To explore the effect and safety of rituximab injection in the treatment of patients with primary membranous nephropathy (PMN).

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.

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).

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.