Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Johns Hopkins Hospital, Baltimore 21205, USA.
Endoscopy. 2011 Apr;43(4):296-9. doi: 10.1055/s-0030-1256125. Epub 2011 Mar 7.
Endoscopic therapy of brisk upper gastrointestinal bleeding remains challenging. A proprietary nanopowder (TC-325) has been proven to be effective in high pressure bleeding from external wounds. The efficacy and safety of TC-325 were assessed in a survival gastrointestinal bleeding animal model.
10 animals were randomized to treatment or sham. All animals received intravenous antibiotics, H2-blockers and heparin (activated clotting time 2 × normal). In a sterile laparotomy the gastroepiploic vessels were dissected, inserted through a 1-cm gastrotomy, and freely exposed in the gastric lumen, and the exposed vessel lacerated by needle knife. The treatment group received TC-325 by a modified delivery catheter while the sham group received no endoscopic treatment. Time to hemostasis, and mortality at 60 minutes, 24 hours, 48 hours, and 7 days were noted. Necropsy was performed in all animals.
Spurting arterial bleeding was achieved in all animals. No control animal showed hemostasis within the first hour compared with 100 % (5 / 5) in the treatment arm (mean 13.8 minutes, P < 0.0079). Durable hemostasis was achieved with no evidence of rebleeding after 1 and 24 hours in 80 % (4 / 5) of the treated animals compared with none in the control group ( P < 0.0098). None of the control animals survived more than 6 hours. Necropsy at 1 week in treated animals revealed healed gastrotomy without foreign body granuloma or embolization to the lung or brain.
TC-325 is safe and highly effective in achieving hemostasis in an anticoagulated severe arterial gastrointestinal bleeding animal model.
内镜治疗急性上消化道出血仍然具有挑战性。一种专利纳米粉末（TC-325）已被证明在外伤性高压出血中有效。本研究旨在评估 TC-325 在一种存活的胃肠道出血动物模型中的疗效和安全性。
将 10 只动物随机分为治疗组或假手术组。所有动物均接受静脉抗生素、H2 阻滞剂和肝素（激活凝血时间为正常的 2 倍）治疗。在无菌剖腹术中，游离显露胃腔中的胃网膜血管，并通过 1cm 的胃造口切开，用针刀切开暴露的血管。治疗组通过改良的输送导管给予 TC-325，而假手术组则不接受内镜治疗。记录止血时间以及 60 分钟、24 小时、48 小时和 7 天的死亡率。所有动物均进行尸检。
所有动物均出现喷射性动脉出血。与对照组（5/5）相比，无对照组动物在第 1 小时内止血（平均 13.8 分钟，P < 0.0079），而治疗组 100%（5/5）止血。与对照组（P < 0.0098）相比，治疗组 80%（4/5）的动物在 1 小时和 24 小时后获得持久止血，无再出血证据。无对照组动物存活超过 6 小时。治疗组动物在第 1 周尸检时发现胃造口愈合，无异物肉芽肿或肺或脑栓塞。
TC-325 是安全的，在抗凝严重动脉性胃肠道出血动物模型中，止血效果显著。
