- 期刊
使用客觀超音波量測之指標及主觀式自填式量表評估新型單針劑型玻尿酸用於膝退化性關節炎之療效：初步報告
Using Objective Ultrasonographic Findings and Subjective Self-reported Measures to Evaluate the Effectiveness of a Novel Single Intra-articular Injection of Hyaluronic Acid for the Treatment of Knee Osteoarthritis: A Preliminary Report
摘要
目的：退化性關節炎是全球最常見的肌肉骨骼系統疾病，其中又以膝退化性關節炎最常見，並且是造成老年人口失能之主要原因。膝關節腔內玻尿酸注射已被證實能夠改善膝退化性關節炎病人之疼痛、功能以及生活品質，然而過去大多之研究皆使用中低分子量之玻尿酸，且使用主觀式自填式量表進行評估。本研究旨在探討新型化學交叉技術製成之單針劑型玻尿酸HYAJOINT Plus於臨床上之效益，除了使用過去研究常見的主觀式自填式量表之外，並使用超音波量測當作追蹤之客觀性指標。方法：本研究為一前瞻性6個月追蹤期之設計，於單一醫院中心進行，收錄39位符合膝退化性關節炎定義且Kellgren-Lawrence分級在1到3級之病人。所有符合收案條件之受試者皆接受單次單針3毫升HYAJOINT Plus (20 mg/ml)的注射，並於注射當天、注射後1、3以及6個月進行常規之評估。使用之評估項目包括1.疼痛視覺類比量表(Visual Analog Scale for pain, VAS pain)；2.西安大略及麥可麥司特大學關節炎量表(Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC)：包含疼痛、僵硬、生理功能三大類別及總分；3. Lequesne's Index；4.注射膝側的大腿腿圍；5.超音波量測之股四頭肌厚度；6.超音波量測之股骨髁間軟骨厚度。結果：共有37名受試者完成測試，使用單因子重覆量數變異數(one-way repeated measure ANOVA)分析發現於6個評估項目中注射前後皆出現統計上顯著差異(p＜0.001)。進行事後檢定發現1.在疼痛視覺類比量表以及西安大略及麥可麥司特大學關節炎量表之疼痛類別上，接受玻尿酸注射一個月/三個月/六個月後與注射前之比較都有顯著之進步(p值分別為＜0.001/＜0.001/＜0.001；0.009/＜0.001/＜0.001)；2.在西安大略及麥可麥司特大學關節炎量表之生理功能及總分、超音波量測之股四頭肌厚度以及股骨髁間軟骨厚度方面，接受玻尿酸注射三個月後/六個月後與注射前之比較都有顯著之進步(p值分別為0.004/＜0.001；0.001/＜0.001; ＜0.001/＜0.001；0.002/0.039)；3.在西安大略及麥可麥司特大學關節炎量表之僵硬類別、Lequesne's Index、大腿腿圍方面，接受玻尿酸注射六個月後與注射前比較出現顯著之進步(p值分別為0.01、0.008及0.009)。所有受試者皆未出現感染、過敏等嚴重之不良反應。結論：新型單針劑型玻尿酸HYAJOINT Plus於膝退化性關節炎病人之注射是有效且安全的，除了病患主觀的自填式測試量表之進步外，客觀超音波量測之股四頭肌厚度以及股骨髁間軟骨厚度也顯著增加，且其臨床效益可以維持六個月。
並列摘要
Purpose: Osteoarthritis (OA) is the most common musculoskeletal disease worldwide. Knee OA is the most common type of OA and is the main cause of disability in elderly people. Intra-articular (IA) injection of hyaluronic acid (HA) has been widely proven to improve pain, physical function, and quality of life among patients with knee OA. However, most of the previous studies have used low-to-moderate molecular weight (MW) HA and have evaluated the clinical benefits by using subjective self-reported measures. In this study, we evaluated the efficacy of a single IA injection of a novel cross-linked HA (HYAJOINT Plus) through objective ultrasonographic assessment of the thickness of quadriceps and femoral intercondylar cartilage (FIC) in addition to subjective self-reported measures. Methods: In this prospective trial with 6-month follow-up, 39 patients with knee OA (Kellgren-Lawrence grades 1 to 3) were recruited from a single medical center. These patients received one IA injection of 3 mL HYAJOINT Plus (20 mg/mL). All patients were assessed at baseline and 1, 3 and 6-months after HA injection. The outcome measures were (1) Visual Analog Scale for pain (VAS Pain); (2) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which generates three subscale scores (pain, stiffness, and physical function) and a total score; (3) Lequesne's Index, (4) thigh circumference at the injected knee site, (5) thickness of quadriceps under ultrasonography, and (6) thickness of FIC under ultrasonography. Results: A total of 37 patients completed the 6-month follow-up. One-way repeated measure analysis of variance revealed that compared with the baseline, VAS Pain, WOMAC, Lequesne's index, thigh circumference, ultrasonographic thickness of quadriceps and FIC improved significantly after HA injection by using one-way repeated measure ANOVA (p ＜ 0.001 for all). Post-hoc analysis revealed the following results. First, compared with the baseline, VAS Pain and WOMAC-pain subscale score improved significantly 1, 3, and 6 months after HA injection (VAS Pain: p ＜0.001, ＜0.001, and ＜0.001 and WOMAC-pain subscale score: p =0.009, ＜0.001, and ＜0.001, respectively). Second, WOMAC-physical function subscale score, WOMAC-total score, and ultrasonographic thickness of quadriceps and FIC improved significantly 3 and 6 months after HA injection (WOMAC-physical function subscale score: p=0.004 and ＜0.001; WOMAC-total score: p=0.001 and ＜0.001; quadriceps thickness: p＜0.001 and ＜0.001; and FIC thickness: p=0.002 and 0.039, respectively). Third, compared with the baseline, WOMAC-stiffness subscale scores, Lequesne's index, and thigh circumference improved significantly 6 months after HA injection (p=0.01, 0.008, and 0.009, respectively). No serious adverse events occurred following injections. Conclusion: A single IA injection of a novel cross-linked HA, HYAJOINT Plus, is effective and safe for 6 months in patients with knee OA. This study demonstrated the clinical benefits of HYAJOINT Plus through not only subjective self-reported measures but also objective measures comprising thigh circumference, and ultrasonographic thickness of quadriceps and FIC.
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