氨甲环酸关节腔给药联合静脉给药可有效减少全膝关节置换后出血

doi:10.3969/j.issn.2095-4344.2016.17.001

中国组织工程研究 ›› 2016, Vol. 20 ›› Issue (17): 2437-2442.doi: 10.3969/j.issn.2095-4344.2016.17.001

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氨甲环酸关节腔给药联合静脉给药可有效减少全膝关节置换后出血

徐建，哈承志，田少奇，王远贺，刘宁宁，孙康

青岛大学附属医院关节外科，山东省青岛市 266000

收稿日期:2016-03-07 出版日期:2016-04-22 发布日期:2016-04-22
通讯作者: 孙康，博士，博士生导师，青岛大学附属医院关节外科，山东省青岛市 266000
作者简介:Xu Jian, Studying for master’s degree, Department of Joint Surgery, Affiliated Hospital of Qingdao University, Qingdao 266000, Shandong Province, China
基金资助:
国家自然科学基金(81141078)

Intra-articular and intravenous injection of tranexamic acid effectively reduces blood loss after total knee arthroplasty

Xu Jian, Ha Cheng-zhi, Tian Shao-qi, Wang Yuan-he, Liu Ning-ning, Sun Kang

Department of Joint Surgery, Affiliated Hospital of Qingdao University, Qingdao 266000, Shandong Province, China

Received:2016-03-07 Online:2016-04-22 Published:2016-04-22
Contact: Sun Kang, M.D., Doctoral supervisor, Department of Joint Surgery, Affiliated Hospital of Qingdao University, Qingdao 266000, Shandong Province, China
About author:徐建，男，1989 年生，山东省人，汉族，青岛大学医学院在读硕士，主要从事关节外科的基础与临床研究。
Supported by:
the National Natural Science Foundation of China, No. 81141078

摘要/Abstract

摘要：

文章快速阅读：

氨甲环酸：氨甲环酸的化学结构与赖氨酸(1，5-二氨基己酸)相似，也有止血效应。主要用于急性或慢性、局限性或全身性纤维蛋白溶解亢进所致的各种出血。试验采用关节腔注射氨甲环酸，静脉注射氨甲环酸以及两种联合使用对全膝关节置换术患者术后出血量的影响，对比结果找出最合理有效的氨甲环酸给药方式。

膝关节腔穿刺术：常用于检查关节腔内积液的性质，或抽液后向关节腔内注药。常规膝关节穿刺部位：患者仰卧位，膝关节伸直，髌骨上缘与髌骨内外侧缘的交点为两点，斜向髌股关节中心，以45°角穿刺。膝关节微屈约30°，从髌骨下方的髌韧带内侧或外侧关节间隙垂直进针。

背景：有研究表明氨甲环酸能够有效减少全膝关节置换术患者的术后出血量，但是氨甲环酸的给药方式有多种，包括关节腔注射，静脉注射和两者联合用药，但效果尚无定论。

目的：探讨关节腔注射，静脉注射和两者联合用药3种氨甲环酸给药方式是否能够有效的减少全膝关节置换后出血。

方法：试验选择2014年12月到2015年12月进行单侧全膝关节置换术的患者103例，根据氨甲环酸的给药方式不同随机分为4组：关节腔注射组术中膝关节切口缝合后给予关节腔注射液 2 000 mg氨甲环酸；静脉注射组在止血带使用前15 min静脉注射1 000 mg氨甲环酸；联合治疗组采用上述2种方法联合干预；空白对照组不采用氨甲环酸干预。

结果与结论：①总出血量和输血率：关节腔注射组和联合治疗组的总出血量和输血率均少于静脉给药组(P < 0.05)，且关节腔注射组总出血量略多于联合治疗组，但差异无显著性意义(P > 0.05)，两组输血率均为0%；②不良反应：各组中均未出现深静脉血栓、肺部血栓、切口感染、血肿和坏疽等不良反应；③结果证实：氨甲环酸关节腔给药联合静脉给药可有效减少全膝关节置换后出血，效果略优于单独给药。
中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程
ORCID: 0000-0002-7806-5176(Sun Kang)

关键词: 骨科植入物, 人工假体, 关节腔注射, 氨甲环酸, 引流管, 出血量, 全膝关节置换术, 联合治疗, 隐性出血, 显性出血, 静脉注射, 血红蛋白丢失量, 国家自然科学基金

Abstract:

BACKGROUND: Studies have shown that tranexamic acid can effectively reduce postoperative blood loss in patients with total knee arthroplasty. There are many means to inject tranexamic acid (intra-articular injection, intravenous injection and their combination). Which is the best way has no conclusion.

