阿法迪三~冲击和每日治疗对血液透析患者继发性甲旁亢疗效的随机多中心对照临床研究

Effect of oral pulse versus daily alfacalcidol therapy on secondary hyperparathyroidism in maintenance hemodialysis patients:a randomized, controlled,multi-center study

目的评价阿法迪三犤1α-(OH)-D3犦每日或冲击治疗血液透析患者继发性甲状旁腺功能亢进(甲旁亢)的有效性和安全性。方法选择158例维持性血透患者,血全段甲状旁腺激素(iPTH)水平>200pg/ml,随机分为冲击组和每日组,分别采用阿法迪三2μgbiw～tiw口服和0.5μgqd口服治疗,总观察期为20周,终点指标为iPTH水平<200pg/ml。分别检测治疗前后血iPTH及钙磷代谢相关指标,并对不良反应进行监测。结果(1)两组患者年龄、透析龄、基础肾病分布、曾接受活性VitD3治疗比例、平均血iPTH水平犤冲击组(570.47±295.86)pg/ml,每日组(498.33±207.84)pg/ml犦及血钙血磷等生化指标均无显著性差异。(2)冲击组治疗4周达标率明显高于每日组(35.2%比19.4%,P<0.05)。治疗至终点时两组总达标率相比无明显差异。iPTH%/周水平在iPTH200～500pg/ml亚组冲击法高于每日法犤(10.68±7.32)%比(7.42±7.89)%,P<0.05犦。治疗终点时两组患者碱性磷酸酶(AKP)水平均较治疗前明显下降。(3)治疗终点和治疗前相比,每日组血磷、钙磷乘积均上升,而冲击组治疗前后无明显差异。(4)两组患者不良反应轻微。结论(1)阿法迪三(1α-(OH)-D3)口服和冲击治疗均能有效控制血透患者继发性甲旁亢,安全性良好。(2)早期冲击疗法对于血透患者中度继发性甲旁亢患者疗效更?

Objective To investigate the efficacy and safety of a treatment protocol involving alfacalcidol(1α (OH) D3 )pulse versus daily therapy in treating secondary hyperparathyroidism in maintenance hemodialysis patients. Methods One hundred and fifty eight maintenance hemodialysis patients from 10 dialysis centers with intact parathyroid hormone (iPTH) levels above 200 pg/ml were randomly divided into two groups to receive either pulse(2 μg twice weekly or thrice weekly) or daily (0 5 μg every day) oral alfacalcidol in a 20 week course. The therapeutic end point parameter was defined as iPTH level< 200 pg/ml. Levels of serum iPTH, index of calcium and phosphorus metabolism were tested before and during the study period. The side effects were monitored throughout the study.Results No significant difference was observed in age, time on hemodialysis, presence of underlying renal disease, proportion of patients who had received vital vitamin D therapy before, mean initial iPTH level[pulse group(570 47±295 86)pg/ml, daily group (498 33±207 84)pg/ml]and other biochemistry index between two groups. After 4 weeks treatment, the percentage of patients reaching end point parameter in pulse group was significantly higher than that in daily group(35 2%vs 19 4%, P< 0 05). In iPTH 200～500 pg/ml subgroup, mean iPTH%/week (iPTH%/week=100×(iPTH0week iPTHend)/iPTH0 week/weekend) in pulse group was significantly higher than that in daily group[(10.68±7 32)%vs (7 42±7 89)%, P< 0 05]. AKP levels decreased significantly in both groups at therapeutic end point parameter. Serum phosphate and calcium phosphate product levels in daily group were higher after therapy, while those in pulse group remained unchanged. Side effects for both groups were minimal and well tolerated. Conclusions Alfacalcidol(1α (OH) D3) exerts good therapeutic effects with safety on secondary hyperparathyroidism in maintenance hemodialysis patients. The efficacy and early effects of pulse therapy are superior to those of daily therapy in moderate hyperparathyrodism patients.