Zhang Peng, Lv Hong, Qi Xia, Xiao Wenjing, Xue Qinghua, Zhang Lei, Li Lihuan, Shi Jia
Department of Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.
Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.
J Cardiothorac Surg. 2020 May 14;15(1):98. doi: 10.1186/s13019-020-01144-9.
Major bleeding and allogeneic transfusion leads to negative outcomes in patients receiving cardiac surgery with cardiopulmonary bypass (CPB). Ulinastatin, a urine trypsin inhibitor, relieves systemic inflammation and improves coagulation profiles with however sparse evidence of its effects on blood loss and allogeneic transfusion in this specific population.
In this prospective randomized controlled trial, 426 consecutive patients receiving open heart surgery with CPB were randomly assigned into three groups to receive ulinastatin (group U, n = 142), tranexamic acid (group T, n = 143) or normal saline (group C, n = 141). The primary outcome was the total volume of post-operative bleeding and the secondary outcome included the volume and exposure of allogeneic transfusion, the incidence of stroke, post-operative myocardial infarction, renal failure, respiratory failure and all-cause mortality. A ten-year follow-up was carried on to evaluate long-term safety.
Compared with placebo, ulinastatin significantly reduced the volume of post-operative blood loss within 24 h (688.39 ± 393.55 ml vs 854.33 ± 434.03 ml MD - 165.95 ml, 95%CI - 262.88 ml to - 69.01 ml, p < 0.001) and the volume of allogeneic erythrocyte transfusion (2.57 ± 3.15 unit vs 3.73 ± 4.21 unit, MD-1.16 unit, 95%CI - 2.06 units to - 0.26 units, p = 0.002). The bleeding and transfusion outcomes were comparable between the ulinastatin group and the tranexamic acid group. In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups.
Ulinastatin reduced post-operative blood loss and allogeneic erythrocyte transfusion in heart surgery with CPB. The mortality and major morbidity was comparable among the groups shown by the 10-year follow-up.
The trial was retrospectively registered on February 2, 2010.
https://www.clinicaltrials.gov Identifier: NCT01060189.
在接受体外循环心脏手术（CPB）的患者中，严重出血和异体输血会导致不良后果。乌司他丁是一种尿胰蛋白酶抑制剂，可减轻全身炎症并改善凝血状况，但关于其对这一特定人群失血和异体输血影响的证据却很少。
在这项前瞻性随机对照试验中，426例连续接受CPB心脏直视手术的患者被随机分为三组，分别接受乌司他丁治疗（U组，n = 142）、氨甲环酸治疗（T组，n = 143）或生理盐水治疗（C组，n = 141）。主要结局是术后总出血量，次要结局包括异体输血的量和次数、中风、术后心肌梗死、肾衰竭、呼吸衰竭的发生率以及全因死亡率。进行了为期十年的随访以评估长期安全性。
与安慰剂相比，乌司他丁显著减少了24小时内的术后失血量（688.39±393.55毫升 vs.854.33±434.03毫升，MD - 165.95毫升，95%CI - 262.88毫升至 - 69.01毫升，p < 0.001）以及异体红细胞输血量（2.57±3.15单位 vs.3.73±4.21单位，MD - 1.16单位，95%CI - 2.06单位至 - 0.26单位；p =0.002）。乌司他丁组和氨甲环酸组的出血和输血结局相当。住院结局和十年随访显示，各组之间在死亡率和主要发病率方面无统计学差异。
乌司他丁减少了CPB心脏手术中的术后失血量和异体红细胞输血量。十年随访显示各组之间的死亡率和主要发病率相当。
该试验于2010年2月2日进行回顾性注册。
