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羟基氧化铁蔗糖对日本血液透析患者的疗效及其对胃肠道症状的影响。

Efficacy of sucroferric oxyhydroxide treatment in Japanese hemodialysis patients and its effect on gastrointestinal symptoms.

作者信息

Suzuki D, Ichie T, Hayashi H, Sugiura Y, Sugiyama T

出版信息

Pharmazie. 2017 Feb 1;72(2):118-122. doi: 10.1691/ph.2017.6848.

Abstract

Sucroferric oxyhydroxide (SFOH) is a non-calcium, iron-based phosphate binder indicated for the treatment of hyperphosphatemia in adult dialysis patients. Studies in Japan about the side effects of SFOH treatment indicate that the incidence of diarrhea (25%) is greater while that of constipation (2.9%) is lesser in comparison to that observed upon treatment with an existing phosphate binder. In the present study, the effect of treatment with a combination of the existing phosphate binders and SFOH on the serum phosphorus level and digestive symptoms was observed in hemodialysis patients with hyperphosphatemia, which is untreatable using only the existing phosphate binders. We evaluated the serum phosphorus levels and gastrointestinal symptoms (using the gastrointestinal symptom rating scale) of 6 patients (2 men, 4 women) before and 2, 4, 6, and 8 weeks after continuous administration. The serum phosphorus levels before and 2, 4, 6, and 8 weeks after combination treatment were 7.4±1.0 mg/dL, 5.9±1.3 mg/dL, 5.8±1.5 mg/dL, 5.8±1.4 mg/dL, and 5.8±1.3 mg/dL, respectively, with significant reduction in the levels being observed 2 weeks after administration (p<0.05) and persisting even 8 weeks after continuous administration. The constipation scores before and 2, 4, and 8 weeks after drug administration were 2.39±0.85, 2.34±1.93, 2.56±1.44, and 3.28±2.19, respectively, with no changes observed during the investigation period. The diarrhea scores before and 2, 4, and 8 weeks after drug administration were 2.22±0.91, 2.06±1.16, 1.28±0.39, and 1.06±0.13 respectively. The scores improved significantly, 4 weeks after drug administration (p<0.05), and the improvement persisted, even 8 weeks after continuous administration. Thus, by using a combination of the existing phosphate binders and SFOH, we were able to reduce the serum phosphorus level in patients with hyperphosphatemia, which is untreatable using the existing phosphate binder alone, with no sign of exacerbation of the gastrointestinal symptoms despite a few contradictory case reports.

摘要

羟基氧化铁蔗糖(SFOH)是一种非钙的、铁基磷酸盐结合剂,用于治疗成年透析患者的高磷血症。日本关于SFOH治疗副作用的研究表明,与使用现有磷酸盐结合剂治疗相比,腹泻发生率(25%)更高,而便秘发生率(2.9%)更低。在本研究中,观察了在仅使用现有磷酸盐结合剂无法治疗的高磷血症血液透析患者中,联合使用现有磷酸盐结合剂和SFOH治疗对血清磷水平和消化症状的影响。我们评估了6例患者(2例男性,4例女性)在连续给药前以及给药后2、4、6和8周的血清磷水平和胃肠道症状(使用胃肠道症状评分量表)。联合治疗前以及治疗后2、4、6和8周的血清磷水平分别为7.4±1.0mg/dL、5.9±1.3mg/dL、5.8±1.5mg/dL、5.8±1.4mg/dL和5.8±1.3mg/dL,给药后2周观察到水平显著降低(p<0.05),并且在连续给药8周后仍持续降低。给药前以及给药后2、4和8周的便秘评分分别为2.39±0.85、2.34±1.93、2.56±1.44和3.28±2.19,在研究期间未观察到变化。给药前以及给药后2、4和8周的腹泻评分分别为2.22±0.91、2.06±1.16、1.28±0.39和1.06±0.13。给药后4周评分显著改善(p<0.05),并且在连续给药8周后改善仍持续。因此,通过联合使用现有磷酸盐结合剂和SFOH,我们能够降低仅使用现有磷酸盐结合剂无法治疗的高磷血症患者的血清磷水平,尽管有一些相互矛盾的病例报告,但未出现胃肠道症状加重的迹象。

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