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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
2016-07-19
导师左力
专业内科学
授予单位北京大学
授予地点北京大学第一临床医学院
学位硕士
关键词帕立骨化醇 继发性甲状旁腺功能亢进症 给药方式
其他题名Comparative Efficacy and Safety of Different Paricalcitol Regimens on Secondary Hyperparathyroidism in Hemodialysis Patients: A retrospective study
分类号R581.1
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周的洗脱后开始给药,US组15例,PCT起始剂量:0.04ug/kg,每周三次;EU组17例,PCT起始剂量:全段甲状旁腺激素(intact parathyroid hormone,iPTH)(pg/mL)/80ug,每周三次,共治疗12周,两组患者均根据血iPTH或钙、磷水平每两周调整剂量,停药后观察4周。比较两组患者iPTH达标率(连续两次测定iPTH较基线下降>30%)的差异评估有效性,观察两组并发不良事件(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(前六周前)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(后六周)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;

英文摘要

Objective:The objectives of this study were to examine efficacy and safety of two dosing regimens of ive vitamin D receptor activator paricalcitol in the treatment of secondary hyperparathyroidism of maintenance hemodialysis patients.

Methods: This retrospective study recruited 32 maintenance hemodialysis patients with secondary hyperparathyroidism. Patients were randomized to two treatment arms by initial dose of paricalcitolpackage (PI): USgroup(initialdose:0.04ug/kg)and EU group(initial dose:iPTH(pg/mL)/80ug). After a wash out period of 2-4 weeks, they received different initial doses of US or EU three times weekly for 12 weeks and onemonth follow-up after drug withdrawal. And adjusted the dose of paricalcitol biweekly according to the serumiPTH, calcium (Ca) and phosphorus (P) levels in themonitoring weeks.Finally evaluated the efficacy and safety of paricalcitol in comparison with two groups in the primary endpoint of two consecutive ≥ 30% iPTH decreases and tendency to adverse effects including hypercalcemia, hypoerphosphatemia, elevated Ca-P product, hypoparathyroidism and drug suspension.

Results: The effective rate of two groups was similar, and no inferiority was demonstrated (88.2% vs. 73.3%, P>0.05). In the prior 6 weeks,EU group, with the relatively higher initial dose, was more likely to induce adverse events and withdrawal due to adverse events than US group(Hypercalcaemia:47.1% of EU vs. 42.2% of US,elevatedCa-P product:58.5% of EU vs. 37.8% of US).In the posterior 6 weeks, US group, with increasing cumulative dose, was more likely to induce adverse events and withdrawal due to adverse events than EU group (Hypoercalcaemia:44.4% of US vs.27.5% of EU, elevated Ca-P product:60.0%of  US vs.35.3% of EU).Both were statistically significant, P<0.05.

 

Conclusions: Both EU and US PI paricalcitol dosing strategies effectively reduced iPTH levels in Chinese subjects with SHPT, with minimal impact on Ca and P levels. But patients with higher dose of paricalcitol have increased risk of dose adjustment and drug withdrawal due to adverse events Including hypercalcaemia, hypophosphatemia, elevated Ca-P product and hypoparathyroidism. In order to get the best clinical benefits of paricalcitol, different initial dose and personalized regimen is required.

Keywords: Paricalcitol, Secondary Hyperparathyroidism, Regimens

语种中文
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文献类型学位论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/125268
专题北京大学第一临床医学院
作者单位北京大学第一临床医学院
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郝娟. 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[D]. 北京大学第一临床医学院. 北京大学,2016.
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