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目的:评价妊娠全程使用低剂量维生素K拮抗剂(VKA)的抗凝方案与妊娠早期短程使用低分子肝素/肝素的方案应用于心脏机械瓣膜置换术患者妊娠期的安全性与有效性。方法:计算机检索The Cochrane Library(2016年第2期)、Pub Med、EMbase、CBM、清华同方(CNKI)、万方数据库和维普(VIP)数据库,搜集妊娠全程使用低剂量维生素K拮抗剂的方案与妊娠早期短程使用低分子肝素/肝素的抗凝方案的相关文献,检索时限均为从建库至2016-06。由2位评价者独立筛选文献、提取资料和评价纳入研究的偏倚风险后,采用Rev Man 5.3软件进行Meta分析。结果:最终纳入了12项队列研究。Meta分析结果显示:与妊娠早期短程使用低分子肝素/肝素的抗凝方案组相比,妊娠全程使用低剂量维生素K拮抗剂的抗凝方案组降低了瓣膜血栓发生率(OR=0.26,95%CI:0.13~0.54,P<0.001)及自然流产率(OR=1.99,95%CI:1.21~3.26,P=0.006),增加了胎儿畸形发生率(OR=3.39,95%CI:1.11~10.37,P=0.03),两组差异有统计学意义;但是,在产妇死亡率(OR=0.79,95%CI:0.24~2.58,P=0.70)、围产期出血发生率(OR=0.56,95%CI:0.27~1.18,P=0.13)及死胎发生率(OR=1.80,95%CI:0.94~3.44,P=0.07)方面,两组差异无统计学意义。结论:当前证据显示,对于心脏机械瓣膜置换术后孕妇的抗凝治疗,与妊娠早期短程使用低分子肝素/肝素的抗凝方案组相比,妊娠全程使用低剂量维生素K拮抗剂抗凝方案组明显降低了瓣膜血栓发生率和自然流产率,但是增加了胎儿畸形发生率,受纳入研究治疗的限制,上述结论尚需开展更多高质量的研究予以验证。
OBJECTIVE: To evaluate the safety and efficacy of anticoagulation with low-dose vitamin K antagonist (VKA) throughout pregnancy and the use of low-molecular-weight heparin / heparin in the first trimester of pregnancy during cardiac pregnancy in patients undergoing mechanical heart valve replacement. METHODS: The Cochrane Library (2016 issue 2), Pub Med, EMbase, CBM, CNKI, VIP database and VIP databases were searched by computer to collect the scheme of using low-dose vitamin K antagonist during pregnancy The relevant literature on the anticoagulation regimen of short-term low molecular weight heparin / heparin during early pregnancy was retrieved from the database until 2016-06. After two reviewers independently screened the literature, extracted data, and assessed the risk of being included in the study, Meta-analysis was performed using RevMan 5.3 software. Results: Finally, 12 cohort studies were included. Meta-analysis showed that the anticoagulation regimen with low-dose vitamin K antagonist throughout pregnancy reduced the incidence of valvular thrombosis compared with the short-course anticoagulation regimen with low molecular weight heparin / heparin during early pregnancy (OR = 0.26, 95% (OR = 3.39, 95% CI: 1.11-10.37, CI = 0.13-0.54, P <0.001) and spontaneous abortion rate (OR = 1.99,95% CI: 1.21-3.26, P = 0.006) , P = 0.03). There was significant difference between the two groups; however, there was no significant difference in the incidence of perinatal bleeding between the two groups (OR = 0.79,95% CI: 0.24-2.58, P = 0.70) % CI: 0.27-1.18, P = 0.13) and the incidence of stillbirth (OR = 1.80,95% CI: 0.94-3.44, P = 0.07). There was no significant difference between the two groups. CONCLUSIONS: Current evidence shows that for anticoagulant therapy in pregnant women after mechanical heart valve replacement, the low-dose vitamin K antagonist anticoagulant regimen was used throughout pregnancy as compared to the short-course anticoagulation regimen with low molecular weight heparin / heparin during early pregnancy Significantly reduced the incidence of valve thrombosis and spontaneous abortion, but increased the incidence of fetal malformations, limited by the inclusion of research and treatment, the above conclusions still need to carry out more high-quality research to be verified.