盐酸司维拉姆对慢性肾衰竭维持性血液透析患者高磷血症的影响

The effect of Sevelamer hydrochloride on hyperphosphatemia in chronic renal failure patients on maintenance hemodialysis

目的评价盐酸司维拉姆治疗慢性肾衰竭维持性血液透析患者高磷血症的临床疗效及安全性。方法选取广东医学院附属医院2013年7月~2014年7月维持性血液透析患者24例,按照随机数字表法将患者分为实验组和对照组。实验组应用盐酸司维拉姆片,对照组应用碳酸钙咀嚼片,疗程12周。观察2组患者血磷、血钙、钙磷乘积及甲状旁腺激素水平以评价药物的有效性,并对生命体征、实验室检查指标进行监测,以评价药物的安全性。结果 2组24例患者中共有23例患者完成了全部试验。在盐酸司维拉姆治疗4周、8周及12周后,患者血磷、钙磷乘积水平较治疗前明显下降,差异有统计学意义（血磷：治疗组F=6.222,P=0.001;对照组F=3.821,P=0.016。钙磷乘积：治疗组F=6.222,P=0.001;对照组F=2.944,P=0.043）;血钙水平,治疗组无明显变化（F=1.074,P=0.370）,对照组治疗8周、12周明显升高,与治疗前及治疗组相比较差异有统计学意义（F=4.240,P=0.008）;2组患者i PTH无明显变化,差异无统计学意义（治疗组F=0.578,P=0.633,对照组F=0.538,P=0.659）。2组患者治疗前后生命征、实验室检查各项指标均无明显变化,2组间差异无统计学意义（ALB：治疗组F=0.108,P=0.955,对照组F=0.771,P=0.517;SCr：治疗组F=0.105,P=0.957,对照组F=1.111,P=0.356;BUN：治疗组F=0.123,P=0.946,对照组F=2.409,P=0.073;HGB：治疗组F=0.591,P=0.624,对照组F=0.518,P=0.672）。盐酸司维拉姆的不良反应主要是胃肠道反应,表现为便秘、腹胀、恶心。结论盐酸司维拉姆可有效降低慢性肾衰竭维持血液透析患者的血磷水平及钙磷乘积水平,且安全性高,值得临床推广应用。

Objective The purpose of this study was to evaluate the efficacy and safety of Sevelamer hydrochloride in the treatment of maintenance hemodialysis（MHD） patients with hyperphosphatemia. Methods Twenty-four MHD patients treated in the Affiliated Hospital of Guangdong Medical College between July 2013 and July 2014 were enrolled in this study. They were randomly divided into 2 groups according to randomized list. The control group（n=12） received calcium carbonate, while the treatment group（n=12） received Sevelamer hydrochloride for 12 weeks. Efficacy of the treatment was evaluated by changes of serum phosphorus, calcium, calcium- phosphate product, and i PTH. Safety of the treatment was assessed by vital signs and laboratory examination results. Results Twenty-three of the 24 patients completed the study. After Sevelamer hydrochloride treatment for 4 weeks, 8 weeks and 12 weeks, serum phosphorus and calcium- phosphate product decreased significantly（for serum phosphorus, F=6.222 and P=0.001 in treatment group vs. F=3.821 and P =0.016 in control group; for calcium-phosphate product, F=6.222 and P=0.001 in treatment group vs. F=2.944 and P=0.043 in control group）. Serum calcium increased significantly in the control group（F=4.240, P=0.008）, but changed insignificantly in the treatment group（F=1.074, P=0.370）. Serum i PTH level changed insignificantly in both groups（F=0.578 and P=0.633 in treatment group vs. F=0.538 and P=0.659 in control group）. Vital signs and laboratory indexes had no significant changes in both groups（for ALB, F=0.108 and P=0.955 in treatment group vs. F=0.771 and P=0.517 in control group; for SCr, F=0.105 and P=0.957 in treatment group vs. F=1.111 and P=0.356 in control group; for BUN, F=0.123 and P=0.946 in treatment group vs.F=2.409 and P=0.073 in control group; for HGB, F=0.591 and P=0.624 in treatment group vs. F=0.518 and P=0.672 in control group）. The common adverse reactions of Sevelamer were gastrointestinal symptoms such as constipation, ventosity and nausea. Conclusion Sevelamer hydrochloride can effectively reduce serum phosphorus and calcium-phosphorus product levels with higher safety. It is therefore worthwhile to be used clinically.