Int J Clin Pharmacol Ther. 2022 Nov;60(11):463-468. doi: 10.5414/CP204219.
The aim of this prospective study was to investigate the effect of a high dose of ulinastatin on platelets and coagulation in patients undergoing mitral valve and/or aortic valve replacement with cardiopulmonary bypass (CPB).
273 patients were enrolled in this open-label study. According to patients' willingness, 243 patients were assigned to the ulinastatin group and 30 to the control group. In the ulinastatin group, ulinastatin (300,000 U) was given after the induction of anesthesia, ulinastatin (400,000 U) was added to the CPB pump prime, and then ulinastatin (300,000 U) was administered after weaning from CPB. Complete blood count and coagulation function test were conducted 1 day before surgery and on the first postoperative day. Bleeding and other safety events were recorded during hospitalization.
Less postoperative major bleeding occurred in the ulinastatin group (0.4 vs. 6.7%, p = 0.03). Moreover, 1 day after CPB, platelet count in the ulinastatin group increased significantly compared to that in the control group (157.7 ± 71.0 vs. 132.1 ± 59.6, p = 0.03). Interestingly and contrary to what was expected, activated partial thromboplastin time (APTT) and prothrombin time (PT) did not differ significantly between the two groups. Ulinastatin application did not cause significant increase in total costs (p = 0.89).
In heart valve replacement surgery with CPB, high-dose ulinastatin could reduce postoperative bleeding and promote platelet recovery with no significant additional medical cost.
本前瞻性研究旨在探讨心肺转流（CPB）下二尖瓣和/或主动脉瓣置换术患者应用大剂量乌司他丁对血小板和凝血的影响。
本研究共纳入 273 例患者，根据患者意愿，243 例患者被分为乌司他丁组，30 例患者被分为对照组。乌司他丁组在麻醉诱导后给予乌司他丁（30 万 U），CPB 泵预充时加入乌司他丁（40 万 U），CPB 脱机后给予乌司他丁（30 万 U）。术前 1 天和术后第 1 天检测血常规和凝血功能。记录住院期间出血等安全性事件。
乌司他丁组术后主要出血发生率较低（0.4%比 6.7%，p=0.03）。此外，CPB 后 1 天，乌司他丁组血小板计数明显高于对照组（157.7±71.0 比 132.1±59.6，p=0.03）。有趣的是，与预期相反，两组患者活化部分凝血活酶时间（APTT）和凝血酶原时间（PT）无显著差异。乌司他丁应用并未显著增加总费用（p=0.89）。
CPB 下心瓣膜置换术中应用大剂量乌司他丁可减少术后出血，促进血小板恢复，且无显著增加医疗费用。
