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後腰椎体間固定術におけるトラネキサム酸とリバロキサバンの併用は、血栓症のリスクを増加させることなく、出血量と輸血率を安全に減少させる-プロスペクティブ、層別化、無作為化、対照試験-
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.
PMID: 32676780 DOI: 10.1007/s00264-020-04699-3.
抄録
目的:
この前向き、層別化、無作為化、単盲検、プラセボ対照の多施設共同試験では、狭窄症または脊椎症を有する患者を対象に、トラネキサム酸（TXA）とリバロキサバンを併用して、後腰椎体間固定術（PLIF）中の出血量を減少させ、静脈血栓塞栓症（VTE）を予防することの安全性と有効性を検討した。
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.
方法:
Autarスコアは入院後の患者で評価された。Autarスコア≦10の患者をA群またはB群に無作為に割り付け、A群をプラセボ対照群とした。B群の患者には1gのTXAを静脈内注射で投与し、外用として1gのTXAを投与した。Autarスコアが10以上の患者をC群またはD群に無作為に割り付け、C群の患者には術後35日間、10mgのリバロキサバンを1日1回投与した。D群はB群と同様の治療を術中および術後に受けた。
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.
結果:
本臨床試験には8病院から合計599名の患者が参加しました。TXA投与により、総出血量、術中出血量、ドレナージ量が減少し（A群対B群、P<0.01、C群対D群、P<0.01）、輸血率も減少した（A群対B群、P<0.01、C群対D群、P<0.01）。VTE発症率にはA群とB群で有意差（P>0.05）はなく，ハイリスク血栓症患者では，リバロキサバン投与後のVTE発症は3例と7例にとどまった。硬膜外血腫は，本試験ではどの患者でも発見されなかった．
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.
結論:
トラネキサム酸とリバロキサバンの併用により，PLIF手術中の出血量と輸血率が有意に減少し，血栓症の発生確率と硬膜外血腫の発生を回避した．
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.
試験登録番号と登録日:
ChiCTR-1800016430 2018-06-01.
TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: ChiCTR-1800016430 2018-06-01.