Erkens Petra Mg, Prins Martin H
Department of General Practice, University of Maastricht, Debyeplein 1, Maastricht, Netherlands, 6229 HA.
Cochrane Database Syst Rev. 2010 Sep 8(9):CD001100. doi: 10.1002/14651858.CD001100.pub3.
Low molecular weight heparins (LMWHs) have been shown to be effective and safe in preventing venous thromboembolism (VTE). They may also be effective for the initial treatment of VTE. This is an update of a Cochrane review first published in 1999 and previously updated in 2004.
To determine the effect of LMWH compared with unfractionated heparin (UFH) for the initial treatment of VTE.
Trials were identified by searching the Cochrane Peripheral Vascular Diseases Group Specialised Register and CENTRAL (The Cochrane Library). Colleagues and pharmaceutical companies were contacted for additional information.
Randomised controlled trials comparing fixed dose subcutaneous LMWH with adjusted dose intravenous or subcutaneous UFH in people with VTE.
Two review authors assessed trials for inclusion and quality, and extracted data independently.
Twenty-three studies were included (n = 9587). Thrombotic complications occurred in 3.6% of participants treated with LMWH compared with 5.3% treated with UFH (odds ratio (OR) 0.70; 95% confidence interval (CI) 0.57 to 0.85). Thrombus size was reduced in 53% of participants treated with LMWH and 45% treated with UFH (OR 0.69; 95% CI 0.59 to 0.81). Major haemorrhages occurred in 1.1% of participants treated with LMWH compared with 1.9% treated with UFH (OR 0.58; 95% CI 0.40 to 0.83). In 19 trials, 4.3% of participants treated with LMWH died compared with 5.8% of participants treated with UFH (OR 0.77; 95% CI 0.63 to 0.93).Nine studies (n = 4451) examined proximal thrombosis, 2192 participants were treated with LMWH and 2259 with UFH. Subgroup analysis showed statistically significant reductions favouring LMWH in thrombotic complications and major haemorrhage. By end of follow up, 80 (3.6%) participants treated with LMWH had thrombotic complications compared with 143 (6.3%) treated with UFH (OR 0.57; 95% CI 0.44 to 0.75). Major haemorrhages occurred in 18 (1.0%) participants treated with LMWH compared with 37 (2.1%) treated with UFH (OR 0.50; 95% CI 0.29 to 0.85). Nine studies showed a statistically significant reduction in mortality favouring LMWH. By the end of follow up, 3.3% (70/2094) of participants treated with LMWH had died and 5.3% (110/2063) treated with UFH.
AUTHORS' CONCLUSIONS: Fixed dose LMWH is more effective and safer than adjusted dose UFH for the initial treatment of VTE. Compared to UFH, LMWH significantly reduced the incidence of thrombotic complications, the occurrence of major haemorrhage during initial treatment and overall mortality at follow up.
低分子量肝素（LMWHs）已被证明在预防静脉血栓栓塞（VTE）方面有效且安全。它们也可能对VTE的初始治疗有效。这是Cochrane综述的更新版，该综述于1999年首次发表，此前于2004年进行过更新。
确定与普通肝素（UFH）相比，低分子量肝素用于VTE初始治疗的效果。
通过检索Cochrane外周血管疾病小组专业注册库和CENTRAL（Cochrane图书馆）来识别试验。还联系了同事和制药公司以获取更多信息。
比较固定剂量皮下注射低分子量肝素与调整剂量静脉注射或皮下注射普通肝素用于VTE患者的随机对照试验。
两位综述作者评估试验是否纳入及质量，并独立提取数据。
纳入了23项研究（n = 9587）。接受低分子量肝素治疗的参与者中3.6%发生血栓并发症，而接受普通肝素治疗的为5.3%（比值比（OR）0.70；95%置信区间（CI）0.57至0.85）。接受低分子量肝素治疗的参与者中53%血栓大小减小，接受普通肝素治疗的为45%（OR 0.69；95%CI 0.59至0.81）。接受低分子量肝素治疗的参与者中1.1%发生大出血，而接受普通肝素治疗的为1.9%（OR 0.58；95%CI 0.40至0.83）。在19项试验中，接受低分子量肝素治疗的参与者中4.3%死亡，而接受普通肝素治疗的为5.8%（OR 0.77；95%CI 0.63至0.93）。9项研究（n = 4451）检查了近端血栓形成，2192名参与者接受低分子量肝素治疗，2259名接受普通肝素治疗。亚组分析显示，在血栓并发症和大出血方面，低分子量肝素具有统计学上显著更低发生率的优势。到随访结束时，接受低分子量肝素治疗的80名（3.6%）参与者发生血栓并发症，而接受普通肝素治疗的为143名（6.3%）（OR 0.57；95%CI 0.44至0.75）。接受低分子量肝素治疗的18名（1.0%）参与者发生大出血，而接受普通肝素治疗的为37名（2.1%）（OR 0.50；95%CI 0.29至0.85）。9项研究显示低分子量肝素在死亡率方面有统计学上显著的降低。到随访结束时，接受低分子量肝素治疗的参与者中3.3%（70/2094）死亡，接受普通肝素治疗的为5.3%（110/2063）。
固定剂量低分子量肝素在VTE初始治疗中比调整剂量普通肝素更有效且更安全。与普通肝素相比，低分子量肝素显著降低了血栓并发症的发生率、初始治疗期间大出血的发生率以及随访时的总体死亡率。
