用大鼠皮下植入模型评估安全性。在大鼠肝脏模型中，与纱布对照组（240.63±32.31秒）相比，ATC显著缩短了止血时间（70.00±7.35秒），减少了70%。ATC与FLOSEAL（58.75±13.42秒）之间无显著差异。在猪心脏模型中，两种药剂均在3分钟内实现了100%止血，2分钟内成功率无显著差异（ATC为87.5%，FLOSEAL为75%）。纱布对照组在所有试验中均失败。大鼠皮下植入模型在48小时后未观察到ATC的明显迹象，表明其具有生物相容性，未观察到炎症。ATC在两种体内模型中表现出与FLOSEAL相似的有效止血性能，在大鼠肝脏模型中止血更快。它还显示出优异的安全性和生物相容性，表明其在手术和紧急出血控制方面的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9b1/11355466/3aa0adb371b2/jcm-13-04770-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9b1/11355466/c1637f32651e/jcm-13-04770-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9b1/11355466/ef1267c9bbe1/jcm-13-04770-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9b1/11355466/bd3abd943a84/jcm-13-04770-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9b1/11355466/3aa0adb371b2/jcm-13-04770-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9b1/11355466/c1637f32651e/jcm-13-04770-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9b1/11355466/ef1267c9bbe1/jcm-13-04770-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9b1/11355466/bd3abd943a84/jcm-13-04770-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9b1/11355466/3aa0adb371b2/jcm-13-04770-g004.jpg

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本文引用的文献

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Bioabsorbable Carboxymethyl Starch-Calcium Ionic Assembly Powder as a Hemostatic Agent.可生物吸收的羧甲基淀粉-钙离子组装粉末作为止血剂
Polymers (Basel). 2022 Sep 19;14(18):3909. doi: 10.3390/polym14183909.
2
Real-World Clinical and Economic Outcomes Associated with Surgiflo vs Floseal in Cardiovascular Surgeries in the US.美国心血管手术中Surgiflo与Floseal相关的真实世界临床和经济结果
Clinicoecon Outcomes Res. 2022 Mar 10;14:129-138. doi: 10.2147/CEOR.S338672. eCollection 2022.
3
Hemostatic efficacy of two topical adjunctive hemostats in a porcine spleen biopsy punch model of moderate bleeding.
两种局部辅助止血剂在猪脾脏活检冲孔模型中度出血中的止血效果。
J Mater Sci Mater Med. 2021 Sep 30;32(10):127. doi: 10.1007/s10856-021-06586-8.
4
Efficacy, safety, and physicochemical properties of a flowable hemostatic agent made from absorbable gelatin sponge via vacuum pressure steam sterilization.经真空压力蒸汽灭菌的可吸收明胶海绵制成的流动性止血剂的功效、安全性和理化性质。
J Biomater Appl. 2021 Feb;35(7):776-789. doi: 10.1177/0885328220950899. Epub 2020 Aug 24.
5
Effectiveness of Gelatin-Thrombin Matrix Sealants (Floseal®) on Postoperative Spinal Epidural Hematoma during Single-Level Lumbar Decompression Using Biportal Endoscopic Spine Surgery: Clinical and Magnetic Resonance Image Study.凝胶-纤维蛋白胶基质封合剂（Floseal®）在双通道内窥镜脊柱手术中用于单节段腰椎减压术后硬膜外血肿的疗效：临床和磁共振成像研究。
Biomed Res Int. 2020 Jul 8;2020:4801641. doi: 10.1155/2020/4801641. eCollection 2020.
6
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A systematic review on the use of topical hemostats in trauma and emergency surgery.关于局部止血剂在创伤和急诊手术中应用的系统评价。
BMC Surg. 2018 Aug 29;18(1):68. doi: 10.1186/s12893-018-0398-z.
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