中国临床药理学杂志2025，Vol.41Issue(19)：2730-2734,5.DOI:10.13699/j.cnki.1001-6821.2025.19.006
司维拉姆联合肾衰宁、骨化三醇治疗慢性肾脏病5期合并CKD-MBD的临床研究
Clinical study on the treatment of stage 5 chronic kidney disease complicated with CKD-MBD using sevelamer,Shen Shuai Ning,and calcitriol
摘要
Abstract
Objective To investigate the clinical efficacy of sevelamer combined with Shenshuaining and calcitriol in the treatment of stage 5 chronic kidney disease(CKD)patients complicated with chronic kidney disease-mineral and bone disorder(CKD-MBD).Methods Patients with stage 5 CKD and CKD-MBD were randomly assigned by a random number table method to the control group(n=54)and the treatment group(n=54).The control group received sevelamer(800 mg per dose,three times daily,taken with meals).On this basis,the treatment group additionally received Shenshuaining oral solution(10 mL per dose,three times daily)and calcitriol(0.25 μg,once daily,orally).The treatment lasted for 12 weeks.The two groups were compared in terms of clinical efficacy,renal function indicators[24-hour urinary total protein(24hUTP),serum creatinine(SCr),and blood urea nitrogen(BUN)],inflammatory cytokines[interleukin-6(IL-6),high-sensitivity C-reactive protein(hs-CRP),and tumor necrosis factor-α(TNF-α)],biochemical indices[intact parathyroid hormone(iPTH)],bone metabolism indices[alkaline phosphatase(ALP)and 25-hydroxyvitamin D(25(OH)D)],and adverse reactions.Results A total of 120 patients were screened,and 108 were enrolled(54 in each group).After treatment,the total effective rate was 96.30％(52 cases/54 cases)in the treatment group,higher than 81.48％(44 cases/54 cases)in the control group(P＜0.05).After treatment,24 h UTP,SCr,and BUN levels in the treatment and control groups were(0.83±0.25)vs.(1.32±0.41)g·L-1;(130.28±29.74)vs.(174.91±34.18)μmol·L-1;and(9.42±1.94)vs.(12.15±2.61)mmol·L-1;respectively.IL-6,hs-CRP,and TNF-α levels were(14.32±3.07)vs.(17.61±3.58)ng·L-1;(3.38±1.14)vs.(6.75±1.63)mg·L-1;and(16.93±3.15)vs.(21.34±3.81)ng·L-1,respectively.Serum phosphorus and PTH levels were significantly lower in the treatment group[(1.75±0.37)vs.(2.11±0.42)mmol·L-1;(101.78±8.68)vs.(125.46±10.73)pg·mL-1];while ALP was reduced[(64.31±7.28)vs.(76.45±9.31)IU·L-1](all P＜0.05).The incidence of adverse drug reactions was 11.11％(6 cases/54 cases)in the treatment group and 7.41％(4 cases/54 cases)in the control group,with no significant difference(P＞0.05).Conclusion Sevelamer combined with Shen Shuai Ning and Calcitriol significantly improves renal function,bone metabolism,and inflammation in stage 5 CKD patients complicated with CKD-MBD compared to Sevelamer alone,with similar safety and better clinical efficacy.关键词
司维拉姆/肾衰宁/骨化三醇/慢性肾脏病/矿物质和骨异常Key words
Sevelamer/Shen Shuai Ning/calcitriol/chronic kidney disease/mineral and bone disorder分类
医药卫生引用本文复制引用
LIU Qing,YAO Ping,LIU Shuang,LI Si-qi..司维拉姆联合肾衰宁、骨化三醇治疗慢性肾脏病5期合并CKD-MBD的临床研究[J].中国临床药理学杂志,2025,41(19):2730-2734,5.基金项目
黑龙江省自然科学基金资助项目(LH2022H073) （LH2022H073）
