行全膝關節置換術病人術中傷口局部注射transamin acid是否可減少術後出血量及降低輸血率?Can Intraoperative Local injection of Tranexamic Acid in Patients of TKA Reduce Postoperative Bleeding Volume and Blood Transfusion Rate?

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2019-05-03 已刊登
新刊登 綜 整 預防/治療/介入類型

作  者

李思璇 林心怡* 林小絹 鄭智庭

實證知識類別

B 類:實證健康照護應用

PICO

治療/預防性問題

治療/介入措施

一般外科醫學 General Surgery

科別

  • 骨骼護理 Orthopaedic Nursing
  • 臨床指引/實證照護成效 Clinical Guidelines/Evidence Based Outcomes

中文關鍵詞

全膝關節置換術 局部注射 傳明酸 失血量 輸血率

英文關鍵詞

Total knee arthroplasty Topical injection tranexamic acid Blood loss blood transfusion

機構名稱

台灣基督長老教會馬偕醫療財團法人新竹馬偕紀念醫院

申請單位

外科病房

中文摘要

形成臨床提問:
近年來隨著人口老化,行全膝關節置換術(Total knee arthroplasty,TKA)病人逐年增加。根據研究顯示因該手術接受輸血約11-21%;輸血可能產生免疫反應、感染、血管內溶血、腎功能衰竭。Tranexamic acid(TXA)是一種合成抗纖維蛋白溶解劑,可同時抑制纖維溶解和纖維溶解酶原激活,達到止血。其使用方式有局部及靜脈注射,前者對於降低失血量及輸血率的效果較佳。臨床上發現TKA術後病人Hemovac(H/V)引流量多、術後血紅素(Hemoglobin,Hb)下降比例高,常需輸血,故想探討行TKA病人術中傷口局部注射TXA是否可減少術後出血量及降低輸血率?
文獻搜尋的方法與分析:
以PICO相關關鍵字、同義字、切截字、MeSH terms,運用布林邏輯「AND」、「OR」搜尋資料庫,排除與主題不符及重複文章,選出五篇符合PICO文章,一篇為系統性文獻回顧(systematic review,SR),四篇為隨機對照試驗(randomized controlled trial,RCT)。
文獻的品質評讀:
依NHS CASP評讀SR及RCT工具進行評讀,再根據英國牛津大學CEBM發表的實證醫學證據應用等級來評估,SR文獻為Level 1,四篇RCT文獻則為Leve 2,文獻均支持局部使用TXA能有效減少TKA出血量和輸血率,也可減少術後引流管血量和血紅素下降比例,尤其高濃度效果較低濃度佳。
證據之臨床應用:
本小組審視104年行TKA之病歷146位,有施打TXA者,術後總導管引流量及輸血率明顯較未施打TXA者有顯著下降,與文獻相符;再依據SR推論,設定高濃度組為TXA 6支+20c.c. N/S(30mg/mL)、低濃度組為TXA 3支+35c.c. N/S(15mg/mL),以比較術後出血量及輸血率,隨機分派病人,採雙盲方式,手術過程中所有病人皆使用相同的麻醉及手術方式,住院期間由三班護理人員記錄病人手術前後的Hb數值、導管引流量、輸血人數及輸血量。
成效評值:
自105年10月1日至106年8月15日共收案174人,高濃度組共91人(52.3%),男性25人,女性66人,平均年齡為70.3歲;低濃度組共83人(47.7%),男性23人,女性60人,平均年齡為70.9歲。術後第一天H / V引流量,高濃度組顯著低於低濃度組(133±129.4ml,182.4±161.6ml,p <0.01),高濃度組有6人(6.6%)輸血,低濃度組有9人(10.8%)輸血,輸血人數(p <0.01)有顯著差異。
結論與建議:
對於行TKA的病人,建議可使用術中局部注射TXA可減少術後出血量及降低輸血率。尤其局部注射高濃度TXA可減少術後第一天的導管引流量、輸血率及輸血單位數。可減少醫療成本、護理人員照護上負擔及病人及家屬的對輸血不良反應的擔憂,但未來可納入更多樣本數及進一步確認不同濃度或劑量TXA於行全膝關節置換術後出血量及降低輸血率之療效。

