Meta-analysis of the efficacy and safety of tranexamic acid in the perioperative period of posterior lumbar fusion
- 
					 摘要:
目的 采用meta分析对氨甲环酸(TXA)在腰椎后路椎间融合术(PLIF)围手术期中的有效性和安全性进行评估,研究其在减少手术出血并促进患者恢复方面的作用。 方法 检索PubMed、Cochrane Library、EMbase、中国知网、万方和维普数据库,纳入氨甲环酸用于PLIF围手术期的随机对照试验,筛选出22项研究(共2 577例患者,其中氨甲环酸组1 300例,对照组1 277例)。采用Endnote X9整理文献,Revman 5.3软件分析数据,观察指标包括术中失血量、总失血量等。 结果 TXA应用于PLIF能显著降低术中失血量、总失血量与术后引流量,缩短手术时间,降低输血率,还能减少术后血红蛋白丢失量、红细胞压积下降幅度,缩短住院时间,且未增加术后并发症的发生风险。 结论 TXA在PLIF围手术期中应用能减少相关失血量、输血率,缩短手术时间,改善指标变化,且未增加术后并发症的发生风险,可以在临床推广。 Abstract:Objective To conduct a meta-analysis assessing the effectiveness and safety of tranexamic acid (TXA) during the perioperative period of posterior lumbar interbody fusion (PLIF), investigating its role in reducing surgical bleeding and promoting patient recovery. Methods PubMed, Cochrane Library, EMbase, CNKI, Wanfang, and VIP databases were searched for randomized controlled trials of tranexamic acid in the perioperative period of PLIF, and 22 studies (2 577 patients, 1 300 tranexamic acid group and 1 277 control group) were selected. Endnote X9 was used to organize the literature, Revman 5.3 software was used to analyze the data, and the detection indicators covered intraoperative blood loss, total blood loss, etc. Results The application of TXA to PLIF significantly reduced intraoperative and total blood loss and postoperative drainage, shortened the operation time, reduced the blood transfusion rate compared to the control group, and also reduced the postoperative hemoglobin loss and hematocrit, shortened the hospital stay, and did not increase the risk of postoperative complications. Conclusion The application of TXA in the perioperative period of PLIF can reduce the related blood loss and blood transfusion rate, shorten the operation time, improve the change of indicators, and does not increase the risk of postoperative complications, which supports clinical promotion.  - 
						
    
表 1 22篇研究的基本特征
Table 1. Basic characteristics of the 22 studies
纳入研究 发表国家 研究类型 样本量(男性/女性, 例) 年龄 干预方式 BMI 结局指标 TXA 对照组 TXA 对照组 TXA 对照组 TXA 对照组 HE B, 2020[8] 中国 RCT 8/12 11/9 57.95±12.44 57.90±11.76 A+B 10 mg/kg+6~ 8 mg/(kg·h) 0.9%生理盐水 25.02±5.19 24.75±4.42 ①③④⑤⑩ KIM T K, 2014[9] 韩国 RCT 12/12 15/9 61.0±9.0 65.2±7.0 A+B 10 mg/kg+ 2 mg/(kg·h) 0.9%生理盐水 25.9±3.2 25.1±3.2 ①②③④⑥⑩ LIANG J, 2016[10] 中国 RCT 14/16 15/15 63.1±7.1 53.6±6.4 C 2 000 mg 0.9%生理盐水 25.3±5.2 26.2±4.1 ①③④⑤⑦⑧⑨ MU X, 2019[11] 中国 RCT 27/18 23/19 54.20±7.37 52.57±6.73 A 15 mg/kg+ 1 mg/(kg·h) 0.9%生理盐水 24.83±1.95 23.93±1.35 ①②③⑤⑥⑦⑧⑨ NAGABHUSHAN J, 2018[12] 印度 RCT 9/16 11/14 49.60±9.79 51.72±9.71 A+B 10 mg/kg+ 1 mg/(kg·h) 0.9%生理盐水 51.72±9.71(体重) 60.96±7.35(体重) ①③④⑦⑧ OU Y, 2018[13] 中国 RCT 30/29 31/28 64.2±4.6 64.0±5.1 A+C 15 mg/kg+1.0 g 0.9%生理盐水 22.64±3.29 22.57±3.2 ①②③④⑤⑦⑧⑨ SHI H, 2017[14] 中国 RCT 25/25 22/24 53.76±12.06 55.87±13.14 A+B 30 mg/kg+ 2 mg/(kg·h) 0.9%生理盐水 62.13±9.98(体重) 63.10±10.82(体重) ①②③④⑤⑦⑧ WANG J, 2013[15] 中国 RCT 14/16 12/18 63.1±4.0 62.0±4.6 A 