Efficacy and Safety of Tranexamic Acid on Hidden Blood Loss in Osteoporotic Vertebral Compression Fractures Patients Treated with Percutaneous Kyphoplasty: A Prospective Randomized Controlled Trial.
IF 2.8 3区 医学Q1 Pharmacology, Toxicology and Pharmaceutics
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引用次数: 0
Abstract
Purpose: To evaluate the efficacy and safety of intravenous tranexamic acid (TXA) in patients undergoing percutaneous kyphoplasty (PKP), and identify the factors influencing hidden blood loss (HBL).
Methods: This randomized, placebo-controlled trial included 146 patients undergoing PKP surgery from September 2023 to July 2024. Patients were randomly assigned into the TXA group (75 patients received 1.0 g/100mL TXA intravenously) and the placebo group (71 patients received 100mL of normal saline intravenously). Demographic and clinical characteristics were comparable between groups. HBL was calculated and compared on postoperative days 1 (POD1) and 3 (POD3). Visual analog scale (VAS) scores were also recorded preoperatively and during the follow-up. Multivariate logical regression analysis identified independent risk factors for HBL.
Results: The HBL in the TXA group was 183.78±115.48mL on POD 1 and 240.65±114.73mL on POD 3, which was significantly lower than the placebo group at 251.30±235.58mL on POD1 (P=0.032) and 384.94±223.18mL on POD3 (P<0.001). The drop in hemoglobin in the TXA group was generally lower than that of the placebo group on POD1 (4.72±3.54 vs 7.62±8.38 g/L, P=0.007), but showed no significant difference on POD 3. The drop in hematocrit in the TXA group was significantly lower than that in the placebo group on POD1 (1.91±1.21% vs 2.65±2.42%, P=0.023) and POD3 (2.49±1.23% vs 3.92±2.09%, P<0.001). Additionally, the VAS scores on POD1 (2.28±0.88 vs 2.82±0.98, P<0.001) and POD3 (1.95±0.75 vs 2.25±0.69, P=0.011) were lower in the TXA group than in the placebo group. Multivariate logical regression analysis revealed that the use of TXA (P<0.001), injury time (P<0.001), number of punctures (P=0.004), cement leakage (P=0.001), and restoration of vertebral height (P=0.002) were significantly correlated with HBL.
Conclusion: A single of 1g dose of intravenous TXA reduces HBL and early postoperative pain in PKP patients without increasing the complication rate. The use of TXA, injury time, number of punctures, cement leakage, and restoration of vertebral height were risk factors for HBL in PKP surgery. (ChiCTR2300075428).
目的：评价经皮后凸成形术（PKP）患者静脉注射氨甲环酸（TXA）的疗效和安全性，探讨影响隐性失血量（HBL）的因素。方法：这项随机、安慰剂对照试验纳入了2023年9月至2024年7月期间接受PKP手术的146例患者。将患者随机分为TXA组（75例患者静脉注射1.0 g/100mL TXA）和安慰剂组（71例患者静脉注射100mL生理盐水）。组间人口学和临床特征具有可比性。计算HBL并在术后第1天（POD1）和第3天（POD3）进行比较。术前及随访期间分别记录视觉模拟评分（VAS）。多变量逻辑回归分析确定了HBL的独立危险因素。结果：TXA组POD1的HBL为183.78±115.48mL， POD3的HBL为240.65±114.73mL，显著低于安慰剂组POD1的HBL为251.30±235.58mL （P=0.032）和POD3的HBL为384.94±223.18mL (PP=0.007)，而POD3的HBL无显著差异。与安慰剂组相比，TXA组在POD1（1.91±1.21% vs 2.65±2.42%，P=0.023）和POD3（2.49±1.23% vs 3.92±2.09%，PPP=0.011）上的红细胞压积下降明显低于安慰剂组。多因素逻辑回归分析显示，TXA的使用（PPP=0.004）、水泥渗漏（P=0.001）和椎体高度恢复（P=0.002）与HBL有显著相关。结论：单次静脉注射1g的TXA可降低PKP患者的HBL和术后早期疼痛，且未增加并发症发生率。TXA的使用、损伤时间、穿刺次数、水泥渗漏和椎体高度的恢复是PKP手术中HBL的危险因素。(ChiCTR2300075428)。
期刊介绍：
Therapeutics and Clinical Risk Management is an international, peer-reviewed journal of clinical therapeutics and risk management, focusing on concise rapid reporting of clinical studies in all therapeutic areas, outcomes, safety, and programs for the effective, safe, and sustained use of medicines, therapeutic and surgical interventions in all clinical areas.
The journal welcomes submissions covering original research, clinical and epidemiological studies, reviews, guidelines, expert opinion and commentary. The journal will consider case reports but only if they make a valuable and original contribution to the literature.
As of 18th March 2019, Therapeutics and Clinical Risk Management will no longer consider meta-analyses for publication.
The journal does not accept study protocols, animal-based or cell line-based studies.
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