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.
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.
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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