OBJECTIVE: To explore whether all three ways (intra-articular injection, intravenous injection and their combination) to inject tranexamic acid can all effectively reduce the bleeding after total knee arthroplasty.

METHODS: 103 patients undergoing unilateral total knee arthroplasty from December 2014 to December 2015 were enrolled in this study. The patients were allocated into four groups according to injection way. In the intra-articular injection group, 2 000 mg of tranexamic acid was given through the intra-articular injection after incision suture. In the intravenous injection group, 1 000 mg of tranexamic acid was given through the intravenous injection at 15 minutes before the use of tourniquet. In the combined modality therapy group, above methods were used. In the blank control group, tranexamic acid was not given.

RESULTS AND CONCLUSION: (1) Total blood loss and blood transfusion rate were less in the intra-articular injection group and combined modality therapy group than in the intravenous injection group (P < 0.05). The total blood loss was more in the intra-articular injection group than in the combined modality therapy group (P > 0.05). The blood transfusion rate was 0% in the intra-articular injection group and combined modality therapy group. (2) Adverse reaction: deep vein thrombosis, pulmonary embolism, wound infection, hematoma or gangrene was not observed in all groups. (3) Results confirmed that intra-articular combined with intravenous injection can reduce effectively postoperative blood loss and the effect is better than separate administration.
中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Tissue Engineering, Knee Joint, Tranexamic Acid

徐建，哈承志，田少奇，王远贺，刘宁宁，孙康. 氨甲环酸关节腔给药联合静脉给药可有效减少全膝关节置换后出血[J]. 中国组织工程研究, 2016, 20(17): 2437-2442.

Xu Jian, Ha Cheng-zhi, Tian Shao-qi, Wang Yuan-he, Liu Ning-ning, Sun Kang. Intra-articular and intravenous injection of tranexamic acid effectively reduces blood loss after total knee arthroplasty[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(17): 2437-2442.

图/表（结果） 1

Quantitative analysis of participants

The study included 103 patients. All the 103 patients completed the study, no dropout or changing treatment. All patients participated in the result analysis.

Baseline analysis of subjects

No significant difference in age, gender, height, weight and operation side was detected among the four groups (P > 0.05).

Blood loss

The results are summarized in Table 1. The total blood loss was obviously different in the four groups (P < 0.01). Total blood loss was less in the intra-articular injection group than in the intravenous injection group (P < 0.05). Total blood loss was less in the combined modality therapy group than in the intravenous injection group (P < 0.05). No significant difference was identified between the intra-articular retrograde injection group and combined modality therapy group (P > 0.05).

Hematoglobin loss

Significant differences in total hematoglobin loss were detected among the four groups (P < 0.01). Hematoglobin loss was less in the intra-articular injection group than in the intravenous injection group [(2.61±9.80) vs. (7.55±10.21) g/L, P < 0.05)]. Hematoglobin loss was less in the combined modality therapy group than in the intravenous injection group [(26.33±6.65) vs. (37.55±10.21) g/L, P < 0.05)]. Hematoglobin loss was more in the intra-articular injection group than in the combined modality therapy group [(32.61±9.80) vs. (26.33±6.65) g/L, P < 0.05)].

Blood transfusion

There was a great reduction in both autogenic and allogeneic transfusion rates in total three groups using TA than in the control group (the rates from the first group to the four group: 0% vs. 7.5% vs. 0% vs. 29.4%).

Complications

Symptomatic deep vein thrombosis, pulmonary embolism, and wound trouble including necrosis, infection, and hematoma were not observed in all groups.

参考文献

[1] Mähringer-Kunz A, Efe T, Fuchs-Winkelmann S, et al. Bleeding in TKA: posterior stabilized vs. cruciate retaining. Arch Orthop Trauma Surg. 2015;135(6):867-870.

[2] Ishii Y, Noguchi H, Sato J, et al., Effect of a single injection of tranexamic acid on blood loss after primary hybrid TKA. Knee. 2015;22(3):197-200.

[3] Yue C, Pei F, Yang P, et al. Effect of topical tranexamic acid in reducing bleeding and transfusions in TKA. Orthopedics. 2015;38(5):315-324.

[4] Wassilew GI, Perka C, Janz V, et al., Tranexamic acid reduces the blood loss and blood transfusion requirements following peri-acetabular osteotomy. Bone Joint J. 2015;97-B(12):1604-1607.