英文摘要

Ask an answerable question (PICO):
As the population ages, the number of patients undergoing total knee arthroplasty (TKA) increases year by year. Studies shows that about 11-21% of blood transfusion are received in the surgery and blood transfusions may present some potential risks, such as infection, renal failure and even death. Tranexamic acid (TXA) is a synthetic anti-fibrinolytic agent that inhibits fiber lysis and plasmin activation to achieve hemostasis. Clinically, TXA is used in local and intravenous injections. The effect of local injection on reducing blood loss and blood transfusion rate is better than that of intravenous injection. The purpose of this study is to investigate whether local injection of TXA in total knee arthroplasty can reduce postoperative bleeding volume and blood transfusion rate.
The Method and Analysis of Literature Review:
Use P, I, C, O related Chinese and English keywords, synonyms, cut-off words, MeSH terms, use Boolean Logic "AND", "OR" to search the database, exclude the disagreement with the theme and repeat the article, select five Articles in accordance with PICO, one for systematic review (SR) and four for randomized controlled trial (RCT).
Critical Appraisal:
The Critical Appraisal Skills Programme(CASP, 2013) and level of Evidence published by CEBM(Oxford University, 2011) was used to appraise the quality of the reviewed studies. The SR literature is Level 1, and the four RCTs are For Leve 2, the searched literature supports local use of TXA to effectively reduce TKA bleeding and transfusion rates, as well as reduce the proportion of postoperative drainage tube blood and hemoglobin, Especially the high concentration is better than low concentration.
Clinical Application of Evidence:
The team examined 146 patients who performed TKA surgery in 104 years. Those who received TXA had a significant decrease in total drainage amount and transfusion rate compared with those who did not receive TXA, which was consistent with the literature. Based on SR inference, The high concentration group was TXA 6 ampoules+20c.c. N/S (30mg/mL), and the low concentration group was TXA 3 ampoules+35c.c. N/S (15mg/mL) to compare the postoperative blood loss and blood transfusion rate. Patients were randomly allocated in a double-blind manner. All patients underwent the same anesthesia and surgical procedures during the operation. During the hospitalization, the three-shift nursing staff recorded the Hb values, drainage amount, number of blood transfusions.
Evaluation of Effectiveness:
The total number of people collected was 174, with an average age of 70.3 years old. High concentration group had a total of 91 (52.3%) patients with 25 males and 66 females. low concentration group had a total of 83 (48.7%) patients with 23 males and 60 females. On the first day after operation, the drainage amount of high concentration group was significantly less than that of low concentration group (133±129.4ml, 182.4±161.6ml, p<0.01), and there was no significant difference between the two groups in terms of the drainage amount on the second day after operation (175.5±103.2ml, 183.2±112.0ml, p=0.63), total drainage amount(308.6±210.1ml, 365.6±250.7ml, p=0.05) and total blood loss (618.3±282.5ml, 641.6±275.6ml, p=0.28). 6 patients (6.6%) in high concentration group received 14 bags of blood transfusion, 9 patients in low concentration group (10.8%) received a total of 18 bags of blood transfusion, and the number people with blood transfusions (p<0.01) and the number of blood transfusion units (p<0.01) were significantly different.
Conclusions and Recommendations:
For patients with TKA, it is recommended that intraoperative local injection of TXA can reduce postoperative bleeding and blood transfusion rate. In particular, local injection of high-concentration TXA can reduce drainage amount on the first postoperative day, transfusion rate, and number of transfusion units. It can reduce the cost of medical care, the burden of nursing care, and the patient's and family's concerns about adverse reactions to blood transfusion, but in the future, need more samples can be included and further confirmation of different concentrations or doses of TXA use in TKA surgery the effect of reduction postoperative blood loss blood transfusion rate.