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阿仑膦酸钠短期治疗对中枢性尿崩症患者骨密度和骨标志物的影响。

Effect of a short-term treatment with alendronate on bone density and bone markers in patients with central diabetes insipidus.

作者信息

Pivonello R, Faggiano A, Di Somma C, Klain M, Filippella M, Salvatore M, Lombardi G, Colao A

机构信息

Department of Molecular and Clinical Endocrinology and Oncology, Federico II University, Naples, Italy.

出版信息

J Clin Endocrinol Metab. 1999 Jul;84(7):2349-52. doi: 10.1210/jcem.84.7.5816.

Abstract

The aim of this open prospective randomized study was to evaluate the effect of a 6-month treatment with alendronate on the bone mineral density (BMD) at lumbar spine in patients with central diabetes insipidus. Eighteen patients with central diabetes insipidus and 18 sex- and age-matched healthy subjects entered this study. At study entry, all subjects underwent BMD assessment at the lumbar spine and measurement of serum osteocalcin (OC) and cross-linked N-telopeptides of type I collagen (Ntx). Thereafter, 9 of the 18 patients were randomized to receive treatment with alendronate at a dose of 10 mg, orally, once daily for 6 months (group 1), whereas the remaining 9 patients did not receive any treatment affecting bone status during this period (group 2). After 6 months, bone metabolism and bone density study were repeated in all patients. At baseline, lumbar BMD values (0.86+/-0.03 vs. 1.01+/-0.02 g/cm2; P<0.001) and serum OC levels (4.7+/-0.3 vs. 7.9+/-0.2 microg/L; P<0.001) were significantly lower, whereas urinary Ntx levels were significantly higher [72.0+/-1.9 vs. 64.6+/-1.7 nmol bone collagen equivalents (BCE)/nmol creatinine (Cr); P<0.01] in patients than in controls. After randomization, no difference in lumbar BMD, serum OC, or urinary Ntx was found between patients of group 1 and group 2. At the 6 month follow-up, no difference in serum OC levels was found compared to baseline evaluation in patients of both group 1 and group 2. By contrast, a significant decrease in urinary Ntx levels was found in patients of group 1 (70.3+/-3.0 vs. 75.4+/-2.1 nmol BCE/nmol Cr; P<0.05), but not in patients of group 2 (68.8+/-3.3 vs. 68.5+/-3.0 nmol BCE/nmol Cr; P = NS). A significant increase in lumbar BMD values was found in patients of group 1 (0.88+/-0.04 vs. 0.83+/-0.04 g/cm2; P<0.05), whereas a significant decrease in lumbar BMD values was found in patients of group 2 (0.86+/-0.05 vs. 0.89+/-0.05 g/cm2; P<0.05). Lumbar BMD increased 7.0+/-1.5% in patients of group 1 and decreased 4.2+/-1.8% in patients of group 2 (P<0.001). In conclusion, this study demonstrated that a 6-month treatment with alendronate in patients with central diabetes insipidus was effective in significantly improving BMD at the lumbar spine, which was significantly worsened in untreated patients. Therefore, alendronate treatment could be used in patients with central diabetes insipidus with documented osteopenia or osteoporosis.

摘要

这项开放性前瞻性随机研究的目的是评估阿仑膦酸钠治疗6个月对中枢性尿崩症患者腰椎骨密度(BMD)的影响。18例中枢性尿崩症患者和18例年龄及性别匹配的健康受试者进入本研究。研究开始时,所有受试者均接受腰椎骨密度评估以及血清骨钙素(OC)和I型胶原交联N端肽(Ntx)的测定。此后,18例患者中的9例被随机分配接受阿仑膦酸钠治疗,剂量为10 mg,口服,每日1次,共6个月(第1组),而其余9例患者在此期间未接受任何影响骨状态的治疗(第2组)。6个月后,所有患者重复进行骨代谢和骨密度研究。基线时,患者的腰椎骨密度值(0.86±0.03 vs. 1.01±0.02 g/cm²;P<0.001)和血清OC水平(4.7±0.3 vs. 7.9±0.2 μg/L;P<0.001)显著低于对照组,而尿Ntx水平显著高于对照组[72.0±1.9 vs. 64.6±1.7 nmol骨胶原当量(BCE)/nmol肌酐(Cr);P<0.01]。随机分组后,第1组和第2组患者的腰椎骨密度、血清OC或尿Ntx无差异。在6个月随访时,第1组和第2组患者的血清OC水平与基线评估相比无差异。相比之下,第1组患者的尿Ntx水平显著降低(70.3±3.0 vs. 75.4±2.1 nmol BCE/nmol Cr;P<0.05),而第2组患者未降低(68.8±3.3 vs. 68.5±3.0 nmol BCE/nmol Cr;P =无统计学意义)。第1组患者的腰椎骨密度值显著增加(0.88±0.04 vs. 0.83±0.04 g/cm²;P<0.05),而第2组患者的腰椎骨密度值显著降低(0.86±0.05 vs. 0.89±0.05 g/cm²;P<0.05)。第1组患者的腰椎骨密度增加7.0±1.5%,第2组患者降低4.2±1.8%(P<0.001)。总之,本研究表明,阿仑膦酸钠治疗6个月对中枢性尿崩症患者有效,可显著改善腰椎骨密度,未治疗患者的腰椎骨密度显著恶化。因此,阿仑膦酸钠治疗可用于已证实存在骨质减少或骨质疏松的中枢性尿崩症患者。

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