Alendronate在預防骨質流失於使用類固醇治療之停經前類風濕性關節炎病患之效果

The Efficacy of Alendronate in the Prevention of Bone Loss in Premenopausal Rheumatoid Arthritis Patients Receiving Glucocorticoid

骨質疏鬆症（骨鬆症）是長期使用類固醇治療後最常見的合併症之一，而類風濕性關節炎更是造成骨鬆症的重要危險因子，雙磷酸鹽類藥物（Bisphosphonate）除經證實對於類固醇引起之骨鬆症有預防及治療的效果，但未證實是否對於未停經前之類風濕性關節炎使用類固醇治療後，仍有保護的效果，在此，我們報告Alendronate一年期開放式，平行對照研究於此類病患的治療效果。方法及材料對象：我們從1999年3月至2000年5月期間，收集60位於高雄長庚風濕科門診追蹤之類風濕性關節炎病患進行這項研究，這些病患已接受類固醇6個月以上，並在未來一年仍可能繼續類固醇治療者，吾人排除一些有其他可能造成骨鬆症的重要因子的病患進入研究。研究設計：這是一個一年期、開放式、前瞻性及隨機對照型的研究，60個病患分成兩組各30人，一組接受每天10mg A1endronate加上600mg的鈣質，而另一組30人則只每天接受相同量鈣質而為對照組。骨密度的測定：60位病患分別於治療前及經治療一年後分別以雙能量X光吸收儀測量其腰椎及髖骨骨密度，再計算其前後百分比之變化。而骨生化指標包括尿中deoxypyridinoline（DPD）及血清骨特異性鹼性磷酸酶（BSAP）則分別於治療前，治療後3、6及12個月後各測量一次，我們再紀錄其治療前後骨密度及骨生化指標百分比之變化。結果：兩組病患在基本資料上並無明顯差別，在治療組其骨密度在腰椎及髖骨經一年的治療後各有1.1 ± 2.8% 及1.3 ± 4.4%之增加，反觀對照組各別各有1.9 ± 4.0%（p

This study aimed at investigating the effect of alendronate (ALN) in the prevention of bone loss of premenopausal rheumatoid arthritis (RA) patients receiving glucocorticoid. 60 premenopausal RA patients who had been treated with glucocorticoid were enrolled in the study. Patients were allocated into two groups and received either oral ALN (10 mg/day) plus calcium carbonate (600 mg/day elemental calcium) or calcium only for 12 months. The primary endpoint was the percentage of change in lumbar spine bone mineral density (BMD). Secondary endpoints included changes in hip BMD and biochemical markers of bone remodeling. The results showed that after 12 months, the lumbar spine and hip BMD did not change substantially compared with baseline in either groups, while the mean percentage of differences in BMD of spine between ALN plus calcium group and calcium group only were 1.1 ± 2.8%, (n=23) and -1.9 ± 4.4%, (n=21) (p<0.01) but the changes of BMD in the hip was not obviously different between the groups. There was significant decrease in bone-specific alkaline phosphatase (BSAP) from baseline at 3, 6, but not 12 months, in the ALN group. Compared to baseline, there was a trend, but not significant, of decrease in urinary deoxypyridinium crosslink (DPD) excretion in the treatment group but slight increase of DPD in the control group through the study period. We conclude that ALN prevents bone loss of lumbar spine and hip in premenopausal RA patients receiving glucocorticoid.