帕立骨化醇联合西那卡塞治疗维持性血液透析难治性继发性甲状旁腺功能亢进的观察性研究  

The observational study of paricalcitol combine with cinacalcet in treatment of hemodialysis patients with refractory secondary hyperparathyroidism

作　　者：杨茜 董建华 吴边 范文静 黄力 李川 葛永纯 YANG Xi;DONG Jianhua;WU Bian;FAN Wenjing;HUANG Li;LI Chuan;GE Yongchun(National Clinical Research Center of Kidney Diseases,Jinling Hospital,Nanjing University School of Medicine,Nanjing 210016 China)

机构地区：[1]东部战区总医院国家肾脏疾病临床医学研究中心、全军肾脏病研究所,南京210016

出　　处：《肾脏病与透析肾移植杂志》2022年第6期514-518,共5页Chinese Journal of Nephrology,Dialysis & Transplantation

基　　金：江苏省自然科学基金面上项目(BK20201235);军队卫勤保障能力创新与生成专项(21WQ038)。

摘　　要：目的:观察帕立骨化醇联合西那卡塞治疗维持性血液透析(MHD)患者难治性继发性甲状旁腺功能亢进(SHPT)的疗效及安全性。方法:选取国家肾脏疾病临床医学研究中心血液净化中心MHD并发SHPT患者,经骨化三醇与西那卡塞联合治疗无效,血全段甲状旁腺素(iPTH)仍>800 pg/mL,予帕立骨化醇联合西那卡塞治疗,分别于治疗前及治疗后第4周、12周监测患者iPTH、血钙、血磷、碱性磷酸酶、钙磷乘积和血红蛋白水平。主要疗效指标为治疗12周后iPTH较基线下降>30%,次要疗效包括治疗12周iPTH下降率,iPTH降至正常上限2~9倍(130~585 pg/mL),血钙、血磷、钙磷乘积变化及不良事件发生。结果:12例患者纳入本研究,平均年龄54±17岁,平均透析龄56.8±10.0月,基线iPTH 1291.65±370.96 pg/mL,血钙2.25±0.29 mmol/L,血磷2.12±0.58 mmol/L。帕立骨化醇起始剂量为5μg(3次/周)联合西那卡塞25~50 mg/d治疗。治疗4周后iPTH降至895.57±479.42 pg/mL(P=0.054),4例(33.3%)iPTH下降>30%,3例(25%)iPTH控制在130~585 pg/mL;治疗12周后iPTH为794.91±417.12 pg/mL,显著低于治疗前(P=0.011),其中7例(58.3%)iPTH下降>30%,4例(33.3%)iPTH控制在130~585 pg/mL,平均iPTH下降率为36.59%±24.48%(2.2%~91.9%)。血磷、血钙浓度与基线比较无统计学差异。治疗过程中患者耐受性良好。结论:帕立骨化醇联合西那卡塞治疗能安全且有效降低难治性SHPT的MHD患者iPTH水平。Objective:To observe efficacy and safety of paricalcitol combin with cinacalcet in treatment of refractory secondary hyperparathyroidism(SHPT)in maintenance hemodialysis(MHD)patients.Methodology:A retrospective study was conducted in MHD patients with SHPT whose serum intact parathyroid hormone(iPTH)was still>800 pg/mL,although treated with calcitriol and cinacalcet,Serum levels of calcium,phosphorus,iPTH,alkaline phosphatase,calcium phosphorus product and hemoglobin were measured at baseline,4 and 12 weeks after treatment.Results:Twelve patients were enrolled in this study(6 males and 6 females),the baseline iPTH was 1291.65±370.96 pg/mL,serum calcium was 2.25±0.29 mmol/L,and serum phosphorus was 2.12±0.58 mmol/L.The initial dose of paricalcitol is 5μg,tiw,combined with cinacalcet 25~50 mg/d.After 4 weeks of treatment,iPTH decreased to 895.57±479.42 pg/mL(P=0.054),the proportion of patients with iPTH reduction rate>30%and with iPTH reduction to 150~585 pg/mL was 33.3%and 25%respectively;After 12 weeks of treatment,iPTH level was 794.91±417.12 pg/mL(P=0.011),the proportion of patients with iPTH reduction rate>30%and with iPTH reduction to 150~585 pg/mL was 58.3%and 33.3%respectively.The mean decline rate of iPTH was 36.59±24.48%(2.2%~91.9%).Compared with the baseline,there was no statistical difference with serum phosphorus and calcium during follow up.No adverse events were observed.Conclusion:Paricalcitol combined with cinacalcet can reduce the level of iPTH in MHD-SHPT patients safely and effectively.

关 键 词：帕立骨化醇 西那卡塞 继发性甲状旁腺功能亢进 血液透析 

分 类 号：R692.5[医药卫生—泌尿科学] R582.1[医药卫生—外科学]