Clinical trial of rituximab combined with Shenfukang tablets in the treatment of patients with refractory primary membranous nephropathy
10.13699/j.cnki.1001-6821.2024.23.002
- VernacularTitle:利妥昔单抗联合肾复康片治疗难治性原发性膜性肾病患者的临床研究
- Author:
Yi-jun DONG
1
;
Shu ZHOU
1
;
Juan XU
1
;
Yu-xia SONG
1
;
Tian-tian LIAO
1
Author Information
1. 遵义医科大学附属医院肾脏病科,贵州遵义 563000
- Publication Type:Journal Article
- Keywords:
rituximab injection;
Shenfukang tablet;
refractory primary membranous nephropathy;
M-type phospholipase A2 receptor;
clinical efficacy;
safety evaluation
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(23):3376-3379
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy and safety of rituximab injection in combination with Shenfukang tablets in the treatment of patients with refractory primary membranous nephropathy(PMN).Methods Patients with refractory PMN were divided into control group and treatment group by cohort method.The control group received intravenous infusion of 375 mg·m-2 rituximab,once a week.On the basis of control group,the treatment group was combined with oral Shenfukang tablets 1.92 g per time,tid.Two groups were treated for 3 months.The clinical efficacy,renal function,positive rates of M-type phospholipase A2 receptor(PLA2R)antigen and antibody,and safety were compared between two groups.Results The treatment and control groups included 100 and 96 cases,respectively.After treatment,the total effective rates of treatment and control groups were 98.00％(98 cases/100 cases)and 88.54％(85 cases/96 cases)with significant difference(P＜0.05).After treatment,the albumin levels of treatment and control groups were(40.41±2.12)and(32.03±2.01)g·L-1;the 24 h urine protein levels were(1.68±0.77)and(2.24±0.94)g·d-1;the PLA2R antigen positive rates were 5.00％and 19.79％;the PLA2R antibody positive rates were 3.00％and 18.75％,respectively,with statistically significant differences(all P＜0.05).The adverse drug reactions of two groups were nausea,vomiting,fever and diarrhea.The total incidences of adverse drug reaction rates in the treatment and control groups were 10.00％and 7.29％without significant difference(P＞0.05).Conclusion Rituximab injection combination with Shenfukang tablets has a better clinical efficacy and safety in the treatment of patients with refractory PMN.
