中国临床药理学杂志2024，Vol.40Issue(15)：2165-2169,5.DOI:10.13699/j.cnki.1001-6821.2024.15.003
利妥昔单抗治疗磷脂酶A2受体相关膜性肾病患者的临床研究
Clinical trial of rituximab in the treatment of patients with phospholipase A2 receptor-associated membranous nephropathy
摘要
Abstract
Objective To observe the clinical efficacy and safety of rituximab injection in the treatment of patients with phospholipase A2 receptor-associated membranous nephropathy(PLA2R-MN).Methods The PLA2R-MN patients were randomly divided into control group and treatment group.The control group received oral prednisone tablets,initial dose of 40-60 mg·d-1,gradually reduced the dose according to the patients'condition after 2 months,cyclophosphamide injection 0.6 g per time,intravenous infusion,once every 2 weeks,for 6 consecutive times,then adjusted to 1.0 g per time,intravenous infusion,once a month;the treatment group received 375 mg·m-2 rituximab injection intravenous infusion,once a week,for 4 consecutive weeks,on the basis of the control group treatment.Both groups of patients were treated for 6 months.The clinical efficacy,24 h urine protein quantification,serum creatinine(SCr),glomerular filtration rate(eGFR),urinary microalbumin(UAlb),urinary creatinine(UCr)and adverse drug reactions were compared between two groups.Results Fifty-three patients were enrolled in the treatment group,2 cases dropped out,and 51 cases were finally included in the statistical analysis.Fifty-three patients were enrolled in the control group,2 cases dropped out,and 51 cases were finally included in the statistical analysis.After treatment,the total effective rate of the treatment group and the control group were 92.16％(47 cases/51 cases)and 76.47％(39 cases/51 cases),and the difference was statistically significant(P＜0.05).After treatment,the 24 h urine protein quantification of the treatment and control groups were(0.86±0.30)and(1.04±0.27)g·24 h-1;SCr levels were(103.37±18.80)and(120.55±19.94)μmol·L-1;eGFR levels were(65.89±8.17)and(55.87±9.36)mL·min-1·1.73 m-2;UAlb levels were(47.45±13.52)and(98.21±25.50)mg·L-1;UCr were(1.55±0.42)and(1.96±0.51)mg·g-1,respectively,and the differences were all statistically significant(all P＜0.05).The adverse drug reactions of two groups were mainly nausea,vomiting,liver function damage,skin itching,infection,hair loss,etc.The total incidences of adverse drug reactions in the treatment and control groups were 43.14％and 37.25％,without significant difference(P＞0.05).Conclusion Rituximab injection has a definite clinical efficacy in the treatment of PLA2R-MN patients,which can significantly improve the renal function of patients,and does not increase the incidence of adverse drug reactions.关键词
利妥昔单抗注射液/醋酸泼尼松片/环磷酰胺注射剂/膜性肾病/磷脂酶A2受体/肾功能/安全性评价Key words
rituximab injection/prednisone acetate tablet/cyclophosphamide injection/membranous nephropathy/phospholipase A2 receptor/kidney function/safety evaluation分类
药学引用本文复制引用
刘海霞,褚夫宝,安玲,刘文花..利妥昔单抗治疗磷脂酶A2受体相关膜性肾病患者的临床研究[J].中国临床药理学杂志,2024,40(15):2165-2169,5.基金项目
青海省卫生健康委员会指导性计划课题资助项目(2019-wjzdx-33) （2019-wjzdx-33）
