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口服西那卡塞转换为静脉用依特卡塞治疗血液透析患者继发性甲状旁腺功能亢进症的控制改善,尤其在不依从患者中。

Improved Control of Secondary Hyperparathyroidism in Hemodialysis Patients Switching from Oral Cinacalcet to Intravenous Etelcalcetide, Especially in Nonadherent Patients.

机构信息

Department of Nephrology and Renal Transplantation, Hospital Clínic de Barcelona, Barcelona, Spain.

Department of Biochemistry and Molecular Genetics, Hospital Clínic de Barcelona, Barcelona, Spain.

出版信息

Blood Purif. 2019;48(2):106-114. doi: 10.1159/000496562. Epub 2019 Jan 30.

Abstract

BACKGROUND

Etelcalcetide is a novel second-generation calcimimetic that, because of its intravenous administration, could improve treatment adherence in secondary hyperparathyroidism (SHPT). The aim of this study was to evaluate the effectiveness of etelcalcetide compared with that of cinacalcet in controlling SHPT in patients under hemodialysis.

METHODS

A prospective observational study was performed in 29 patients with SHPT under hemodialysis who switched from cinacalcet to etelcalcetide with a follow-up of 6 months. A survey was conducted of adherence to the oral calcimimetic. The primary end-point of the study was to assess whether etelcalcetide was more effective than cinacalcet in controlling SHPT.

RESULTS

After the switch of treatment, none of the patients developed clinical intolerance or new adverse effects. Etelcalcetide was more effective than cinacalcet in controlling intact parathyroid hormone (iPTH), with an overall decrease in iPTH levels that was significant from the second month. Average calcium levels remained within the normal range, with a higher percentage of hypocalcemia with etelcalcetide (6.9 vs. 13.8%), which was asymptomatic in all cases. Patients who were nonadherent to cinacalcet (38%) showed a significant reduction in calcium and iPTH during follow-up with etelcalcetide. The adherent group (62%) also showed a trend to lower iPTH levels reaching statistical significance after 5 months of follow-up. The dose conversion factor for the switch from cinacalcet to etelcalcetide was etelcalcetide/session = 0.111*mg cinacalcet/day + 0.96, R2 = 0.57.

CONCLUSIONS

Etelcalcetide was more effective than cinacalcet in this patient population, especially in the nonadherent subgroup, leading to better SHPT control without adverse effects.

摘要

背景

依替膦酸钙是一种新型第二代拟钙剂,由于其为静脉内给药,因此可能改善继发性甲状旁腺功能亢进症(SHPT)患者的治疗依从性。本研究的目的是评估依替膦酸钙与西那卡塞相比在控制血液透析患者 SHPT 方面的疗效。

方法

对 29 例接受血液透析的 SHPT 患者进行前瞻性观察性研究,这些患者从西那卡塞转为依替膦酸钙治疗,并随访 6 个月。对口服拟钙剂的依从性进行了调查。本研究的主要终点是评估依替膦酸钙是否比西那卡塞更有效地控制 SHPT。

结果

在治疗转换后,没有患者出现临床不耐受或新的不良反应。与西那卡塞相比,依替膦酸钙在控制全段甲状旁腺激素(iPTH)方面更有效,iPTH 水平从第 2 个月开始显著下降。平均血钙水平仍在正常范围内,依替膦酸钙组低钙血症的比例更高(6.9%比 13.8%),但所有病例均无症状。不依从西那卡塞治疗(38%)的患者在接受依替膦酸钙治疗期间,血钙和 iPTH 显著下降。依从组(62%)在接受依替膦酸钙治疗 5 个月后,iPTH 水平也呈下降趋势,具有统计学意义。从西那卡塞转换为依替膦酸钙的剂量转换系数为依替膦酸钙/次=0.111*mg 西那卡塞/天+0.96,R2=0.57。

结论

在该患者人群中,依替膦酸钙比西那卡塞更有效,尤其是在不依从亚组中,可更好地控制 SHPT,且无不良反应。

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