Papaefthymiou Apostolis, Aslam Nasar, Hussein Mohamed, Alzoubaidi Durayd, Gross Seth A, Serna Alvaro De La, Varbobitis Ioannis, Hengehold Tricia A, López Miguel Fraile, Fernández-Sordo Jacobo Ortiz, Rey Johannes W, Hayee Bu, Despott Edward J, Murino Alberto, Moreea Sulleman, Boger Phil, Dunn Jason M, Mainie Inder, Mullady Daniel, Early Dayna, Latorre Melissa, Ragunath Krish, Anderson John T, Bhandari Pradeep, Goetz Martin, Kiesslich Ralf, Coron Emmanuel, Santiago Enrique Rodríguez De, Gonda Tamas A, O'Donnell Michael, Norton Benjamin, Telese Andrea, Simons-Linares Roberto, Haidry Rehan
Digestive Diseases and Surgery institute, Cleveland Clinic, London, UK (Apostolis Papaefthymiou, Alberto Murino, Benjamin Norton, Andrea Telese, Rehan Haidry).
Department of Gastrointestinal Services, University College London Hospitals NHS Foundation Trust, London, UK (Nasar Aslam, Rehan Haidry).
Ann Gastroenterol. 2024 Jul-Aug;37(4):418-426. doi: 10.20524/aog.2024.0897. Epub 2024 Jun 20.
Hemostatic powders are used as second-line treatment in acute gastrointestinal (GI) bleeding (AGIB). Increasing evidence supports the use of TC-325 as monotherapy in specific scenarios. This prospective, multicenter study evaluated the performance of TC-325 as monotherapy for AGIB.
Eighteen centers across Europe and USA contributed to a registry between 2016 and 2022. Adults with AGIB were eligible, unless TC-325 was part of combined hemostasis. The primary endpoint was immediate hemostasis. Secondary outcomes were rebleeding and mortality. Associations with risk factors were investigated (statistical significance at P≤0.05).
One hundred ninety patients were included (age 51-81 years, male: female 2:1), with peptic ulcer (n=48), upper GI malignancy (n=79), post-endoscopic treatment hemorrhage (n=37), and lower GI lesions (n=26). The primary outcome was recorded in 96.3% (95% confidence interval [CI]: 92.6-98.5) with rebleeding in 17.4% (95%CI 11.9-24.1); 9.9% (95%CI 5.8-15.6) died within 7 days, and 21.7% (95%CI 15.6-28.9) within 30 days. Regarding peptic ulcer, immediate hemostasis was achieved in 88% (95%CI 75-95), while 26% (95%CI 13-43) rebled. Higher ASA score was associated with mortality (OR 23.5, 95%CI 1.60-345; P=0.02). Immediate hemostasis was achieved in 100% of cases with malignancy and post-intervention bleeding, with rebleeding in 17% and 3.1%, respectively. Twenty-six patients received TC-325 for lower GI bleeding, and in all but one the primary outcome was achieved.
TC-325 monotherapy is safe and effective, especially in malignancy or post-endoscopic intervention bleeding. In patients with peptic ulcer, it could be helpful when the primary treatment is unfeasible, as bridge to definite therapy.
止血粉被用作急性胃肠道（GI）出血（AGIB）的二线治疗方法。越来越多的证据支持在特定情况下将TC - 325作为单一疗法使用。这项前瞻性、多中心研究评估了TC - 325作为AGIB单一疗法的疗效。
2016年至2022年期间，欧洲和美国的18个中心参与了一项登记研究。患有AGIB的成年人符合条件，除非TC - 325是联合止血的一部分。主要终点是即时止血。次要结局是再出血和死亡率。研究了与风险因素的关联（P≤0.05时有统计学意义）。
纳入了190名患者（年龄51 - 81岁，男性与女性比例为2:1），病因包括消化性溃疡（n = 48）、上消化道恶性肿瘤（n = 79）、内镜治疗后出血（n = 37）和下消化道病变（n = 26）。主要结局记录在96.3%（95%置信区间[CI]：92.6 - 98.5）的患者中，再出血率为17.4%（95%CI 11.9 - 24.1）；9.9%（95%CI 5.8 - 15.6）的患者在7天内死亡，21.7%（95%CI 15.6 - 28.9）的患者在30天内死亡。对于消化性溃疡，88%（95%CI 75 - 95）的患者实现了即时止血，而26%（95%CI 13 - 43）的患者出现再出血。较高的美国麻醉医师协会（ASA）评分与死亡率相关（OR 23.5，95%CI 1.60 - 345；P = 0.02）。恶性肿瘤和干预后出血的所有病例均实现了即时止血，再出血率分别为17%和3.1%。26名患者因下消化道出血接受了TC - 325治疗，除1例患者外，其余患者均达到了主要结局。
TC - 325单一疗法安全有效，尤其是在恶性肿瘤或内镜干预后出血的情况下。对于消化性溃疡患者，当一线治疗不可行时，它可作为确定性治疗的桥梁，可能会有所帮助。
