磺达肝素预防术后肺血栓栓塞的荟萃分析

Fondaparinux prevention of pulmonary thromboembolism after surgery:a Meta-analysis

目的:评估磺达肝素对术后发生肺血栓栓塞(PTE)的预防作用,并系统分析磺达肝素和一般低分子肝素(LMWH)疗效和安全性的差异。方法:从Medline、Cochrane图书馆和中国生物医学文献数据库(CBM)检索公开发表的文章(2000年1月—2007年6月),以磺达肝素或LMWH类药物(对照)预防术后PTE的随机对照试验(RCT)为研究对象,采用Rev Man 4.2软件进行统计分析。结果:对符合纳入标准的5篇文献共10 271例病人进行荟萃分析,根据意向性分析(ITT)磺达肝素组和对照组术后PTE发病率分别为0.31%和0.25%,2组比数比(OR)为1.23(95%CI为0.59～2.57),差异无显著意义(P>0.05)。2组术后严重出血发生率分别为2.82%和1.89%,OR值为1.51(95%CI为0.73～1.83),差异有显著意义(P<0.01)。2组术后轻微出血发生率分别为2.73%和2.37%,OR值为1.15(95%CI为0.90～1.48),差异无显著意义(P>0.05)。结论:磺达肝素预防术后PTE的疗效与一般LMWH相当,两者术后轻微出血发生率相似,但磺达肝素引起术后严重出血的危险性相对较高。

AIM： To assess the efficacy and safety of fondaparinux versus low molecular weight heparin （LMWH） for the prevention of pulmonary thromboembolism （PTE） after surgery. METHODS： All the randomized controlled trials （RCT） of ＇fondaparinux＇ or ＇LMWH＇ in prevention of PTE after surgery from Medline, the Cochrane Library, CMB （January 2000 to June 2007） were comprehensively undertaken with furthermore Meta-analysis conducted on combining the odd ratios of the individual studies through Rev Man 4.2 software statistically. RESULTS： Of the 5 standardized articles screened, 10 271 cases were included in the Meta-analysis with the occurrence rates of PTE after surgery （intention-to-treat, ITT） in fondaparinux group as 0.31% vs control group 0.25 %, the odds ratio （OR） outcoming 1.23 （95 % CI was 0.59-2.57）, with no statistical significance （P 〉 0.05） . The incidence of major bleeding after surgery of the two groups were 2.82 % and 1.89 %, respectively, the OR was 1.51 （95 % CI was 0.73-1.83）, with statistically significant difference （P 〈 0.01） . The incidence of minor bleeding after surgery of the two groups were 2.73 % and 2.37 %, respectively, with OR 1.15 （95 % CI was 0.90-1.48） , having no statistical significance （P 〉 0.05） . CONCLUSION： Fondaparinux is as effective as LMWH in prevention of PTE after surgery, similar the risk of minor bleeding after surgery, but with a high risk of severe bleeding after surgery in comparing with LMWH.