15 mg/kg 0.9%生理盐水 21.7±1.9 22.2±1.9 ①②④⑨ XU D, 2020[16] 中国 RCT 19/21 13/27 53.1±12.0 57.4±10.7 C 1 g 0.9%生理盐水 25.6±2.8 24.9±3.9 ①②③④⑤⑨ YAN L, 2021[17] 中国 RCT 16/24 22/18 53±7 52±8 A+B 20 mg/kg+ 10 mg/(kg·h) 0.9%生理盐水 70±10(体重) 67±12(体重) ①②④⑤⑥⑦⑧ ZHANG L, 2020[18] 中国 RCT 47/91 57/94 57.04±10.20 54.73±9.93 A+C 1 g+1 g 0.9%生理盐水 25.20±3.54 25.82±3.28 ①②③④⑤⑥⑦⑧ ZHU X, 2020[19] 中国 RCT 22/28 21/29 56.0±9.5 54.8±10.3 A 15 mg/kg 0.9%生理盐水 23.8±2.9 23.8±2.8 ①②③④⑤ ROOPA K N, 2018[20] 印度 RCT 25 25 51.72±9.71 49.60±9.79 A+B 10 mg/kg+ 1 mg/(kg·h) 0.9%生理盐水 58.84±3.31(体重) 60.96±7.35(体重) ①②③④⑥ WONG J, 2008[21] 加拿大 RCT 21/52 26/48 56.8±16.2 50.0±16.2 A+B 10 mg/kg+ 1 mg/(kg·h) 0.9%生理盐水 72.9±17.2(体重) 73.9±16.1(体重) ③④⑤⑩ WANG Q, 2018[22] 中国 RCT 25/18 18/19 41.2±10.3 42.5±9.5 A+B 10 mg/kg+ 1 mg/(kg·h) 0.9%生理盐水 63.2±18.3(体重) 64.3±19.1(体重) ③④⑥⑩ SUN H, 2019[23] 中国 RCT 45/45 22/15 57.12±11.55 51.51±13.57 A 15 mg/kg 0.9%生理盐水 24.86±4.72 24.44±3.57 ①②③④⑤⑥ LI X, 2023[24] 中国 RCT 74/138 84/143 55.40±10.61 55.26±10.44 A+C 2 g+1 g 0.9%生理盐水 25.73±3.31 25.71±3.63 ①②④⑤⑥ WEI Y, 2023[25] 中国 RCT 24/35 26/37 58.66±6.87 60.51±9.30 A 1 g 0.9%生理盐水 24.36±2.89 24.90±3.26 ④⑤⑩ ELWATIDY S, 2008[26] 沙·阿 RCT 21/11 18/14 51.56±19.08 49.75±21.04 A+B 30 mg/kg+ 1 mg(kg·h) 0.9%生理盐水 72.48±13.81(体重) 69.63±17.29(体重) ①②③④⑤ FARROKHI M R, 2011[27] 德国 RCT 11/27 7/31 45.5±11.6 51.4±11.6 A+B 10 mg/kg+ 1 mg/(kg·h) 0.9%生理盐水 66.6±9.9(体重) 66.9±9.4(体重) ①②④⑤ GOLOVINA V A, 2017[28] 德国 RCT 15/29 15/38 59.2 50.8 A+B 10 mg/kg+ 2 mg/(kg·h) 0.9%生理盐水 72.0(体重) 67.7(体重) ④⑤⑥ BU G Y, 2014[29] 中国 RCT 102/31 109/25 54.2±13.1 52.6±16.3 C 1 000 mg 0.9%生理盐水 23.84±4.40 23.71±4.80 ①③⑤ 注:干预方式,A为静脉使用;B为术中维持;C为局部使用。结局指标,①术中失血量;②总失血量;③术后引流量;④手术时间;⑤输血率;⑥深静脉血栓发生率;⑦术后血红蛋白;⑧术后红细胞压积;⑨住院时间;⑩术后并发症发生率。  - 
						
[1] NAKAJIMA H, WATANABE S, HONJOH K, et al. Indication and limitation of intradiscal condoliase injection for patients with lumbar disc herniation: literature review and meta-analysis[J]. Spine Surg Relat Res, 2024, 8(4): 362-372. doi: 10.22603/ssrr.2023-0294 [2] NISHIDA N, MUMTAZ M, TRIPATHI S, et al. The effect of posterior lumbar interbody fusion in lumbar spine stenosis with diffuse idiopathic skeletal hyperostosis: a finite element analysis[J]. World Neurosurg, 2023, 176: e371-e379. doi: 10.1016/j.wneu.2023.05.063 [3] 许川雅, 宗亚楠, 周阳, 等. 成人脊柱手术患者术中输血情况的回顾性分析[J]. 临床麻醉学杂志, 2019, 35(3): 230-234.XU C Y, ZONG Y N, ZHOU Y, et al. Retrospective analysis of intraoperative blood transfusion in adult patients undergoing spine surgery[J]. Journal of Clinical Anesthesiology, 2019, 35(3): 230-234. [4] 何睿, 曾勇, 李庆, 等. 微创手术对脊柱创伤患者围术期指标、脊柱功能及术后并发症的影响[J]. 