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帕立骨化醇用于继发性甲状旁腺功能亢进的血液透析患者及其潜在益处。

Paricalcitol in hemodialysis patients with secondary hyperparathyroidism and its potential benefits.

作者信息

Chen Xiu, Zhao Feng, Pan Wei-Juan, Di Jia-Mei, Xie Wei-Nan, Yuan Ling, Liu Zhi

机构信息

Department of Nephrology, The First Affiliated Hospital of Anhui University of Science and Technology (The First People's Hospital of Huainan), Huainan 232007, Anhui Province, China.

出版信息

World J Clin Cases. 2021 Nov 26;9(33):10172-10179. doi: 10.12998/wjcc.v9.i33.10172.

DOI:10.12998/wjcc.v9.i33.10172
PMID:34904087
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8638032/
Abstract

BACKGROUND

Secondary hyperparathyroidism (SHPT) is a common complication in patients with end-stage renal disease and it is also common in hemodialysis patients. SHPT can increase bone fragility and calcification of blood vessels and soft tissues, which greatly increases the risk of death.

AIM

To discuss the outcome, safety and other potential benefits of paricalcitol injection in hemodialysis patients with SHPT.

METHODS

We recruited 40 patients who received hemodialysis at our hospital for chronic renal failure with SHPT between March and December 2019. They received paricalcitol injection for 24 wk (starting dose, 0.06-0.08 μg/kg), three times per week. They were followed up at the baseline (week 0), week 4, week 12 and week 24. The primary outcome indicator was the percentage of patients with a > 30% decrease in intact parathyroid hormone (iPTH) levels at week 24 compared with the baseline. The secondary outcome indicators included percentage decrease in iPTH levels at week 24, standard-reaching rate of iPTH (percentage of patients with iPTH down to 130-585 pg/mL), changes in serum levels of calcium (Ca), phosphate (P), Ca × P product, alkaline phosphatase (ALP), creatinine (Cre), hemoglobin (Hb), and C-reactive protein (CRP), and incidence of adverse events (AEs).

RESULTS

After 24 wk of treatment, iPTH levels decreased significantly (598.88 ± 381.29 pg/mL 888.84 ± 376.88 pg/mL, < 0.05). More than 30% decrease of iPTH was found in 21 of 36 (58.33%) patients. The average decrease in iPTH levels was 32.16 ± 4.33%; the standard-reaching rate of iPTH levels was 66.67% (24/36); and ALP levels decreased significantly compared with the baseline (113.72 ± 41.73 IU/L 133.45 ± 56.86 IU/L) ( = 2.798, < 0.05). There were no significant differences in the serum levels of calcium, Hb, Cre and CRP compared with the baseline ( > 0.05). After 24 wk of treatment, serum P levels decreased compared with the baseline (1.91 ± 0.40 mmol/L 2.16 ± 0.66 mmol/L) ( = 2.830, < 0.05). Ca × P product decreased significantly compared with the baseline (56.38 ± 13.22 mg/dL 63.97 ± 20.30 mg/dL) ( = 2.717, < 0.05). No serious adverse events occurred.

CONCLUSION

Paricalcitol was a safe and effective treatment for hemodialysis patients with SHPT. It decreased serum levels of iPTH, ALP and P and maintained stability of serum Ca levels.

摘要

背景

继发性甲状旁腺功能亢进(SHPT)是终末期肾病患者的常见并发症,在血液透析患者中也很常见。SHPT会增加骨骼脆性以及血管和软组织钙化,大大增加死亡风险。

目的

探讨帕立骨化醇注射液治疗血液透析合并SHPT患者的疗效、安全性及其他潜在益处。

方法

选取2019年3月至12月在我院接受血液透析治疗的慢性肾衰竭合并SHPT患者40例。给予帕立骨化醇注射液治疗24周(起始剂量0.06 - 0.08μg/kg),每周3次。在基线(第0周)、第4周、第12周和第24周进行随访。主要结局指标为第24周时与基线相比,血清全段甲状旁腺激素(iPTH)水平下降>30%的患者百分比。次要结局指标包括第24周时iPTH水平下降百分比、iPTH达标率(iPTH降至130 - 585 pg/mL的患者百分比)、血清钙(Ca)、磷(P)、Ca×P乘积、碱性磷酸酶(ALP)肌酐(Cre)、血红蛋白(Hb)和C反应蛋白(CRP)水平的变化以及不良事件(AE)发生率。

结果

治疗24周后,iPTH水平显著下降(598.88±381.29 pg/mL对888.84±376.88 pg/mL,P<0.05)。36例患者中有21例(58.33%)iPTH下降超过30%。iPTH水平平均下降32.16±4.33%;iPTH水平达标率为66.67%(24/36);与基线相比,ALP水平显著下降(113.72±41.73 IU/L对133.45±56.86 IU/L)(P = 2.798,P<0.05)。与基线相比,血清Ca、Hb、Cre和CRP水平无显著差异(P>0.05)。治疗24周后,血清P水平较基线下降(1.91±0.40 mmol/L对2.16±0.66 mmol/L)(P = 2.830,P<0.05)。Ca×P乘积较基线显著下降(56.38±13.22 mg/dL对63.97±20.30 mg/dL)(P = 2.717,P<0.05)。未发生严重不良事件。

结论

帕立骨化醇治疗血液透析合并SHPT患者安全有效。它可降低血清iPTH、ALP和P水平,并维持血清Ca水平稳定。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a164/8638032/8e84a9233e03/WJCC-9-10172-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a164/8638032/8e84a9233e03/WJCC-9-10172-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a164/8638032/8e84a9233e03/WJCC-9-10172-g001.jpg

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