| 研究生: |
何國維 Ho, Kuo-Wei |
|---|---|
| 論文名稱: |
減除白血球過濾致紅血球溶血之分析 - 以某醫學中心為例 An analysis of red blood cell hemolysis during leukoreduction filtration – a case study from a medical center |
| 指導教授: |
徐立群
Shu, Lih-Chyun |
| 學位類別: |
碩士 Master |
| 系所名稱: |
管理學院 - 高階管理碩士在職專班(EMBA) Executive Master of Business Administration (EMBA) |
| 論文出版年: | 2022 |
| 畢業學年度: | 110 |
| 語文別: | 英文 |
| 論文頁數: | 32 |
| 中文關鍵詞: | 溶血 、減除白血球 、過濾 |
| 外文關鍵詞: | Hemolysis, Leukoreduction, Filtration |
| 相關次數: | 點閱:64 下載:0 |
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紅血球血品的全面減除白血球(簡稱:減白)作法在台灣已於2021年8月達成。然而,卻有些顯著溶血的減白紅血球血品被醫療單位退回。確認結果暗示,減白紅血球血品可以比原先非減白血品溶血更嚴重。本次基於血液管理資訊系統的回溯性研究目的是鑑定減白紅血球血品溶血的危險因子,並提供捐血中心實證建議以預防不符合規範的溶血。
本研究收集自2021年5月1日至2021年10月31日供應到一間醫學中心血庫的減白紅血球血品的特徵數據,同時包含退回血品的溶血紀錄,以統計學方法評估與不符合規範溶血有關聯的各項變數。
本研究共收集17,811袋減白紅血球血品,當中沒有分離前隨袋減白紅血球血品因溶血而退回。分離後儲存前減白紅血球血品的溶血不合格率是0.29%,低於先進國家品質管理數據近2%的溶血不合格率。捐血城市及地點發現與溶血無顯著相關,僅X公司連接過濾器和周末捐血與溶血有顯著正相關,其勝算比分別為61.2和2.5。
本回溯性研究成功分析血液管理資訊系統數據,揭示減白紅血球溶血取決於減白過濾器品項和紅血球保存時間,並且建議捐血中心使用Z公司的整合隨袋過濾器處理晚到血袋,以預防不符合規範的溶血。
Universal leukocyte reduction of red blood cell (RBC) components in Taiwan was accomplished by Aug 2021. However, grossly hemolyzed RBC units were returned from medical institutions. The recheck results implied a fact that leukocyte-reduced (LR) RBC products can hemolyzed more severely than its non-LR predecessor. The purpose of this retrospective study based on Blood Management System (BMS) was to determine the risk factors of LR RBC hemolysis and provide evidence-based suggestions to blood centers to prevent unacceptable hemolysis.
The study collected characteristic data of LR RBC products distributed to a tertiary teaching hospital’s blood bank in May 1, 2021 until October 31, 2021, as well as hemolysis records of returned LR RBC units. Statistical analyses were performed to assess variables in association with unacceptable hemolysis.
A total of 17,811 LR RBC products were included, and there was no returned “pre-separation” in-line LR RBC unit due to suspected hemolysis. The disqualified rate of hemolysis of “post-separation” pre-storage LR RBC components was 0.29%, which was lower than quality management data of other developed countries of approximate 2%. Donation cities and sites were found no signficance in hemolysis, but Company X_connect filter and donation in weekend significantly increased hemolysis with odds ratio of 61.2 and 2.5 respectively.
This retrospective study successfully analysed BMS dataset and revealed that LR RBC hemolysis depends on the type of leukoreduction filters and the holding-time of RBCs, and advised blood center choosing Company Z_integral in-line filter for late-arrival blood units to prevent unacceptable hemolysis.
Journal
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Book
Cohn, C. S., Delaney, M., Johnson, S. T., & Katz, L. M. (2020). Technical Manual. Bethesda, Maryland: AABB.
EDQM. (2020). Guide to the preparation, use and quality assurance of blood components. Strasbourg, France: European Directorate for the Quality of Medicines & HealthCare, Council of Europe.
Fung, M. K., Grossman, B. J., Hillyer, C. D., & Westhoff, C. M. (2014). Technical Manual. Bethesda, Maryland: AABB.
Mintz, P. D. (2011). Transfusion Therapy: Clinical Principles and Practice (3 ed.). Bethesda, Maryland: AABB Press.
Simon, T. L., McCullough, J., Snyder, E. L., Solheim, B. G., & Strauss, R. G. (2016). Rossi's principles of transfusion medicine (5 ed.). Oxford: Wiley Blackwell.
王樂明, 林東燦, 陳宜雍, 溫武慶, 蔡欣怡, & 羅仕錡. (2020). 精實輸血手冊. 台北市: 醫療財團法人台灣血液基金會.
Standard
Guidance for industry pre-storage leukocyte reduction of whole blood and blood components intended for transfusion. (2012). U.S. Food and Drug Administration.
全民健康保險醫療服務給付項目及支付標準. (2013). 衛生福利部中央健康保險署.
血品退回、召回作業準則. SP-B3-065 (2019). 醫療財團法人台灣血液基金會.
血液成品QC測試作業規範. QP-BB-032 (2013). 醫療財團法人台灣血液基金會.
減除白血球之紅血球製備作業準則. SP-B2-294 (2021). 醫療財團法人台灣血液基金會.
校內:2027-07-07公開