创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

糖皮质激素不同减量方案在肾病综合征中的应用研究

Application of Different Glucocorticoid Tapering Regimens in Nephrotic Syndrome

  • 摘要: 目的 探讨糖皮质激素直接减量与逐渐减量2种方案在肾病综合征患者中的临床疗效。方法 选择2022年1月至2025年1月在淮安市淮安医院接受治疗的204例肾病综合征患者作为研究对象,采用随机数字表法将患者分为直接减量组和逐渐减量组,各102例,其中直接减量组按在初始治疗8周后,第9周起逐步减至20 mg·d-1并维持1周,第12周起维持20 mg·d-1,第13减至10 mg·d-1维持4周,第17周减至5 mg·d-1维持12周,第29周停药,总疗程28周,累计剂量约3 640 mg (按60 kg计算);逐渐减量组初始治疗8周后逐步减量(第9~10周每周减10 mg,13~14周每周减2.5 mg,19~20周每周减1.25 mg,期间维持相应剂量),第21~28周维持5 mg·d-1,第29周停药,总周期28周,累计剂量约3 180 mg(按60 kg计算)。比较2组患者治疗前后的肾功能指标血尿素氮(blood urea nitrogen,BUN)、血肌酐(serum creatinine,Scr)、24 h尿蛋白总量、免疫功能指标外周血T淋巴细胞亚群(CD3+、CD4+、CD8+)及不良反应发生情况。结果 治疗28周后,2组患者的BUN、Scr和24 h尿蛋白量降低,CD3+、CD4+和CD4+/CD8+升高(P < 0.05)。与直接减量组相比,逐渐减量组的BUN、Scr和24 h尿蛋白量降低更显著,CD3+、CD4+和CD4+/CD8+升高更明显(P < 0.05)。2组的不良反应总发生率比较无统计学差异(P > 0.05)。结论 糖皮质激素逐渐减量方案相比直接减量方案能更有效地改善肾病综合征患者的肾功能和免疫功能,可作为肾病综合征糖皮质激素减量的优选方案。

     

    Abstract: Objective To compare the clinical efficacy of direct reduction versus gradual tapering regimens of glucocorticoids in patients with nephrotic syndrome. Methods A total of 204 patients with nephrotic syndrome treated at Huai,an Hospital of Huai,an City from January 2022 to January 2025 were enrolled and randomly assigned via a random number table to a direct reduction group (n = 102) or a gradual tapering group (n=102). the direct dose reduction group gradually decreased the dose to 20 mg·d-1 starting from the 9th week after the initial 8-week treatment period, maintained this dose for 1 week, then continued at 20 mg · d-1 from the 12th week onward. The dose was reduced to 10 mg·d-1 at the 13th week and maintained for 4 weeks, further reduced to 5 mg·d-1 at the 17th week and maintained for 12 weeks, followed by discontinuation at the 29th week,the total treatment duration was 28 weeks, with an accumulated dose of approximately 3 640 mg (calculated based on a 60 kg body weight); The gradual tapering group underwent stepwise dose reduction after an initial 8-week treatment (decreasing by 10 mg per week during weeks 9~10, 2.5 mg per week during weeks 13~14, and 1.25 mg per week during weeks 19 ~ 20, maintaining the corresponding doses between reductions).The maintenance dose of 5 mg per day was then administered during weeks 21~28, followed by discontinuation at week 29. The total treatment cycle was 28 weeks, with a cumulative dose of approximately 3 180 mg (calculated based on a body weight of 60 kg). Renal function indicators blood urea nitrogen (BUN), serum creatinine (Scr), 24- hour urinary protein, immune function parameters peripheral blood T lymphocyte subsets (CD3+, CD4+, CD8+) before and after treatment, and the incidence of adverse reactions were compared between the two groups. Results After 28 weeks of treatment, both groups showed significant decreases in BUN, Scr, and 24-hour urinary protein levels, and increases in CD3+, CD4+, and CD4+/CD8+ ratio (P < 0.05). Compared with the direct reduction group, the gradual tapering group exhibited more pronounced reductions in BUN, Scr, and 24-hour urinary protein levels, as well as greater increases in CD3+, CD4+, and CD4+/CD8+ ratio (P < 0.05). There was no statistically significant difference in the overall incidence of adverse reactions between the two groups (P > 0.05). Conclusion The gradual tapering regimen of glucocorticoids is more effective than the direct reduction regimen in improving renal and immune function in patients with nephrotic syndrome. It may therefore be considered a preferable tapering strategy for these patients.

     

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