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中华关节外科杂志(电子版)

中华关节外科杂志(电子版) ›› 2020, Vol. 14 ›› Issue (04) : 408 -416. doi: 10.3877/cma.j.issn.1674-134X.2020.04.004

所属专题： 文献；

临床论著

氨甲环酸对全髋关节置换术的止血及安全分析
张紫机1, 邓增发1, 盛璞义1, 徐栋梁1, 傅明1, 何爱珊1, 廖威明1, 康焱1,†()   
  1. 1. 510080　广州，中山大学附属第一医院关节外科
  • 收稿日期:2019-11-21 出版日期:2020-08-01
  • 通信作者: 康焱

Analysis of hemostatic effect and safety of tranexamic acid in total hip arthroplasty

Ziji Zhang1, Zengfa Deng1, Puyi Sheng1, Dongliang Xu1, Ming Fu1, Aishan He1, Weiming Liao1, Yan Kang1,†()   

  1. 1. Department of Joint Surgery, First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, China
  • Received:2019-11-21 Published:2020-08-01
  • Corresponding author: Yan Kang
  • About author:
    Corresponding author: Kang Yan, Email:
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引用本文：

张紫机, 邓增发, 盛璞义, 徐栋梁, 傅明, 何爱珊, 廖威明, 康焱. 氨甲环酸对全髋关节置换术的止血及安全分析[J]. 中华关节外科杂志(电子版), 2020, 14(04): 408-416.

Ziji Zhang, Zengfa Deng, Puyi Sheng, Dongliang Xu, Ming Fu, Aishan He, Weiming Liao, Yan Kang. Analysis of hemostatic effect and safety of tranexamic acid in total hip arthroplasty[J]. Chinese Journal of Joint Surgery(Electronic Edition), 2020, 14(04): 408-416.

目的

探讨氨甲环酸(TXA)对初次单侧全髋关节置换术(THA)围手术期的输血率及术后并发症的影响。

方法

回顾性分析2010年1月至2018年12月在中山大学附属第一医院关节外科行过初次单侧THA患者的病历资料。纳入标准：行初次单侧非骨水泥THA患者；术前凝血正常；髋关节疾病类型为髋关节骨关节炎、股骨头缺血性或无菌性坏死、发育性髋关节发育不良、股骨颈骨折、类风湿性关节炎以及强直性脊柱炎；术前切皮前按体重15 mg/kg给予TXA。排除标准：行髋关节翻修患者，同时有合并除单侧THA其他手术患者；凝血功能异常；合并恶性肿瘤；既往有心肌梗死或下肢血栓史；使用骨水泥假体；其他髋关节疾病类型；术前切皮前不是按体重15 mg/kg给予TXA等。根据术后使用抗凝药与未使用抗凝药两种情况，初次单侧THA术后使用抗凝药的患者，使用TXA实验组共556例，未使用TXA对照组共244例；初次单侧THA术后未使用抗凝药的患者，使用TXA实验组共248例，未使用TXA对照组共130例。本研究采用独立样本t检验、Wilcoxon秩和检验及卡方检验统计学方法，比较两种情况下两组输血率、输悬浮红细胞(RBC)量、血红蛋白(HB)最大丢失量、并发症及术后住院时间等。

结果

对于行初次单侧THA患者，在术后使用抗凝药物情况下，实验组输血率14.4%，对照组48.4%，差异有统计学意义(χ2＝105.085，P<0.001)；实验组中输悬浮RBC量低于对照组(2.0 U vs 2.5 U，Z＝-2.600，P<0.01)(1 U＝200 ml)；实验组HB最大丢失量低于对照组(32.0 g/L vs 36.3 g/L，Z＝-4.402，P<0.001)。实验组伤口周围瘀斑(0例)低于对照组(5例)(P<0.05)；伤口其他并发症及发生血栓事件差异无统计学意义(P>0.05)；实验组与对照组术后住院时间差异无统计学意义(P>0.05)。在术后未使用抗凝药情况下，实验组输血率低于对照组(9.7% vs 53.8%，χ2＝89.058，P<0.001)，实验组输入悬浮RBC量与对照组差异无统计学意义(3.5 U vs 4.0 U，Z ＝-0.303，P>0.05)，实验组HB最大丢失量低于对照组(29.8 g/L vs 39.5 g/L，Z ＝-6.285，P<0.001)。实验组出现伤口感染低于对照组(1例vs 5例，P<0.05)；伤口其他并发症及血栓事件差异无统计学意义(P>0.05)；实验组术后住院时间低于对照组(7.0 d vs 8.0 d，Z＝-6.165，P<0.001)。

