Li Xiang, Jiao Guangjun, Li Jingyi, Ji Weibin, Hao Zhiwei, Gong Fangli, Chen Yunzhen
Department of Orthopedics, Qilu Hospital of Shandong University, Lixia District, Ji'nan, Shandong, China.
Department of Endocrinology, Shandong Provincial Hospital, Huaiyin District, Jinan, Shandong, China.
Global Spine J. 2023 Jun;13(5):1229-1237. doi: 10.1177/21925682211024556. Epub 2021 Sep 26.
A prospective, randomized, double-blind, placebo-controlled study.
There are few studies examining the balance between preventing venous thrombus embolism (VTE) and reducing blood loss in posterior/transforaminal lumbar interbody fusion (PLIF/TLIF) surgeries. This study aimed to evaluate the efficacy and safety of the combine application of TXA and rivaroxaban in patients undergoing PLIF/TLIF and explore relevant factors related to blood loss and VTE.
Patients in group A which was the control group received 0.9% NaCl solution intravenously. Group B was treated by an intravenous injection of 2 g tranexamic acid (TXA) and the local use of 1 g intraoperatively. Group C was treated the same as group B intraoperatively, and they received 10 mg rivaroxaban qd treatment postoperatively. Eligible patients with an Autar score ≤ 10 were randomly assigned to group A or group B. Patients with an Autar score >10 were allocated into group C.
The intraoperative blood loss and postoperative drainage were lower in groups B and C than in group A ( < .001). The blood transfusion rate in group B was lower than that in group A ( < .001), while the incidence of VTE in group C was lower ( < .001). Four factors were found to be positively correlated with obvious total blood loss ( < .05). The data showed that 5 factors were correlated with the development of a thrombus ( < .1).
The combination of TXA and rivaroxaban in PLIF/TLIF patients is safe and effective in reducing D-dimer levels associated with VTE and reducing blood loss.
一项前瞻性、随机、双盲、安慰剂对照研究。
很少有研究探讨后路/经椎间孔腰椎椎间融合术(PLIF/TLIF)手术中预防静脉血栓栓塞(VTE)与减少失血之间的平衡。本研究旨在评估氨甲环酸(TXA)和利伐沙班联合应用于接受PLIF/TLIF手术患者的疗效和安全性,并探讨与失血和VTE相关的因素。
A组为对照组,静脉输注0.9%氯化钠溶液。B组静脉注射2g氨甲环酸(TXA),术中局部使用1g。C组术中治疗同B组,术后接受10mg利伐沙班每日一次治疗。Autar评分≤10的符合条件患者随机分配至A组或B组。Autar评分>10的患者分配至C组。
B组和C组术中失血量和术后引流量低于A组(P<0.001)。B组输血率低于A组(P<0.001),而C组VTE发生率较低(P<0.001)。发现四个因素与明显的总失血量呈正相关(P<0.05)。数据显示五个因素与血栓形成有关(P<0.1)。
TXA和利伐沙班联合应用于PLIF/TLIF患者在降低与VTE相关的D-二聚体水平和减少失血方面是安全有效的。