Fujii Naohiko, Hamano Takayuki, Mikami Satoshi, Nagasawa Yasuyuki, Isaka Yoshitaka, Moriyama Toshiki, Horio Masaru, Imai Enyu, Hori Masatsugu, Ito Takahito
FASN Department of Internal Medicine, Osaka University School of Medicine, Box A8, 2-2 Yamada-oka, Suita 565-0871, Japan.
Nephrol Dial Transplant. 2007 Jun;22(6):1601-7. doi: 10.1093/ndt/gfl567. Epub 2006 Nov 23.
Recent post hoc analysis proved the efficacy and tolerability of risedronate in osteoporotic patients with renal impairment, but the combination of active vitamin D in chronic kidney disease (CKD) patients taking glucocorticoids remains unknown.
We conducted a prospective study enrolling 114 CKD patients (creatinine clearance > or =30 ml/min/1.73 m(2)) receiving glucocorticoid therapy for > or =6 months. Eighty-eight subjects who had received active vitamin D (aVD) were randomly assigned to either a group treated with aVD only (group A), or to a group also receiving risedronate 2.5 mg/day (group B). The remaining patients (group C) received risedronate only.
After 1 year 100 subjects were analysed. Risedronate was effective on the lumbar spine, but not on the femoral neck. The lumbar bone mineral density (BMD) significantly increased by 2.8 and 2.5% in groups B and C, respectively, but decreased by 1.0% in group A. Serum N-terminal telopeptides of type I collagen (S-NTX) and bone alkaline phosphatase (ALP) fell significantly in groups B and C at 3 and 6 months, respectively, while in group A S-NTX remained unchanged and bone ALP significantly increased. There was no significant difference between groups B and C regarding BMD and bone markers. The reduction rate of S-NTX (bone ALP) at 6 months predicted the increase in lumbar BMD at 1 year with a sensitivity of 73% (34%) and a specificity of 46.2% (100%).
Risedronate is effective in increasing BMD with or without aVD in CKD patients receiving long-term glucocorticoid therapy. Bone markers are of some use in predicting the response to anti-resorptive therapy.
近期的事后分析证实了利塞膦酸盐对肾功能不全的骨质疏松症患者的疗效和耐受性，但在服用糖皮质激素的慢性肾脏病（CKD）患者中联合使用活性维生素D的情况仍不明确。
我们进行了一项前瞻性研究，纳入了114例接受糖皮质激素治疗≥6个月的CKD患者（肌酐清除率≥30 ml/min/1.73 m²）。88例接受活性维生素D（aVD）治疗的受试者被随机分为仅接受aVD治疗的组（A组）或同时接受每日2.5 mg利塞膦酸盐治疗的组（B组）。其余患者（C组）仅接受利塞膦酸盐治疗。
1年后对100例受试者进行了分析。利塞膦酸盐对腰椎有效，但对股骨颈无效。B组和C组的腰椎骨密度（BMD）分别显著增加了2.8%和2.5%，而A组下降了1.0%。I型胶原血清N端肽（S-NTX）和骨碱性磷酸酶（ALP）在B组和C组分别在3个月和6个月时显著下降，而A组的S-NTX保持不变，骨ALP显著增加。B组和C组在BMD和骨标志物方面无显著差异。6个月时S-NTX（骨ALP）的降低率预测1年时腰椎BMD增加的敏感性为73%（34%），特异性为46.2%（100%）。
在接受长期糖皮质激素治疗的CKD患者中，无论是否使用aVD，利塞膦酸盐在增加BMD方面均有效。骨标志物在预测抗吸收治疗反应方面有一定作用。
