阿司匹林与低分子肝素在骨科大手术中的应用:一项随机对照试验的Meta分析

Application of aspirin and low molecular weight heparin in major orthopedic surgery:Meta analysis of a randomized controlled trial

目的:阿司匹林被认为在预防骨科大手术后的静脉血栓栓塞方面不逊于低分子肝素,并被国际临床指南推荐。为此,本文采用Meta分析的方法评价了阿司匹林与低分子肝素的疗效与安全性。方法:应用计算机检索中国知网、万方和维普以及PubMed、Cochrane Library、Web of Science等数据库,根据纳入及排除标准检索出关于骨科大手术应用阿司匹林和低分子肝素预防深静脉血栓形成的随机对照研究10篇,使用Endnote软件管理文献,使用Revman 5.3软件对所提取的数据进行Meta分析,主要分析这两种药物对骨科大手术后的肺栓塞、深静脉血栓形成、主要出血事件、轻微出血事件、伤口并发症、90 d内死亡率及失血量的影响。结果:纳入10项质量较高的随机对照试验,共纳入12974例患者,阿司匹林组有7026例,低分子肝素组有5948例;Meta分析结果显示:阿司匹林比低分子肝素有着更高的肺栓塞发生率[OR=1.59,95%CI(1.02,2.49),P=0.04]和深静脉血栓发生率[OR=1.60,95%CI(1.26,2.02),P=0.0001];(3)两组药物的主要出血事件发生率[OR=0.85,95%CI(0.47,1.55),P=0.60]、轻微出血事件发生率[OR=0.79,95%CI(0.55,1.12),P=0.18]、伤口不良反应发生率[OR=0.79,95%CI(0.48,1.31),P=0.36]、90 d内死亡率[OR=0.69,95%CI(0.20,2.31),P=0.55]及围手术期失血量[OR=37.93,95%CI(-3.53,79.39),P=0.07]的差异无统计学意义。结论:低分子肝素在预防骨科大手术后肺栓塞、下肢深静脉血栓形成方面均优于阿司匹林,但安全性及药物不良反应方面两组药物基本相似。基于此,建议在预防骨科大手术中深静脉血栓形成时应首选低分子肝素,然而纳入的RCT仍然有限,有必要进行高质量、大样本的长期随访临床研究。

Objective:The perioperative period of major orthopedic surgery is associated with a high risk of thrombosis,but the best chemopreventive agent for thrombosis prophylaxis is still inconclusive.For this reason,this paper evaluated the efficacy and safety of aspirin versus low-molecular heparin using a Meta-analysis.Methods:Ten randomized controlled studies on the application of aspirin and low-molecular heparin for the prevention of deep vein thrombosis in orthopedic major surgery were retrieved by computer searches of PubMed,CochraneLibrary,Web of Science,China Knowledge Network,Wanfang,and Vipul databases according to inclusion and exclusion criteria,and the literature was managed using Endnote software,and the data were analyzed using Revman 5.3 software was used to perform Meta-analysis of the extracted data,focusing on the effects of these two drugs on pulmonary embolism,deep vein thrombosis,major bleeding events,minor bleeding events,wound complications,mortality and blood loss within 90 days after major orthopedic surgery.Results:Ten randomized controlled trials of high quality were included,with a total of 12974 patients,7026 in the aspirin group and 5948 in the low-molecular heparin group;Metaanalysis showed that aspirin had a higher incidence of pulmonary embolism[OR=1.59,95%CI(1.02,2.49),P=0.04]and deep vein thrombosis[OR=1.60,95%CI(1.26,2.02),P=0.0001]than low molecular heparin;(3)The incidence of major bleeding events[OR=0.85,95%CI(0.47,1.55),P=0.60],minor bleeding events[OR=0.79,95%CI(0.55,1.12),P=0.18],adverse wound re-actions[OR=0.79,95%CI(0.48,1.31),P=0.36],mortality within 90 days[OR=0.69,95%CI(0.20,2.31),P=0.55]and perioperative blood loss[OR=37.93,95%CI(−3.53,79.39),P=0.07]were not statistically significant.Conclusion:Low-molecular heparin was superior to aspirin in the prevention of pulmonary embolism and lower extremity deep vein thrombosis after major orthopedic surgery,but the safety and adverse drug reactions of both groups were basically similar.Based on this,the authors recommend that low-molecular heparin should be preferred for the prevention of deep vein thrombosis in major orthopaedic surgery;however,the inclusion of randomized controlled trials remains limited,necessitating high-quality,large-sample,long-term follow-up clinical studies.The perioperative period of major orthopedic surgery is associated with a high risk of thrombosis,but the best chemopreventive agent for thrombosis prophylaxis is still inconclusive.For this reason,this paper evaluated the efficacy and safety of aspirin versus low-molecular heparin using a Meta-analysis.