随机对照试验研究两种氨甲环酸给药方案在成人脊柱畸形手术中的应用。
Randomized, controlled trial of two tranexamic acid dosing protocols in adult spinal deformity surgery.
机构信息
Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, MO, USA.
Department of Orthopedic Surgery, Columbia University Medical Center, New York, NY, USA.
出版信息
Spine Deform. 2022 Nov;10(6):1399-1406. doi: 10.1007/s43390-022-00539-z. Epub 2022 Jun 25.
BACKGROUND
Tranexamic acid (TXA) is an anti-fibrinolytic effective in reducing blood loss in orthopedic surgery. The appropriate dosing protocol for adult spinal deformity (ASD) surgery is not known. The purpose of this study was to evaluate two TXA protocols [low dose (L): 10 mg/kg bolus, 1 mg/kg/hr infusion; high dose (H): 50 mg/kg, 5 mg/kg/hr] in complex ASD surgery.
METHODS
Inclusion criteria were ASD reconstructions with minimum 10 fusion levels or planned 3-column osteotomy (3CO). Standard demographic and surgical data were collected. Intraoperative estimated blood loss (EBL) was calculated by suction canisters minus irrigation plus estimated blood lost in sponges, estimated to the nearest 50 mL. Serious adverse events (SAE) were defined a priori as: venothromboembolic event (VTE), cardiac arrhythmia, myocardial infarction, renal dysfunction, and seizure. All SAE were recorded. Simple t tests compared EBL between groups. Mean EBL by total blood volume (TBV), transfusion volume, complications related to TXA were secondary outcomes.
RESULTS
Sixty-two patients were enrolled and 52 patients completed the study; 25 were randomized to H and 27 to L. Demographic and surgical variables were not different between the two groups. EBL was not different between groups (H: 1596 ± 933 cc, L: 2046 ± 1105 cc, p = 0.12, 95% CI: - 1022 to 122 cc). EBL as a percentage of TBV was lower for the high-dose group (H: 29.5 ± 14.8%, L: 42.5 ± 26.2%, p = 0.03). Intraoperative transfusion volume (H: 961 ± 505 cc, L: 1105 ± 808 cc, p = 0.5) and post-operative transfusion volume (H: 513 ± 305 cc, L: 524 ± 245 cc, p = 0.9) were not different. SAE related to TXA were not different (p = 0.7) and occurred in 2 (8%) H and 3 (11%) L. There was one seizure (H), 2 VTE, and 2 arrhythmias.
CONCLUSION
No differences in EBL, transfusion volume, nor SAE were observed between H and L dose TXA protocols. High dose was associated with decreased TBV loss (13%). Further prospective study, with pharmacologic analysis, is required to determine appropriate TXA dosage in ASD surgeries.
LEVEL OF EVIDENCE
Therapeutic Level II.
TRIAL REGISTRATION
The study was registered at Clinicaltrials.gov (NCT02053363) February 3, 2014.
背景
氨甲环酸（TXA）是一种抗纤维蛋白溶解药物，可有效减少骨科手术中的失血量。但目前尚不清楚成人脊柱畸形（ASD）手术的合适给药方案。本研究旨在评估两种 TXA 方案[低剂量（L）：10mg/kg 推注，1mg/kg/hr 输注；高剂量（H）：50mg/kg，5mg/kg/hr]在复杂 ASD 手术中的应用。
方法
纳入标准为至少有 10 个融合节段或计划进行 3 柱截骨术（3CO）的 ASD 重建。收集标准的人口统计学和手术数据。术中估计失血量（EBL）通过吸引罐减去冲洗液加上估计在海绵中丢失的血液来计算，估计值精确到最接近的 50ml。严重不良事件（SAE）定义为：静脉血栓栓塞事件（VTE）、心律失常、心肌梗死、肾功能障碍和癫痫发作。所有 SAE 均记录在案。采用简单 t 检验比较两组间 EBL 的差异。根据总血容量（TBV）、输血量评估 EBL 是主要结局，与 TXA 相关的并发症是次要结局。
结果
共纳入 62 例患者，52 例完成研究；25 例随机分为 H 组，27 例随机分为 L 组。两组的人口统计学和手术变量无差异。两组间 EBL 无差异（H：1596±933cc，L：2046±1105cc，p=0.12，95%CI：-1022 至 122cc）。高剂量组的 EBL 占 TBV 的百分比较低（H：29.5±14.8%，L：42.5±26.2%，p=0.03）。术中输血量（H：961±505cc，L：1105±808cc，p=0.5）和术后输血量（H：513±305cc，L：524±245cc，p=0.9）无差异。与 TXA 相关的 SAE 无差异（p=0.7），且 H 组和 L 组各有 2 例（8%）和 3 例（11%）发生。H 组发生 1 例癫痫发作，2 例 VTE 和 2 例心律失常。
结论
高剂量和低剂量 TXA 方案在 EBL、输血量或 SAE 方面均无差异。高剂量组与 TBV 丢失减少（13%）有关。需要进一步进行前瞻性研究，结合药物分析，以确定 ASD 手术中 TXA 的合适剂量。
证据水平
治疗性 II 级。
试验注册
该研究于 2014 年 2 月 3 日在 Clinicaltrials.gov（NCT02053363）注册。
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