[5] He P, Zhang Z, Li Y, et al., Efficacy and safety of tranexamic acid in bilateral total knee replacement: a meta-analysis and systematic review. Med Sci Monit. 2015;21:3634-3642.

[6] Raveendran R, Wong J. Tranexamic acid reduces blood transfusion in surgical patients while its effects on thromboembolic events and mortality are uncertain. Evid Based Med. 2013;18(2):65-66.

[7] Gillette BP, DeSimone LJ, Trousdale RT, et al., Low risk of thromboembolic complications with tranexamic acid after primary total hip and knee arthroplasty. Clin Orthop Relat Res. 2013;471(1):150-154.

[8] Kratzer S, Irl H, Mattusch C, et al., Tranexamic acid impairs gamma-aminobutyric acid receptor type A-mediated synaptic transmission in the murine amygdala: a potential mechanism for drug-induced seizures? Anesthesiology. 2014;120(3):639-649.

[9] Roberts I, Prieto-Merino D, Manno D. Mechanism of action of tranexamic acid in bleeding trauma patients: an exploratory analysis of data from the CRASH-2 trial. Crit Care. 2014;18(6):685.

[10] Liu JJ, Yao YY, Zhao X, et al. Effect of different dose of tranexamic acid in blood loss after single knee arthroplasty. Qingdao Daxue Yixueyuan Xuebao. 2015;19(2):163-168.

[11] Ejaz A, Laursen AC, Jakobsen T, et al. Absence of a tourniquet does not affect fixation of cemented tka: a randomized rsa study of 70 patients. J Arthroplasty. 2015; 30(12):2128-2132.

[12] Tanavalee A, Sakdinakiattikoon M, Hangsaphuk N, et al. The effect of knee flexion during tourniquet inflation, fat pad excision and lateral tibial release on patellar subluxation during MIS TKA. Knee. 2009;16(2):125-129.

[13] Ejaz A, Laursen AC, Kappel A, et al. Tourniquet induced ischemia and changes in metabolism during TKA: a randomized study using microdialysis. BMC Musculoskelet Disord. 2015;16:326.

[14] Pour AE, Keshavarzi NR, Purtill JJ, et al., Is venous foot pump effective in prevention of thromboembolic disease after joint arthroplasty: a meta-analysis. J Arthroplasty. 2013;28(3):410-417.

[15] Lewis CG, Inneh IA, Schutzer SF, et al., Evaluation of the first-generation AAOS clinical guidelines on the prophylaxis of venous thromboembolic events in patients undergoing total joint arthroplasty: experience with 3289 patients from a single institution. J Bone Joint Surg Am. 2014;96(16):1327-1332.

[16] Heath DI, Kent SJ, Johns DL, et al. Arterial thrombosis associated with graduated pressure antiembolic stockings. Br Med J (Clin Res Ed). 1987;295(6598):580.

[17] Nelson LD Jr, Montgomery SP, Dameron TB Jr, et al. Deep vein thrombosis in lumbar spinal fusion: a prospective study of antiembolic and pneumatic compression stockings. J South Orthop Assoc. 1996;5(3):181-184.

[18] Walker L, Lamont S. The use of antiembolic stockings. part 2: a clinical audit. Br J Nurs. 2008;17(1):32-36.

[19] Bidolegui F, Arce G, Lugones A, et al., Tranexamic acid reduces blood loss and transfusion in patients undergoing total knee arthroplasty without tourniquet: a prospective randomized controlled trial. Open Orthop J. 2014;8:250-254.

[20] Sehat KR, Evans RL, Newman JH. Hidden blood loss following hip and knee arthroplasty. Correct management of blood loss should take hidden loss into account. J Bone Joint Surg Br. 2004;86(4):561-565.

[21] Cicekcioglu F, Cagli K, Emir M, et al. Effects of minimal dose aprotinin on blood loss and fibrinolytic system-complement activation in coronary artery bypass grafting surgery. J Card Surg. 2006;21(4):336-341.

[22] Monaco M, Di Tommaso L, Stassano P, et al., Impact of blood coagulation and fibrinolytic system changes on early and mid term clinical outcome in patients undergoing stent endografting surgery. Interact Cardiovasc Thorac Surg. 2006;5(6): 724-728.

[23] Na HS, Shin HJ, Lee YJ, et al. The effect of tranexamic acid on blood coagulation in total hip replacement arthroplasty: rotational thromboelastographic (ROTEM) analysis. Anaesthesia. 2016;71(1):67-75.

