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中华关节外科杂志(电子版) ›› 2021, Vol. 15 ›› Issue (04) : 438 -449. doi: 10.3877/cma.j.issn.1674-134X.2021.04.008

荟萃分析

氨甲环酸不同使用方法在膝关节置换中的疗效分析
李浩1, 李亚坤1, 王浩浩1, 张民1,()   
  1. 1. 030009 山西医科大学附属太原市中心医院
  • 收稿日期:2020-06-16 出版日期:2021-09-29
  • 通信作者: 张民

Effect analysis of different methods of tranexamic acid application in knee arthroplasty

Hao Li1, Yakun Li1, Haohao Wang1, Min Zhang1,()   

  1. 1. Department of Orthopedics, Taiyuan Central Hospital of Shanxi Medical University, Taiyuan 030009, China
  • Received:2020-06-16 Published:2021-09-29
  • Corresponding author: Min Zhang
引用本文:

李浩, 李亚坤, 王浩浩, 张民. 氨甲环酸不同使用方法在膝关节置换中的疗效分析[J/OL]. 中华关节外科杂志(电子版), 2021, 15(04): 438-449.

Hao Li, Yakun Li, Haohao Wang, Min Zhang. Effect analysis of different methods of tranexamic acid application in knee arthroplasty[J/OL]. Chinese Journal of Joint Surgery(Electronic Edition), 2021, 15(04): 438-449.

目的

比较关节腔注射、静脉滴注和联合二者应用氨甲环酸(TXA)对全膝关节置换(TKA)患者失血量和输血量的影响。

方法

通过计算机检索PubMed、Cochrane Library、荷兰医学文摘(Embase)等英文数据库和中国知网、万方、维普及中国生物医学等中文数据库,搜索氨甲环酸用于膝关节置换术的相关文献,纳入其中研究方法为随机对照的文献,并对文献进行质量评价,所提取数据使用软件StataV.15.1进行Meta分析。

结果

共纳入40项随机对照临床试验,共包括5 295例患者。Meta分析结果显示关节腔注射与静脉点滴氨甲环酸相比,在总失血量、术后引流量、术后血红蛋白水平、血红蛋白下降值、输血率及血栓事件发生率方面疗效相似,差异无统计学意义(P>0.05);联合静脉滴注和关节腔注射与单一方案应用氨甲环酸相比,可显著减少总失血量[加权均数差(WMD)=-116.39,95%置信区间(CI)(-149.26,-83.52),P<0.05],减少术后引流量[WMD=-57.99,95% CI(-85.92,-30.06),P=0.005],提高术后血红蛋白水平[标准化均数差(SMD)=0.73,95%CI(0.49,0.98),P=0.001],降低血红蛋白丢失量[SMD=-0.66,95% CI(-1.06,-0.28),P=0.025],降低输血率[相对危险度(RR)=0.43,95% CI(0.30,0.61),P<0.05],而在血栓事件上两者差异没有统计学意义(P>0.05)。

结论

在全膝关节置换术中,推荐联合静脉滴注和关节腔局部注射应用氨甲环酸,可以明显改善临床结局。

Objective

To compare the effects of intraarticular injection, intravenous drip and combined application of tranexamic acid (TXA) on blood loss and blood transfusion in patients undergoing total knee arthroplasty (TKA).

Methods

Through computer retrieval of English databases such as PubMed, Cochrane Library and Excerpta Medica Database(Embase) and Chinese databases such as China National Knowledge Infrastructure (CNKI), WanFang, VIP and Chinese BioMedical Literature Database (CBM), the relevant literature on the use of tranexamic acid in knee arthroplasty was searched. The literatures with randomized control methods were included, and the quality of the literatures was evaluated. The extracted data were analyzed by the software StataV.15.1.

Results

A total of 40 randomized controlled trials were included, including 5 295 patients. The results of meta analysis showed that compared with intravenous drip of tranexamic acid, intra-articular injection had similar effects on total blood loss, drainage volume, postoperative hemoglobin level, hemoglobin reduction, blood transfusion rate and incidence of thrombotic events, there was no significant difference (P>0.05). Compared with single regimen, combined intravenous and local application of TXA could significantly reduce total blood loss[weighted mean difference (WMD)=-116.39, 95% confidence interval (CI) (-149.26, -83.52), P<0.05], reduce postoperative drainage [WMD=-57.99, 95%CI (-85.92, -30.06), P=0.005], increase postoperative hemoglobin level [standardized mean difference (SMD)=0.73, 95%CI (0.49, 0.98), P=0.001], decrease hemoglobin loss[SMD=-0.66, 95%CI(-1.06, -0.28), P=0.025] and blood transfusion rate[relative risk (RR)=0.43, 95%CI(0.30, 0.61), P<0.05]. There was no statistically significant difference in thrombus events between the two groups(P>0.05).

