間斷服用Ibandronate能有效地預防骨質疏鬆症


  Oct. 8, 2003--根據一項發表於十月刊Annals of Rheumatic Disease的研究結果顯示,間斷服用伊班膦酸鹽(Ibandronate)對於預防骨質疏鬆症是有效且有良好耐受性。
  
  來自挪威Haugesund CECOR AS 的J. A. Stakkestad及其在間斷服用伊班膦酸鹽研究小組的同事表示,儘管雙磷酸類藥物已被證實具有療效,仍需依照嚴格的建議劑量來給予病患持續每日服用的雙磷酸類藥物,減少雙磷酸類藥物服用時刻的頻率會增加病患的便利且可能對於病患樂意遵守雙磷酸類藥物用法有正面的影響。
  
  在這項多中心、雙盲試驗中,依照停經期和試驗開始時的腰脊柱骨礦物密度分成不同等級的629位停經後女性,隨機分配到每三個月接受ibandronate(0.5,1mg,或2mg)或是安慰劑的靜脈注射(IV),所有婦女每日均服用鈣補充劑。
  
  一年之中,有2 .5%(2 .5%)的2 -mg 劑量注射組,1 .8%(2 .6%)的1 -mg 劑量注射組,及1.0%(2.8%)的0.5mg ibandronate注射組的女性,其平均(標準差)腰脊柱BMD有劑量相關的增加,與三個不同劑量的注射ibandronate組相比,注射安慰劑組的女性損失了0 .4%的BMD (2 .4%) (P = .0001)。量測髖骨的BMD也得到相似的結果。
  
  在劑量相關的型式中,與安慰劑相比,ibandronate也能抑制骨代謝指標,注射有良好的耐受性,雖然女性在施打bandronate時的肌肉疼痛是很普遍的。
  
  作者表示,這是第一個研究證實以間斷性IV注射雙磷酸類藥物預防停經不久的女性骨質流失的功效和耐受性,停經後女性預防骨質流失,每三個月注射一次IV ibandronate,或許是一個有效的可替代口服雙磷酸類藥物和荷爾蒙的治療方法。

Intermittent Ibandronate Effec

By Laurie Barclay, MD
Medscape Medical News

Oct. 8, 2003 — Intermittent ibandronate for prevention of osteoporosis is effective and well tolerated, according to the results of a study published in the October issue of the Annals of Rheumatic Disease.

"Despite their proven efficacy, conventional daily bisphosphonates must be given in accordance with stringent dosing recommendations," write J. A. Stakkestad, from CECOR AS in Haugesund, Norway, and colleagues from the Ibandronate Intravenous Study Group. "Less frequent bisphosphonate dosing schedules increase patient convenience and are likely to have a positive impact on patients' willingness to comply with bisphosphonate administration."

In this multicenter, double-blind trial, 629 postmenopausal women, stratified according to time since menopause and baseline lumbar spine bone mineral density (BMD), were randomized to receive intravenous (IV) ibandronate (0.5 mg, 1 mg, or 2 mg) or placebo every three months. All women received daily calcium supplementation.

At one year, women in the ibandronate groups had a dose-dependent increase from baseline in mean (standard deviation) lumbar spine BMD of 2.5% (2.5%) with the 2-mg dose, 1.8% (2.6%) with the 1-mg dose, and 1.0% (2.8%) with 0.5 mg ibandronate. Women in the placebo group had a loss of BMD of 0.4% (2.4%) for each ibandronate dose vs. placebo (P = .0001). Results were similar for BMD measured at the hip.

In a dose-dependent fashion, ibandronate also suppressed markers of bone turnover in comparison with placebo. Injections were well tolerated, although myalgia was more common in women receiving ibandronate.

"This is the first study demonstrating the efficacy and tolerability of intermittent IV injections of a bisphosphonate in preventing bone loss in early postmenopausal women," the authors write. "IV ibandronate injections, given every three months, may be an effective alternative to oral bisphosphonates and hormonal therapy in the prevention of bone loss in postmenopausal women."

F. Hoffmann-La Roche Ltd. sponsored this trial.

Ann Rheum Dis. 2003;62:969-975

Reviewed by Gary D. Vogin, MD

    
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