结论

TXA对行初次单侧THA患者，在使用抗凝药与未使用抗凝药两种情况下，均能降低输血率、HB最大丢失量，具有明显的止血效果，且不增加术后伤口及发生血栓并发症，具有一定的安全性。

关键词: 氨甲环酸, 关节成形术, 置换, 髋
Objective

To explore the effect of tranexamic acid (TXA) on the rate of transfusion and postoperative complications during the primary unilateral total hip arthroplasty (THA).

Methods

The patients who underwent the primary unilateral THA from January 2010 to December 2018 were retrospectively analyzed. Inclusion criteria: the patients accept primary unilateral THA with uncemented prothesis, with primary normal coagulation function, diagnosis of the hip joint are osteoarthritis, ischemic or aseptic necrosis of the femoral head, developmental dysplasia of the hip joint, femoral neck fracture, rheumatoid arthritis and ankylosing spondylitis, receiving 15 mg/kg TXA before skin incision. Exclusion criteria: the patients accept revision or other surgical procedures, with preoperative abnormal coagulation function, the patients with malignant tumors, history of myocardial infarction or lower limb thrombosis, using cement prosthesis, not receiving 15 mg/kg TXA before skin incision, ect. In the postoperative anticoagulants group, 556 patients received TXA, 244 patients did not take TXA as control. In the non-postoperative anticoagulants group, 248 patients received TXA, while 130 patients did not take TXA as control. The primary outcomes were transfusion rate and the maximum loss of hemoglobin (HB). Secondary outcomes included volume of red blood cell (RBC) transfusion, complications and postoperative length of stay. Independent t test, Wilcoxon test and chi-square test were applied for data analysis.

Results

For the patients who underwent primary unilateral THA and administrated anticoagulants postoperatively, the blood transfusion rate of the experimental group was 14.4% and that of the control group was 48.4%, the difference was statistically significant (χ2=105.085, P<0.001). The amount of RBC in the experimental group was lower than that in the control group (2.0 U vs 2.5 U, Z =-2.600, P<0.01) (1 U =200 ml). The maximum loss of HB in the experimental group was lower than that in the control group(32.00 g/L vs 36.29 g/L, Z =-4.402, P<0.001). The ecchymosis around incisions in the experimental group(zero case) was lower than that in the control group(five cases)(P<0.05). There was no significant difference in other complications of incisions and thrombosis events (P>0.05). There was no statistically significant difference in postoperative hospital stay between the experimental group and the control group (P>0.05). For patients who underwent primary unilateral THA and administrated no anticoagulants postoperatively, the blood transfusion rate in the experimental group was lower than that in the control group (9.7% vs 53.8%, χ2=89.058, P<0.001). There was no statistically significant difference between the amount of RBC in the experimental group and the control group (3.5 U vs 4.0 U, Z =-0.303, P>0.05), and the maximum loss of HB in the experimental group(29.82 g/L) was lower than that in the control group (39.48 g/L)(Z =-6.285, P<0.001). Wound infection in the experimental group(one case) was lower than that in the control group(five cases) (P<0.05). There was no statistically significant difference in other wound complications and thrombosis events (P>0.05). Postoperative hospital stay in the experimental group(7 d) was lower than that in the control group (8 d) (Z=-6.165, P<0.001).

