西那卡塞片联合骨化三醇胶丸治疗血液透析伴高钙血症的临床研究  

Clinical trial of cinacalcet tablets combined with calcitriol soft capsules in the treatment of hemodialysis patients with hypercalcemia

作　　者：刘智楠[1] 郑慧[1] 郭向辉 

机构地区：[1]唐山市工人医院肾内科,河北唐山063000

出　　处：《中国临床药理学杂志》2017年第23期2381-2383,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察西那卡塞片联合骨化三醇胶丸治疗血液透析伴高钙血症的临床疗效和安全性。方法将48例持续性血液透析伴高钙血症患者随机分为对照组24例和试验组24例。对照组予以西那卡塞每次25 mg,qd,口服;试验组在对照组治疗的基础上,加用骨化三醇胶丸每次0.25μg,每周3次,口服。2组患者均治疗3个月。比较2组患者的临床疗效、血清钙和磷浓度、全段甲状旁腺激素(I-PTH)水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为91.67%(22例/24例)和66.67%(16例/24例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的钙浓度分别为(2.91±0.37)和(2.28±0.21)mmol·L^(-1),磷浓度分别为(1.35±0.17)和(1.55±0.21)mmol·L^(-1),I-PTH分别为(261.47±30.18)和(301.38±43.05)pg·m L^(-1),差异均有统计学意义(均P<0.05)。试验组发生药物不良反应有肌肉疼痛、恶心呕吐和高血压,对照组发生药物不良反应有肌肉疼痛、恶心呕吐和腹泻。试验组和对照组的总药物不良反应发生率分别为12.50%和16.67%,差异无统计学意义(P>0.05)。结论西那卡塞片联合骨化三醇胶丸治疗血液透析伴高钙血症的临床疗效,可显著地降低血清钙和磷浓度、以及I-PTH水平,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of cinacalcet tablets combined with calcitriol soft capsules in the treatment of hemodialysis patients with hypercalcemia. Methods A total of 48 cases of hemodialysis patients with hypercalcemia were randomly divided into control group and treatment group with 24 cases per group. Control group was treated with cinacalcet 25 mg,qd,orally. Treatment group was given calcitriol soft capsule 0. 25 μg,three times a week,orally,on the basis of the control group. Two groups were treated for 3 months. The clinical efficacy, serum concentration of calcium and phosphorus, intact parathyroid hormone（ I-PTH） and adverse drug reactions were compared between two groups. Results After treatment, the total effective rates in treatment and control groups were 91. 67%（ 22 cases/24 cases） and 66. 67%（ 16 cases/24 cases） with significant difference（ P〈0. 05）. After treatment,the main indexes in treatment and control groups were compared： the serum concentrations of calcium were（ 2. 91 ± 0. 37） and（ 2. 28 ± 0. 21） mmol·L-1,the serum concentrations of phosphorus were（ 1. 35 ± 0. 17） and（ 1. 55 ± 0. 21） mmol·L-1,I-PTH were（ 261. 47 ± 30. 18） and（ 301. 38 ± 43. 05） pg·m L-1,the differences were statistically significant（ all P〈0. 05）. The adverse drug reactions in treatment group were based on muscle pain,nausea and high blood pressure,which in control group were muscle pain,nausea and diarrhea. The incidences of adverse drug reactions in treatment and control groups were 12. 50% and 16. 67% without significant difference（ P〈0. 05）. Conclusion Cinacalcet tablet combined with calcitriol soft capsule has a definitive clinical efficacy in the treatment of hemodialysis patients with hypercalcemia,which can reduce the serum concentrations of calcium and phosphorus and the levels of I-PTH,without increasing the incidences of adverse drug reactions.

关 键 词：西那卡塞片 骨化三醇胶丸 血液透析 高钙血症 安全性 

分 类 号：R977[医药卫生—药品]