西那卡塞联合小剂量骨化三醇治疗透析患者继发性甲状旁腺功能亢进的疗效观察

Efficacy and safety of xanthoxine combined with low-dose calcitriol in dialysis patients with secondary hyperparathyroidism

目的探讨西那卡塞联合小剂量骨化三醇对透析患者继发性甲状旁腺功能亢进(secondary hyperparathyroidism,SHPT)的疗效及安全性。方法纳入海口市人民医院2012年1月至2015年9月确诊为终末期肾病并且已经透析治疗的SHPT患者84例,其中男41例,女43例,年龄61~89岁,随机分为2组,每组各42例。对所有纳入研究的患者进行终末期肾病的基础治疗,包括饮食控制、降压、促红细胞生成素等治疗,根据实验室检测结果决定对治疗药物加量或减量或维持现有剂量,每2~4周调整1次剂量。对照组采用进食时口服盐酸西那卡塞片,初始剂量为25 mg/d,最大剂量75 mg/d。治疗组在对照组基础上口服骨化三醇胶丸,初始剂量为0.25μg/d,每2~4周调整1次剂量,若能耐受则调节剂量至最大剂量0.5μg/d。2组均连续治疗3个月,分别观察2组患者治疗前及治疗后6个月的血钙、血磷、全段甲状旁腺素(immunoreactive parathyroid hormone,iPTH)水平,并进行统计分析。结果治疗6个月结束后,2组的iPTH及血磷与治疗前比较明显下降(P<0.05),治疗组血钙水平未见明显变化(P>0.05),对照组的血钙水平与治疗前相比下降(P<0.05)。和对照组比较,治疗组iPTH下降的更明显下降(P<0.05)。结论西那卡塞联合小剂量骨化三醇治疗能够降低终末期肾脏病继发甲状旁腺功能亢进患者的甲状旁腺激素,且并可降低血磷水平,对高转运型肾性骨病起到安全有效的治疗作用。

Objective To investigate the efficacy and safety of xinaxacet combined with low-dose calcitriol in patients with secondary hyperparathyroidism.Methods Eighty-four patients with secondary hyperparathyroidism who had been diagnosed as end-stage renal disease and who had been dialyzed from January 2012 to September 2015, including 41 males and 43 females with age ranging from 61 to 89 years old, were randomly divided into two groups （n=42 each group）.All patients underwent basic treatment of end-stage renal disease, including diet control, pressure reduction, and erythropoietin treatment.According to the results of laboratory tests to determine the amount of treatment or reduction or maintenance of the existing dose, every 2 to 4 weeks to adjust the dose.The control group was treated with oral cinnarashcitate tablets at an initial dose of 25 mg / d and a maximum dose of 75 mg/d.Treatment group in the control group based on oral ossification triol capsules, the initial dose of 0.25 μg / d, Every 2 to 4 weeks to adjust the dose, if the tolerance is adjusted to the maximum dose of 0.5 μg/d.Both groups were treated continuously for 3 months.The levels of serum calcium, serum phosphorus and total immunoreactive parathyroid hormone （iPTH） were measured before and 6 months after treatment, and the results were statistically analyzed.Results After treatment for 6 months, the levels of iPTH and serum phosphorus in both groups were significantly decreased （P〈0.05）, and the levels of serum calcium in the treatment group had no significant change （P〉0.05）.The level of serum calcium in the control group was decreased as compared with that before treatment （P〈0.05）.As compared with the control group, the iPTH in the treatment group decreased more significantly （P〈0.05）.Conclusions The combination of cenolafine and low-dose calcitriol can reduce parathyroid hormone and the level of blood phosphorus in patients with terminal hyperthyroidism, and can obtain safe and effective therapeutic effect.