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支持Arista™可吸收止血粉的证据综述。

Review of Evidence Supporting the Arista™ Absorbable Powder Hemostat.

作者信息

LyBarger Kristopher S

机构信息

Sarah Cannon Cancer Center - HCA MidAmerica, Kansas City, MO, USA.

出版信息

Med Devices (Auckl). 2024 May 21;17:173-188. doi: 10.2147/MDER.S442944. eCollection 2024.

DOI:10.2147/MDER.S442944
PMID:38800552
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11127658/
Abstract

BACKGROUND

Uncontrolled and diffuse bleeding is a dreaded event during open and laparoscopic surgery that may lead to postoperative complications, obstruction of the surgical field that reduces visualization, and prolonged operating times. Powder hemostats can be used to control bleeding and are easy to use, have a safe profile, and can achieve broad coverage area at a low cost.

METHODS

A strategic literature search of peer-reviewed, English language studies was conducted to capture evidence on the clinical efficacy and safety of a Microporous Polysaccharide Hemosphere (MPH) based Hemostat (Arista™ Absorbable Hemostat (Arista™ AH)).

RESULTS

Six preclinical studies were found which supported the use of MPH in various animal models of laparoscopic and open surgery, all of which demonstrated its safety and efficacy. Five single-arm and 11 comparative clinical studies similarly supported the efficacy and safety of MPH in various surgery types, including cardiac, renal, and dermatologic surgery.

CONCLUSION

Published evidence supports the safe and effective use of MPH across a variety of surgical settings.

摘要

背景

在开放手术和腹腔镜手术期间,无法控制的弥漫性出血是一种可怕的情况,可能导致术后并发症、手术视野受阻从而降低可视性以及手术时间延长。粉末状止血剂可用于控制出血,使用方便,安全性良好,且能以低成本实现广泛的覆盖面积。

方法

对同行评审的英文研究进行了策略性文献检索,以获取关于基于微孔多糖微球(MPH)的止血剂(Arista™ 可吸收止血剂(Arista™ AH))临床疗效和安全性的证据。

结果

发现六项临床前研究支持在腹腔镜手术和开放手术的各种动物模型中使用MPH,所有这些研究均证明了其安全性和有效性。五项单臂研究和十一项比较性临床研究同样支持MPH在包括心脏、肾脏和皮肤科手术在内的各种手术类型中的疗效和安全性。

结论

已发表的证据支持在各种手术环境中安全有效地使用MPH。

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Microporous polysaccharide hemosphere efficacy and safety in primary total knee arthroplasty.微孔多糖微球在初次全膝关节置换术中的疗效与安全性。
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本文引用的文献

1
Role of Absorbable Polysaccharide Hemostatic Powder in the Prevention of Bleeding and Wound Events after Thyroid Surgery.可吸收多糖止血粉在预防甲状腺手术后出血及伤口相关事件中的作用
J Clin Med. 2023 Aug 31;12(17):5684. doi: 10.3390/jcm12175684.
2
A Comparative Study of the Resorption and Immune Response for Two Starch-Based Hemostat Powders.两种淀粉基止血粉的吸收和免疫反应比较研究。
J Surg Res. 2023 Feb;282:210-224. doi: 10.1016/j.jss.2022.09.022. Epub 2022 Oct 31.
3
Topical Hemostatic Agents at Time of Obstetric and Gynecologic Surgery: ACOG Committee Opinion, Number 812.产科和妇科手术时使用的局部止血剂:ACOG 委员会意见,第 812 号。
Obstet Gynecol. 2020 Oct;136(4):e81-e89. doi: 10.1097/AOG.0000000000004104.
4
Evaluation of local hemostatic effect of microporous polysaccharide hemospheres products in thyroid surgery: a prospective randomized controlled study.微孔多糖微球产品在甲状腺手术中局部止血效果的评估:一项前瞻性随机对照研究。
Turk J Surg. 2019 Mar 1;35(1):49-53. doi: 10.5578/turkjsurg.4162. eCollection 2019 Mar.
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A comprehensive review of topical hemostatic agents: The good, the bad, and the novel.一种全面的局部止血剂综述:好的、坏的和新颖的。
J Trauma Acute Care Surg. 2020 Jan;88(1):e1-e21. doi: 10.1097/TA.0000000000002508.
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Application techniques of a novel hemostat in cardiac operations: HEMOBLAST.一种新型心脏手术止血器(HEMOBLAST)的应用技术
J Card Surg. 2019 Sep;34(9):849-853. doi: 10.1111/jocs.14171. Epub 2019 Jul 26.
7
The impact of the ultrasonic, bipolar and integrated energy devices in the adrenal gland surgery: literature review and our experience.超声、双极和集成能量设备在肾上腺手术中的影响:文献综述及我们的经验
BMC Surg. 2019 Apr 24;18(Suppl 1):123. doi: 10.1186/s12893-018-0457-5.
8
Advanced hemostasis in axillary lymph node dissection for locally advanced breast cancer: new technology devices compared in the prevention of seroma formation.局部晚期乳腺癌腋窝淋巴结清扫术中的高级止血:比较预防血清肿形成的新技术设备
BMC Surg. 2019 Apr 24;18(Suppl 1):125. doi: 10.1186/s12893-018-0454-8.
9
Microporous polysaccharide hemosphere efficacy and safety in primary total knee arthroplasty.微孔多糖微球在初次全膝关节置换术中的疗效与安全性。
J Orthop. 2018 Dec 6;16(1):19-24. doi: 10.1016/j.jor.2018.11.006. eCollection 2019 Jan-Feb.
10
Effect of topical microporous polysaccharide hemospheres on the duration and amount of fluid drainage following mastectomy: a prospective randomized clinical trial.局部微孔多糖球对乳腺癌术后引流液持续时间和引流量的影响:一项前瞻性随机临床试验。
BMC Cancer. 2019 Jan 23;19(1):99. doi: 10.1186/s12885-019-5293-1.