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研究生(外文):Hsien-Pin Sun
論文名稱(外文):The Study on the Effect of Sodium Hyaluronate Injection on the Treatment of Unilateral Osteoarthritis of the Ankle
指導教授(外文):Yun-Peng Chao
外文關鍵詞:Ankle jointBalanceHyaluronic acidOsteoarthritisViscosupplementation
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背景: 連續三到五週,每週一次給予膝關節玻尿酸注射的黏液補充治療,在膝部骨關節炎病患已是廣為接受的治療選項。先前的研究報告指出,連續五週給予踝骨關節炎病患玻尿酸注射,是安全有效的治療。但是,連續三週玻尿酸注射,對踝骨關節炎病患的療效,目前很少被研究。本篇研究的目的,是探討踝關節連續三週玻尿酸sodium hyaluronate (Hyalgan) 注射,對於單側踝骨關節炎病患的療效及安全性評估。
研究方法: 本研究,在醫學院附屬醫學中心進行,以前瞻性、觀察者單盲的方式執行。46位單側踝關節疼痛持續至少六個月以上,放射學診斷分類為Kellgren-Lawrence二至三級的病患,作為研究對象。病患接受每週一次,於患側踝關節進行關節內玻尿酸注射。主要結果的判定,是在第三次注射後六個月,以踝骨關節量尺(Ankle Osteoarthritis Scale )的變化作分析。其他的次級成果,包括利用美國骨科足與踝學會的踝與腳跟量尺、踝部矢狀切面活動範圍、以及臨床所作的四種平衡測試。乃是於注射前及每次注射後回診追蹤時,所作的評估。同時,也針對止痛藥物的使用量,病患的滿意度,以及不良反應作分析。
結果: 總共有四十六位參與者,完成本次的測試。我們發現,和未注射前比較,在第一、三、及完成注射後六個月,AOS 量尺均顯著下降 1 (p < 0.001) ;平均減少的數值,是1.9,2.1 和 2.3。美國骨科足與踝學會的踝與腳跟量尺的分數,由注射前的平均60.5分,顯著進步到在第一、三、及完成注射後六個月時的73.5, 75.5 及 76.7 (p < 0.001) 。 踝部矢狀切面活動範圍明顯改善(p < 0.001),此外止痛藥物乙醯氨酚的使用量也明顯減少(p < 0.001)。 四種臨床平衡測試,在每次追蹤時,也都比治療前呈現明顯進步(p<0.001 )。病患的滿意度很高,同時並沒有嚴重的不良反應產生。
結論: 本研究的結果顯示,對於單側踝骨關節炎病患,連續三週,每週一次的玻尿酸注射,有良好的耐受性,不僅疼痛減輕,踝關節功能和平衡能力明顯改善。不過這個結果,需要更大規模和更加嚴謹的研究加以確認。
Background: Viscosupplementation with 3 to 5 weekly hyaluronate injections is a well-established treatment option in knee osteoarthritis. Previous studies reported that five weekly hyaluronate injections were safe and effective for the treatment of ankle osteoarthritis. However, the effect of three weekly injections has rarely been investigated. The purpose of this study was to evaluate the efficacy and safety of three weekly injections of sodium hyaluronate (Hyalgan) in patients with unilateral ankle osteoarthritis.
Methods: As a prospective observer-blind study done in a university-affiliated tertiary care medical center, 50 patients with unilateral ankle pain for at least 6 months and radiographically classified as Kellgren-Lawrence grade 2 or 3 ankle osteoarthritis were recruited. Patients received three weekly intraarticular injections of Hyalgan into symptomatic ankles. The primary outcome was the change in the Ankle Osteoarthritis Scale (AOS) score at 6 months after the third injection. Several secondary outcomes including the American Orthopedic Foot and Ankle Society ankle/hindfoot score, ankle sagittal range of motion and four clinical balance tests were assessed before first injection and at each follow-up visit. Consumption of rescue analgesics, patients’ global satisfaction and adverse events were analyzed also.
Results: Forty-six participants completed the study. Significantly greater reduction in AOS scores by more than 1 was noted at 1, 3 and 6 months after the third injection (p < 0.001 for each following visit compared with baseline before first injection). The average reduction of AOS score was 1.9, 2.1 and 2.3 at each following visit. The mean American Orthopedic Foot and Ankle Society ankle/hindfoot score improved from 60.5 points at baseline to 73.5, 75.5 and 76.7 points at 1-month, 3-month and 6-month follow-up, respectively (p < 0.001). Ankle sagittal range of motion improved and acetaminophen consumption dropped significantly following treatment (p < 0.001). Patients demonstrated significant improvements in four clinical balance tests at each follow-up visit compared with baseline (p<0.001 for each test). The patients’ satisfaction requires confirmation in larger, well-controlled trial.
中文摘要 i
Abstract iii
目錄 v
圖目錄 vii
表目錄 viii
第一章 介紹 1
第一節 退化性關節炎 1
第一段 軟骨的健康 1
第二段 關節炎的病理變化 2
第二節 玻尿酸 8
第一段 玻尿酸的特性 9
第二段 玻尿酸的來源 9
第三段 玻尿酸的應用範疇: 11
第四段 玻尿酸對關節的作用 13
第二章 材料與方法 18
第一節 參與者 18
第二節 排除的條件 19
第三節 研究設計 19
第四節 結果測量 21
第一段 主要結果的判定 21
第二段 次級成果判定 21
第三章 統計與分析 27
第一節 樣本數的決定 27
第二節 統計軟體與統計方法 29
第四章 結果 30
第一節 踝骨關節量尺AOS及疼痛和行動障礙的結果 31
第二節 美國骨科學會的踝與腳跟量尺AOFAS ankle/hindfoot score的分數 31
第三節 踝部矢狀切面活動範圍 32
第四節 止痛藥物的使用量 32
第五節 臨床四種平衡測試 32
第六節 病患的滿意度 32
第七節 不良反應 33
第五章 討論 34
第六章 結論 37
參考文獻 44
附錄一 Ankle Osteoarthritis Scale 48
附錄二 AOFAS ankle/hindfoot score (100 points total) 49
附錄三 玻尿酸注射健保給付相關使用的限制和規定: 51
附錄四 Berg Balance Scale 52
附錄五 Functional Reach Test 57
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