低分子肝素对比其他抗凝药物预防脊柱脊髓损伤后静脉栓塞症疗效及安全性的Meta分析

Comparison of efficacy and safety between low molecular weight heparin and other anticoagulants in preventing venous thromboembolism after spine trauma and spinal cord injury: a meta-analysis

中文关键词:  低分子肝素  静脉栓塞症  脊柱创伤  脊髓损伤  直接口服抗凝剂

英文关键词:Low molecular weight heparin  Venous thromboembolism  Spine trauma  Spinal cord injury  Direct oral anticoagulant

中文摘要:

  【摘要】 目的：系统评价低分子肝素（low molecular weight heparin，LMWH）对比直接口服抗凝药（direct oral anticoagulants，DOACs）与普通肝素（unfractionated heparin，UFH）预防脊柱脊髓损伤后静脉栓塞症（venous thromboembolism，VTE）的疗效以及安全性。方法：在中国知网、万方数据库、维普数据库、中国生物医学文献数据库以及外文数据库包括PubMed、考克兰图书馆、Embase、Web of Science中检索对比LMWH与其他抗凝药物包括DOACs、UFH预防脊柱脊髓损伤患者VTE的文献，检索时限为自建库起至2022年4月20日，筛选符合纳入标准的回顾性队列研究及前瞻性随机对照试验（randomized controlled trials，RCTs）。将相关文献纳入并提取干预措施、实验设计等数据采用RevMan 5.3软件进行Meta分析，分析结果由森林图表示，RCTs用Cochrane风险偏倚评估工具进行评价，队列研究用纽卡斯尔-渥太华质量评分表（Newcastle-Ottawa Scale，NOS）进行文献质量评价。结果：共纳入11篇文献，其中8篇为回顾性队列研究，3篇为RCTs研究，均为中高质量文献。Meta分析结果表明，DOACs在预防深静脉血栓（deep venous thrombosis，DVT）方面优于LMWH（P＜0.00001），在预防总VTE方面优于LMWH（P=0.002），但两者在预防肺栓塞（pulmonary embolism，PE）方面无统计学差异（P=0.23）。LMWH与UFH在预防脊柱脊髓损伤患者DVT、PE以及总VTE未见明显差异。进一步对比LMWH与小剂量普通肝素（low-dose unfractionated heparin，LDUH），发现LMWH在预防脊柱脊髓损伤患者PE方面优于LDUH（P=0.0006），而在DVT与总VTE方面无明显差异。根据研究设计不同进行亚组分析，对比预防脊柱脊髓损伤患者PE，发现在回顾性队列研究中LMWH优于LDUH（P=0.004），在RCTs研究中二者无明显差异（P=0.05）。对于安全性的比较，回顾性队列研究中LMWH与LDUH无明显差异（P=0.67）。由于Meta分析各结局指标所纳入的文献数量较少，未能进行敏感性分析与偏倚性分析。结论：与LMWH相比，DOACs可对脊柱脊髓损伤患者VTE进行更有效的预防性治疗，但在预防PE方面二者疗效上无明显区别。与UHF和LDUH相比，LMWH综合预防疗效、安全性、便捷性以及实用性等各方面更适合于脊柱脊髓患者VTE的预防。

英文摘要:

  【Abstract】 Objectives: To compare the efficacy and safety between low molecular weight heparin(LMWH) and direct oral anticoagulants(DOACs) and unfractionated heparin(UFH) in preventing venous thromboembolism(VTE) after spine trauma and spinal cord injury. Methods: The literature on comparing the prevention of VTE in patients with spine trauma and spinal cord injury with LMWH and other anticoagulants such as DOACs and UFH published from the inception till April 20, 2022 was searched in CNKI, Wanfang database, VIP, SinoMed, and foreign language databases including PubMed, Cochrane Library, Embase, and Web of Science. Retrospective cohort studies and prospective randomized controlled trials(RCTs) that met the inclusion and exclusion criteria were screened. Relevant literature was included and data such as intervention and study design were extracted for meta-analysis with RevMan 5.3 software, and the results were presented by forest plots. RCTs were evaluated using the Cochrane risk of bias assessment tool, and cohort studies were evaluated by the Newcastle-Ottawa Scale(NOS) for quality assessment. Results: A total of 11 studies of medium and high quality were included, containing 8 retrospective cohort studies and 3 RCTs studies. Meta-analysis showed that DOACs were superior to LMWH in preventing deep venous thrombosis(DVT) (P<0.00001) and total VTE(P=0.002), but no statistical difference was found between the two in preventing pulmonary embolism(PE) (P=0.23). There was no significant difference between LMWH and UFH in the prevention of DVT, PE, and total VTE in patients with spine trauma and spinal cord injury. LMWH was further compared with low-dose unfractionated heparin(LDUH), and was found to be superior to LDUH in preventing PE in patients with spinal cord injury(P=0.0006), while there was no significant difference in the prevention of DVT and total VTE. In subgroup analysis based on study design, for the prevention of PE, LMWH was superior to LDUH in preventing PE in patients with spinal cord injury in retrospective cohort studies(P=0.004), and no significant difference between the two in RCTs(P=0.05). For comparison of safety, there was no significant difference between LMWH and LDUH in retrospective cohort study(P=0.67). Due to the small amount of literature included in the meta-analysis for each outcome indicator, sensitivity analysis and bias analysis were not performed. Conclusions: Comparing with LMWH, DOACs can provide more effective prophylactic treatment for VTE in patients with spine trauma and spinal cord injury, but there is no significant difference in efficacy between the two in the prevention of PE. Comparing with UFH and LDUH, LMWH is more suitable for the prevention of VTE in spine trauma and spinal cord patients in terms of combined prophylactic efficacy, safety, convenience and practicality.