西那卡塞治疗血液透析患者继发性甲状旁腺功能亢进症的临床研究

通过研究两个相同随机、双盲、安慰剂对照试验,本研究评估了拟钙剂盐酸西那卡塞治疗血液透析患者继发性甲状旁腺功能亢进症的临床效果。将接受血液透析及进行标准治疗仍控制不佳的继发性甲状旁腺功能亢进患者随机分配接受西那卡塞(80名患者)或安慰剂(80名患者)治疗26周。每日一次的剂量从30 mg增加到180 mg,以达到患者体内每毫升250 mg或更少的完整甲状旁腺激素水平。主要终点是进行为期14周的疗效评估阶段的患者在该范围内的值的百分比。西那卡塞组有43%的患者达到主要终点,而安慰剂组仅为5%(p<0.001)。总体而言,接受西那卡塞治疗的患者平均甲状旁腺激素水平下降43%,而安慰剂组平均甲状旁腺激素水平下降9%(p<0.001)。西那卡塞组患者体内血清钙磷乘积下降15%,安慰剂组则维持不变(p<0.001)。西那卡塞可有效降低甲状旁腺激素水平,而不依赖于疾病严重程度或维生素D甾醇剂量的变化。西那卡塞可降低接受血液透析的不受控制继发性甲状旁腺功能亢进症患者体内的甲状旁腺激素水平,提高钙磷稳态。

Clinical Study of Sinacasse in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients

To evaluate the clinic efficacy of the quasi calcium hydrochloride stopper(Sinacasse) in the treatment of secondary hyperparathyroidism in hemodialysis patients by studying two identical randomized,double-blind,placebo controlled trials.Patients with secondary hyperparathyroidism who were still poorly controlled by hemodialysis and standard treatment were randomly assigned to receive Sinacasse(80 patients) or placebo(80 patients)for 26 weeks.The daily dose was increased from 30 mg to 180 mg to achieve complete parathyroid hormone levels per ml of 250 mg or less in the patient’s body.The primary endpoint was the percentage of patients who performed a 14-week clinical evaluation phase of the patient’s value within that range.43% of the patients in the Sinacasse group reached the main endpoint,and the placebo group was only 5%(p<0.001).Overall,the average parathyroid hormone level decreased by 43% in patients receiving the treatment of Sinacasse,while the average parathyroid hormone level in the placebo group decreased 9%(p<0.001).The product of serum calcium and phosphorus in the patients in the Sinacasse group decreased by 15% and the placebo group remained unchanged(p<0.001).This can effectively reduce the level of parathyroid hormone,not depending on the severity of the disease or changes in the dosage of vitamin D sterol.It can reduce the level of parathyroid hormone in the patients with uncontrolled secondary hyperparathyroidism undergoing hemodialysis and improve the homeostasis of calcium and phosphorus.