氨甲环酸与利伐沙班联合用于腰椎后路椎间融合术可安全减少失血和输血率，且不增加血栓形成风险——一项前瞻性、分层、随机、对照试验
Combined use of tranexamic acid and rivaroxaban in posterior lumbar interbody fusion safely reduces blood loss and transfusion rates without increasing the risk of thrombosis-a prospective, stratified, randomized, controlled trial.
作者信息
Zhang Lu, Li Yanming, Liu Dong, Xiao Xing, Guan Tingjin, Yue Hongwei, Xue Haipeng, Zhou Hongming, Jiao Guangjun, Wu Wenliang, Wang Hongliang, Liu Haichun, Meng Chunyang, Sun Zhaozhong, Chen Yunzhen
机构信息
Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.
Department of Shandong University Spine and Spine Cord Disease Research Center, Jinan, Shandong, China.
出版信息
Int Orthop. 2020 Oct;44(10):2079-2087. doi: 10.1007/s00264-020-04699-3. Epub 2020 Jul 17.
PURPOSE
This prospective, stratified, randomized, single-blind, placebo-controlled multicentre study investigated the safety and effectiveness of reducing blood loss and preventing venous thromboembolism (VTE) during posterior lumbar interbody fusion (PLIF) in patients with stenosis or spondylolisthesis using the combination of tranexamic acid (TXA) and rivaroxaban.
METHODS
The Autar score was evaluated in patients after admission. Patients with an Autar score ≤ 10 were randomized to group A or B. Group A was the placebo-controlled group. Patients in group B were treated with 1 g TXA via intravenous injection and 1 g TXA for external use. Patients with an Autar score > 10 were randomized to group C or D. Patients in group C were treated with 10-mg rivaroxaban qd for 35 days after surgery. Patients in group D received the same treatment as those in group B intra-operatively and as those in group C post-operatively.
RESULTS
A total of 599 patients from eight hospitals participated in this clinical trial. The total blood loss, intra-operative blood loss, and drainage volume were reduced by the administration of TXA (group A vs group B, P < 0.01; group C vs group D, P < 0.01), and the blood transfusion rate was also decreased (group A vs group B, P < 0.01; group C vs group D, P < 0.01). There were no significant differences (P > 0.05) in the VTE incidence rates among group A and group B. In patients with high-risk thrombosis, the number of patients with VTE was only three and seven after the application of rivaroxaban. Epidural haematoma was not discovered in any patients in our trial.
CONCLUSION
The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma.
TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION
ChiCTR-1800016430 2018-06-01.
目的
本前瞻性、分层、随机、单盲、安慰剂对照的多中心研究，探讨了在狭窄或椎体滑脱患者的后路腰椎椎间融合术（PLIF）中，使用氨甲环酸（TXA）和利伐沙班联合用药减少失血及预防静脉血栓栓塞（VTE）的安全性和有效性。
方法
入院后对患者进行Autar评分。Autar评分≤10分的患者随机分为A组或B组。A组为安慰剂对照组。B组患者静脉注射1g TXA并外用1g TXA。Autar评分>10分的患者随机分为C组或D组。C组患者术后35天每天口服10mg利伐沙班。D组患者术中接受与B组相同的治疗，术后接受与C组相同的治疗。
结果
来自八家医院的599例患者参与了本临床试验。使用TXA后，总失血量、术中失血量和引流量均减少（A组与B组，P<0.01；C组与D组，P<0.01），输血率也降低（A组与B组，P<0.01；C组与D组，P<0.01）。A组和B组的VTE发生率无显著差异（P>0.05）。在高血栓风险患者中，应用利伐沙班后VTE患者分别仅为3例和7例。本试验中未发现任何患者发生硬膜外血肿。
结论
氨甲环酸和利伐沙班联合应用显著减少了PLIF手术中的失血量和输血率，避免了血栓形成概率增加和硬膜外血肿的发生。
试验注册号及注册日期
ChiCTR-1800016430 2018年6月1日。
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