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质子泵抑制剂使用12个月与血清镁水平变化无关:一项前瞻性开放标签对照研究。

Proton pump inhibitor use for 12 months is not associated with changes in serum magnesium levels: a prospective open label comparative study.

作者信息

Bahtiri Elton, Islami Hilmi, Hoxha Rexhep, Gashi Afrim, Thaçi Kujtim, Karakulak Çağla, Thaçi Shpetim, Qorraj Bytyqi Hasime

机构信息

Department of Pharmacology, Prishtina University School of Medicine, Prishtina, Kosovo.

出版信息

Turk J Gastroenterol. 2017 Mar;28(2):104-109. doi: 10.5152/tjg.2016.0284. Epub 2017 Jan 13.

DOI:10.5152/tjg.2016.0284
PMID:28082254
Abstract

BACKGROUND/AIMS: Proton pump inhibitors (PPIs) are a widely used class of drugs because of a generally acceptable safety profile. Among recently raised safety issues of the long-term use of PPIs is the increased risk of developing hypomagnesemia. As there have been very few prospective studies measuring serum magnesium levels before and after PPI therapy, we aimed to prospectively assess the potential association between PPI therapy for 12 months and the risk of hypomagnesemia as well as the incidence of new-onset hypomagnesemia during the study. In addition, the association of PPI therapy with the risk of hypocalcemia was assessed.

MATERIALS AND METHODS

The study included 250 patients with normal serum magnesium and total calcium levels, who underwent a long-term PPI treatment. Serum magnesium, total calcium, and parathormone (PTH) levels were measured at baseline and after 12 months.

RESULTS

Of the 250 study participants, 209 completed 12 months of treatment and were included in the statistical analysis. The Wilcoxon signed rank test showed no statistically significant differences in serum magnesium levels between measurements at two different time points. However, there were statistically significant differences in serum total calcium and PTH levels in PPI users.

CONCLUSION

Stable serum magnesium levels were demonstrated after 12 months and no association between PPI use and risk of hypomagnesemia was shown in the general population. Significant reductions of serum total calcium levels were demonstrated among PPI users; nevertheless, further research is required before recommending any serum calcium and PTH level monitoring in patients initiated on long-term PPI therapy.

摘要

背景/目的:质子泵抑制剂(PPIs)因其总体上可接受的安全性而成为广泛使用的一类药物。长期使用PPIs最近引发的安全问题之一是发生低镁血症的风险增加。由于很少有前瞻性研究测量PPI治疗前后的血清镁水平,我们旨在前瞻性评估12个月的PPI治疗与低镁血症风险之间的潜在关联,以及研究期间新发低镁血症的发生率。此外,还评估了PPI治疗与低钙血症风险的关联。

材料与方法

该研究纳入了250例血清镁和总钙水平正常且接受长期PPI治疗的患者。在基线和12个月后测量血清镁、总钙和甲状旁腺激素(PTH)水平。

结果

250名研究参与者中,209人完成了12个月的治疗并纳入统计分析。Wilcoxon符号秩检验显示两个不同时间点测量的血清镁水平无统计学显著差异。然而,PPI使用者的血清总钙和PTH水平存在统计学显著差异。

结论

12个月后血清镁水平稳定,在一般人群中未显示PPI使用与低镁血症风险之间存在关联。PPI使用者的血清总钙水平显著降低;然而,在建议对开始长期PPI治疗的患者进行任何血清钙和PTH水平监测之前,还需要进一步研究。

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