Conclusion

TXA can reduce the rate of transfusion and the maximum loss of HB in primary unilateral THA with postoperative anticoagulants administrated or not, and it would not increase postoperative complications of incision and thrombosis, which shows effective hemostasis and safety.

Key words: Tranexamic acid, Arthroplasty, replacement, hip
表1 实验组与对照组术前基本资料比较
资料 使用抗凝药 统计值 P值 资料 未使用抗凝药 统计值 P值
实验组 对照组 实验组 对照组
例数 556 244 例数 248 130
年龄[岁，M(P25，P75)] 60.00(49.00，68.00) 62.00(53.00，69.00) Z＝-1.884 >0.05 年龄[岁，M(P25，P75)] 59.00(48.00，68.00) 63.00(52.00，73.00) Z＝-1.943 >0.05
男/女(例) 239/317 89/155 χ2＝2.971 >0.05 男/女(例) 104/144 56/74 χ2＝0.046 >0.05
BMI [kg/m2，M(P25，P75)] 23.62(22.27，24.75) 23.44(21.37，25.23) Z＝-0.716 >0.05 BMI[kg/m2，M(P25，P75)] 23.89(22.89，24.22) 23.34(20.89，24.97) Z＝-1.776 >0.05
全麻/椎管(例) 180/376 78/166 χ2＝0.013 >0.05 全麻/椎管(例) 41/207 31/99 χ2＝2.959 >0.05
患髋类型[例(%)] 患髋类型[例(%)]
OA 84(15.1) 33(13.5) χ2＝0.340 >0.05 OA 19(7.7) 12(9.2) χ2＝0.279 >0.05
ONFH 208(37.4) 101(41.4) χ2＝1.135 >0.05 ONFH 106(42.7) 62(47.7) χ2＝0.847 >0.05
DDH 149(26.8) 53(21.7) χ2＝2.316 >0.05 DDH 74(29.8) 36(27.7) χ2＝0.190 >0.05
FNF 84(15.1) 49(20.1) χ2＝3.027 >0.05 FNF 38(15.3) 16(12.3) χ2＝0.633 >0.05
RA 8(1.4) 4(1.6) χ2＝0.046 >0.05 RA 2(0.8) 0(0.0) χ2＝1.054 >0.05
AS 23(4.1) 4(1.6) χ2＝3.243 >0.05 AS 9(3.6) 4(3.1) χ2＝0.078 >0.05
合并其他疾病[例(%)] 合并其他疾病[例(%)]
高血压 96(17.3) 42(17.2) χ2<0.001 >0.05 高血压 35(14.1) 27(20.8) χ2＝2.756 >0.05
糖尿病 33(5.9) 17(7.0) χ2＝0.308 >0.05 糖尿病 13(5.2) 8(6.2) χ2＝0.135 >0.05
术前贫血情况 术前贫血情况
轻度贫血 56(10.1) 19(7.8) χ2＝1.042 >0.05 轻度贫血 27(10.9) 13(10.0) χ2＝0.071 >0.05
中度贫血 3(0.5) 0(0.0) - >0.05 中度贫血 2(0.8) 3(2.3) χ2＝1.473 >0.05
低分子肝素/拜瑞妥(例) 197/385 92/152 χ2＝0.358 >0.05 低分子肝素/拜瑞妥(例) - - - -
HB [g/L，M(P25，P75)] 132.00(122.00，142.00) 129.00(122.00，139.00) Z＝-1.557 >0.05 HB[g/L，M(P25，P75)] 129.50±15.98 128.52±16.44 t＝-0.560 >0.05
HCT(±s) 0.39±0.04 0.39±0.04 t＝-1.800 >0.05 HCT(±s) 0.39±0.04 0.39±0.07 t＝0.272 >0.05
