中国血液净化

中国血液净化 ›› 2015, Vol. 14 ›› Issue (09): 540-544.doi: 10.3969/j.issn.1671-4091.2015.09.008

• 临床研究 • 上一篇    下一篇

帕立骨化醇不同给药方式治疗继发性甲状旁腺功能亢进症的对照研究

郝娟1，2 ,程叙扬1, 左力3, 陈育青1 ,燕宇3, 刘莉1 ,武蓓3 ,鲍云非1 ,甘良英3 ,王梅3   

  1. 1 北京大学第一医院肾内科,北京大学肾脏疾病研究所,卫生部肾脏疾病重点实验室,慢性肾脏病防治教育部重点实验室
    2 北京市第六医院肾内科
    3 北京大学人民医院肾内科
  • 收稿日期:2015-05-28 修回日期:2015-07-02 出版日期:2015-09-12 发布日期:2015-09-12
  • 通讯作者: 甘良英 ganliangying@yahoo.com) E-mail:Alicehao2011@163.com

Comparative efficacy and safety of different paricalcitol regimens on secondary hyperparathyroidism in hemodialysis patients: a retrospective study

  • Received:2015-05-28 Revised:2015-07-02 Online:2015-09-12 Published:2015-09-12

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摘要： 【摘要】目的探讨帕立骨化醇(Paricalcitol，PCT)不同给药方式治疗透析患者合并继发性甲状旁腺功能亢进症(secondary hyperparathyroidism,SHPT)的有效性及安全性。方法维持性血液透析合并SHPT 患者32 例随机分为US 组(美国批准的方案：起始剂量按0.04ug/kg 给药)和EU 组(欧洲批准方案：起始剂量全段甲状旁腺激素(iPTH)(pg/mL)/80ug 给药)，经2～4 周洗脱开始给PCT，US 组15 例，PCT 起始剂量：0.04 ug/kg，每周3 次；EU 组17 例，PCT 起始剂量：全段甲状旁腺激素(intact parathyroid hormone,iPTH)(pg/mL)/80ug，每周3 次，共治疗12 周，两组均根据血iPTH 或钙、磷水平每两周调整剂量，停药后观察4 周。比较2 组患者iPTH 达标率(连续2 次测定iPTH 较基线下降＞30%)的差异，评估有效性，观察2 组并发不良事件(高钙血症、高磷血症、高钙磷乘积、甲状旁腺功能减退及暂时停药)的差异，评估安全性。结果EU 组和US 组达标率相似(88.2% vs.73.3%，P＞0.05)，起始剂量较大的EU 组,治疗期间帕立骨化醇的剂量呈递减趋势，治疗前期(前6 周)因并发不良事件而暂时停药的风险也相应升高(高磷血症47.1% vs.42.2%，P＜0.05，高钙磷乘积58.8% vs.37.8%，P＜0.05)，而起始剂量较小的US 组,治疗期间帕立骨化醇的剂量呈递增趋势，治疗后期(后6 周)更易因并发不良事件而暂时停药(高磷血症44.4% vs.27.5%，P＜0.05；高钙磷乘积60.0% vs.35.3%，P＜0.05)，差异均有统计学意义。结论帕立骨化醇可明显降低继发甲状旁腺功能亢进透析患者的iPTH 水平，但剂量较高时仍有并发高钙、高磷血症的风险而需调整剂量或暂时停药，须根据患者具体情况选择不同的给药方式及个体化剂量以获得最佳的临床疗效。

关键词: 帕立骨化醇, 继发性甲状旁腺功能亢进症, 给药方式

Abstract: 【Abstract】Objective The objective of this study was to examine efficacy and safety of two dosing regimens of selective vitamin D receptor activator paricalcitol for the treatment of secondary hyperparathyroidism (SHPT) in maintenance hemodialysis (MHD) patients. Methods This retrospective study recruited 32 MHD patients with SHPT. Patients were randomized to two treatment arms by initial dose of paricalcitol package insert (PI): US group (initial dose 0.04 μg/kg) and EU group (initial dose iPTH (pg/mL)/80μg). After a wash out period of 2- 4 weeks, they received initial dose of US or EU regimen three times weekly for 12 weeks and one month follow-up after drug withdrawal. The dose of paricalcitol was adjusted biweekly according to serum iPTH, calcium (Ca) and phosphorus (P) levels in the monitoring weeks. The efficacy and safety of paricalcitol were evaluated between the two groups by comparison of the primary endpoint (iPTH reduced by ≥ 30% of baseline in two consecutive assays) and the tendency to adverse effects including hypercalcemia, hyperphosphatemia, elevated Ca-P product, hypoparathyroidism and drug suspension. Results The effective rate was similar (88.2% vs. 73.3%, P＞0.05), and no inferiority was demonstrated between the two groups. In the prior 6 weeks in EU group with relatively higher initial dose of paricalcitol, patients were more likely to have adverse events and withdrawal due to adverse events than the patients in US group; hypercalcemia was 47.1% and 42.2% (P＜0.05), elevated Ca-P product was 58.5% and 37.8% (P＜0.05), in EU group and US group, respectively. In the posterior 6 weeks in US group with increasing cumulative dose of paricalcitol, patients were more likely to have adverse events and withdrawal due to adverse events than the patients in EU group; hypercalcemia was 44.4% and 27.5% (P＜0.05), elevated Ca-P product was 60.0% and 35.3% (P＜ 0.05), in US group and EU group, respectively. Conclusions Both EU and US PI paricalcitol dosing strategies effectively reduced iPTH level in Chinese subjects with SHPT with minimal impact on serum Ca and P levels, but patients with higher dose of paricalcitol had increased possibility of dose adjustment and drug withdrawal due to adverse events including hypercalcemia, hyperphosphatemia, elevated Ca-P product and hypoparathyroidism.
To get the best clinical benefits of paricalcitol, different initial dose and personalized regimen are required.

Key words: paricalcitol, secondary hyperparathyroidism, regimens