摘要
目的探讨局部应用氨甲环酸(TXA)镇痛合剂(TXAA)对接受腰椎后路椎间融合内固定(PLIF)术患者围手术期出血、术后疼痛及血栓形成风险的影响。方法选择2017年3月至2020年1月,于廊坊市第四人民医院行PLIF的105例腰椎间盘突出或腰椎管狭窄患者为研究对象。患者年龄为(54.8±14.3)岁;男性患者为69例,女性为36例;腰椎间盘突出患者为60例,腰椎管狭窄者为45例。采用随机数字表法将患者随机分为TXAA组(n=35,术前静脉滴注TXA 1.0 g,深筋膜关闭前切口局部注射TXAA 50 mL),TXA组(n=35,术前静脉滴注TXA 1.0 g)和对照组(n=35,围手术期不应用TXA),分别记录3组患者出血相关指标:围手术期总出血量、显性出血量、隐性出血量、术后引流量、输血率,术后疼痛相关指标:视觉模拟评分法(VAS)疼痛评分、前列腺素(PGE)2水平、缓激肽水平,以及血栓发生风险相关指标:国际标准化比值(INR)、血栓弹力图(TEG)-血栓最大幅度(MA)值、D-二聚体水平等。并且于手术后3个月内对患者进行不良事件随访。对于呈正态分布、方差齐的计量资料,如围手术期总出血量、显性出血量、VAS疼痛评分等,3组及各组中不同时间点的总体比较采用单因素方差分析,组间及组内不同时间点的两两比较采用LSD法。性别构成比、输血率等计数资料的3组整体比较和组间两两比较采用χ2检验,检验水准校正采用Bonferroni校正法。3组患者的性别构成比、年龄、人体质量指数、术前血红蛋白(Hb)值、术前纤维蛋白原水平、术前D-二聚体水平等一般临床资料分别比较,差异均无统计学意义(P>0.05)。本研究遵循的程序符合廊坊市第四人民医院人体试验委员会制定的标准,经过该伦理委员会批准(批准文号:lfsyll-2016-6),并与所有受试者签署临床研究知情同意书。结果①本研究TXAA组、TXA组和对照组患者的围手术期总出血量、显性出血量、术后24 h引流量、术后总引流量、围手术期异体悬浮红细胞输注量分别比较,差异均有统计学意义(P<0.05)。TXAA组患者的上述5项指标分别为(599.6±67.3)、(379.9±38.8)、(169.9±56.9)、(272.8±83.1)、(217.0±64.1)mL,均低于TXA组和对照组,并且差异均有统计学意义(TXAA组比TXA组:LSD-t=5.397、3.987、3.561、4.156、3.451,P=0.008、0.023、0.029、0.021、0.031;TXAA组比对照组:LSD-t=6.901、4.563、5.967、9.321、6.045,P<0.001、=0.019、=0.006、<0.001、=0.003)。②3组患者术后12、24及48 h时的VAS疼痛评分,以及术后1、3 d时的PGE2和缓激肽水平,分别较术前升高,并且差异均有统计学意义(P<0.05)。TXAA组患者术后12、24、48 h时的VAS疼痛评分分别为(2.1±0.9)、(2.4±1.0)和(1.9±0.9)分,均低于TXA组及对照组,并且差异均有统计学意义(TXAA组比TXA组:LSD-t=6.063、10.736、29.654,P=0.011、<0.001、<0.001;TXAA组比对照组:t=6.239、11.079、31.078,P=0.007、<0.001、<0.001)。TXAA组术后1、3 d时的PGE2水平分别为(154.4±23.1)和(195.4±30.8)pg/mL,缓激肽水平分别为(167.8±15.4)和(217.1±14.9)ng/mL,均低于TXA组及对照组,并且差异均有统计学意义(P<0.05)。③TXAA组患者术后1 d时的TEG-MA值为(67.4±6.0)mm,分别高于术前、TXA组及对照组,并且差异均有统计学意义(LSD-t=5.693、0.383、8.963,P=0.021、=0.046、<0.001)。3组患者术后1、3 d时的D-二聚体水平分别较术前升高,并且差异均有统计学意义(P<0.05);而TXAA组术后1、3 d的D-二聚体水平分别为(398.3±73.2)和(283.7±49.6)mmol/L,分别低于TXAA组和对照组,并且差异亦均有统计学意义(P<0.05)。3组患者INR的组间及组内各时间点分别比较,差异均无统计学意义(P>0.05)。④所有患者术后切口均获良好愈合,未出现切口感染、愈合延迟及血肿压迫神经等情况。术后超声随访未发现深静脉血栓形成(DVT)。结论对接受PLIF术的腰椎间盘突出或腰椎管狭窄患者,在术前静脉滴注TXA的基础上,切口内局部注射TXAA,有助于提高止血效果,减轻术后疼痛,并且不增加血栓等不良事件发生风险。
Objective To explore of topical tranexamic acid(TXA)analgesia agent(TXAA)on blood loss,postoperative pain and thrombosis risk in patients undergoing posterior lumbar inferbody fusion surgery(PLIF).Methods From March 2017 to January 2020,a total of 105 patients with lumbar disc herniation or lumbar spinal stenosis who underwent PLIF in Fourth People′s Hospital of Langfang City were selected as research subjects.The age of patients was(54.8±14.3)years old.There were 69 male and 36 female patients;as well as 60 patients with lumbar disc herniation and 45 cases with lumbar spinal stenosis.Patients were randomly divided into and TXAA group(n=35,TXA 1.0 g was intravenously before PLIF,and TXAA 50 mL was locally injected into incision before deep fascia closure),TXA group(n=35,preoperative intravenous infusion of TXA 1.0 g),control group(n=35,no TXA was used during perioperative period)by random number table.The bleeding,postoperative pain and thrombosis risk-related indicators of patients in 3 groups were recorded respectively.Bleeding related indicators included total perioperative blood loss volume,dominant blood loss volume,latent blood loss volume,postoperative drainage volume,blood transfusion rate.Postoperative pain related indicators included visual analogue scale(VAS)pain score,prostaglandin(PG)E2 level,and bradykinin level.Thrombosis related indicators included international standardized ratio(INR),thrombelastogram(TEG)-maximum thrombus(MA)value,and D-dimer level.And adverse events were followed up 3 months after operation.For the measurement data with normal distribution and equal variance,such as total perioperative blood loss volume,dominant blood loss volume,VAS pain score,etc.,one-way ANOVA was used for overall comparison among 3 groups and at different time points in each group,and LSD method was used for pairwise comparison between groups and at different time points in each group.The Chi-square test was used for overall comparison among 3 groups and pairwise comparison of the count data such as sex composition ratio and blood transfusion rate,and the Bonferroni correction method was used for test level correction.There were no