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).

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.

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).

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.