Oremus K. Tranexamic acid for the reduction of blood loss in total knee arthroplasty. Ann Transl Med. 2015; 3(Suppl 1):S40.

引言

材料方法

Design

A randomized controlled trial.

Time and settings

This study was conducted from December 2014 to December 2015 in the Joint Surgery of Affiliated Hospital of Qingdao University of China.

Subjects

103 patients undergoing unilateral primary TKA were enrolled in this study, including 39 males and 64 females, aged 47-87 years, mean 65.47±8.88 years. This study was approved by the Ethics Committee of Affiliated Hospital of Qingdao University of China. Informed consent was obtained from each patient.

Diagnostic criteria

Diagnostic criteria for osteoarthritis of the knee joint of American Rheumatism Association.

Inclusion criteria

First unilateral knee arthroplasty patients, and patients with normal blood coagulation function.

Exclusion criteria

Exclusion criteria were known allergy to TA, bilateral TKA, patients of coagulant function abnormality, patients having heart and cerebrovascular accident.

Materials

The implants used in all patients were form Stryker Corporation. Manufacturing company was Howmedica Osteonics Corp. Production address was 325 Corporate Drive Mahwah, NJ 07430, USA.

Methods

Randomization and blinding

The patients were assessed preoperatively by an independent observer and the schedule for randomisation will be randomly generated using a computer before initiation of the study. To conceal the outcomes of the randomization, the allocation numbers will be put into concealed, opaque envelopes. An independent researcher will prepare the envelopes. Following informed consent, a randomization envelope will be opened. The randomization allocation will not be notified to either the patient or the independent researcher, as both patient and investigator will be blinded to the outcome of the randomization.

Group assignment

After these exclusions, 103 patients remained. The patients were allocated into four groups. Control group (n=17): patients did not undergo any treatment. Intra-articular injection group (n=28): by retrograde intra-articular injection, TA 2 000 mg was given at the end of the operation, followed by clamping the drainage for 2 hours. Intravenous injection group (n=40): TA 1 000 mg was intravenously injected^[10] before the use of tourniquet^[11-13], followed by clamping the drainage for 2 hours. Intra-articular and intravenous injection group (combined modality therapy, n=18): both TA

1 000 mg before tourniquet used and retrograde intra-articular injection of TA 2 000 mg at the end of the operation, followed by clamping the drainage for 2 hours.

Therapeutic methods

All patients were given general anesthesia. The patella was replaced. Surgery was performed under tourniquet control. After a midline skin incision was made, a medial parapatellar approach was used. An intramedullary alignment rod was used for femoral cutting and an extramedullary guide system for tibial cutting. The femoral canal for intramedullary guidance was routinely plugged with bone.

The tourniquet was not released until skin closure and application of a compressive dressing. Intraoperative blood loss was negligible in all patients because the tourniquet was not deflated until wound closure. We used an intra-articular drain connected to a vacuum bag.

TA medication is that control group did not undergo any treatment about TA; intra-articular injection group: retrograde intra-articular injection of TA 2 000 mg at the end of the operation followed by clamping the drainage for 2 hours; intravenous injection group: injected TA 1 000 mg before tourniquet used followed by clamping the drainage for 2 hours. Intra-articular and intravenous injection group (combined modality therapy): both TA 1 000 mg before tourniquet used and retrograde intra-articular injection of TA 2 000 mg at the end of the operation followed by clamping the drainage for 2 hours. This dose was found acceptable in previous studies. In all groups, the drainages were removed 24 hours after the operation.

Following surgery, all patients underwent intravenous prophylactic antibiotic therapy consisting of 1 g cefazolin every 12 hours for 5 days. Standard thromboprophylaxis was also prescribed for all patients after surgery. Rivaroxaban was administered by oral application 10 mg starting 10 hours after surgery and continuing every 24 hours for 21 days. A foot pump and antiembolic stockings were used for thromboembolic prophylaxis^[14-18].

Sutures were removed from all patients 3 weeks after surgery. As part of the postoperative care for four groups, continuous passive movement was started on postoperative day (POD) 1, and standing and full weight-bearing walking were allowed 1 week after the operation.

