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氨甲环酸对经皮椎体后凸成形术治疗的骨质疏松性椎体压缩骨折患者隐性失血的有效性和安全性:一项前瞻性随机对照试验

 

Authors Lou Z , Jiang K, Xia S, Chen S, Jiang Y, Zhu J, Zhu J

Received 5 September 2024

Accepted for publication 20 December 2024

Published 25 December 2024 Volume 2024:20 Pages 907—917

DOI https://doi.org/10.2147/TCRM.S494728

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Deyun Wang

Zhenqi Lou, Kanling Jiang, Sanqiang Xia, Sihui Chen, Yi Jiang, Jinyu Zhu, Jieyang Zhu

Department of Orthopedics, Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, People’s Republic of China

Correspondence: Jinyu Zhu; Jieyang Zhu, Department of Orthopedics, Affiliated Hospital of Jiaxing University, 1882 Zhonghuan South Road, Jiaxing, Zhejiang, People’s Republic of China, Email zhujinyu@hotmail.com; zjyzjy970612@163.com

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).

Keywords: hidden blood loss, osteoporotic vertebral compression fractures, Percutaneous kyphoplasty, tranexamic acid, multiple regression analysis