significant differences in general clinical data such as gender composition ratio,age,body mass index,preoperative hemoglobin(Hb,value,preoperative fibrinogen level,and preoperative D-dimer level of patients among 3 groups(P>0.05).The procedures followed in this study were in accordance with the standards established by the Committee of Investigation in Human Beings of Fourth People′s Hospital of Langfang City,and this study was approved by the committee(Approval No.lfsyll-2016-6).All the subjects signed the informed consents for clinical trials.Results①In this study,the total perioperative blood loss volume,dominant blood loss volume,postoperative 24 h drainage volume,postoperative total drainage volume,and perioperative allogeneic suspended red blood cell transfusion volume of patients in TXAA group,TXA group and control group were compared respectively,and the differences were statistically significant(P<0.05).The above 5 indexes of patients in TXAA group were(599.6±67.3),(379.9±38.8),(169.9±56.9),(272.8±83.1)and(217.0±64.1)mL,which were lower than those of patients in TXA group and control group.and the differences were statistically significant(TXAA group vs TXA group:LSD-t=5.397,3.987,3.561,4.156,3.451,P=0.008,0.023,0.029,0.021,0.031;TXAA group vs control group:LSD-t=6.901,4.563,5.967,9.321,6.045,P<0.001,=0.019,=0.006,<0.001,=0.003).②The VAS pain scores at 12,24 and 48 h after operation,as well as levels of PGE2 and bradykinin on 1 and 3 d after operation of patients in 3 groups were higher than those before operation,and the differences were statistically significant(P<0.05).The VAS pain scores of patients in TXAA group at 12,24 and 48 h after operation were(2.1±0.9),(2.4±1.0)and(1.9±0.9)scores respectively,which were lower than those in TXA group and control group,and the differences were statistically significant(TXAA group vs TXA group:LSD-t=6.063,10.736,29.654,P=0.011,<0.001,<0.001;TXAA group vs control group:t=6.239,11.079,31.078,P=0.007,<0.001,<0.001).The levels of PGE2 of patients in TXAA group on 1 and 3 d after operation were(154.4±23.1)and(195.4±30.8)pg/mL,and levels of bradykinin were(167.8±15.4)and(217.1±14.9)ng/mL,respectively,which were lower than those of TXA group and control group,and the differences were statistically significant(P<0.05).③The TEG-MA value of patients in TXAA group on 1 d after operation was(67.4±6.0)mm,which were higher than those before operation,and of TXA group and control group respectively,and the differences were statistically significant(LSD-t=5.693,0.383,8.963,P=0.021,=0.046,<0.001).The D-dimer levels of patients in 3 groups on 1 and 3 d after operation were higher than those before operation respectively,and the differences were statistically significant(P<0.05).However,the D-dimer levels of patients in TXAA group on 1 and 3 d after operation were(398.3±73.2)and(283.7±49.6)mmol/L,which were lower than those in TXAA group and control group respectively,and the differences were also statistically significant(P<0.05).There was no significant difference in INR among 3 groups and at each time point within group(P>0.05).④The postoperative incisions of all patients were well healed,and no incisional infection,delayed healing,or nerve compression by hematoma were observed.Postoperative ultrasound follow-up revealed no deep venous thrombosis(DVT).Conclusions For patients with lumbar intervertebral disc herniation or lumbar spinal stenosis who received PLIF,on the basis of preoperative intravenous infusion of TXA,local injection of TXAA into the incision can help to improve the hemostasis effect,relieve postoperative pain,and not increase the adverse effects risk such as thrombosis.
作者
杨玉芬
袁建茹
张红颖
刘沫轩
闫辉
Yang Yufen;Yuan Jianru;Zhang Hongying;Liu Moxuan;Yan Hui(Fourth People′s Hospital of Langfang City,Langfang 065700,Shandong Province,China)
出处
《国际输血及血液学杂志》
CAS
2022年第3期253-261,共9页
International Journal of Blood Transfusion and Hematology
基金
廊坊市科学技术研究与发展计划(2019013118)。
关键词
氨甲环酸
肾上腺素
罗哌卡因
脊柱融合术
失血
手术
疼痛
手术后
氨甲环酸镇痛合剂
Tranexamic acid
Epinephrine
Ropivacaine
Blood loss,surgical
Spinal fusion
Blood loss,surgical
Pain,postoperative
Tranexamic acid analgesia agent
