Shimamatsu K, Maeda T, Harada A, Nishitani H, Onoyama K, Fujimi S, Omae T
Nephron. 1981;28(2):70-5. doi: 10.1159/000182113.
A 1-year controlled trial was performed to confirm the effects of 1 alpha-hydroxycholecalciferol (1 alpha-OH-D3) in chronic hemodialysis patients. Initially, a daily dose of 2 micrograms of 1 alpha-OH-D3 was given orally to 24 patients and its placebo to another 24 patients during the first 3 months. For the following 9 months the dose of 1 alpha-OH-D3 or its placebo was reduced to 1 microgram per day in the individual groups. Serum calcium was significantly increased to the normal level after 1 month of treatment and sustained at this level for 1 year. Serum parathyroid hormone was significantly decreased at 3 months. Serum alkaline phosphatase was decreased to the normal level at the 5th month and thereafter. At 2 months serum phosphorus was significantly increased in the 1 alpha-OH-D3 group. None of the patients on 1 alpha-OH-D3 showed increased subperiosteal resorption on X-rays, whereas 8 out of 20 patients on placebo did (p less than 0.002). No adverse effects were seen apart from 3 patients with the 'red eye' of scleral calcification.
进行了一项为期1年的对照试验，以证实1α-羟胆钙化醇（1α-OH-D3）对慢性血液透析患者的疗效。最初，在前3个月，每天给24例患者口服2微克1α-OH-D3，给另外24例患者口服其安慰剂。在接下来的9个月里，各小组中1α-OH-D3或其安慰剂的剂量减至每天1微克。治疗1个月后血清钙显著升高至正常水平，并维持该水平1年。血清甲状旁腺激素在3个月时显著降低。血清碱性磷酸酶在第5个月及之后降至正常水平。在1α-OH-D3组中，2个月时血清磷显著升高。接受1α-OH-D3治疗的患者在X射线下均未显示骨膜下吸收增加，而接受安慰剂治疗的20例患者中有8例出现（p<0.002）。除3例出现巩膜钙化“红眼”的患者外，未观察到不良反应。
