Brito Viviana, Ciapponi Agustín, Kwong Joey
Coronary Care Unit, Hospital de Clinicas, Universidad de Buenos Aires, Avenida Cordoba 2351 Piso Sala 1, Ciudad Autonoma Buenos Aires, Capital Federal, Argentina.
Cochrane Database Syst Rev. 2011 Jan 19(1):CD007038. doi: 10.1002/14651858.CD007038.pub2.
The activation of coagulation mechanisms plays a central role in the pathogenesis of acute coronary syndromes (ACS). Administration of unfractionated heparin (UFH) and low molecular weight heparins (LMWH), agents preventing the progression of thrombus formation, is a crucial therapeutic strategy. However, some limitations related to their use have recently stimulated the development of new synthetic agents.
To evaluate the clinical efficacy and safety of factor Xa inhibitors for treatment of ACS compared to UFH or LMWH.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) of the Cochrane Library (Issue 1, 2008), PubMed, EMBASE and LILACS as well as the publications from International Congresses and the reference lists of the selected studies in December 2008.
We used randomized controlled trials (RCTs) comparing factor Xa inhibitors to UFH or LMWH during the course of ACS. Outcome measures included all-cause mortality, myocardial infarction, re-infarction, ischemia recurrence, and adverse events.
The selection, quality assessment and data extraction of the included trials were done independently by two authors and disagreements were resolved by consensus. Data were analysed by the use of risk ratio (RR) with 95% confidence interval (CI), and the numbers needed to treat (NNT) were reported as needed.
A total of four RCTs involving 27,976 subjects were included. Fondaparinux was the only factor Xa inhibitor identified in our included RCTs. Fondaparinux appeared to be related to a lower risk in all-cause mortality at 90 to 180 days (RR 0.89; 95% CI 0.81 to 0.97), especially in the group where enoxaparin (a LMWH) was the control drug. Fondaparinux was also associated with a lower risk in major and minor bleeding at 30 days compared to enoxaparin (RR 0.63, 95% CI 0.55 to 0.73; RR 0.34, 95% CI 0.28 to 0.43, respectively), but not when compared to UFHs (RR 1.41; 95% CI 0.49 to 4.10; RR 0.70, 95% CI 0.14 to 3.39 respectively).
AUTHORS' CONCLUSIONS: The therapeutic efficacy of factor Xa inhibitors in ACS seemed to be related to a reduced risk in all-cause mortality at 90 to 180 days, with a better safety profile than enoxaparin in terms of reduce incidence of major and minor bleeding.
凝血机制的激活在急性冠状动脉综合征（ACS）的发病机制中起核心作用。普通肝素（UFH）和低分子量肝素（LMWH）作为预防血栓形成进展的药物，其应用是关键的治疗策略。然而，与它们使用相关的一些局限性最近促使了新型合成药物的研发。
评估与UFH或LMWH相比，Xa因子抑制剂治疗ACS的临床疗效和安全性。
我们检索了Cochrane图书馆2008年第1期的Cochrane对照试验中心注册库（CENTRAL）、PubMed、EMBASE和LILACS，以及国际大会的出版物和2008年12月所选研究的参考文献列表。
我们采用随机对照试验（RCT），比较ACS病程中Xa因子抑制剂与UFH或LMWH。结局指标包括全因死亡率、心肌梗死、再梗死、缺血复发和不良事件。
纳入试验的选择、质量评估和数据提取由两位作者独立完成，分歧通过协商解决。采用风险比（RR）及95%置信区间（CI）进行数据分析，必要时报告所需治疗人数（NNT）。
共纳入4项涉及27976名受试者的RCT。磺达肝癸钠是我们纳入的RCT中唯一确定的Xa因子抑制剂。磺达肝癸钠在90至180天时似乎与全因死亡率风险较低相关（RR 0.89；95%CI 0.81至0.97），尤其是在依诺肝素（一种LMWH）作为对照药物的组中。与依诺肝素相比，磺达肝癸钠在30天时还与大出血和小出血风险较低相关（RR分别为0.63，95%CI 0.55至0.73；RR 0.34，95%CI 0.28至0.43），但与UFH相比则不然（RR分别为1.41；95%CI 0.49至4.10；RR 0.70，95%CI 0.14至3.39）。
Xa因子抑制剂在ACS中的治疗效果似乎与90至180天时全因死亡率风险降低相关，在降低大出血和小出血发生率方面比依诺肝素具有更好的安全性。