We used the principle of transfusion based on the criteria and guidelines for perioperative transfusion suggested by the Chinese Medical Doctor Association, which states that the decision to transfuse blood depends on clinical assessment aided by laboratory data, indicating that the patient has symptoms and signs associated with acute anemia. Therefore, our indication for blood transfusion was set at a hemoglobin concentration of 7 g/dl or a postoperative hemoglobin level of 7–9.0 g/dl with clinical evidence of acute anemia. It may be adjusted according to the patient’s cardiovascular status.

Observation items

Bleeding-related outcome measures included: (1) drained-blood loss; (2) total postoperative blood loss; (3) need for autogenic or allogenic blood transfusions, and the transfusion rate; (4) hemoglobin loss. Hemoglobin levels were measured on PODs 3 and (5) a formula proposed by some studies was used to calculate the total post- operative blood loss^[19-20]. It was based on the maximum postoperative decrease in hemoglobin level adjusted for the weight and height of the patient.

We recorded the operating time. We also monitored the wound condition (skin necrosis, hematoma, infection) and the possibility of deep venous thrombosis and/or pulmonary embolism for 4 weeks after the operation.

Statistical analysis

Statistical analysis adopted SPSS 21.0 software (SPSS Inc., Chicago, IL, USA) for data statistics. Measurement data were shown as mean ± SD. Count data were expressed as percentage. The comparison between the groups used chi-square test or one-way analysis of variance test. Statistical significance was assumed at a P < 0.05.

讨论

There were four important findings of the present study. First, in all the three groups using TA, postoperative blood loss and the need for blood transfusion were effectively reduced after TKA. This proved that all methods were efficacious. Second, blood loss was more in the intra-articular retrograde injection group and combined modality therapy group than in the intravenous injection group. However, they used larger doses of TA. We think that is the cause to solve the appearance. This certificated that following the dose of TA addition, hemostatic result raised. Third, in all the three groups used TA, hematoglobin loss was effectually reduced. Furthermore, hematoglobin loss reduced as the drug injection increasing. This is the same to the second finding. Fourth, symptomatic deep vein thrombosis, pulmonary embolism, and wound trouble including necrosis, infection, and hematoma were not observed in all groups. This certificated that the application of TA 3 000 mg is safe.

The mechanism of tranexamic acid is complicated. The fibrinolytic system is activated transiently after any surgery^[21-22]. Tranexamic acid is a synthetic amino acid that inhibits fibrinolysis by reversibly blockading lysine-binding sites on plasminogen molecules, thereby inhibiting its activation. This prevents plasmin from binding with fibrinogen and fibrin structures after clot formation. Because of its antifibrinolytic effects, the risk of increasing venous thromboembolism when using TA is a cause for concern^[23]. However, tranexamic acid does not influence fibrinolytic activity in vein walls. Therefore, neither our study nor previous studies observed a greater incidence of venous thrombosis in patients treated with TA^[23-24]. The incidence of subcutaneous and intra-joint hematomas was reduced in the study group compared to the control group because of the small amount of bleeding after TKA.

Tranexamic acid can reduce blood transfusion, and improve clinical safety. One of the main problems after TKA is the need for blood transfusion. Although the incidence is low, serious complications involving allogeneic blood transfusions (e.g., viral infections, graft-versus-host disease) have been reported. Because the need for blood transfusion was reduced using TA, transfusion-associated complications were reduced. Disadvantages of intravenous TA are prolonged high systemic drug levels from multiple injections or continuous infusion, leading to drug-induced systemic thromboembolic events. Because intra-articular retrograde injection was valid, we suggested using intra-articular retrograde injection to dominate drug-induced systemic thromboembolic events. Further investigations using smaller amounts of TA as compared with this study may be required.

Tranexamic acid can increase the risk of cardio-cerebral tube infarction. In the experiment, heart and cerebrovascular accident did not happen. In the clinical work, we should grasp the indications and contraindications of tranexamic acid to avoid accidents.

The study has limitations. First, sample content was not enough. Although there were no differences in patient characteristics in the four groups, selection bias was not completely excluded. Second, more studies (randomized controlled trials) are needed to determine dosage and administration. Also, investigations using thromboembolism screening tests such as ultrasonography may be required.

In the three groups using TA, postoperative blood loss and the need for blood transfusion were effectively reduced after TKA. As the drug injection increasing, hemostatic effects were increasing. Combined modality therapy using TA 3 000 mg was the best way to control the bleeding in TKA.
中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

氨甲环酸关节腔给药联合静脉给药可有效减少全膝关节置换后出血

Intra-articular and intravenous injection of tranexamic acid effectively reduces blood loss after total knee arthroplasty

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