德谷胰岛素利拉鲁肽注射液联合骨化三醇治疗糖尿病肾病的临床研究

Clinical study on the combination of insulin degludec/liraglutide and calcitriol in the treatment of diabetic nephropathy

摘要:

目的 探讨德谷胰岛素利拉鲁肽联合骨化三醇治疗糖尿病肾病的疗效。方法 将糖尿病肾病患者随机分为对照组、试验组和联合组。对照组服用骨化三醇胶囊，并皮下注射德谷门冬双胰岛素，0.1～0.2 u/kg，1 次/d；试验组仅皮下注射德谷胰岛素利拉鲁肽10 u/次，1 次/d；联合组服用骨化三醇胶囊，并皮下注射德谷胰岛素利拉鲁肽，剂量同上。比较3组治疗3个月后的疗效、血糖、炎症因子、肾间质纤维化及肾功能，并记录药物不良反应情况。结果 3组各入组58例患者，其中对照组脱落5例，最终有53例纳入统计分析；试验组脱落2例，最终纳入56例；联合组脱落4例，最终有54例纳入统计分析。联合组与试验组治疗前后糖化血红蛋白（HbA1c）、餐后2 h血糖（2 hPG）和空腹血糖（FBG）的差值均大于对照组（P <0.05），试验组与联合组治疗前后HbA1c、2 hPG和FBG的差值比较，差异均无统计学意义（P >0.05）；联合组治疗前后C反应蛋白（CRP）、降钙素原（PCT）、血管内皮生长因子（VEGF）、转化生长因子-β₁（TGF-β₁）的差值均大于试验组和对照组（P <0.05），对照组治疗前后CRP、PCT、VEGF、TGF-β₁的差值均大于试验组（P <0.05）；联合组治疗前后β2微球蛋白、血尿素氮（BUN）、血肌酐（Scr）的差值均大于试验组和对照组（P <0.05），对照组和试验组治疗前后β2微球蛋白、BUN、Scr的差值比较，差异均无统计学意义（P >0.05）；联合组治疗总有效率高于对照组和试验组（P <0.05），试验组与对照组总有效率比较，差异无统计学意义（P >0.05）；联合组和试验组低血糖发生率均低于对照组（P <0.05），试验组与联合组比较，差异无统计学意义（P >0.05）。3组患者恶心呕吐和腹泻发生率比较，差异无统计学意义（P >0.05）。结论 德谷胰岛素利拉鲁肽注射液联合骨化三醇治疗糖尿病肾病，有助于提高临床疗效，改善肾功能，并降低低血糖发生风险。

Abstract:

Objective To investigate the clinical efficacy and safety of insulin degludec/liraglutide (IDegLira) combined with calcitriol in diabetic nephropathy (DN).Methods DN patients were randomized into three groups: Control (n = 53, calcitriol + insulin degludec), Experimental (n = 56, IDegLira alone), and Combination (n = 54, IDegLira + calcitriol). Efficacy, changes in glycemic control (HbA1c, FBG, 2 hPG), inflammatory markers (CRP, PCT, VEGF, TGF-β₁), renal function (β2-MG, BUN, Scr), and adverse events after 3 months were compared.Results The magnitude of improvement in HbA1c, FBG, and 2 hPG was significantly greater in the Experimental and Combination groups than in the Control group (P < 0.05), but similar between Experimental and Combination groups (P > 0.05). The magnitude of reduction in CRP, PCT, VEGF, and TGF-β₁ was significantly greater in the Combination group than in the Experimental and Control groups (P < 0.05), and greater in the Control than Experimental group (P < 0.05). The magnitude of reduction in β2-MG, BUN, and Scr was significantly greater in the Combination group than in the Experimental and Control groups (P < 0.05), but similar between Control and Experimental groups (P > 0.05). The total effective rate was significantly higher in the Combination group than in the other groups (P < 0.05). The incidence of hypoglycemia was significantly lower in the Experimental and Combination groups than in the Control group (P < 0.05). Rates of nausea/vomiting/diarrhea were comparable.Conclusion IDegLira combined with calcitriol improves glycemic control, reduces inflammation, enhances renal function, and lowers hypoglycemia risk in DN patients compared to insulin degludec plus calcitriol or IDegLira alone.