比伐卢定在体外膜肺氧合抗凝治疗中优于肝素？现在下结论还为时过早。
Superiority of bivalirudin over heparin anticoagulation therapy for extracorporeal membrane oxygenation? Too early to draw conclusions.
作者信息
Gu Jie, Yu Hongjie, Lin Dang
机构信息
Department of Respiratory Medicine, Suzhou Municipal Hospital, Suzhou Hospital Affiliated Nanjing Medical University, Suzhou, Jiangsu, China.
Department of Thoracic Surgery, The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital, Suzhou, China.
出版信息
Heliyon. 2023 Feb 6;9(2):e13530. doi: 10.1016/j.heliyon.2023.e13530. eCollection 2023 Feb.
BACKGROUND
We aimed to compare the efficacy and safety of bivalirudin versus heparin as the anticoagulant in patients undergoing extracorporeal membrane oxygenation (ECMO).
METHODS
We conducted a search in PubMed, Embase and the Cochrane Library for all the studies in which bivalirudin was compared to heparin as the anticoagulant for ECMO. Efficacy outcomes were defined as the time to reach therapeutic levels, time within therapeutic range (TTR), thrombotic events, circuit thrombosis, circuit exchanges. Safety outcomes were reported as heparin-induced thrombocytopenia (HIT), major bleeding events, minor bleeding events. Other outcomes included hospital length of stay (LOS), ICU LOS, mortality, 30-day mortality and in-hospital mortality.
RESULTS
Ten studies with 1091 patients were included for meta-analysis. A significant reduction in thrombotic events [OR 0.51, 95%CI 0.36,0.73, = 0.0002, I = 0%], major bleeding events [OR 0.31, 95%CI 0.10,0.92, = 0.04, I = 75%] and in-hospital mortality [OR 0.63, 95%CI 0.44,0.89, = 0.009, I = 0%] treated with bivalirudin were found compared with heparin. There were no significant differences between groups regarding the time to reach therapeutic levels [MD 3.53, 95%CI -4.02,11.09, = 0.36, I = 49%], TTR [MD 8.64, 95%CI -1.72,18.65, = 0.10, I = 77%], circuit exchanges [OR 0.92, 95%CI 0.27,3.12, = 0.90, I = 38%], HIT [OR 0.25, 95%CI 0.02,2.52, = 0.24, I = 0%], minor bleeding events [OR 0.93, 95%CI 0.38,2.29, = 0.87, I = 0%], hospital LOS [MD -2.93, 95%CI -9.01,3.15, = 0.34, I = 45%], ICU LOS [MD -4.22, 95%CI -10.07,1.62, = 0.16, I = 0%], mortality [OR 1.84, 95%CI 0.58,5.85, = 0.30, I = 60%] and 30-day mortality [OR 0.75, 95%CI 0.38,1.48, = 0.41, I = 0%].
CONCLUSION
Bivalirudin probably be a potential choice for ECMO anticoagulation. However, based on the included studies' limitation, the superiority of bivalirudin over heparin for anticoagulation in the ECMO population still require further prospective randomized controlled studies before a definite conclusion.
背景
我们旨在比较比伐卢定与肝素作为体外膜肺氧合（ECMO）患者抗凝剂的疗效和安全性。
方法
我们在PubMed、Embase和Cochrane图书馆中检索了所有将比伐卢定与肝素作为ECMO抗凝剂进行比较的研究。疗效指标定义为达到治疗水平的时间、治疗范围内的时间（TTR）、血栓形成事件、回路血栓形成、回路更换。安全性指标报告为肝素诱导的血小板减少症（HIT）、大出血事件、小出血事件。其他指标包括住院时间（LOS）、重症监护病房住院时间、死亡率、30天死亡率和住院死亡率。
结果
纳入10项研究共1091例患者进行荟萃分析。结果发现，与肝素相比，使用比伐卢定治疗的血栓形成事件[比值比（OR）0.51，95%置信区间（CI）0.36,0.73，P = 0.0002，I² = 0%]、大出血事件[OR 0.31，95%CI 0.10,0.92，P = 0.04，I² = 75%]和住院死亡率[OR 0.63，95%CI 0.44,0.89，P = 0.009，I² = 0%]显著降低。两组在达到治疗水平的时间[平均差（MD）3.53，95%CI -4.02,11.09，P = 0.36，I² = 49%]、TTR[MD 8.64，95%CI -1.72,18.65，P = 0.10，I² = 77%]、回路更换[OR 0.92，95%CI 0.27,3.12，P = 0.90，I² = 38%]、HIT[OR 0.25，95%CI 0.02,2.52，P = 0.24，I² = 0%]小出血事件[OR 0.93，95%CI 0.38,2.29，P = 0.87，I² = 0%]、住院LOS[MD -2.93，95%CI -9.01,3.15，P = 0.34，I² = 45%]、重症监护病房LOS[MD -4.2（此处原文有误，应为4.22），95%CI -10.07,1.62，P = 0.16，I² = 0%]、死亡率[OR 1.84，95%CI 0.58,5.85，P = 0.30，I² = 60%]和30天死亡率[OR 0.75，95%CI 0.38,1.48，P = 0.41，I² = 0%]方面无显著差异。
结论
比伐卢定可能是ECMO抗凝的一个潜在选择。然而，基于纳入研究的局限性，在得出明确结论之前，比伐卢定在ECMO人群中抗凝优于肝素的优势仍需要进一步的前瞻性随机对照研究。
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