氨甲环酸联合磺达肝癸钠在髋关节置换术中应用的有效性和安全性研究

Efficacy and safety of tranexamic acid combined with sulfonda hepatdecyl sodium in hip replacement

目的:观察氨甲环酸和磺达肝癸钠在髋关节置换术围手术期中应用的疗效,探讨失血量与围手术期血栓形成的关系,以期达到减少出血和降低深静脉血栓(Venous Thrombo embolism,VTE)发生率的目的。方法:本研究共纳入168例髋关节置换患者,按照抽签法分为四组(A组、B组、C组、D组),每组42例。按照不同的预定方案进行围手术期止血和抗凝(A组:术前使用生理盐水,术后使用磺达肝癸钠抗凝;B组:术前使用氨甲环酸止血,术后使用磺达肝癸钠抗凝;C组:术前使用生理盐水,术后使用低分子量肝素钙抗凝;D组:术前使用氨甲环酸止血,术后使用低分子量肝素钙抗凝),观察记录四组患者的出血指标:术中出血量(Intraoperative bleeding,IB)、手术前后血红蛋白(hemoglobin,HB)及血细胞比容(Hematocrit,HCT)的水平;凝血功能指标:治疗前后的凝血酶原时间(Prothrombin time,PT)、活化部分凝血酶时间(Actived partial thromboplastin time reagent,APTT)、治疗前后纤维蛋白原(Fibrinogen,FIB)、D-二聚体(D-Dimer,D-D)的水平;不良事件发生情况:静脉血栓栓塞症、DVT、大出血及肺栓塞等不良事件的发生率。应用SPSS 23.0统计学软件进行数据的统计分析。结果:A组、B组、C组、D组患者在性别、年龄、BMI、手术时间及合并症比较方面的差异均无统计学意义(P>0.05)。术前各组的HB、HCT、IB水平相比差异无统计学意义(P>0.05)。术后各组的HB、HCT、IB水平相比差异有统计学意义(P<0.05)。事后检验显示:A组的HB丢失量大于B组,C组的HB丢失量大于D组,A组的HCT丢失量大于B组,C组的HCT丢失量大于D组,A组的IB大于B组,C组的IB大于D组,可以推断使用氨甲环酸止血的效果明显。术前各组的FIB、PT、APTT、D-D水平相比差异无统计学意义(P>0.05)。术后各组的APTT、D-D水平相比差异有统计学意义(P<0.05),其余各项均无统计学意义(P>0.05);A组的APTT明显长于其余3组,D组的D-D水平明显高于其余三组。各组中均未发生肺栓塞及大出血事件。各组的VTE发生率相比差异无统计学意义(P>0.05)。各组的输血率相比差异有统计学意义(P<0.05),其中B组、D组的输血率较低。结论:在全髋关节置换术中,单纯使用低分子量肝素钙及磺达肝癸钠两种药物的疗效相似。在此基础上联用氨甲环酸均能减少出血量及HB丢失,但联合使用时磺达肝癸钠的血液指标更好,更有助于血栓的预防。

Objective:To observe the curative effect of tranatemic acid and Venous Thrombo embolism in perioperative hip replacement,and to investigate the relationship between blood loss and perioperative thrombo embolism,in order to reduce bleeding and reduce the incidence of venous thrombo embolism(VTE).Methods:A total of 168 patients with hip replacement were enrolled in this study and divided into four groups(group A,group B,group C and group D)according to the lottery method,with 42 cases in each group.Perioperative hemostasis and anticoagulation were performed according to different predetermined plans(Group A:normal saline was used before surgery,and anticoagulation with sulfonda liver decane sodium was used after surgery;Group B:Tranexamic acid was used to stop bleeding before surgery,and sulfonda liver decane sodium was used to anticoagulation after surgery.Group C:preoperative use of normal saline,postoperative use of low molecular weight heparin calcium anticoagulation;Group D:tranexamic acid was used before surgery to stop bleeding,and low molecular weight heparin calcium was used after surgery for anticoagulation).Bleeding indexes of the four groups were observed and recorded:Intraoperative bleeding(IB),levels of hemoglobin(HB)and Hematocrit(HCT)before and after surgery;Coagulation function index:Prothrombin time(PT),Actived partial thromboplastin time reagent(APTT),Fibrinogen,before and after treatment (FIB)and D-Dimer(D-dimer,D-D)levels;Occurrence of adverse events:incidence of venous thromboembolism,DVT,massive hemorrhage,pulmonary embolism and other adverse events.SPSS23.0 statistical software was used to analyze the data.Results:There were no significant differences in gender,age,BMI,operation time and complications among group A,B,C and D(P>0.05).There was no significant difference in HB,HCT and IB levels among all groups before surgery(P>0.05).There were statistically significant differences in HB,HCT and IB levels among all groups after surgery(P<0.05).The postmortem examination showed that the amount of HB lost in group A was greater than that in group B,that in group C was greater than that in group D,that in group A was greater than that in group D,that in group A was greater than that in group B,and that in group C was greater than that in group D.It could be inferred that the hemostasis effect of tranexamic acid was obvious.There were no significant differences in FIB,PT,APTT and D-D levels among all groups before surgery(P>0.05).There were statistically significant differences in APTT and D-D levels among all groups after surgery(P<0.05),but no statistical significance in other items(P>0.05).APTT of group A was significantly longer than that of the other three groups,and D-D level of group D was significantly higher than that of the other three groups.No pulmonary embolism or massive hemorrhage occurred in each group.There was no significant difference in the incidence of VTE among all groups(P>0.05).The blood transfusion rate of all groups was statistically significant(P<0.05),and the blood transfusion rate of group B and Group D was lower.Conclusion:In total hip replacement,low molecular weight heparin calcium and sulfonda hepatodeca sodium alone have similar efficacy.On this basis,tranexamic acid combined with tranexamic acid can reduce the amount of blood loss and HB loss,but the combined use of sulfonda liver decane sodium has better blood indexes and is more conducive to the prevention of thrombosis.