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烟酸在无肾衰竭患者中的低磷血症作用:一项随机试验。

Hypophosphatemic effect of niacin in patients without renal failure: a randomized trial.

机构信息

Rhode Island Hospital, Division of Kidney Diseases and Hypertension, 593 Eddy Street, Providence, RI, 02903, USA.

出版信息

Clin J Am Soc Nephrol. 2010 Apr;5(4):582-9. doi: 10.2215/CJN.07341009. Epub 2010 Mar 18.

Abstract

BACKGROUND AND OBJECTIVES

Niacin administration lowers the marked hyperphosphatemia that is characteristic of renal failure. We examined whether niacin administration also reduces serum phosphorus concentrations in patients who have dyslipidemia and are free of advanced renal disease.

DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We performed a post hoc data analysis of serum phosphorus concentrations that had been determined serially (at baseline and weeks 4, 8, 12, 18, and 24) among 1547 patients who had dyslipidemia and were randomly assigned in a 3:2:1 ratio to treatment with extended release niacin (ERN; 1 g/d for 4 weeks and dose advanced to 2 g/d for 20 weeks) combined with the selective prostaglandin D2 receptor subtype 1 inhibitor laropiprant (L; n = 761), ERN alone (n = 518), or placebo (n = 268).

RESULTS

Repeated measures analysis revealed that ERN-L treatment resulted in a net mean (95% confidence interval) serum phosphorus change comparing ERN-L with placebo treatment of -0.13 mmol/L (-0.15 to -0.13 mmol/L; -0.41 mg/dl [-0.46 to -0.37 mg/dl]). These results were consistent across the subgroups defined by estimated GFR of <60 or > or =60 ml/min per 1.73 m(2), a serum phosphorus of >1.13 mmol/L (3.5 mg/dl) versus < or =1.13 mmol/L (3.5 mg/dl), the presence of clinical diabetes, or concomitant statin use.

CONCLUSIONS

We have provided definitive evidence that once-daily ERN-L treatment causes a sustained 0.13-mmol/L (0.4-mg/dl) reduction in serum phosphorus concentrations, approximately 10% from baseline, which is unaffected by estimated GFR ranging from 30 to > or =90 ml/min per 1.73 m(2) (i.e., stages 1 through 3 chronic kidney disease).

摘要

背景和目的

烟酸的使用可降低肾衰竭患者明显的高磷血症。我们研究了烟酸的使用是否也可降低血脂异常且无晚期肾脏疾病的患者的血清磷浓度。

设计、设置、参与者和测量方法:我们对 1547 名血脂异常患者进行了血清磷浓度的事后数据分析,这些患者被随机分为 3:2:1 的比例,分别接受延长释放烟酸(ERN;4 周内 1 g/d,然后 20 周内增加至 2 g/d)联合选择性前列腺素 D2 受体亚型 1 抑制剂 laropiprant(L;n = 761)、ERN 单药(n = 518)或安慰剂(n = 268)治疗,并按基线和第 4、8、12、18 和 24 周进行了连续血清磷浓度检测。

结果

重复测量分析显示,ERN-L 治疗与安慰剂治疗相比,血清磷的净平均变化(95%置信区间)为-0.13 mmol/L(-0.15 至-0.13 mmol/L;-0.41 mg/dl[-0.46 至-0.37 mg/dl])。这些结果在按估计肾小球滤过率(eGFR)<60 或≥60 ml/min/1.73 m2、血清磷>1.13 mmol/L(3.5 mg/dl)与≤1.13 mmol/L(3.5 mg/dl)、存在临床糖尿病或同时使用他汀类药物的亚组中是一致的。

结论

我们提供了明确的证据,表明每日一次的 ERN-L 治疗可使血清磷浓度持续降低 0.13 mmol/L(0.4 毫克/分升),大约为基线的 10%,且不受 eGFR 范围为 30 至≥90 ml/min/1.73 m2(即慢性肾脏病 1 至 3 期)的影响。

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