Conclusion

It is recommended to use tranexamic acid locally and intravenously in total knee arthroplasty, which can significantly improve the clinical outcome.

表1 关节腔注射和静脉滴注TXA(氨甲环酸)基本情况
作者(年份) 样本量 年龄(岁) 性别(男/女) 手术方案 静脉滴注组 关节腔注射组 止血带使用 血栓预防方案
梁洪忠[30](2017) 80 70 (35/45) 单侧TKA 关闭切口前10 mg/kg 缝合关节囊后0.5 g 低分子肝素
宝音[22](2017) 60 66 (20/40) 单侧TKA 术前0.5 h 、20 mg/kg 缝合关节囊后1 g 利伐沙班
李华贵[28](2017) 80 67 (32/48) 单侧TKA 止血带充气前20 min、松止血带前15 min、术后3 h各10 mg/kg 缝合关节囊后3 g 利伐沙班
潘云春[32](2016) 140 67 (48/92) 单侧TKA 松止血带前30 min 20 mg/kg 松止血带前30 min 3 g 利伐沙班
柴星宇[23](2015) 90 71 (28/62) 单侧TKA 麻醉诱导期10 mg/kg 假体安装后2 g 利伐沙班
高智慧[26](2018) 100 64 (28/72) 单侧TKA 止血带充气前1 g +缝合关节囊后1 g 缝合关节囊后2 g 利伐沙班
杨伟臻[36](2016) 121 73 (40/81) 单侧TKA 切皮前10 min 10 mg/kg 缝合关节囊后1 g 低分子肝素
张岩[37](2019) 128 64 (52/76) 单侧TKA 止血带充气前1 g +止血带充气后1 g 假体安装后3 g -
胡文浩[27](2018) 70 68 (13/57) 单侧TKA 切皮前1 g +缝合皮肤时1 g 缝合皮肤后2 g 低分子肝素
Chen[39](2016) 100 65 (25/75) 单侧TKA 麻醉诱导后30 min 1.5 g 假体安装后20 min 1.5 g 低分子肝素
Digas[40](2015) 60 71 (9/51) 单侧TKA 松止血带前15 mg/kg 关闭切口后2 g 亭扎肝素
Drosos[41](2016) 60 70 (12/48) 单侧TKA 缝合切口开始时1 g 缝合切口开始时1 g -
George[42](2017) 113 64 (38/75) 单侧TKA 止血带充气前10 mg/kg+松止血带前10 mg/kg 关闭切口前1.5 g 依诺肝素
Barrena[43](2014) 78 71 (27/51) 单侧TKA 松止血带前20 min 15 mg/kg+术后3 h 15 mg/kg 松止血带前3 g 依诺肝素
Elysee[46](2019) 63 65 (23/40) 单侧TKA 止血带充气前2 g 松止血带前5 min 3 g -
Lee[47](2017) 396 73 (50/346) 单侧TKA 松止血带前30 min 10 mg/kg +术后3 h 10 mg/kg 关闭切口前2 g 利伐沙班
Maniar[49](2012) 80 67 (16/64) 单侧TKA 松止血带前15 min 10 mg/kg 松止血带前5 min 3 g 低分子肝素
Abdel[38](2018) 640 66 (260/380) 单侧TKA 止血带充气前1 g 松止血带前3 g 阿司匹林
May[50](2016) 131 64 (29/102) 单侧TKA 麻醉诱导后2 g 关节囊缝合后2 g 低分子肝素
 Öztaş[52](2015) 60 68 (9/51) 单侧TKA 止血带充气前1 h 15 mg/kg+松止血带后1 h 10 mg/kg 关节囊缝合后2 g 依诺肝素
Patel[53](2014) 89 65 (23/66) 单侧TKA 松止血带前10 min 10 mg/kg 松止血带前2 min 2 g 低分子肝素
Sarzaeem[54](2014) 100 68 (13/87) 单侧TKA 切口关闭后1.5 g 切口关闭后1.5 g -
Seo[55](2013) 100 67 (11/89) 单侧TKA 切口关闭后1.5 g 切口关闭后1.5 g -
Song[56](2017) 100 69 (14/86) 单侧TKA 止血带充气前20 min +松止血带前15 min+第二次给药后3 h各10 mg/kg 切口闭合后1.5 g 低分子肝素
