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題名 | Effects of Alendronate on Bone Turnover Markers in Early Postmenopausal Women=比較福善美 (Fosamax) 及安慰劑對早期停經婦女骨代謝指標之影響 |
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作者 | 楊再興; 昝舜華; 陳春榮; 張昇平; 袁九重; Yang, Tzay-shing; Tsan, Shun-hwa; Chen, Chuen-rong; Chang, Sheng-ping; Yuan, Chiou-chung; |
期刊 | 中華醫學雜誌 |
出版日期 | 19981000 |
卷期 | 61:10 1998.10[民87.10] |
頁次 | 頁568-576 |
分類號 | 418.2183 |
語文 | eng |
關鍵詞 | 福善美; 骨代謝指標; 停經; 骨質疏鬆症; Alendronate; Bone turnover markers; Menopause; Osteoporosis; |
中文摘要 | 背景 福善美(Fosamax: alendronate sodium)為一種氨基雙磷酸鹽類( aminobisphonate)藥物,口服後它會迅速分佈至骨表面,直接抑制噬骨細胞的骨再吸收作用 ,從而造成骨代謝速率減緩,骨質增生。 方法 此為一隨機、雙盲、安慰劑對照之研究,比較每天服用一粒福善美(aiendronate 10 mg) 或安慰劑對骨代謝指標之影響。共計40位早期(<3年)停經婦女完成為期3個月的治療 。在整個研究過程中,患者每天服用安慰劑或福善美10 mg,同時所有患者每天均服用500 mg 之碳酸鈣,在3個月治療期間,分別於服藥前、服藥後第六週及3個月研究結束時,測定 骨代謝的生化指標,並於每次覆診時記錄不良事件之發生情形。 結果 服用藥物組患者其骨耗損指標(尿液)-deoxpyridinoline(Dpd) 及骨生成指標(血清)- bone specific alkaline phosphatase (Alkphase-B) 均顯著降低,而安慰劑組患者其骨 耗損及骨生成指標則呈上升之勢。3個月研究結束時,藥物組之Dpd 及Alkphase-B 值與用藥 前(baseline) 相比,平均百分比分別下降了30.49%及29.45%。相反地,安慰組則分別增 加了2.39%及1.52%。整體而言,兩組之Dpd及Alkphase-B 差異以analysis of variances 來分析有顯著差異(p<0.01)。此藥物之耐受性佳,與安慰劑組相比,藥物組之胃腸不適及食 道刺激等副作用的發生率無明顯增加。 結論 本研究證實,福善美可快速抑制骨質吸收,同時無明顯副作用,故此非荷爾蒙類藥物 可作為治療停經後骨質疏鬆症之另一選擇。 |
英文摘要 | Background. Alendronate sodium(Fosamax��, Merck, Sharp & Dohme, Whitehouse Station, NJ, USA) is an aminobisphosphonate that can inhibit osteoclast-mediated bone resorption activity to reduce bone turnover rate and improve progressive gains in bone mass. Methods. This was a randomized, double-blind, placebo-controlled study comparing the effects on bone turnover markers between daily treatment with alendronate sodium 10 mg and placebo. Forty early postmenopausal women completed three months of treatment. The bone turnover rate was determined by measuring the biochemical markers at baseline, week 6 and at the end of the three-month treatment period. All adverse events were recorded during each follow-up visit. Results. Patients receiving alendronate treatment had a significant decrease in urinary excretion of the bone resorption marker deoxypyridinoline(Dpd) as well as one of the bone formation markers, bone-specific alkaline phosphatase(AlkP-B) . Patients receiving placebo tended to have increased urinary excretion of bone resorption and formation markers. At the end of three months, the mean percentage change of Dpd and AlkP-B form baseline in the group receiving 10 mg alendronate was 30.49% and 29.45% reduction, respectively. The placebo group had 2.39% and 1.52% increase, respectively. Overall, three biochemical markers(Dpd, AlkP-B and osteocalcin) differed significantly between the treatment and control groups after three months of treatment. The drug was well tolerated, without a significant increase in incidence of adverse effects such as gastrointestinal discomfort and esophageal irritation. Conclusions. Bone turnover rate decreased quickly following drug administration. The incidence of adverse did not differ significantly between the alendronate and placebo groups. Alendronate is, therefore, recommended as an effective nonhormonal treatment for postmenopausal osteoporosis. |
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