巴曲酶、氨甲环酸及二者联合在减少腰椎融合手术失血中的有效性和安全性。
Effectiveness and Safety of Batroxobin, Tranexamic Acid and a Combination in Reduction of Blood Loss in Lumbar Spinal Fusion Surgery.
机构信息
Department of Spine Surgery, Ganga Hospital, Coimbatore, Tamil Nadu, India.
出版信息
Spine (Phila Pa 1976). 2018 Mar 1;43(5):E267-E273. doi: 10.1097/BRS.0000000000002315.
STUDY DESIGN
A prospective randomized double blind placebo controlled trail.
OBJECTIVE
To evaluate and compare the efficacy and safety of batroxobin (botropase), tranexamic acid (TXA), and their combination in reduction of perioperative blood loss in lumbar spine single level fusion surgeries.
SUMMARY OF BACKGROUND DATA
Spinal surgeries are associated with significant blood loss leading to perioperative anemia and increased need for allogenic transfusion. TXA competitively inhibits plasmin and batroxobin converts fibrinogen to fibrin and theoretically their combination is synergistic. Though TXA is widely studied in controlling blood loss, there is little information on use of batroxobin and their combination. Thus, we aimed to study effect and safety of individual drugs and their combination in controlling blood loss in spinal surgery.
METHODS
Hundred patients were randomized into four groups. Group B received batroxobin, group T received TXA, group BT received batroxobin and TXA and group P received placebo. Outcomes assessed are intraoperative and postoperative blood loss, hematocrit, allogenic blood transfusion, and deep vein thrombosis (DVT), postoperatively.
RESULT
Mean intraoperative blood loss in Group B, T, BT, and P were 268.32 ± 62.92 mL, 340.72 ± 182.75 mL, 256.96 ± 82.64 mL, and 448.44 ± 205.86 mL, respectively. Postoperative surgical site drain collection in Group B, T, BT, and P were 218.00 ± 100.54 mL, 260.40 ± 100.85 mL, 191.00 ± 87.84 mL, and 320.00 ± 125.83 mL, respectively. Intraoperative blood loss of Group P was statistically higher than Groups B and BT (P < 0.001). Mean postoperative surgical site drain collection was statistically significant (P < 0.001). No statistically significant differences in fluid administration (P = 0.751), blood transfusion (P = 1.000), preoperative and postoperative hemoglobin (P = 0.090, P = 0.134, respectively), and deep vein thrombosis (P = 1.000).
CONCLUSION
Batroxobin and combination of batroxobin with tranexamic acid significantly reduced perioperative blood loss when compared with placebo.
LEVEL OF EVIDENCE
研究设计
前瞻性随机双盲安慰剂对照试验。
目的
评估和比较巴曲酶（博来霉素）、氨甲环酸（TXA）及其联合应用在减少腰椎单节段融合手术围手术期失血方面的疗效和安全性。
背景资料总结
脊柱手术会导致大量失血，导致围手术期贫血和异体输血需求增加。TXA 竞争性抑制纤溶酶，巴曲酶将纤维蛋白原转化为纤维蛋白，理论上它们的联合应用具有协同作用。尽管 TXA 在控制失血方面已广泛研究，但关于巴曲酶及其联合应用的信息很少。因此，我们旨在研究单独使用药物和联合使用药物对脊柱手术中控制失血的效果和安全性。
方法
100 例患者随机分为四组。B 组给予巴曲酶，T 组给予 TXA，BT 组给予巴曲酶和 TXA，P 组给予安慰剂。评估的结果是术中及术后失血量、血细胞比容、异体输血和术后深静脉血栓形成（DVT）。
结果
B 组、T 组、BT 组和 P 组的平均术中失血量分别为 268.32±62.92ml、340.72±182.75ml、256.96±82.64ml 和 448.44±205.86ml。B 组、T 组、BT 组和 P 组术后手术部位引流量分别为 218.00±100.54ml、260.40±100.85ml、191.00±87.84ml 和 320.00±125.83ml。P 组术中失血量明显高于 B 组和 BT 组（P<0.001）。术后手术部位引流量差异有统计学意义（P<0.001）。液体输入量（P=0.751）、输血（P=1.000）、术前和术后血红蛋白（P=0.090，P=0.134）、深静脉血栓形成（P=1.000）无统计学差异。
结论
与安慰剂相比，巴曲酶和巴曲酶联合氨甲环酸可显著减少围手术期失血。
证据水平
2 级。
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