摘要
目的研究醋酸钙治疗血液透析患者高磷血症的疗效与安全性。方法采用随机、对照、多中心研究的方法，171例来自全国10家三甲医院的血液透析高磷血症患者分别进入试验组（醋酸钙片，86例）和对照组（碳酸钙片，85例）。经过2周药物洗脱筛选后，根据患者的血磷水平分为两层（1．94～2．26mmol／L和2．27～2．75mmol／L，1mg／dl=0．323mmol／L），每天分别给予含有元素钙1000mg、1500mg的醋酸钙片、碳酸钙片进行治疗，疗程8周，期间不再调整药物剂量。结果纳人研究的171例患者全部进入安全性分析集，其中123例符合方案完成研究的患者进入疗效分析集。与治疗前相比，两组的血磷、钙磷乘积、全段甲状旁腺激素（iPTH）水平均显著下降（均P〈0．05），血钙水平略有上升；两组患者血磷水平[（1．73±1．85）比（0．99±1．60）mmol／L]、药物响应比率（与基线相比血磷水平下降超过25％）（51．6％比32．8％）比较差异有统计学意义（P〈0．05）。两组患者不良事件发生率（19．8％比18．8％）、不良反应发生率（8．1％比4．7％）的差异无统计学意义（均P〉0．05）。醋酸钙的主要不良反应为轻中度胃肠道反应（包括恶心、呕吐等），转归良好。结论醋酸钙可用于治疗慢性肾脏病血透患者高磷血症，并有效降低钙磷乘积、iPTH水平，降磷能力优于碳酸钙。不良反应以轻中度胃肠道反应最常见。
Objective To evaluate the efficacy and safety of calcium acetate in treating hemodialysis（HD） patients with hyperphosphatemia. Methods A randomized, controlled muhieenter study was performed. Phosphate binders were discontinued during a two-week washout period. A total of 171 hemodialysis patients from 10 sites with serum phosphorus during 1.94-2.75 mmol/L after two-week washout period were randomized to calcium acetate or calcium carbonate for 8- week treatment period. Patients with serum phosphorus between 1.94-2.26 mmol/L were given elemental calcium 1000 mg/d andbetween 2.27- 2.75 mmol/L were given elemental calcium 1500 mg/d. The dose was constant during the 8-week treatment period. Results All of 171 patients entered the safety analysis set, including 123 cases who completed the study into effect analysis set. In terms of efficacy： compared with the baseline, serum phosphorus, calcium- phosphorus products, parathyroid hormone （iPTH） levels were significantly decreased （all P 〈 0.05） and serum calcium levels increased slightly in both groups; compared with the calcium carbonate group, calcium acetate group had a significant advantage in the change of serum phosphorus content [（1.73±1.85） vs （0.99 ± 1.60） mmol/L, P 〈 0.05] and drug response ratio （compared with the baseline serum phosphorus level fell more than 25%） （51.6% vs 32.8%, P〈0.05）. In safety aspects, calcium acetate group and the control group had no significant differences in the incidence of adverse events （19.8% vs 18.8%） and adverse reactions （8.1% vs 4.7%）, all P ~0.05. The main adverse reactions of calcium acetate were mild to moderate gastrointestinal reactions, including nausea, vomiting. Conclusions In hemodialysis patients with hyperphosphatemia, calcium acetate can decrease serum phosphorus and reduce the levels of calcium- phosphorus product and iPTH. In the phosphate binding capacity, calcium acetate is superior to calcium carbonate. Mild to moderate gastrointestinal reactions are most common after administration.
出处
《中华肾脏病杂志》
CAS
CSCD
北大核心
2013年第6期429-434,共6页
Chinese Journal of Nephrology
关键词
血液透析
高磷血症
醋酸钙片
钙磷乘积
甲状旁腺激素
Hemodialysis
Hyperphosphatemia
Calcium acetate
Calcium- phosphorus
Parathyroid hormone
