Klawansky Sidney, Komaroff Eugene, Cavanaugh Paul F, Mitchell David Y, Gordon Matthew J, Connelly Janet E, Ross Susan D
MetaWorks Inc., Medford, MA 02155, USA.
Osteoporos Int. 2003 Jul;14(7):570-6. doi: 10.1007/s00198-003-1435-y. Epub 2003 Jul 3.
Bisphosphonate drugs for treating osteoporosis are excreted by the kidney. However, many of the major trials on efficacy and safety of the bisphophonates for treating osteoporosis excluded patients with significant renal compromise. Since both osteoporosis and renal insufficiency become more prevalent with age, it seems prudent for physicians to be aware of the prevalence of renal dysfunction in patients with osteoporosis who are candidates for treatment with bisphosphonates. Data on 13,831 men and women aged 20+ from the Third National Health and Nutrition Examination Survey, 1988-1994 (NHANES III) were used to study the occurrence of compromise in renal clearance function in men and women with osteopenia and osteoporosis. To estimate creatinine clearance (CCr), a measure of renal function, serum creatinine (sCr), weight and age were inserted into the Cockcoft-Gault (C-G) formula. The World Health Organization gender specific bone mineral density (BMD) cut-offs were used to define the populations with osteopenia and osteoporosis. For women ages 20-80+ with osteoporosis, the percent prevalence (95% CI) for mild to moderate compromise of CCr </=60 ml/min is estimated to be 85% (79%, 91%) and for severe renal compromise of CCr <35 ml/min to be 24% (19%, 29%). In women with osteoporosis and severe compromise, the age specific prevalence is negligible through ages 50-59 and then rises steeply to 54% (46%, 62%) for ages 80+. Similarly, in women with osteopenia and severe renal compromise, the age specific prevalence is also negligible through ages 50-59 and then rises to 37% (28%, 45%) for ages 80+. Lower prevalence estimates hold for men with about 11% of men with osteoporosis having severe renal compromise as compared to 24% for women. These data suggest that there is a substantial prevalence of candidates for treatment of osteoporosis and osteopenia who have significant renal compromise but for whom there is a dearth of clinical trial data on the impact of treatment.
用于治疗骨质疏松症的双膦酸盐药物经肾脏排泄。然而，许多关于双膦酸盐治疗骨质疏松症疗效和安全性的主要试验都排除了有严重肾功能损害的患者。由于骨质疏松症和肾功能不全都随着年龄增长而更为普遍，对于考虑使用双膦酸盐治疗的骨质疏松症患者，医生了解其肾功能障碍的患病率似乎是谨慎之举。利用1988 - 1994年第三次全国健康和营养检查调查（NHANES III）中13831名20岁及以上男性和女性的数据，研究骨质减少和骨质疏松症男性和女性肾功能清除功能受损的发生率。为了估算作为肾功能指标的肌酐清除率（CCr），将血清肌酐（sCr）、体重和年龄代入Cockcroft - Gault（C - G）公式。采用世界卫生组织针对不同性别的骨密度（BMD）临界值来定义骨质减少和骨质疏松症人群。对于20 - 80岁及以上患有骨质疏松症的女性，CCr≤60 ml/min的轻度至中度受损患病率估计为85%（79%，91%），CCr<35 ml/min的严重肾功能受损患病率为24%（19%，29%）。在患有骨质疏松症且严重肾功能受损的女性中，50 - 59岁年龄段的年龄特异性患病率可忽略不计，然后在80岁及以上年龄段急剧上升至54%（46%，62%）。同样，在患有骨质减少且严重肾功能受损的女性中，50 - 59岁年龄段的年龄特异性患病率也可忽略不计，然后在80岁及以上年龄段上升至37%（28%，45%）。男性的患病率估计较低，患有骨质疏松症的男性中约11%有严重肾功能受损，而女性为24%。这些数据表明，在骨质疏松症和骨质减少症的治疗候选者中，有相当一部分人存在严重肾功能损害，但缺乏关于治疗影响的临床试验数据。