贵州医科大学学报, 2020, 45(7): 844-848.HE R, ZENG Y, LI Q, et al. Effect of minimally invasive surgery on perioperative indexes, spinal function and postoperative complications in patients with spinal trauma[J]. Journal of Guizhou Medical University, 2020, 45(7): 844-848. [5] LI S, YANG J, WATSON C, et al. Drainage relieves pain without increasing post-operative blood loss in high tibial osteotomy: a prospective randomized controlled study[J]. Int Orthop, 2020, 44(6): 1037-1043. doi: 10.1007/s00264-020-04530-z [6] ZHAO H Y, YEERSHENG R, KANG X W, et al. The effect of tourniquet uses on total blood loss, early function, and pain after primary total knee arthroplasty: a prospective, randomized controlled trial[J]. Bone Joint Res, 2020, 9(6): 322-332. doi: 10.1302/2046-3758.96.BJR-2019-0180.R3 [7] LIER H, MAEGELE M, SHANDER A. Tranexamic acid for acute hemorrhage: a narrative review of landmark studies and a critical reappraisal of its use over the last decade[J]. Anesth Analg, 2019, 129(6): 1574-1584. doi: 10.1213/ANE.0000000000004389 [8] HE B, LI Y, XU S, et al. Tranexamic acid for blood loss after transforaminal posterior lumbar interbody fusion surgery: a double-blind, placebo-controlled, randomized study[J]. Biomed Res Int, 2020, 2020: 8516504. DOI: 10.1155/2020/8516504. [9] KIM T K, CHANG C B, KANG Y G, et al. Clinical value of tranexamic acid in unilateral and simultaneous bilateral TKAs under a contemporary blood-saving protocol: a randomized controlled trial[J]. Knee Surg Sports Traumatol Arthrosc, 2014, 22(8): 1870-1878. doi: 10.1007/s00167-013-2492-1 [10] LIANG J, LIU H, HUANG X, et al. Combined use of intravenous and topical tranexamic acid in primary total knee arthroplasty[J]. Orthop Surg, 2016, 8(3): 300-304. [11] MU X, WEI J, WANG C, et al. Intravenous administration of tranexamic acid significantly reduces visible and hidden blood loss compared with its topical administration for double-segment posterior lumbar interbody fusion: a single-center, placebo-controlled, randomized trial[J]. World Neurosurg, 2019, 122: e821-e827. doi: 10.1016/j.wneu.2018.10.154 [12] NAGABHUSHAN J, MATHEW J, DAVID T. Effectiveness of tranexamic acid in reducing blood loss in total knee replacement[J]. Indian J Orthop, 2018, 52(1): 58-63. doi: 10.4103/ortho.IJOrtho_195_17 [13] OU Y, XIE J, HUANG Z, et al. Combined intravenous and topical tranexamic acid administration in total knee arthroplasty[J]. J Bone Joint Surg Am, 2018, 100(13): 1093-1099. [14] SHI H, WANG J, BAI Y, et al. The efficacy and safety of high-dose tranexamic acid in total knee arthroplasty[J]. BMC Musculoskelet Disord, 2017, 18(1): 273. DOI: 10.1186/s12891-017-1639-5. [15] WANG J, WANG Q, ZHANG X, et al. Single-dose tranexamic acid for reducing bleeding and transfusion in TKA[J]. Chin Med J(Engl), 2013, 126(5): 855-859. [16] XU D, CHEN X, LI Z, et al. Tranexamic acid reduce hidden blood loss in posterior lumbar interbody fusion (PLIF) surgery[J]. Medicine(Baltimore), 2020, 99(11): e19552. DOI: 10.1097/MD.0000000000019552. [17] YAN L, YANG H, JIANG H, et al. Impact of the tranexamic acid on bleeding amount of surgical patient with degenerative spinal disease: a randomized blinded study[J]. Front Surg, 2021, 8: 655692. DOI: 10.3389/fsurg.2021.655692. [18] ZHANG L, LI Y, LIU D, et al. Combined use of tranexamic acid and rivaroxaban in posterior lumbar interbody fusion safely reduces blood