新型口服抗凝剂和传统抗凝剂在需要抗凝治疗的肝硬化患者中的疗效与安全性比较

Comparison of efficacy and safety between new oral anticoagulants and traditional anticoagulants in patients with liver eirrhosis requiring anticoagulant therapy

目的通过比较新型口服抗凝剂(NOACs)与传统抗凝剂的优缺点,评价其对需要抗凝治疗的肝硬化患者的疗效与安全性。方法通过计算机检索在PubMed,Embase、Cochrane图书馆、知网、万方、维普等数据库检索相关文献,使用NOS量表对文献进行质量评价,提取数据后使用RevMan5.3软件进行Meta分析。结果共纳入7篇研究,有1篇为随机对照试验,6篇为回顾性队列研究,共3042例患者,其中1677例患者使用了NOACs,1365例患者使用了传统抗凝剂。Meta分析结果显示,与传统抗凝药物组比较,NOACs组具有更低的大出血发生率[OR=0.56,95%CI(0.37~0.85),P<0.01]及更高的血栓再通率[OR=7.77,95%CI(3.48~17.34),P<0.01],差异均有统计学意义。而在全因出血率[OR=0.72,95%CI(0.13~3.91),P=0.07]、全因死亡率[OR=0.72,95%CI(0.25~2.07),P=0.54].复发栓塞和卒中率[OR=0.90,95%CI(0.59~1.39),P=0.64]的比较上,两组差异均无统计学意义。结论NOACs与传统抗凝剂相比,在肝硬化患者治疗中有着较高的安全性和较好的疗效,但国内并未被广泛应用,未来还需要大样本的随机对照试验及前瞻性研究进一步证实。

Objective:To compare the advantages and disadvantages of new oral anticoagulants(NOACS)with traditional anticoagulants,in an attempt to evaluate their efficacy and safety in patients with liver cirrhosis requiring anticoagulant therapy.Methods:Relevant literatures were searched from PubMed,Embase,Cochrane Library,HowNet,Wanfang,VIP and other databases by computer retrieval.The literatures quality was evaluated by NOS.The extracted data were meta-analyzed by RevMan5.3 software.Results:A total of seven studies were included,including one randomized controlled trial and six retrospective cohort studies with a total of 3042 cases.Among them,1677 and 1365 cases used NOACs and traditional anticoagulants.Meta-analysis results showed that compared with the traditional anticoagulant group,the NOACs group had a lower incidence of massive hemorrhage[OR=0.56,95%CI(0.37-0.85),P<0.01]and a higher thrombotic recanalization rate[OR=7.77,95%CI(3.48~17.34),P<0.01],and the difference was statistically significant,while there were no statistically significant differences between thq two groups in comparison to all-cause bleeding rates[OR=0.72,95%CI(0.13-3.91),P=0.07],all-cause mortality[OR=0.72,95%CI(0.25-2.07),P=0.54],recurrent embolism and stroke rates[OR=0.90,95%CI(0.59-1.39),and P=0.64].Conclusion:Compared with traditional anticoagulants,NOACs have higher safety and better efficacy in the treatment of patients with liver cirrhosis,but it has not been widely used in China.Therefore,large-scale randomized controlled trials and prospective studies are further needed to confirm it in the future.