盐酸司维拉姆治疗维持性血液透析患者高磷血症的短期疗效  

Short-term efficacy of sevelamer hydrochloride on hyperphosphatemia in patients undergoing maintenance hemodialysis

作　　者：方艺[1] 丁小强[1] 邹建洲[1] 方燕[2] 钱家麒[2] 戎殳[3] 梅长林[3] 邱强[4] 陈香美[4] 郑智华[5] 余学清[5] 

机构地区：[1]复旦大学附属中山医院肾内科,上海200032 [2]上海交通大学附属仁济医院肾内科 [3]第二军医大学附属长征医院肾内科 [4]解放军总医院肾内科 [5]中山大学附属第一医院肾内科

出　　处：《中华肾脏病杂志》2012年第3期183-188,共6页Chinese Journal of Nephrology

摘　　要：目的评价盐酸司维拉姆治疗终末期肾病维持性血液透析（MHD）患者高磷血症的短期疗效和安全性。方法来自国内5所综合性医院共138例并发高磷血症（透析前血磷〉1．78mmol／L）的MHD患者纳人本研究。经过2周磷结合剂洗脱后，根据患者血磷水平予以相应口服剂量的盐酸司维拉姆片剂治疗，疗程为10周，随后为2周的停药观察期，总观察期为14周。给药期间每2周根据患者血清钙磷水平调整药物剂量。结果共有111例患者完成全部试验。经盐酸司维拉姆治疗2周后，患者血磷和血清钙磷乘积水平明显下降。10周疗程结束时，与用药前比较，患者血磷[（1．85±0．50）比（2．57±0．54）mmol／L，P〈0．01]、钙磷乘积[（4．16±1．72）比（5．79±1．50）mmol^2／L^2，P〈0．01]和血清低密度脂蛋白水平[（1．64±0．76）比（2．31±0．87）mmol／L，P〈0．011显著下降，而血浆全段甲状旁腺激素（iPTH）水平和血清校正血钙水平无显著变化。停药后2周，血磷和钙磷乘积水平高于10周治疗结束时，但仍显著低于基线水平[（2．26±0．7）比（2．57±0．54）mmol／L；（5．12±1．63）比（5．79±1．50）mmol^2／L^2，P〈0．011。纳入研究的138例患者中，106例（76.8％）发生了214件不良事件，其中89例（64．5％）的121件为不良反应。胃肠道不良事件总发生率为68．11％（94／138），以轻至中度的便秘最为常见，经对症处理后可缓解或消失。结论盐酸司维拉姆可有效纠正终末期肾病MHD患者的高磷血症，并能降低血清钙磷乘积和血清低密度脂蛋白水平。用药后便秘等胃肠道症状较常见。Objective To evaluate the short-term efficacy and safety of sevelamer hydrochloride in treating maintenance hemodialysis （MHD） patients with hyperphosphemia. Methods A muhieenter, open-labeled, self-control study was performed. Phosphate binders were discontinued during a two-week washout period. Patients with more than 1.78 mmol/L serum phosphorus after two-week washout period were eligible for the trial. The dose was adjusted every two weeks as necessary to achieve serum phosphorus control. Sevelamer hydrochloride was administered to 138 MHD patients for 10 weeks and a second two-week washout period followed. Results A total of 111 from 138 patients fulfilled the whole 14-week study. Mean serum phosphorus and calcium-phosphate products starte to decline after two-week sevelamer hydrochloride treatment. By the end of 10-week sevelamer hydrochloride treatment, mean serum level of phosphorus [（1.85±0.50） vs （2.57±0.54） mmol/L, P〈0.01], calcium-phosphate product [（4.16± 1.72） vs （5.79±1.50） mmol^2/L^2, P〈0.01] and low density lipoprotein [（1.64±0.76） vs （2.31±0.87） retool/L, P〈0.01] were significantly decreased, while the adjusted serum level of calcium and serum intact parathyroid hormone kept steady. Both serum phosphorus and calcium-phosphrus product increased after the second washout period, but the levels were still lower as compared to pre-treatment [（2.26±0.71） vs （2.57±0.54） mmol/L; （5.12±1.63） vs （5.79±1.50） mmol^2/L^2, P〈 0.01]. Of the 138 patients involved, 214 episodes in 106 patients and 121 episodes in 89 patients were reported as adverse events and adverse drug reaction respectively. Gastrointestinal symptoms, of which most were mild or moderate, happened to 68.1% （94/138） patients. Conclusions Sevelamer hydrochloride can control serum phosphorus and reduce the levels of calcium-phosphorus product and cholesterol. Slight gastrointestinal symptoms like constipation are common during the treatment.

关 键 词：血液透析 盐酸司维拉姆 高磷血症 钙磷乘积 

分 类 号：R692.5[医药卫生—泌尿科学]