O'Doherty D P, Gertz B J, Tindale W, Sciberras D G, Survill T T, Kanis J A
Department of Human Metabolism and Clinical Biochemistry, University of Sheffield Medical School, UK.
J Bone Miner Res. 1992 Jan;7(1):81-7. doi: 10.1002/jbmr.5650070112.
We report a randomized placebo-controlled double-blind study of amino-hydroxybutylidene bisphosphonate (alendronate), infused over 1 h, in 15 patients with Paget's disease of bone. Alendronate, 10 mg/day for 5 days, suppressed urinary hydroxyproline to 44.9 +/- 4.8% and serum alkaline phosphatase to 74.6 +/- 5.4% of their pretreatment values within 1 month of the start of treatment. Within 5 months of the start of treatment serum alkaline phosphatase fell to 47.9 +/- 6.3% of pretreatment values. These effects were associated with a decrease in serum calcium and phosphate and in urinary calcium excretion and with a rise in serum iPTH values. A transient fever was observed in 3 of 10 patients who received alendronate during the course of the infusions, and this was associated with a decrease in the total and differential white cell count. No adverse effects were noted on renal function as judged by glomerular filtration rate and indices of proximal and distal tubular function. This regimen may simplify the management of patients with Paget's disease of bone.
我们报告了一项针对15例骨Paget病患者的随机、安慰剂对照、双盲研究，研究对象为氨基羟丁基二膦酸盐（阿仑膦酸盐），静脉输注1小时。阿仑膦酸盐，每天10毫克，共5天，在治疗开始后1个月内，尿羟脯氨酸降至治疗前值的44.9±4.8%，血清碱性磷酸酶降至治疗前值的74.6±5.4%。在治疗开始后5个月内，血清碱性磷酸酶降至治疗前值的47.9±6.3%。这些效应与血清钙和磷、尿钙排泄减少以及血清iPTH值升高有关。在输注过程中接受阿仑膦酸盐治疗的10例患者中有3例出现短暂发热，这与白细胞总数和分类计数减少有关。根据肾小球滤过率以及近端和远端肾小管功能指标判断，未发现对肾功能有不良影响。该治疗方案可能会简化骨Paget病患者的管理。