loss and transfusion rates without increasing the risk of thrombosis-a prospective, stratified, randomized, controlled trial[J]. Int Orthop, 2020, 44(10): 2079-2087. doi: 10.1007/s00264-020-04699-3 [19] ZHU X, SHI Q, LI D, et al. Two doses of tranexamic acid reduce blood loss in primary posterior lumbar fusion surgery: a randomized-controlled trial[J]. Clin Spine Surg, 2020, 33(10): E593-E597. doi: 10.1097/BSD.0000000000000999 [20] ROOPA K N, MAHESH B, SHASHIDHAR K. Tranexamic acid in Indian patients undergoing TKA[J]. J Clin Orthop Trauma, 2018, 9(Suppl 1): S53-S57. [21] WONG J, ABRISHAMI A, EL BEHEIRY H, et al. Topical tranexamic acid reduces blood loss in high-risk orthopedic surgery[J]. Can J Anaesth, 2008, 55(8): 509-516. [22] WANG Q, LIU J, FAN R, et al. Tranexamic acid in spinal surgery[J]. Eur Spine J, 2018, 27(2): 173-178. [23] SUN H, DENG L, DENG J, et al. The efficacy and safety of prophylactic intravenous tranexamic acid on perioperative blood loss in patients treated with posterior lumbar interbody fusion[J]. World Neurosurg, 2019, 125: e198-e204. doi: 10.1016/j.wneu.2019.01.040 [24] LI X, JIAO G, LI J, et al. Combined use of tranexamic acid and rivaroxaban in posterior/transforaminal lumbar interbody fusion surgeries safely reduces blood loss and incidence of thrombosis: evidence from a prospective, randomized, double-blind, placebo-controlled study[J]. Global Spine J, 2023, 13(5): 1229-1237. doi: 10.1177/21925682211024556 [25] WEI Y, ZHANG Y, YANG Y, et al. Low-dose tranexamic acid in TKA[J]. Front Pharmacol, 2023, 14: 1123456. DOI: 10.3389/fphar.2023.1123456. [26] ELWATIDY S, JAMJOOM Z, ELGAMAL E, et al. Tranexamic acid in cardiac surgery[J]. Saudi Med J, 2008, 29(5): 734-738. [27] FARROKHI M R, KAZEMI A P, EFTEKHARIAN H R, et al. Efficacy of tranexamic acid in spine surgery[J]. Eur Spine J, 2011, 20(12): 2201-2205. [28] GOLOVINA V A, SEREDA A P, KOCHENOV A. Tranexamic acid in hip arthroplasty[J]. Z Orthop Unfall, 2017, 155(1): 82-87. [29] BU G Y, LIU L, LI H. Oral tranexamic acid in Chinese TKA patients[J]. Chin J Orthop, 2014, 34(5): 512-517. [30] MOHME M, MENDE K C, PANTEL T, et al. Intraoperative blood loss in oncological spine surgery[J]. Neurosurg Focus, 2021, 50(5): E14. DOI: 10.3171/2021.2.FOCUS201117. [31] MARTIN B I, MIRZA S K, SPINA N, et al. Trends in lumbar fusion procedure rates and associated hospital costs for degenerative spinal diseases in the United States, 2004 to 2015[J]. Spine(Phila Pa 1976), 2019, 44(5): 369-376. doi: 10.1097/BRS.0000000000002822 [32] 张楠, 王苗, 张鹏, 等. 切口内留置引流管对腰椎后路椎管减压内固定术后患者切口愈合和感染指标的影响[J]. 