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作为急性胃肠道出血的单疗法,Hemospray® (血静剂粉 TC-325):一个多中心前性研究

Apostolis Papaefthymiou¹, Nasar Aslam², Mohamed Hussein^3,4

¹Digestive Diseases and Surgery institute, Cleveland Clinic, London, UK (Apostolis Papaefthymiou, Alberto Murino, Benjamin Norton, Andrea Telese, Rehan Haidry).

Annals of gastroenterology

|July 8, 2024

概括

TC-325粉是急性胃肠道出血 (AGIB) 的安全有效单疗法,特别是在恶性瘤和干预后病例中. 当其他治疗方法失败时,它对胃潰瘍有希望.

科学领域:

胃肠病学胃肠病学
内镜检查是指内镜检查.
医疗器械医疗器械

背景情况:

静血粉是急性胃肠道出血 (AGIB) 的第二线治疗方法.
在特定的AGIB场景中,TC-325越来越多地被认为是其作为单一疗法的潜力.
这项研究评估了TC-325作为AGIB独立治疗的性能.

研究的目的:

评估TC-325作为治疗急性胃肠道出血 (AGIB) 的单一疗法的疗效和安全性.
为了确定与TC-325单一治疗相关的即时血液静止,再出血和死亡率.
探索与TC-325.25治疗的AGIB患者的患者风险因素和结果之间的关联.

主要方法:

一项从2016年到2022年在18个欧洲和美国中心进行的前性多中心注册表研究.
包括患有AGIB的成年人,不包括TC-325是联合静血的一部分的病例.
主要终点:立即止血;次要终点:再出血和死亡率;统计学意义设置为P≤0.05.

主要成果:

分析了190名患者 (平均年龄为64岁),患有各种AGIB原因 (胃潰瘍,恶性瘤,干预后,下部肠道病变).
在96.3%的患者中,立即实现了血液静止.
再出血发生在17.4%,7天死亡率在9.9%,30天死亡率在21.7%. 较高的ASA得分与死亡率相关 (OR 23.5,P=0.02).
在恶性瘤和干预后出血中,TC-325显示出100%的即时血静,再出血率较低 (分别为17%和3.1%).
对于胃潰瘍,即時靜血為88%,復出血率為26%. 在下肠道出血方面,26名患者接受TC-325治疗,除了一例外,所有患者的血液静止都成功.

结论:

单独治疗TC-325对于AGIB是安全有效的,特别是在恶性瘤和内镜后干预出血的情况下.
对于胃潰瘍出血,TC-325可以在初級治療無法實現時或作為通往最終治療的橋時,是一個有價值的選擇.
这项研究支持TC-325在管理特定急性胃肠道出血情景中的作用.

关键词:

我们使用了Hemospray®.这里是TC-32525的位置.通过内镜检查 (endoscopy) 进行内镜检查上部胃肠道出血胃肠道上部出血

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