Subramanyam[57](2018) 182 63 (66/116) 单侧TKA 止血带充气前10 min 10 mg/kg+松止血带前10 min 10 mg/kg 切口关闭后1.5 g 阿司匹林
Tzatzairis[58](2016) 80 69 (16/64) 单侧TKA 麻醉诱导时1 g 关节囊缝合后1 g 低分子肝素
表2 联合应用和单一给药方案应用TXA(氨甲环酸)组基本情况
作者(年份) 样本量 年龄(岁) 性别(男/女) 手术方案 联合使用组 单一使用组 止血带使用 血栓预防方案
褚国庆[24](2018) 100 68 (40/58) 单侧TKA 切皮前15 min静脉1 g+松止血带前关节腔1 g 切皮前15 min静脉1 g -
李辉[29](2017) 122 66 (24/98) 单侧TKA 松止血带前15 min静脉1 g+松止血带前2 min关节腔1 g 松止血带前2 min关节腔2 g 利伐沙班
孙博[33](2019) 100 68 (56/44) 单侧TKA 松止血带前静脉20 mg/kg+关节腔3 g 松止血带前关节腔3 g -
王庆东[34](2016) 64 67 (12/52) 单侧TKA 止血带充气前10 min静脉1 g+缝合关节囊后关节腔2 g 缝合关节囊后关节腔2 g 低分子肝素
罗太行[31](2018) 60 64 (29/31) 单侧TKA 切皮前1 h静脉500 mg+缝合切口前静脉500 mg+缝合切口前关节腔0.5 g 切皮前1 h静脉500 mg+缝合切口前静脉500 mg 低分子肝素
段虹昊[25](2017) 187 66 (27/160) 单侧TKA 松止血带前20 min静脉1 g+缝合关节囊后关节腔1 g 松止血带前20 min静脉1 g+给药3 h后静脉1 g 利伐沙班
武辉[35](2018) 86 63 (41/45) 单侧TKA 松止血带前20 min静脉10 mg/kg+术后关节腔1 g 术后关节腔1 g 利伐沙班
Huang[44](2014) 184 65 (67/117) 单侧TKA 止血带充气前静脉1.5 g+假体安装后关节腔1.5 g 止血带充气前静脉3 g 低分子肝素
Jain[45](2016) 119 69 (44/75) 单侧TKA 切皮前30 min静脉1.5 g+切口关闭后关节腔1.5 g 切皮前30 min静脉3 g 低分子肝素
Lee[47](2017) 396 73 (50/346) 单侧TKA 低剂量组:止血带充气前30 min和术后3 h各静脉10 mg/kg+关节囊缝合后关节腔1 g 止血带充气前30 min和术后3 h各静脉10 mg/kg
关节囊缝合后关节腔2 g
利伐沙班
高剂量组:止血带充气前30 min和术后3 h各静脉10 mg/kg+关节囊缝合后关节腔2 g
Lin[48](2015) 120 71 (22/98) 单侧TKA 切皮前15 min静脉1 g+关节囊缝合后关节腔1 g 关节囊缝合后关节腔1 g 利伐沙班
Nielsen[51](2016) 60 64 (28/32) 单侧TKA 麻醉诱导时静脉1 g+关节囊缝合后关节腔3 g 麻醉诱导时静脉1 g 利伐沙班
Song[56](2017) 150 69 (21/129) 单侧TKA 术前和术后各静脉10 mg/kg+切口闭合后关节腔1.5 g 止血带充气前20 min+松止血带前15 min+第二次给药后3 h各静脉10 mg/kg 低分子肝素
图1 文献筛选流程图
图2 纳入的各项研究的方法学偏倚
图3 所有研究对于每一项评价内容的偏倚情况
图4 静脉滴注与关节腔注射TXA(氨甲环酸)总失血量森林图
图5 静脉滴注与关节腔注射TXA(氨甲环酸)术后引流量森林图
图6 静脉滴注与关节腔注射TXA(氨甲环酸)术后血红蛋白水平森林图
图7 静脉滴注与关节腔注射TXA(氨甲环酸)血红蛋白下降程度森林图
图8 静脉滴注与关节腔注射TXA(氨甲环酸)术后输血率森林图
图9 静脉滴注与关节腔注射TXA(氨甲环酸)血栓事件发生率森林图
图10 联合应用和单一给药方案应用TXA(氨甲环酸)总失血量森林图
图11 联合应用和单一给药方案应用TXA(氨甲环酸)术后引流量森林图
图12 联合应用和单一给药方案应用TXA(氨甲环酸)术后血红蛋白水平森林图
图13 联合应用和单一给药方案应用TXA(氨甲环酸)血红蛋白下降程度森林图
图14 联合应用和单一给药方案应用TXA(氨甲环酸)术后输血率森林图
图15 联合应用和单一给药方案应用TXA(氨甲环酸)血栓事件发生率森林图
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