司维拉姆片治疗慢性肾衰竭伴高磷血症患者的临床研究

Clinical trial of sevelamer tablets in the treatment of chronic renal failure with hyperphosphatemia patients

目的探讨司维拉姆片治疗慢性肾衰竭伴高磷血症的效果及对血清分泌型Klotho(sKlotho)和转化生长因子β1(TGF-β1)水平的影响。方法根据治疗方案将纳入的慢性肾衰竭伴高磷血症患者分为试验组61例和对照组67例。对照组给予常规治疗,试验组在对照组基础上给予碳酸司维拉姆每次800 mg,每天3次,随餐口服。观察期为4周,共1个疗程。观察2组治疗前后血清磷、sKlotho、TGF-β1水平和药物不良反应(ADR)。结果治疗后1个月,试验组血清磷为(1.67±0.43)mmol·L^(-1),明显低于对照组(1.85±0.33)mmol·L^(-1),差异有统计学意义(P<0.05);试验组的sKlotho、TGF-β1分别为(220.15±44.54)ng·L^(-1)和(4.11±0.80)ng·mL^(-1),明显高于对照组(180.15±54.12)ng·L^(-1)和(3.80±0.68)ng·mL^(-1),差异均有统计学意义(均P<0.05)。2组间比较ADR发生率差异无统计学意义(P>0.05)。结论司维拉姆片治疗慢性肾衰竭伴高磷血症有较好的效果,明显降低患者血清磷水平,升高血清sKlotho和TGF-β_(1)水平。

Objective To investigate the effect of sevelamer tablets in the treatment of chronic renal failure with hyperphosphatemia and the influence of sviram on the levels of serum secretory Klotho(sKlotho)and transforming growth factor-β1(TGF-β1).Methods Patients with chronic renal failure and hyperphosphatemia were selected,according to the treatment plan,the patients were divided into treatment group(61 cases)and control group(67 cases).Patients in the control group was given routine treatment,the treatment group was treated with sevelamer on the basis of the control group.The levels of serum phosphorus,sKlotho,TGF-β1 and adverse drugs reaction(ADR)were observed before and after treatment.Results One month after treatment,the serum phosphorus in the treatment group was(1.67±0.43)mmol·L^(-1),which was significantly lower than that in the control group(1.85±0.33)mmol·L^(-1)(P<0.05);while the levels of sKlotho and TGF-β1 were(220.15±44.54)ng·L^(-1)and(4.11±0.80)ng·mL^(-1)in the treatment group,which were significantly higher than that in the control group(180.15±54.12)ng·L^(-1)and(3.80±0.68)ng·mL^(-1)(all P<0.05).There was no significant difference in the incidence of ADR between the treatment group and the control group(P>0.05).Conclusion Sevelamer tablets has a good effect in the treatment of chronic renal failure with hyperphosphatemia,can significantly reduce the serum phosphorus level and increase the serum levels of sklotho and TGF-β_(1).