关键词: 含糖透析液, 维持性血液透析, 糖尿病, 低血糖, 非劣效性分析

Abstract: Objective:To evaluate the efficacy and safety of glucose⁃containing dialysate in maintenance hemodialysis (MHD) patients. Methods:A prospective, single⁃blind, multicenter, stratified, randomized controlled non⁃inferiority trial was conducted. A total of 260 patients (including 176 in the diabetes subgroup and 84 in the non⁃diabetes subgroup) were randomized into either the experimental group (glucose⁃containing dialysate) or the control group (glucose⁃free dialysate). Both groups underwent a single hemodialysis session. The primary endpoints were the post⁃dialysis electrolyte⁃acid⁃base composite target attainment rate (non⁃inferiority) and the incidence of intradialytic hypoglycemia in the diabetes subgroup (superiority). Secondary endpoints included the overall incidence of hypoglycemia, dialysis adequacy (post⁃dialysis reduction rate of blood urea nitrogen and creatinine), and safety indicators (laboratory tests, vital signs, and adverse events). Results:For the primary endpoints, the post⁃dialysis electrolyte⁃acid⁃base composite reaching the standard after dialysis in the experimental group was non⁃inferior to that in the control group (non⁃inferiority established), and the incidence of intradialytic hypoglycemia in the diabetes subgroup was significantly lower in the experimental group (P=0.000). Regarding secondary endpoints, the overall incidence of hypoglycemia was lower in the experimental group (P=0.000). There was no statistically significant difference in the post⁃dialysis reduction rates of blood urea nitrogen and creatinine between the two groups. In terms of safety, the incidence of adverse events was lower in the experimental group (P=0.015), while no statistically significant differences were observed in other safety indicators. Conclusion: The efficacy of glucose⁃containing dialysate in MHD patients is non⁃inferior to glucose⁃free dialysate. Furthermore, it significantly reduces the risk of hypoglycemia in the diabetes subgroup and demonstrates a favorable safety profile, indicating its value for clinical promotion.

Key words: glucose?containing dialysate, maintenance hemodialysis, diabetes, hypoglycemia, non?inferiority analysis