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膝关节置换术中氨甲环酸局部给药与静脉给药及深静脉血栓形成发生率的比较:一项随机临床试验

Topical vs. intravenous administration of tranexamic acid in knee arthroplasty and prevalence of deep venous thrombosis: a randomized clinical trial.

作者信息

Zekcer Ari, Del Priori Ricardo, Tieppo Clauber, da Silva Ricardo Soares, Severino Nilson Roberto

机构信息

Clínica Ortopédica Tatuapé, São Paulo, SP, Brazil.

Clínica Santa Maria, São Paulo, SP, Brazil.

出版信息

J Vasc Bras. 2016 Apr-Jun;15(2):120-125. doi: 10.1590/1677-5449.007515.

Abstract

BACKGROUND

Tranexamic acid (TXA) is widely used in orthopedic surgery to reduce perioperative bleeding. Since TXA inhibits fibrinolysis, there is concern that it may increase the risk of thromboembolic events.

OBJECTIVES

To verify the prevalence of deep venous thrombosis (DVT) in patients receiving TXA during total knee arthroplasty and to compare topical with intravenous administration of the drug.

METHODS

All patients admitted for total knee arthroplasty due to primary arthrosis between June and November of 2014 were recruited consecutively. Thirty patients were randomized to a "topical group" (1.5 g TXA diluted in 50ml saline sprayed over the area operated, before tourniquet release), 30 to an "intravenous group" (20mg/kg TXA in 100 ml of saline, given at the same time as anesthesia), and 30 to a control group (100 ml of saline, given at the same time as anesthesia). All patients had duplex ultrasound scans of the legs on the 15th postoperative day.

RESULTS

Deep venous thrombosis events occurred in five of the 90 patients operated (one out of 30 in the topical group [3.3%], four out of 30 in the control group [13.3%], and zero in the intravenous group). All were confirmed by duplex ultrasound scans and all were asymptomatic. Prevalence rates of DVT were similar between groups (p = 0.112 for control vs. intravenous; p = 0.353 for control vs. topical; and p =1.000 for intravenous vs. topical, according to two-sided exact tests).

CONCLUSIONS

Both topical and intravenous administration of TXA are safe with regard to occurrence of DVT, since the number of DVT cases in patients given TXA was not different to the number in those given placebo.

摘要

背景

氨甲环酸(TXA)在骨科手术中广泛用于减少围手术期出血。由于TXA抑制纤维蛋白溶解,人们担心它可能会增加血栓栓塞事件的风险。

目的

验证全膝关节置换术中接受TXA治疗的患者深静脉血栓形成(DVT)的发生率,并比较药物的局部应用与静脉内给药。

方法

连续招募2014年6月至11月因原发性关节炎入院接受全膝关节置换术的所有患者。30例患者被随机分为“局部组”(1.5 g TXA稀释于50 ml盐水中,在松开止血带前喷洒在手术区域),30例分为“静脉组”(20 mg/kg TXA溶于100 ml盐水中,与麻醉同时给药),30例分为对照组(100 ml盐水,与麻醉同时给药)。所有患者在术后第15天进行腿部双功超声扫描。

结果

90例接受手术的患者中有5例发生深静脉血栓事件(局部组30例中有1例[3.3%],对照组30例中有4例[13.3%],静脉组为0例)。所有均经双功超声扫描证实,且均无症状。根据双侧精确检验,各组间DVT的发生率相似(对照组与静脉组比较,p = 0.112;对照组与局部组比较,p = 0.353;静脉组与局部组比较,p = 1.000)。

结论

就DVT的发生而言,TXA的局部应用和静脉内给药都是安全的,因为接受TXA治疗的患者中DVT病例数与接受安慰剂治疗的患者数没有差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d49f/5829705/2ddf48c11128/jvb-15-02-120-g01.jpg

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