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随机试验比较脉冲骨化三醇和阿法骨化醇治疗血液透析患者继发性甲状旁腺功能亢进症。

Randomized trial comparing pulse calcitriol and alfacalcidol for the treatment of secondary hyperparathyroidism in haemodialysis patients.

机构信息

Division of Nephrology, Department of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.

出版信息

Nephrology (Carlton). 2011 Mar;16(3):277-84. doi: 10.1111/j.1440-1797.2010.01398.x.

Abstract

AIM

Calcitriol and alfacalcidol are used extensively for the treatment of secondary hyperparathyroidism. Unfortunately, there is limited published data comparing the efficacy and tolerability of both active vitamin D sterols. This study was undertaken to determine whether calcitriol provides a therapeutic advantage to alfacalcidol.

METHODS

This was a randomized, active controlled study. Patients with intact parathyroid hormone (iPTH) >32 pmol/L were randomized to receive orally calcitriol or alfacalcidol after each haemodialysis for up to 24 weeks. Reduction of PTH, changes of plasma albumin-corrected calcium and phosphorus were analysed. The initial dose of alfacalcidol was twice that of calcitriol.

RESULTS

Sixteen patients were randomized into each group. At baseline, plasma albumin-corrected calcium, phosphorus and PTH were no different between groups. At 24 weeks, PTH changes were -50.8 ± 31.8% and -49.4 ± 32.5% from the baseline in the calcitriol and alfacalcidol groups, respectively (P = 0.91). The patients who achieved target PTH of 16-32 pmol/L were 82% in the calcitriol and 67% in the alfacalcidol group (P = 0.44). Plasma albumin-corrected calcium and phosphorus were not significantly different but showed trends toward gradually increasing from baseline in both groups (calcium, 6.0 ± 7.2% vs 10.9 ± 6.5% (P = 0.10); phosphorus, 13.0 ± 29.4% vs 16.7 ± 57.2% (P = 0.83) in calcitriol and alfacalcidol, respectively). The mean dose of calcitriol and alfacalcidol were 4.1 and 6.9 µg/week, respectively (P < 0.0001).

CONCLUSION

Alfacalcidol can be used to control secondary hyperparathyroidism at doses of 1.5-2.0 times that of calcitriol. The two drugs are equally efficacious and lead to similar changes in calcium and phosphorus.

摘要

目的

钙三醇和阿法骨化醇广泛用于治疗继发性甲状旁腺功能亢进症。遗憾的是,比较两种活性维生素 D 固醇类药物的疗效和耐受性的已发表数据有限。本研究旨在确定钙三醇是否优于阿法骨化醇。

方法

这是一项随机、活性对照研究。将甲状旁腺激素(iPTH)>32pmol/L 的患者随机分为两组,在每次血液透析后口服钙三醇或阿法骨化醇,治疗时间长达 24 周。分析甲状旁腺激素的降低情况、血浆白蛋白校正钙和磷的变化。阿法骨化醇的起始剂量是钙三醇的两倍。

结果

16 例患者被随机分为两组。基线时,两组间血浆白蛋白校正钙、磷和甲状旁腺激素无差异。24 周时,钙三醇组和阿法骨化醇组的甲状旁腺激素变化分别为从基线下降 50.8%±31.8%和 49.4%±32.5%(P=0.91)。达到 16-32pmol/L 目标甲状旁腺激素的患者,钙三醇组为 82%,阿法骨化醇组为 67%(P=0.44)。血浆白蛋白校正钙和磷无显著差异,但两组均有从基线逐渐升高的趋势(钙:6.0%±7.2%比 10.9%±6.5%(P=0.10);磷:13.0%±29.4%比 16.7%±57.2%(P=0.83),分别在钙三醇和阿法骨化醇组)。钙三醇和阿法骨化醇的平均剂量分别为 4.1μg/周和 6.9μg/周(P<0.0001)。

结论

阿法骨化醇可以以钙三醇剂量的 1.5-2.0 倍用于控制继发性甲状旁腺功能亢进症。两种药物同样有效,导致钙和磷的变化相似。

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