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第六章 結論與建議

第二節 未來研究的建議方向

增加受試者招募來源醫院與延伸病歷回溯時間。本研究為病歷回溯研究,納 入之受試者僅限於臺安醫院此單一醫院,2012年1月至2013年1月共170名TKA 受術者,雖然本研究欲探討之數個研究依變項(手術失血量,輸血量,住院天數,

醫療成本)較之控制組皆達到顯著差異,但本研究仍有所侷限,若要得到更切確的 結果,須將回溯的時間擴大,並納入更多來自不同醫院之TKA受術者,分析其TXA 局部給藥是否真能如同本研究結果所示,能有效減少手術失血量、輸血量、住院 天數、與醫療成本。由於不同醫生與不同醫院其慣用的TKA手術方式略有不同,

如未來要納入多醫療院所之資料進行研究,需先將各醫院之數據常規化後,方能 進行統整與比較。所幸全膝關節置換術已納入健康保險DRG住院診斷關聯群,各 醫療院所之TKA醫療成本之變異應小於未納入DRG前之TKA醫療成本。

試驗設計由病歷回溯研究改為前瞻性臨床試驗。雙盲隨機對照實驗(Blinded Randomized Controlled Trial)的結果於臨床研究是最有公信力的,此實驗設計透過 隨機配組的方式降低各組受術者的變異,讓各組之間唯一不同的變項就是要研究 的介入措施,再比較各組在不同介入措施之後所產生的結果是否有明顯差別,最 後去決定介入措施與結果之間是否有因果關係存在;同時利用雙盲設計避免試驗 的對象或進行試驗的人員的主觀偏向影響實驗的結果。如果以雙盲隨機對照實驗 設計研究 TXA局部給藥對於TKA手術的影響,應能取得最為可靠的試驗結果,

但所需耗費的人力、物力亦大於病歷回溯研究。由於此試驗為前瞻性試驗,除了 常規的術前術後檢查,我們亦能進一步增添其他研究變項如:術前術後膝關節功 能評比、術後血紅素濃度變化(不同時間點)、超音波檢測血管栓塞等臨床觀察,分 析TXA局部給藥對於受術者除手術失血量、輸血量以外的影響。

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本研究設計主要以研究TXA局部給藥對於TKA手術的影響,建議未來亦可 將TXA靜脈輸注及局部使用之合併於患者的研究當作研究的方向,來探討兩者之 間是否有顯著的差異。

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