摘要
目的对比低剂量利妥昔单抗(low-dose rituximab,LD-RTX)与环磷酰胺(cyclophosphamide,CTX)分别联合激素治疗难治性肾病综合征患者的疗效及安全性。方法选取2023年3月至2024年10月河南科技大学第一附属医院收治的84例难治性肾病综合征患者,按随机数字表分为LD-RTX组(42例,予以利妥昔单抗200 mg·(m^(2))^(-1)重复输注+泼尼松)与CTX组(42例,予以环磷酰胺+泼尼松)。比较两组患者的临床缓解率、肾功能指标、免疫功能指标及安全性。结果治疗3个月时LD-RTX组总缓解率为47.62%(20/42),CTX组为28.57%(12/42),两组比较差异无统计学意义(χ^(2)=3.231,P=0.072)。治疗6个月时LD-RTX组完全缓解率为40.48%(17/42),高于CTX组的19.05%(8/42)(χ^(2)=4.613,P=0.032);LD-RTX组总缓解率为90.48%(38/42),高于CTX组的69.05%(29/42)(χ^(2)=5.974,P=0.015)。治疗后,LD-RTX组24 h尿蛋白定量、血肌酐及尿素氮水平[分别为(0.86±0.31)g、(67.52±9.37)μmol·L^(-1)、(5.43±0.72)mmol·L^(-1)]均低于CTX组[分别为(1.17±0.40)g、(84.15±9.63)μmol·L^(-1)、(6.92±0.84)mmol·L^(-1)](t=3.970、8.021、8.728,均P<0.05);LD-RTX组CD4^(+)/CD8^(+)比值为(1.34±0.26),高于对照组的(1.19±0.17),而CD19^(+)B细胞数目为(21.36±5.47)个·μL^(-1),低于对照组的(34.82±9.21)个·μL^(-1)(t=3.129、8.143,均P<0.05)。两组不良反应发生率差异无统计学意义(χ^(2)=0.283,P=0.595)。结论低剂量利妥昔单抗联合激素治疗难治性肾病综合征患者的疗效优于环磷酰胺联合激素,安全性相当;环磷酰胺方案更经济,临床可按需选择治疗方案。
Objective To compare the efficacy and safety of low-dose rituximab(LD-RTX)and cyclophosphamide(CTX)combined with hormones respectively in the treatment of refractory nephrotic syndrome.Methods A total of 84 patients with refractory nephrotic syndrome admitted to the First Affiliated Hospital of Henan University of Science and Technology from March 2023 to October 2024 were selected and randomly divided into the LD-RTX group(42 cases,treated with RTX 200 mg·(m^(2))^(-1) repeated infusion plus prednisone)and the CTX group(42 cases,treated with CTX plus prednisone)according to a random number table method.The clinical remission rates,renal function indicators,immune function indicators and safety were compared between the two groups.Results After 3 months of treatment,the total remission rate was 47.62%(20/42)in the LD-RTX group and 28.57%(12/42)in the CTX group,with no statistically significant difference between the two groups(χ^(2)=3.231,P=0.072).After 6 months of treatment,the complete remission rate of the LD-RTX group(40.48%(17/42))was higher than that of the CTX group(19.05%(8/42))(χ^(2)=4.613,P=0.032),and the overall remission rate of the LD-RTX group(90.48%(38/42))was higher than that of the CTX group(69.05%(29/42))(χ^(2)=5.974,P=0.015).After treatment,the quantitative values of 24-hour urinary protein,serum creatinine and urea nitrogen in the LD-RTX group((0.86±0.31)g,(67.52±9.37)μmol·L^(-1),(5.43±0.72)mmol·L^(-1))were all lower than those in the CTX group((1.17±0.40)g,(84.15±9.63)μmol·L^(-1),(6.92±0.84)mmol·L^(-1))(t=3.970,8.021,8.728,all P<0.05).Additionally,the CD4^(+)/CD8^(+)ratio in the LD-RTX group(1.34±0.26)was higher than that in the CTX group(1.19±0.17),while the CD19^(+)B cell count in the LD-RTX group((21.36±5.47)cells·μL^(-1))was lower than that in the CTX group((34.82±9.21)cells·μL^(-1))(t=3.129,8.143,both P<0.05).There was no statistically significant difference in the incidence of adverse reactions between the two groups(χ^(2)=0.283,P=0.595).Conclusion The efficacy of LD-RTX combined with hormones in the treatment of patients with refractory nephrotic syndrome is superior to that of CTX combined with hormones,and the safety is comparable.The CTX regimen is more economical and can be selected clinically as needed.
作者
陈勇
王亚倩
宁小元
罗冬平
茹彦海
徐家云
Chen Yong;Wang Yaqian;Ning Xiaoyuan;Luo Dongping;Ru Yanhai;Xu Jiayun(Department of Nephrology,First Affiliated Hospital of Henan University of Science and Technology,Luoyang 471000,China;Fifteen Department of Psychiatry,Fifth People's Hospital of Luoyang City,Luoyang 471000,China)
出处
《中国药物应用与监测》
2025年第5期938-941,共4页
Chinese Journal of Drug Application and Monitoring
关键词
难治性肾病综合征
利妥昔单抗
环磷酰胺
糖皮质激素
疗效
Refractory nephrotic syndrome
Rituximab
Cyclophosphamide
Glucocorticoids
Therapeutic effect
