比伐芦定对比肝素联合替罗非班用于PCI围手术期抗凝治疗的药物经济学

目的：对比研究比伐芦定及普通肝素联合糖蛋白受体拮抗剂替罗非班（H-T）用于中国急性冠脉综合征（ACS）患者经皮冠状动脉介入（PCI）围手术期抗凝治疗的成本效果,为中国人群PCI围手术期抗凝治疗药物的合理选用提供理论依据。方法：参考我国随机、双盲、多中心Ⅲ期临床实验BRIGHT的研究结果,通过建立决策树模型及Markov长期外推模型,模拟计算使用比伐芦定或H-T治疗患者的调整质量生命年（QLAYs）及治疗成本,对比伐芦定用于中国人群PCI抗凝治疗的成本效益进行分析和研究。结果：比伐芦定和H-T组的治疗总成本分别为46 404.80元和43 552.14元,使用比伐芦定患者可获得的QALYs为10.07,采用H-GPI治疗方案的患者QALYs为9.98。增量成本效果分析显示,采用比伐芦定可提高患者的健康效益（△E>0）,但同时增加了治疗成本（△C>0）,其增量成本效果比（ICER）为28 575.77元/QALYs,小于3倍部分城市人均GDP,提示采用比伐芦定具有成本效果优势。一维敏感度分析显示本研究结果稳定可靠。结论：在我国目前整体经济形势下,与H-T的二联抗凝方案相比,比伐芦定用于PCI抗凝具有成本效果优势,可替代传统抗凝方案用于ACS患者PCI围手术期抗凝治疗。     

急性冠状动脉综合征合并高出血风险患者PCI术中应用比伐卢定疗效观察

目的探讨急性冠状动脉综合征合并高出血风险患者行经皮冠状动脉介入治疗(PCI)术中应用比伐卢定的治疗效果及安全性。方法选取108例急性冠状动脉综合征合并高出血风险并且接受PCI治疗的患者,将患者随机平均分为试验组(比伐卢定组)和对照组(普通肝素组),每组54例。比较试验组和对照组术前术后的TIMI血流、活化凝血时间(ACT)达标率、血小板计数、血小板聚集率、高敏C反应蛋白(hs-CRP)和白细胞介素4(IL-4)、30天出血事件及主要不良心血管事件(MACE)发生率。结果试验组与对照组比较,TIMI血流无明显差异。试验组ACT达标率、血小板计数、血小板聚集率、hs-CRP、IL-4等指标均明显优于对照组,差异有统计学意义(P0.05)。试验组出血事件发生率及MACE发生率显著低于对照组,差异有统计学意义(P0.05)。结论急性冠状动脉综合征合并高出血风险患者PCI术中应用比伐卢定,可明显降低出血事件及MACE的发生率,且具有良好的安全性。     

Update on acute coronary syndromes and implications for therapy

Our understanding of the pathophysiology of acute coronary syndromes (ACS), including acute ST elevation myocardial infarction, unstable angina and non-ST-segment elevation (NSTE) myocardial infarction, has evolved considerably over the years, with atherothrombosis playing a pivotal role. This review will discuss the recent advances/recommendations for drug therapy based on this enhanced understanding of the pathophysiology of thrombosis. More recently developed agents, such as low-molecular-weight heparins (LMWHs), glycoprotein (GP) IIb-IIIa inhibitors, direct thrombin inhibitors, Factor Xa inhibitors and thienopyridines, offer several potential advantages, either as an alternative to unfractionated heparin (i.e., LMWHs) or as an add-on therapy to aspirin and unfractionated heparin (or LMWHs; e.g., GP IIb-IIIa inhibitors, thienopyridines). The purpose of this review is to describe recent studies with novel antithrombotic agents (e.g., LMWHs, thienopyridines, GP IIb-IIIa inhibitors, bivalirudin) in patients with NSTE ACS, as well as to highlight recommendations for management of patients with NSTE ACS in the recently updated American College of Cardiology (ACC)/American Heart Association (AHA) guidelines, including the appropriate use of antithrombotic therapies.     

注射用比伐卢定在中国健康受试者中的药代动力学

目的 研究注射用比伐卢定(抗凝药)在中国健康受试者中的药代动力学.方法 48名健康志愿者接受3种不同剂量的单次静脉推注以及序贯(推注后静滴维持剂量)注射用比伐卢定后,用液相色谱质谱-联用法测定其血药浓度,用WinNonlin 5.2.1进行药代动力学参数计算.结果 单次静脉推注0.50,0.75,1.05 mg·kg-1剂量组的主要药代动力学参数如下:C0分别为(4.90±4.56),(6.50±4.66),(6.81±4.13)mg·L-1;t1/2分别为(0.41±0.12),(0.48±0.17),(0.46±0.15)h;AUC0-t分别为(1.13±0.35),(1.97±0.36),(2.29±0.90)h·mg·L-1.序贯组t1/2为(0.94±0.26)h;AUC0-t为(18.03±6.25)h·mg·L-1.结论 中国健康受试者单次静脉推注比伐卢定0.50～1.05 mg·kg-1,药代动力学呈线性动力学特点,在本剂量范围内,能维持较为恒定的血药浓度.     

Prediction of 1‐year mortality and impact of bivalirudin therapy according to level of baseline risk: A patient‐level pooled analysis from three randomized trials

Objectives : We aimed to construct a predictive model for one‐year mortality in patients undergoing invasive coronary evaluation and to examine the impact of bivalirudin on survival according to the level of baseline risk. Background : Compared to heparin plus GP IIb/IIIa inhibitors (HEP/GPI), bivalirudin decreases bleeding complications in a range of clinical presentations. The impact of preprocedural risk assessment on survival and whether this is modified by bivalirudin, has not been investigated in detail. Methods : We examined patient‐level data from the REPLACE‐2, ACUITY, and HORIZONS‐AMI trials (n = 18,819) to construct a risk‐adjusted mortality model using baseline clinical variables. Results : One‐year mortality occurred in 287 patients (3.1%) assigned to bivalirudin and 336 patients (3.6%) assigned to HEP/GPI (HR 0.85; 95% CI, 0.73–1.00; P = 0.048). Using 11 highly significant predictors of mortality, we developed an integer‐risk score to classify patients into risk tertiles. High‐risk patients had a rate of 1‐year mortality over 9‐fold greater than low‐risk patients. Consequently, the absolute mortality reduction attributed to bivalirudin was more marked in high‐risk patients: 3.1% (?0.8% to 7.0%) in the overall cohort, 4.8% (0.5% to 9.2%) in the PCI cohort (P‐interaction versus intermediate and low risk categories, 0.09 and P = 0.02, respectively). Conclusions : In patients undergoing invasive coronary evaluation, 1‐year mortality can be predicted using baseline variables. Bivalirudin treatment (versus HEP/GPI) conferred a survival benefit. © 2015 Wiley Periodicals, Inc.     

Use of systemic bivalirudin with catheter‐directed thrombolysis in a patient with heparin‐induced thrombocytopenia: A case report

In patients with submassive pulmonary embolism, the use of catheter‐directed thrombolysis (CDT), using low‐dose alteplase is associated with improvement in overall hemodynamics. The data for use of CDT in patients with heparin‐induced thrombocytopenia are limited. We report a case of CDT in a patient with HIT using bivalirudin anticoagulation. Data of the use of bivalirudin and argatroban for systemic anticoagulation with CDT are limited.