中华全科医学, 2024, 22(5): 729-732. doi: 10.16766/j.cnki.issn.1674-4152.003490ZHANG N, WANG M, ZHANG P, et al. Effect of indwelling indwelling drainage tube on incision healing and infection indexes in patients after posterior lumbar spinal decompression and internal fixation[J]. Chinese Journal of General Practice, 2024, 22(5): 729-732. doi: 10.16766/j.cnki.issn.1674-4152.003490 [33] HUYNH P A N, MILLER M, WILL R. Intravenous tranexamic acid decreases blood transfusions and blood loss for patients with surgically treated hip fractures[J]. Geriatr Orthop Surg Rehabil, 2021, 12: 21514593211063668. DOI: 10.1177/21514593211063668. [34] HABBAB L M, SEMELHAGO L, LAMY A. Topical use of tranexamic acid in cardiac surgery: a meta-analysis[J]. Thorac Cardiovasc Surg, 2020, 68(3): 212-218. doi: 10.1055/s-0039-1691748 [35] 杨惠鸿, 闫磊, 徐桂萍. 氨甲环酸联合控制性降压对脊柱手术出血的影响[J]. 中华全科医学, 2022, 20(6): 927-930, 981. doi: 10.16766/j.cnki.issn.1674-4152.002489YANG H H, YAN L, XU G P. Effect of tranexamic acid combined with controlled antihypertensive acid on bleeding during spinal surgery[J]. Chinese Journal of General Practice, 2022, 20(6): 927-930, 981. doi: 10.16766/j.cnki.issn.1674-4152.002489 [36] FERSCHL M B, SHIBATA G, WONG J. New surgical approaches to scoliosis repair in pediatric patients: implications for anesthetic management[J]. Curr Anesthesiol Rep, 2024, 14: 475-483. doi: 10.1007/s40140-024-00641-0 [37] 李毅, 仝路, 武刚, 等. 氨甲环酸对腰椎后路椎体间融合术后引流管拔除时机及疗效的影响[J]. 临床骨科杂志, 2023, 26(6): 778-781.LI Y, TONG L, WU G, et al. Effect of tranexamic acid on the timing and efficacy of drainage tube removal after posterior lumbar interbody fusion[J]. Journal of Clinical Orthopedics, 2023, 26(6): 778-781. [38] 邱皓, 朱云, 翁政, 等. 老年股骨转子间骨折治疗过程中氨甲环酸的应用[J]. 中国组织工程研究, 2023, 27(22): 3550-3554.QIU H, ZHU Y, WENG Z, et al. Application of tranexamic acid in the treatment of intertrochanteric fractures in the elderly[J]. Chinese Journal of Tissue Engineering Research, 2023, 27(22): 3550-3554. [39] 江洪耿, 林本丹. 氨甲环酸在全髋关节置换术患者中的应用效果及对血红蛋白的影响研究[J]. 中外医学研究, 2023, 21(19): 157-160.JIANG H G, LIN B D. Effect of tranexamic acid on patients undergoing total hip arthroplasty and its effect on hemoglobin[J]. Chinese and Foreign Medical Research, 2023, 21(19): 157-160. [40] 阿里木江·玉素甫, 阿卜杜吾普尔·海比尔, 覃祺, 等. 氨甲环酸和氨基己酸在全膝关节置换围术期应用的有效性与安全性[J]. 中国组织工程研究, 2023, 27(36): 5812-5817.Alimujiang Yusufu, Abduwupur Haibil, QIN Q, et al. Efficacy and safety of tranexamic acid and aminocaproic acid in the perioperative period of total knee arthroplasty[J]. Chinese Journal of Tissue Engineering Research, 2023, 27(36): 5812-5817. [41] LUO H, YANG Y, WANG Z, et al. Efficacy and safety of tranexamic acid in cervical spine surgery: a systematic review and meta-analysis[J]. Front Neurol, 2024, 15: 1405773. DOI: 10.3389/fneur.2024.1405773. [42] KHADIVI M, SAGHEBDOUST S, MOGHADAM N, et al. Effect of topical administration of tranexamic acid on intraoperative and postoperative blood loss during posterior cervical laminectomy and fusion surgery: a retrospective study[J]. Turk Neurosurg, 2023, 33(1): 94-100. [43] DEFRANCESCO C J, REICHEL J F, GBAJE E, et al. Effectiveness of oral versus intravenous tranexamic acid in primary total hip and knee arthroplasty: a randomised, non-inferiority trial[J]. Br J Anaesth, 2023, 130(2): 234-241. doi: 10.1016/j.bja.2022.11.003  - 
						
						
						
						
						
					 
                
 
							
							
下载: