比伐卢定对比肝素联合鱼精蛋白在成人心脏手术患者中的应用：一项系统评价与荟萃分析。
完整摘要 · 中文译文
目的：总结接受心脏手术的成年患者使用比伐卢定抗凝与普通肝素（UFH）抗凝相比的发病率、死亡率和输血需求的证据。 测量指标和主要结果：共纳入三项随机对照试验（RCT）中的407例患者进行汇总分析。主要结局即因出血再次探查在组间无显著差异（风险比：1.38，95%置信区间：0.42至4.48）。任何次要结局均未观察到差异；血栓栓塞事件（心肌梗死、卒中、肺栓塞）、死亡率或术后输血需求（浓缩红细胞（PRC）、血小板、冷沉淀、新鲜冰冻血浆（FFP））。所有纳入研究均被评估为存在一定的偏倚风险。所有比较的组间异质性均较低。 结论：在心脏手术患者中，比伐卢定未显示出与UFH在临床结局方面有任何显著差异，并且根据当前国际指南，可考虑将其安全用于UFH禁忌的患者。该研究受到纳入研究的偏倚以及比伐卢定药物剂量及其治疗监测变异性的限制；此外，还需要进一步开展有足够把握度的RCT。
完整摘要 · 英文原文
OBJECTIVES: To summarize the evidence on the morbidity, mortality, and transfusion requirements of adult patients undergoing cardiac surgery using bivalirudin for anticoagulation compared to unfractionated heparin (UFH). MEASUREMENTS AND MAIN RESULTS: A total of 407 patients in three randomized controlled trial (RCTs) were included for pooled analysis. There was no significant difference in the primary outcome; reexploration for hemorrhage between groups (risk ratio: 1.38, 95% confidence interval: 0.42 to 4.48). There were no observable differences in any of the secondary outcomes; thromboembolic events (myocardial infarction, stroke, pulmonary embolism), mortality, or postoperative transfusion requirements (packed red cells (PRC), platelets, cryoprecipitate, fresh frozen plasma (FFP)). All studies included were assessed to have some concern for risk of bias. Interstudy heterogeneity was low across all comparisons. CONCLUSION: Bivalirudin has not been shown to have any significant difference to UFH on clinical outcomes in patients undergoing cardiac surgery, and as per current international guidelines, can be considered for safe use in those patients for whom UFH is contraindicated. The study is limited by the bias of the included studies and the variability of bivalirudin drug dosage and its therapeutic monitoring; further, well-powered RCTs are required.