To observe the clinical efficacy and safety of cinacalcet tablets combined with calcitriol pills in diabetic nephropathy (DN) patients undergoing hemodialysis.

DN patients receiving hemodialysis in our hospital were divided into treatment group and control group based on different medication regimens. The control group was treated with calcitriol pills, administered orally twice a week. The dosage was 0.25-1.5 μg for patients with intact parathyroid hormone (iPTH) 300-600 ng·L^-1, 0.5-2.0 μg for those with (iPTH) 600-1 000 ng·L^-1, and 2.0-4.0 μg for those with iPTH > 1 000 ng·L^-1. The treatment group received cinacalcet tablets in addition to the control group’s treatment. The initial dose of cinacalcet tablet was 25 mg per day, adjusted every 2-4 weeks, the dose remained unchanged for patients with serum calcium < 2.1 mmol·L^-1; increased to 50 mg per day for those with serum calcium>2.0 mmol·L^-1; and decreased to 75 mg per day for those with serum calcium<1.8 mmol·L^-1. Both groups were treated for 6 months. Clinical efficacy, calcium-phosphorus metabolism, renal function, bone metabolism, iPTH levels and parathyroid gland volume were compared between the two groups, and safety was evaluated.

A total of 94 patients were included in this study, with 47 cases in each of treatment and control groups. After treatment, the total effective rates were 95.74% (45 cases/47 cases) in treatment group and 80.85% (38 cases /47 cases) in control group, showing statistically significant difference (P<0.05). After treatment, the blood calcium levels in treatment and control groups were (2.78±0.21) and (2.49±0.23) mmol·L^-1, respectively; blood phosphorus levels were (1.11±0.13) and (1.39±0.17) mmol·L^-1, respectively; calcium-phosphorus product levels were 3.09±0.24 and 3.46±0.29, respectively; fibroblast growth factor 23 (FGF23) levels were (60.55±7.21) and (71.62±7.84) ng·L^-1, respectively; alkaline phosphatase levels were (91.06±28.43) and (110.35±32.19) U·L^-1, respectively; osteoprotegerin levels were (6 892.43±395.46) and (7 142.58±411.27) ng·L^-1, respectively; iPTH levels were (623.08±57.19) and (721.57±61.46) ng·L^-1, respectively; and parathyroid gland volumes were (0.81±0.19) and (1.11±0.18) cm³, respectively. All of these indicators in treatment group showed statistically significant differences compared to control group (all P<0.05). The main adverse drug reactions in treatment group included pruritus (2 cases), myalgia (3 cases), nausea and vomiting (1 case) and diarrhea (1 case). In the control group, adverse drug reactions were pruritus (1 case), myalgia (2 cases), nausea and vomiting (2 cases) and diarrhea (1 case). The total incidence of adverse drug reactions were 12.77% (6 cases/47 cases) in treatment group and 14.89% (7 cases/47 cases) in control group, with no statistically significant difference (P>0.05).

The combination of cinacalcet tablets and calcitriol pills effectively corrects disorders of calcium-phosphorus and bone metabolism, reduces iPTH levels, and decreases parathyroid gland volume in DN patients on hemodialysis, with a favorable safety profile.