Baker L R, Muir J W, Sharman V L, Abrams S M, Greenwood R N, Cattell W R, Goodwin F J, Marsh F P, Adami S, Hately W
Clin Nephrol. 1986 Oct;26(4):185-91.
We report on a 5-year, prospective, double-blind trial of 1,25 dihydroxycholecalciferol (calcitriol) versus placebo in 76 hemodialysis patients without biochemical or radiological evidence of bone disease. Calcitriol, 1 microgram daily, regularly induced hypercalcemia. Doses of 0.25 microgram daily or less proved satisfactory in most patients. During calcitriol treatment, plasma calcium concentration was significantly higher and serum parathyroid hormone concentration significantly lower than on placebo. There was no difference in the rates of development or of progression of vascular calcification in the two groups. Significantly more patients on placebo (17 vs. 6, p less than 0.05) developed a sustained elevation of plasma alkaline phosphatase concentration. Calcitriol appeared to protect against the development of histological evidence of osteitis fibrosa but not of osteomalacia, but accumulation of aluminum in bone occurred during the study. We conclude that calcitriol delays and may prevent the development of osteitis fibrosa in patients receiving regular hemodialysis and may reasonably be prescribed routinely in hemodialysis patients without biochemical or radiological abnormality, unless there is a substantial prospect of early renal transplantation.
我们报告了一项为期5年的前瞻性双盲试验，该试验在76例无骨病生化或放射学证据的血液透析患者中比较了1,25 - 二羟胆钙化醇（骨化三醇）与安慰剂的效果。每日1微克骨化三醇常导致高钙血症。大多数患者每日0.25微克或更低剂量效果令人满意。在骨化三醇治疗期间，血浆钙浓度显著高于安慰剂组，血清甲状旁腺激素浓度显著低于安慰剂组。两组血管钙化的发生或进展速率无差异。安慰剂组有更多患者（17例对6例，p小于0.05）出现血浆碱性磷酸酶浓度持续升高。骨化三醇似乎可预防纤维性骨炎的组织学证据出现，但不能预防骨软化，且研究期间骨中铝蓄积。我们得出结论，骨化三醇可延缓并可能预防接受定期血液透析患者纤维性骨炎的发生，对于无生化或放射学异常的血液透析患者，除非有早期肾移植的较大可能性，否则可合理常规开具骨化三醇。
