不同起始剂量罗沙司他在糖尿病肾病合并肾性贫血患者中的疗效

Efficacy of different starting doses of Roxadustat in patients with diabetic nephropathy complicated by renal anemia

摘要:

目的 探讨不同起始剂量罗沙司他在糖尿病肾病合并肾性贫血患者中的治疗效果比较。方法 纳入2023年1月—2024年11月中国人民解放军联勤保障部队第904医院治疗的104例糖尿病肾病合并肾性贫血患者，采用信封抽签法随机分为低剂量组（35例）、中剂量组（35例）和标准剂量组（34例）。治疗期间根据患者血红蛋白水平进行剂量调整，持续12周。比较治疗前后临床疗效、贫血指标（血红蛋白、红细胞计数、红细胞压积）、肾功能［血肌酐（Scr）、估计肾小球滤过率（eGFR）］，铁代谢（血清铁、铁蛋白、总铁结合力、转铁蛋白饱和度）、脂代谢［总胆固醇（TC）、甘油三酯（TG）］、治疗期间的剂量调整及不良反应发生情况。结果 3组治疗总有效率比较，差异无统计学意义（P >0.05）。3组治疗前血红蛋白、红细胞计数、红细胞压积、血清铁、铁蛋白、总铁结合力、转铁蛋白饱和度、Scr、eGFR、TC和TG比较，差异均无统计学意义（P >0.05）；3组治疗后血红蛋白、红细胞计数、红细胞压积、血清铁、铁蛋白、总铁结合力、转铁蛋白饱和度、Scr、eGFR、TC和TG比较，差异均无统计学意义（P >0.05）。治疗12周后，3组患者血红蛋白、红细胞计数、红细胞压积、血清铁、总铁结合力和转铁蛋白饱和度均较治疗前升高（P <0.05），铁蛋白、TC和TG均较治疗前降低（P <0.05）。标准剂量组中有8例（23.53%）下调剂量，中剂量组中有1例（2.86%）下调剂量，低剂量组中有4例（11.43%）上调剂量。3组患者剂量总调整率、调整量及最终总剂量比较，差异均有统计学意义（P <0.05）。3组不良反应总发生率比较，差异无统计学意义（P >0.05）。结论 低剂量和中剂量的罗沙司他均能有效治疗维持性血液透析糖尿病肾病合并肾性贫血，且其疗效与标准剂量组相当，对铁代谢和脂代谢有积极影响。3组治疗效果相近，且治疗过程中未发现明显的剂量相关不良反应，具有较好的耐受性和较少的剂量调整需求。

Abstract:

Objective To compare the efficacy and safety of three different starting doses of Roxadustat for treating renal anemia in diabetic nephropathy (DN) patients undergoing maintenance hemodialysis (MHD).Methods One hundred and four MHD patients with DN complicated by renal anemia were enrolled between January 2023 and November 2024. Using envelope randomization, patients were assigned to a low-dose group (n = 35), medium-dose group (n = 35), or standard-dose group (n = 34). Doses were adjusted based on hemoglobin (Hb) levels over 12 weeks. Clinical efficacy, anemia indicators (Hb, red blood cell count [RBC], hematocrit [Hct] ), renal function (Scr, estimated glomerular filtration rate [eGFR] ), iron metabolism (serum iron [SI], ferritin [Fer], total iron binding capacity [TIBC], transferrin saturation [TSAT] ), lipid metabolism (TC, TG), dose adjustments, and adverse events were recorded.Results No significant differences in total treatment efficacy rates were observed among the groups (P > 0.05). Baseline and post-treatment levels of Hb, RBC, Hct, SI, Fer, TIBC, TSAT, Scr, eGFR, TC, and TG showed no significant differences between groups (P > 0.05). After 12 weeks, Hb, RBC, Hct, SI, TIBC, and TSAT significantly increased from baseline in all groups (P < 0.05), while Fer, TC, and TG significantly decreased (P < 0.05). Dose reductions occurred in 8 (23.53%) standard-dose patients and 1 (2.86%) medium-dose patient; 4 (11.43%) low-dose patients required dose increases. Total dose adjustment rates, adjustment amounts, and final total doses differed significantly among groups (P < 0.05). No significant difference was found in the total incidence of adverse events (P > 0.05).Conclusion Low and medium starting doses of Roxadustat are as effective as the standard dose in treating renal anemia in MHD patients with DN. They positively influence iron and lipid metabolism, demonstrate comparable efficacy and safety, exhibit good tolerance, and require minimal dose adjustments.