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題 名 | The Double-Blind Test of Sodium Hyaluronate (ARTZ) on Osteoarthritis Knee=以Sodium Hyaluronate (ARTZ)對關節炎膝蓋所作之雙盲試驗 |
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作 者 | 吳濬哲; 施麗媛; 許弘昌; 陳天雄; | 書刊名 | 中華醫學雜誌 |
卷 期 | 59:2 1997.02[民86.02] |
頁 次 | 頁99-106 |
分類號 | 416.61 |
關鍵詞 | 雙盲試驗; 關節炎膝蓋; ARTZ(Sodium hyaluronate); Double-blind test; Osteoarthritis knees; |
語 文 | 英文(English) |
中文摘要 | 背景:目前為止,對於關節炎仍無明確的治療方法;玻尿酸(Hyaluronate (ARTZ)乃是滑囊液裡一種重要成分,可在關節活動時保護關節軟骨及軟組織表面免於損傷。 方法:由四位資深骨科醫師診斷為早期膝關節炎(輕度至中度)的 90位病人 116隻腿參予本研究。試驗設計為雙盲模式,對參與試驗的病人,連續五週每週一次;不使用局部麻醉藥,在關節腔內隨機的注射 2.5 ml 藥物(ARTZ或對照藥)。以主觀、客觀症狀及日常活動之評分,作為評估結果。追蹤調查期間為首劑注射後的六個月間。 結果:依照臨床評估及統計分析的結果,ARTZ對關節炎膝蓋確實有療效,且有意義的優於對照藥。 最佳效果出現在打完五針之後一星期,有效期持續達三個月,不需再加其他治療;ARTZ對於關節炎膝蓋之療效,顯著的能減輕動作疼痛,並改善膝蓋運動功能;在六個月期間無任何副作用發生。 結論:基於我們的實驗結果, ARTZ 應為可長期使用的高安全性藥性,可作為膝關節炎治療方法的另一種選擇。 |
英文摘要 | Background: At this time, no definite treatment exists for osteoarthritis disease. Hyaluronate (ARTZ) is one of the most important components of synovial fluid. It is generally accepted that hyaluronic acid protects the articular cartilage and soft tissue surfaces from trauma during joint function. Methods: Ninety patients with 116 knees diagnosed as early arthritis (mild to moderate) by four senior orthopaedic surgeons were selected to join this study. The trial design was applied with a double-blind model. The selected patients were randomly injected with 2.5 ml drugs (ARTZ or placebo) intra-articularly once a week for five consecutive weeks without the use of local anesthetic drugs. Evaluation results included grading of subjective and objective symptoms and daily activities. The follow-up period was up to six months after initial injection. Results: According to the results of clinical evaluation and statistical analysis, SPH (ARTZ) is quite effective for osteoarthritis knees, and significantly better than the placebo. The effective peak was one week after five injections of ARTZ. The effective period could last up to three months without additional treatment. The effficacy of ARTZ on osteoarthritis knees was more prominent for relief of motion pain and improvement of knee movement. No side effects developed during a six month period. Conclusions: Based on clinical results here, SPH is a safe drug for administration as an alternative approach to treat the osteoarthritis knee. |
本系統中英文摘要資訊取自各篇刊載內容。