利妥昔单抗治疗原发性膜性肾病患者的临床研究OA
Clinical trial of rituximab in the treatment of patients with primary membranous nephropathy
目的 研究利妥昔单抗注射液治疗对原发性膜性肾病(PMN)患者的临床疗效和安全性.方法 将PMN患者依据信封法分为对照组和试验组.对照组在常规治疗基础上给予缬沙坦胶囊治疗,每次80 mg,每天1次,试验组在对照组治疗基础上给予375mg·m-2利妥昔单抗注射液治疗,每周1次,治疗1月后调整为每月1次.2组患者均连续治疗6个月.比较2组患者的临床疗效、治疗前后肾功能指标(24 h尿蛋白、肌酐、血尿素氮)、免疫细胞(Th1细胞、Th2细胞、Th17细胞)、免疫相关因子[免疫球蛋白G亚型4(IgG4)、白细胞介素-4(IL-4)]、血管内皮细胞功能[纤溶酶原激活物抑制物-1(PAI-1)、内皮素-1(ET-1)]、可溶性生长刺激表达基因2蛋白(sST2)和内皮细胞功能及和Toll样受体4(TLR4)的水平并进行安全性评价.结果 试验组和对照组的临床治疗有效率分别为86.49％(64例/74例)和63.51％(47例/74例),在统计学上差异均有统计学意义(P＜0.01).治疗后,对照组和试验组的24 h尿蛋白分别为(2.03±0.39)和(1.49±0.32)g·24 h-1,血肌酐分别为(98.11±12.29)和(76.69±10.12)μmoL·L-1,血尿素氮分别为(7.39±0.89)和(6.08±1.27)mmoL·L-1,Th2 细胞 比 例分别为(0.92±0.11)％和(0.76±0.13)％,sST2 分别为(1.59±0.38)和(1.19±0.31)ng·mL-1,TLR4分别为(125.09±13.91)和(91.58±10.67)ng·L-1,ET-1 分别为(53.58±5.34)和(41.77±4.35)pg·mL-1,试验组上述指标与对照组比较,在统计学上差异均有统计学意义(均P＜0.01).试验组和对照组药物不良反应发生率分别为16.22％(12例/74例)和13.51％(10例/74例)(P＞0.05).结论 利妥昔单抗注射液治疗有利于改善PMN患者肾功能和血管内皮细胞功能,降低血清sST2、TLR4水平,降低免疫相关因子表达,提高临床疗效,且安全性较好.
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.
赵新超;祁瑞哲;苑丽华;朱晓晴;马飞
邢台医学院第二附属医院临床药学科,河北邢台 054000邢台医学院第二附属医院临床药学科,河北邢台 054000邢台医学院第二附属医院肾内科,河北邢台 054000青岛市第八人民医院肾内科,山东青岛 266100邢台市药品不良反应和药物滥用监测中心监测中心,河北邢台 054000
医药卫生
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4
rituximab injectionprimary membranous nephropathyvascular endothelial functionrenal functionsoluble serum stimulation-2Toll-like receptor 4
《中国临床药理学杂志》 2026 (7)
940-946,7
邢台市重点研发计划项目(2023ZC123)
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