Tranexamic acid reduces perioperative blood loss in thoracolumbar posterior fusion: a meta-analysis

doi:10.3969/j.issn.2095-4344.0271

Abstract

Abstract:

BACKGROUND: Tranexamic acid has been reported to reduce perioperative blood loss in thoracolumbar posterior fusion, but these studies are small-sample trials. Therefore, it is necessary to systematically evaluate the studies at home and abroad addressing that tranexamic acid can reduce blood loss after thoracolumbar posterior fusion.

OBJECTIVE: To investigate the effectiveness and safety of tranexamic acid for reducing the perioperative blood loss in thoracolumbar posterior fusion.

METHODS: Databases of Cochrane Library, PubMed, EMbase, Medline, CNKI, CBM, WanFang and VIP were searched to retrieve the randomized clinical trials concerning the effects of tranexamic acid in thoracolumbar posterior fusion. The quality of the studies was performed by two researchers, and meta-analysis was conducted using RevMan 5.3 software.

RESULTS AND CONCLUSION: Nine studies were enrolled, including 363 cases in tranexamic acid group and 341 cases in placebo group. Compared with the placebo group, venous injection of tranexamic acid after thoracolumbar posterior fusion, could significantly reduce the intraoperative blood loss (MD=-50.57, 95%CI: -78.69- -22.44), postoperative volume of drainage (MD=-109.45, 95%CI: -124.50- -94.39), perioperative blood transfusion (OR=0.51, 95%CI: 0.31-0.85), and shorten the operation time (MD=-6.28, 95%CI: -12.01- -0.56). Additionally, tranexamic acid did not increase the incidence of deep venous thrombosis (OR=0.46, 95%CI: 0.10-2.06). Tranexamic acid also could reduce the preoperative total blood loss (MD=-184.53, 95%CI: -224.66- -144.40). These results indicate that venous injection of tranexamic acid in thoracolumbar posterior fusion can reduce intraoperative, postoperative blood loss and blood transfusion, with a good effectiveness and safety. However, multi-center large-sample randomized controlled trials are required to support the argument, because of potential bias in the included studies.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Tissue Engineering, Tranexamic Acid, Spine, Hemorrhage

CLC Number:

R318

Zhong De-gui, Wang Wen-hao, Lü Yang, Chen Shan-chuang, Mai Xiu-jun, Huang Yong-ming, Huang Yong-quan, Hou Qiu-ke, Su Hai-tao. Tranexamic acid reduces perioperative blood loss in thoracolumbar posterior fusion: a meta-analysis[J]. Chinese Journal of Tissue Engineering Research, 2018, 22(19): 3103-3109.

Figures/Tables 4

2.3 疗效指标Meta分析术中出血量：纳入的文献中共有6个研究采用术中出血量作为结局指标[5，7，9-10，12-13]，氨甲环酸组248例、对照组220例患者。异质性检验中，χ²= 9.13，P=0.1，I²=45%，提示纳入研究存在同质性，采用固定效应模型进行合并，MD=-50.57，95%CI：-78.69至 -22.44，合并效应量检验Z=3.52，P=0.000 4，提示氨甲环酸具有降低胸、胸椎后路融合术中出血量的作用，其结果具有显著性意义。见图2。术后引流量：纳入的文献中共有5个研究采用术后引流量作为结局指标[5，7，10，12-13]，氨甲环酸组200例、对照组196例患者。异质性检验中，χ²=5.03，P=0.28<0.1，I²= 20%，提示纳入研究存在同质性，采用固定效应模型进行合并，MD=-109.45，95%CI：-124.50至-94.39，合并效应量检验Z=14.25，P < 0.000 01，提示氨甲环酸具有降低胸、胸椎后路融合术后引流量的作用，其结果具有显著性意义。见图3。围手术期总出血量：纳入的文献中共有8个研究采用围手术期总出血量作为结局指标[5-9，11-13]，氨甲环酸组318例、对照组296例患者。异质性检验中，χ²=71.66，P < 0.1，I²=89%，提示纳入研究存在异质性，根据纳入标准中临床特征的差异，按照腰椎后路融合术和胸腰椎后路融合术分为两组，进行亚组分析。5项关于腰椎融合的研究整理合并分析，其中氨甲环酸组170例，对照组141例，异质性检验中，χ²=5.67，P=0.23>0.1，I²=29%，采用固定效应模型进行合并，MD=-184.53，95%CI：-224.66至-144.40，合并效应量检验Z=9.01，P < 0.000 01，提示氨甲环酸具有降低腰椎后路融合围手术期总出血量的作用，其结果具有显著性意义，见图4。3项关于胸腰椎后路融合的研究整理合并分析，纳入303例患者，其中氨甲环酸组148例，对照组155例，异质性检验中，χ²=17.64，I²=89%，通过逐一剔除试验，进行敏感性分析，结果显示剔除Carabini[8]在2017年的研究是MD=-418.28，95%CI：-464.88至-371.61(图5)，这与未剔除时总效应量合并值MD= -281.45，95%CI：-640.23-77.34，存在较大差异，提示该研究可能导致研究结果不稳定，重新检查3项研究的研究对象、干预措施、对照措施和研究结果，发现Carabini等[8]的研究除结果外未发现其他临床异质性，遂不进行Meta分析，故尚无证据证明氨甲环酸可以降低胸腰椎后路融合围手术期总出血量的作用，见图6。手术时间：纳入的文献中共有6个研究采用手术时间作为结局指标[5，7，9-10，12-13]，氨甲环酸组248例、对照组220例患者。异质性检验中，χ²=2.87，P=0.72>0.1，I²=0%，提示纳入研究存在同质性，采用固定效应模型进行合并，MD=-6.28，95%CI：-12.01至-0.56，合并效应量检验Z=2.15，P=0.03，提示氨甲环酸具有降低胸腰椎后路融合手术时间的作用，其结果具有显著性意义，见图7。输血事件发生率：纳入的文献中共有4个研究采用输血事件发生率作为结局指标[5-7，13]，其中氨甲环酸组患者189例，对照组患者192例，氨甲环酸组发生输血事件40例、对照组发生输血事件64例。异质性检验中，χ²=1.03，P=0.79>0.1，I²=0%，提示纳入研究存在同质性，采用固定效应模型进行合并，OR=0.51，95%CI：0.31-0.85，合并效应量检验Z=2.60，P=0.009，提示氨甲环酸具有减少胸腰椎后路融合手术围手术期输血的作用，其结果具有显著性意义，见图8。深静脉血栓事件发生率：纳入的文献中共有7个研究采用深静脉血栓事件发生率作为结局指标[5，6，9-13]，其中氨甲环酸组患者282例，对照组患者265例，氨甲环酸组发生深静脉血栓事件2例、对照组发生深静脉血栓事件4例。异质性检验中，χ²=1.77，P=0.41> 0.1，I²=0%，提示纳入研究存在同质性，采用固定效应模型进行合并，OR=0.46，95%CI：0.10-2.06，合并效应量检验Z=1.02，P=0.31> 0.05，提示氨甲环酸与安慰剂在胸、胸椎后路融合手术围手术期发生深静脉血栓的发生率的差异无显著性意义。见图9。 "

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