Campus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
DRK-Krankenhaus Grevesmühlen, Gastroenterologie und Allgemeine Innere Medizin, Klützer Straße 13-15, 23936, Grevesmühlen, Germany.
Surg Endosc. 2022 May;36(5):2954-2961. doi: 10.1007/s00464-021-08589-6. Epub 2021 Jun 15.
A recently developed haemostatic peptide gel for endoscopic application has been introduced to improve the management of gastrointestinal bleeding. The aim of this pilot study was to evaluate the feasibility, safety, efficacy and indication profiles of PuraStat in a clinical setting.
In this prospective observational multicentre pilot study, patients with acute non-variceal gastrointestinal bleeding (upper and lower) were included. Primary and secondary application of PuraStat was evaluated. Haemoglobin, prothrombin time, platelets and transfusion behaviour were documented before and after haemostasis. The efficacy of PuraStat was assessed during the procedure, at 3 days and 1 week after application.
111 patients with acute gastrointestinal bleeding were recruited into the study. 70 percent (78/111) of the patients had upper gastrointestinal bleeding and 30% (33/111) had lower gastrointestinal bleeding. After primary application of PuraStat, initial haemostatic success was achieved in 94% of patients (74/79, 95% CI 88-99%), and in 75% of the patients when used as a secondary haemostatic product, following failure of established techniques (24/32, 95% CI 59-91%). The therapeutic success rates (absence of rebleeding) after 3 and 7 days were 91% and 87% after primary use, and 87% and 81% in all study patients. Overall rebleeding rate at 30 day follow-up was 16% (18/111). In the 5 patients who finally required surgery (4.5%), PuraStat allowed temporary haemostasis and stabilisation.
PuraStat expanded the therapeutic toolbox available for an effective treatment of gastrointestinal bleeding sources. It could be safely applied and administered without complications as a primary or secondary therapy. PuraStat may additionally serve as a bridge to surgery in order to achieve temporary haemostasis in case of refractory severe bleeding, possibly playing a role in preventing immediate emergency surgery.
一种新研发的用于内镜应用的止血肽凝胶已被引入，以改善胃肠道出血的治疗效果。本研究旨在评估 PuraStat 在临床环境中的可行性、安全性、疗效和适应证。
本前瞻性观察性多中心研究纳入了急性非静脉曲张性胃肠道出血（上消化道和下消化道）患者。评估 PuraStat 的主要和次要应用。在止血前后记录血红蛋白、凝血酶原时间、血小板和输血情况。在治疗过程中、应用后 3 天和 1 周评估 PuraStat 的疗效。
研究共纳入 111 例急性胃肠道出血患者。70%（78/111）患者为上消化道出血，30%（33/111）为下消化道出血。初次应用 PuraStat 后，94%（74/79，95%CI 88-99%）的患者即刻止血成功，24/32（95%CI 59-91%）的患者在使用其他既定技术失败后，PuraStat 作为二线止血产品，也达到了止血效果。初次应用后 3 天和 7 天的治疗成功率（无再出血）分别为 91%和 87%，所有患者的治疗成功率分别为 87%和 81%。30 天随访时总体再出血率为 16%（18/111）。在最终需要手术的 5 例患者（4.5%）中，PuraStat 实现了暂时止血和稳定。
PuraStat 扩大了治疗胃肠道出血源的有效治疗工具包。它可以作为一线或二线治疗药物，安全应用且无并发症。在难治性严重出血的情况下，PuraStat 可以作为手术的桥梁，以实现暂时止血，从而可能在预防立即进行急诊手术方面发挥作用。
