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  

Clinical trial of rituximab combined with Shenfukang tablets in the treatment of patients with refractory primary membranous nephropathy

作　　者：董义军 周姝 许娟 宋雨霞 廖田田 DONG Yi-jun;ZHOU Shu;XU Juan;SONG Yu-xia;LIAO Tian-tian(Department of Nephrology,Affiliated Hospital of Zunyi Medical University,Zunyi 563000,Guizhou Province,China)

机构地区：[1]遵义医科大学附属医院肾脏病科,贵州遵义563000

出　　处：《中国临床药理学杂志》2024年第23期3376-3379,共4页The Chinese Journal of Clinical Pharmacology

基　　金：贵州省科技计划基金资助项目(黔科合成果-LC[2022]034)。

摘　　要：目的观察利妥昔单抗注射液联合肾复康片治疗难治性原发性膜性肾病(PMN)患者的临床疗效及安全性。方法将难治性PMN患者按队列法分为对照组和试验组。对照组静脉滴注375 mg·m^(-2)利妥昔单抗,每周1次;试验组在对照组治疗的基础上,联合口服肾复康片,每次1.92 g,tid。2组患者均连续治疗3个月。比较2组患者的临床疗效、肾功能、M型磷脂酶A2受体(PLA2R)抗原和PLA2R抗体阳性率,以及安全性。结果试验组入组100例,对照组入组96例。治疗后,试验组和对照组的总有效率分别为98.00%(98例/100例)和88.54%(85例/96例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的白蛋白含量分别为(40.41±2.12)和(32.03±2.01)g·L^(-1),24 h尿蛋白定量分别为(1.68±0.77)和(2.24±0.94)g·d^(-1),PLA2R抗原阳性率分别为5.00%和19.79%,PLA2R抗体阳性率分别为3.00%和18.75%,在统计学上差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以恶心呕吐、发热、腹泻为主。试验组和对照组的总药物不良反应发生率分别为10.00%和7.29%,在统计学上差异无统计学意义(P>0.05)。结论利妥昔单抗注射液联合肾复康片治疗难治性PMN患者的临床疗效确切,且不增加药物不良反应发生率。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 Chin J Clin Pharmacol 3377 Vol.40 No.23 December 2024(Serial No.421)sig nifi cant 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.

关 键 词：利妥昔单抗注射液 肾复康片 难治性原发性膜性肾病 M型磷脂酶A2受体 临床疗效 安全性评价 

分 类 号：R97[医药卫生—药品]