中国临床药理学杂志2026，Vol.42Issue(7)：940-946,7.DOI:10.13699/j.cnki.1001-6821.2026.07.007
利妥昔单抗治疗原发性膜性肾病患者的临床研究
Clinical trial of rituximab in the treatment of patients with primary membranous nephropathy
摘要
Abstract
Objective To explore the effect and safety of rituximab injection in the treatment of patients with primary membranous nephropathy(PMN).Methods PMN patients were selected as the study subjects and divided into control group and treatment group according to envelope method.Patients in control group received valsartan capsules,80 mg·d-1,and the patients in treatment group was treated with 375 mg·m-2 rituximab injection,(once a week,and adjusted to once per month after one month of therapy)on the basis of control group.Both groups received continuous treatment for six months.The clinical efficacy,renal function indexes(24-hour urine protein,creatinine,blood urea nitrogen),immune cells(Th1 cells,Th2 cells,Th17 cells),immune-related factors[immunoglobulin G subtype 4(IgG4),interleukin-4(IL-4)],vascular endothelial cell function[plasminogen activator inhibitor-1(PAI-1),endothelin-1(ET-1)],soluble suppression of tumorigenicity 2(sST2)and Toll-like receptor 4(TLR4)levels were compared and analyzed and the safety were evaluated.Results The clinical effective rates of the treatment group and the control group were 86.49％(64 cases/74cases)and 63.51％(47 cases/74 cases),respectively,and the difference was statistically significant(P＜0.01).After treatment,the 24 h urine protein in the control group and the experimental group were(2.03±0.39)and(1.49±0.32)g·24 h-1,respectively;the serum creatinine were(98.11±12.29)and(76.69±10.12)μmoL·L-1,respectively;blood urea nitrogen was(7.39±0.89)and(6.08±1.27)mmoL·L-1,respectively;the proportion of Th2 cells were(0.92±0.11)％and(0.76±0.13)％,respectively;the levels of sST2 were(1.59±0.38)and(1.19±0.31)ng·mL-1,respectively;the levels of TLR4 were(125.09±13.91)and(91.58±10.67)ng·mL-1;the levels of ET-1 were(53.58±5.34)and(41.77±4.35)pg·mL-1.The differences of the above indicators between two groups were all statistically significant(all P＜0.01).The drug adverse effects of treatment group and the control group were 16.22％(12 cases/74 cases)and 13.51％(10 cases/74 cases)(P＞0.05).Conclusion Rituximab injection is beneficial for primary membranous nephropathy to improve renal function and vascular endothelial cell function,reduce the release of sST2 and TLR4,reduce the expression of immune-related factors,improve clinical efficacy,and have a good safety profile.关键词
利妥昔单抗注射液/原发性膜性肾病/内皮细胞功能/肾功能/可溶性生长刺激表达基因2蛋白/Toll样受体4Key words
rituximab injection/primary membranous nephropathy/vascular endothelial function/renal function/soluble serum stimulation-2/Toll-like receptor 4分类
医药卫生引用本文复制引用
赵新超,祁瑞哲,苑丽华,朱晓晴,马飞..利妥昔单抗治疗原发性膜性肾病患者的临床研究[J].中国临床药理学杂志,2026,42(7):940-946,7.基金项目
邢台市重点研发计划项目(2023ZC123) （2023ZC123）
