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胆钙化醇与麦角钙化醇用于慢性肾脏病患者补充25-羟维生素D(25(OH)D)的随机临床试验

Cholecalciferol v. ergocalciferol for 25-hydroxyvitamin D (25(OH)D) repletion in chronic kidney disease: a randomised clinical trial.

作者信息

Wetmore James B, Kimber Cassandra, Mahnken Jonathan D, Stubbs Jason R

机构信息

1Hennepin County Medical Center,Division of Nephrology,Minneapolis,MN55415,USA.

2Division of Nephrology & Hypertension,University of Kansas Medical Center,Kansas City,KS 66160,USA.

出版信息

Br J Nutr. 2016 Dec;116(12):2074-2081. doi: 10.1017/S000711451600427X. Epub 2017 Jan 9.

Abstract

Patients with chronic kidney disease (CKD) demonstrate complex mineral metabolism derangements and a high prevalence of vitamin D deficiency. However, the optimal method of 25-hydroxyvitamin D (25(OH)D) repletion is unknown, and trials analysing the comparative efficacy of cholecalciferol and ergocalciferol in this population are lacking. We conducted a randomised clinical trial of cholecalciferol 1250μg (50 000 IU) weekly v. ergocalciferol 1250μg (50 000 IU) weekly for 12 weeks in forty-four non-dialysis-dependent patients with stage 3-5 CKD. The primary outcome was change in total 25(OH)D from baseline to week 12 (immediately after therapy). Secondary analyses included the change in 1,25-dihydroxyvitamin D (1,25(OH)2D), parathyroid hormone (PTH), D2 and D3 sub-fractions of 25(OH)D and 1,25(OH)2D and total 25(OH)D from baseline to week 18 (6 weeks after therapy). Cholecalciferol therapy yielded a greater change in total 25(OH)D (45·0 (sd 16·5) ng/ml) v. ergocalciferol (30·7 (sd 15·3) ng/ml) from baseline to week 12 (P<0·01); this observation partially resulted from a substantial reduction in the 25(OH)D3 sub-fraction with ergocalciferol. However, following cessation of therapy, no statistical difference was observed for total 25(OH)D change from baseline to week 18 between cholecalciferol and ergocalciferol groups (22·4 (sd 12·7) v. 17·6 (sd 8·9) ng/ml, respectively; P=0·17). We observed no significant difference between these therapies with regard to changes in serum PTH or 1,25(OH)2D. Therapy with cholecalciferol, compared with ergocalciferol, is more effective at raising serum 25(OH)D in non-dialysis-dependent CKD patients while active therapy is ongoing. However, levels of 25(OH)D declined substantially in both arms following cessation of therapy, suggesting the need for maintenance therapy to sustain levels.

摘要

慢性肾脏病(CKD)患者存在复杂的矿物质代谢紊乱,且维生素D缺乏症患病率较高。然而,补充25-羟基维生素D(25(OH)D)的最佳方法尚不清楚,且缺乏分析胆钙化醇和麦角钙化醇在该人群中比较疗效的试验。我们对44例3-5期非透析依赖型CKD患者进行了一项随机临床试验,比较每周服用1250μg(50000IU)胆钙化醇与每周服用1250μg(50000IU)麦角钙化醇,为期12周。主要结局是从基线到第12周(治疗结束后立即)总25(OH)D的变化。次要分析包括从基线到第18周(治疗后6周)1,25-二羟基维生素D(1,25(OH)2D)、甲状旁腺激素(PTH)、25(OH)D和1,25(OH)2D的D2和D3亚组分以及总25(OH)D的变化。从基线到第12周,胆钙化醇治疗组的总25(OH)D变化幅度更大(45.0(标准差16.5)ng/ml),而麦角钙化醇治疗组为(30.7(标准差15.3)ng/ml)(P<0.01);这一观察结果部分是由于麦角钙化醇使25(OH)D3亚组分大幅降低。然而,治疗停止后,胆钙化醇组和麦角钙化醇组从基线到第18周的总25(OH)D变化无统计学差异(分别为22.4(标准差12.7)和17.6(标准差8.9)ng/ml;P=0.17)。我们观察到这些疗法在血清PTH或1,25(OH)2D变化方面无显著差异。在非透析依赖型CKD患者进行积极治疗期间,与麦角钙化醇相比,胆钙化醇治疗在提高血清25(OH)D水平方面更有效。然而,治疗停止后,两组的25(OH)D水平均大幅下降,这表明需要维持治疗以维持其水平。

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