PLT[109个/ L，(±s)] 234.82±51.27 231.87±58.75 t＝-0.678 >0.05 PLT[109个/ L，(±s)] 239.83±70.30 226.92±59.88 t＝-1.782 >0.05
APTT [s，M(P25，P75)] 27.75(25.85，30.30) 28.50(25.85，30.90) Z＝-1.821 >0.05 APTT [s，M(P25，P75)] 27.82±3.79 27.51±3.77 t＝-0.767 >0.05
PT [s，M(P25，P75)] 11.50(10.90，12.05) 11.50(11.00，12.20) Z＝-0.922 >0.05 PT [s，M(P25，P75)] 11.60(11.10，12.20) 11.60(11.10，12.30) Z＝-0.565 >0.05
表2 术后使用抗凝药组围手术期资料的比较[M(P25，P75)]
组别 例数 输血[例(%)] 悬浮RBC(U) 手术时间(min) 术中出血量(ml) 术后引流量(ml) HB最大丢失量(g/L) 术后住院时间(d)
实验组 556 80(14.4%) 2.0(2.0，4.0) 120.0(100.0，145.0) 200.0(200.0，300.0) 399.2(200.0，527.5) 32.0(24.0，40.0) 9.0(7.0，13.0)
对照组 244 118(48.4%) 2.5(2.0，4.0) 115.0(90.0，140.0) 300.0(200.0，600.0) 496.5(307.8，700.0) 36.3(33.0，40.0) 9.0(7.0，13.0)
统计值 χ2＝105.085 Z＝-2.600 Z＝-1.335 Z＝-7.335 Z＝-5.886 Z＝-4.402 Z＝-0.253
P值 <0.001 <0.01 >0.05 <0.001 <0.001 <0.001 >0.05
表3 术后未使用抗凝药组围手术期资料的比较[M(P25，P75)]
组别 例数 输血[例(%)] 悬浮RBC(U) 手术时间(min) 术中出血量(ml) 术后引流量(ml) HB最大丢失量(g/L) 术后住院时间(d)
实验组 248 24(9.7%) 3.5(2.0，4.0) 110.0(85.0，135.0) 200.0(150.0，228.1) 300.0(150.0，500.0) 29.8(21.0，32.0) 7.0(5.0，9.0)
对照组 130 70(53.8%) 4.0(2.0，4.0) 120.0(90.0，140.0) 300.0(200.0，350.0) 383.9(195.0，500.0) 39.5(32.0，43.7) 8.0(7.0，11.0)
统计值 χ2＝89.058 Z＝-0.303 Z＝-0.790 Z＝-5.693 Z＝-2.955 Z＝-5.969 Z＝-6.165
P值 <0.001 >0.05 >0.05 <0.001 <0.01 <0.001 <0.001
表4 术后使用抗凝药组术后伤口并发症及血栓情况[例(%)]
组别 例数 伤口 血栓 其他部位血肿或瘀斑
感染 脂肪液化 愈合不良 周围瘀斑 周围红肿 周围张力性水泡 肌间静脉 PE a DVT a
实验组 556 1(0.18) 2(0.36) 3(0.54) 0(0.00) 2(0.36) 0(0.00) 2(0.36) 0(0.00) 0(0.00) 2(0.36)
对照组 244 1(0.41) 2(0.82) 1(0.41) 5(2.05) 1(0.41) 1(0.41) 0(0.00) 0(0.00) 0(0.00) 0(0.00)
P值 0.517 0.590 1.000 0.003 1.000 0.305 1.000 - - 1.000
表5 术后未使用抗凝药组术后伤口并发症及发生血栓情况[例(%)]
组别 例数 伤口 血栓 其他部位血肿或瘀斑a
感染 脂肪液化a 愈合不良 周围瘀斑a 周围红肿 周围张力性水泡 肌间静脉a PEa DVTa
实验组 248 1(0.40) 0(0.00) 1(0.40) 0(0.00) 2(0.80) 0(0.00) 0(0.00) 0(0.00) 0(0.00) 0(0.00)
对照组 130 5(3.85) 0(0.00) 0(0.00) 0(0.00) 2(1.54) 2(1.54) 0(0.00) 0(0.00) 0(0.00) 0(0.00)
P值 0.020 - 1.000 - 0.610 0.110 - - - -
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