三种氨甲环酸联合用药方案在初次人工全膝关节置换术中的疗效比较

Comparison of combined intravenous and topical use of tranexamic acid with different dosage in primary total knee arthroplasty

目的比较初次人工全膝关节置换术(total knee arthroplasty,TKA)中静脉滴注联合关节腔内注射不同剂量氨甲环酸(tranexamic acid,TXA)减少术后失血效果的差异。方法根据选择标准,研究共纳入2017年1月–6月收治的90例单侧膝关节骨关节炎患者,随机分为A、B、C 3组,每组30例。3组患者在术中止血带充气前10 min静脉滴注TXA 1 g;关闭切口后,A、B、C组分别于关节腔内注射含1、2、3 g TXA的生理盐水50 mL。3组患者性别、年龄、体质量指数、患膝侧别、骨关节炎病程及分期、美国麻醉医师协会(ASA)分级以及术前血红蛋白(hemoglobin,Hb)、血小板计数、凝血酶原时间、活化部分凝血酶原时间比较,差异均无统计学意义(P>0.05)。记录术后切口引流量,术后1、3、7 d血红蛋白(Hb)值以及输血率,术后彩色多普勒超声检查下肢深静脉血栓形成以及症状性肺栓塞发生情况。结果 3组患者术后均获随访,随访时间7～12个月,平均8.4个月。A、B、C组手术时间比较差异无统计学意义(P>0.05);B、C组引流量明显少于A组(P<0.05),B、C组间比较差异无统计学意义(P>0.05)。术后B组1例发生切口皮缘坏死,C组1例发生切口脂肪液化,其余患者切口均Ⅰ期愈合。3组切口并发症发生率比较,差异无统计学意义(P>0.05)。B、C组术后1、3、7 d Hb均高于A组(P<0.05),B、C组间仅术后1 d时差异有统计学意义(P<0.05)。术后A、B、C组分别有9例(30%)、4例(13.3%)、5例(16.7%)患者输血;A组输血率明显高于B、C组(P<0.05),B、C组间比较差别无统计学意义(P>0.05)。双下肢静脉彩色多普勒超声检查显示,3组中仅B组有1例患者在术后3周时健侧腘静脉以下深静脉血栓形成。结论 TKA术前静脉滴注1 g TXA联合术毕关节腔内注射2 g TXA,能有效减少术后出血,降低输血患者比例,且不增加血栓性疾病风险。

Objective To compare the efficacy and safety of intra-articular combined with intravenous administration of tranexamic acid（TXA） with different dosage for reducing blood loss in primary total knee arthroplasty（TKA）. Methods Between January 2017 and June 2017, 90 patients suffering from unilateral osteoarthritis who underwent primary TKA were randomly scheduled to three interventions, named groups A, B, and C. Single dosage of TXA via intravenous injection（IV） and different dosages of TXA via intra-articular injection（IA） were utilized in three groups, respectively. All patients in three groups received 1 g TXA IV at 10 minutes preoperatively, and received 1, 2, and3 g TXA IA diluted in 50 mL saline after wound closure in groups A, B and C, respectively. The age, gender, body mass index, affected side of the knee, grade of osteoarthritis, grade of America Society of Anesthesiologist, preoperativehemoglobin（Hb） concentration, platelet count, preoperative prothrombin time, and activated partial thromboplastin time were not significantly different between groups（P0.05）. The postoperative wound blood drainage, Hb concentration at 1,3, and 7 days after operation, transfusion rate, and thromboembolic complications were observed. All patients were routinely observed for deep vein thrombosis（DVT） by the color Doppler ultrasonography at 1 week, 1 month, and 3 months after operation, and the symptomatic pulmonary embolism（PE） were observed. Results All patients in three groups were followed up 7-12 months（mean, 8.4 months）. There was no significant difference in operation time between groups（P0.05）. The postoperative wound blood drainage was significantly less in groups B and C than that in group A（P0.05）, whereas no significant difference was found between group B and group C（P0.05）. Incision skin necrosis occurred in 1 case of group B and fat liquefaction occurred in 1 case of group C. The other incisions of 3 groups healed by first intention. There was no significant difference in incision complication incidence between groups. The Hb concentration was significantly higher in groups B and C than that in group A at 1, 3, and 7 days after operation（P0.05）.While between group B and group C, the significant difference of Hb concentration only existed at 1 day after operation（P0.05）. The number of patients who got blood transfusion was significantly less in group B（4 cases, 13.3%） and group C（5 cases, 16.7%） than that in group A（9 cases, 30%）（P 0.05）, but no significant difference was found between group B and group C（P0.05）. The result of color Doppler ultrasonography showed that 1 case got DVT in the contralateral calf at3 weeks in group B. And there was no symptomatic PE in 3 groups. Conclusion Combined administration of IV and IA TXA in a clinically relevant reduction in blood loss was effective and safe in primary TKA, and no thromboembolic complication was observed. The combination of 1 g IV with 2 g IA could be the optional choice.