国际医药卫生导报 ›› 2024, Vol. 30 ›› Issue (12): 2030-2034.DOI: 10.3760/cma.j.issn.1007-1245.2024.12.019

• 临床研究 • 上一篇    下一篇

利妥昔单抗应用于难治性原发性IgA肾病的疗效分析

闫丽1  王立珍2   

  1. 1铜川市人民医院南院药学部,铜川 727031;2西安国际医学中心医院药学部,西安 710100

  • 收稿日期:2024-03-13 出版日期:2024-06-15 发布日期:2024-06-26
  • 通讯作者: 陕西省自然科学基础研究计划(2021JM-553)
  • 基金资助:

    陕西省自然科学基础研究计划(2021JM-553)

Efficacy of rituximab in the treatment of refractory primary IgA nephropathy

Yan Li1, Wang Lizhen2   

  1. 1 Department of Pharmacy, Southern Hospital of Tongchuan People's Hospital, Tongchuan 727031, China; 2 Department of Pharmacy, Xi'an International Medical Center Hospital, Xi'an 710100, China

  • Received:2024-03-13 Online:2024-06-15 Published:2024-06-26
  • Contact: Wang Lizhen, Email: wlz198607@163.com
  • Supported by:

    Shaanxi Province Natural Science Basic Research Program (2021JM-553)

摘要:

目的 探讨利妥昔单抗应用于难治性原发性免疫球蛋白A(IgA)肾病的疗效及安全性。方法 选取2021年9月至2023年9月铜川市人民医院和西安国际医学中心医院共同收治的73例难治性原发性IgA肾病患者,根据治疗方法分为试验组(38例)和对照组(35例)。对照组男19例,女16例;年龄(52.03±14.90)岁;体重指数(23.17±1.25)kg/m2;病程(3.19±0.83)年;口服甲泼尼龙片联合他克莫司治疗。试验组男23例,女15例;年龄(50.78±13.22)岁;体重指数(23.52±1.17)kg/m2;病程(3.50±1.02)年;在对照组基础上联合静脉滴注利妥昔单抗治疗。两组均治疗3个周期后,比较两组的疗效、不良反应、肾功能[血肌酐、24 h尿蛋白定量、估计肾小球滤过率(eGFR)]、免疫因子[IgA、IgG、抗半乳糖缺陷型(Gd)-IgA1]。采用独立样本t检验,配对样本t检验和χ2检验。结果 治疗3个周期后,试验组血肌酐[(79.31±6.52)µmol/L]和24 h尿蛋白定量[(0.73±0.21)g]均低于对照组[(83.06±7.14)µmol/L、(0.87±0.23)g],eGFR[(82.16±5.39)ml/(min·1.73 m2)]高于对照组[(79.04±5.51)ml/(min·1.73 m2)],差异均有统计学意义(均P<0.05)。治疗3个周期后,试验组IgA[(1.84±0.41)g/L]、IgG[(9.53±1.37)g/L]水平均高于对照组[(1.53±0.38)g/L、(8.86±1.17)g/L],Gd-IgA1[(6.23±0.95)mg/L]水平低于对照组[(7.01±1.59)mg/L],差异均有统计学意义(均P<0.05)。试验组治疗总有效率[89.47%(34/38)]高于对照组[65.71%(23/35)],差异有统计学意义(P<0.05)。两组药物不良反应总发生率比较,差异无统计学意义(P>0.05)。结论 利妥昔单抗联合他克莫司治疗难治性原发性IgA肾病的疗效及安全性良好。

关键词:

难治性原发性IgA肾病, 利妥昔单抗, 他克莫司, Gd-IgA1, 估计肾小球滤过率

Abstract:

Objective To investigate the efficacy and safety of rituximab in the treatment of refractory primary immunoglobulin A (IgA) nephropathy. Methods Seventy-three cases of refractory primary IgA nephropathy treated at Tongchuan People's Hospital and Xi'an International Medical Center Hospital from September 2021 to September 2023 were selected, and were divided into an experimental group of 38 cases and a control group of 35 cases based on the treatment methods. There were 19 males and 16 females in the control group, the age was (52.03±14.90) years old, the body mass index (BMI) was (23.17±1.25) kg/m2, and the course of disease was (3.19±0.83) years. There were 23 males and 15 females in the experimental group, the age was (50.78±13.22) years old, the BMI was (23.52±1.17) kg/m2, and the course of disease was (3.50±1.02) years. The control group was treated with oral methylprednisolone tablets combined with Tacrolimus capsules, and the experimental group received rituximab via intravenous infusion in addition to the treatment in the control group. After 3 cycles of treatment, the efficacy, adverse reactions, renal function [serum creatinine, 24 h urinary protein quantification, and estimated glomerular filtration rate (eGFR)], and immunological factors [IgA, IgG, and galactose-deficiency (Gd)-IgA1] were compared between the two groups. Independent sample t test, paired t test, and χ2 test were used. Results After 3 cycles of treatment, the levels of serum creatinine [(79.31±6.52) µmol/L] and 24 h urinary protein [(0.73±0.21) g] in the experimental group were lower than those in the control group [(83.06±7.14) µmol/L and (0.87±0.23) g], but the eGFR [(82.16±5.39) ml/(min·1.73 m2)] was higher than that in the control group [(79.04±5.51) ml/(min·1.73 m2)], with statistically significant differences (all P<0.05). After 3 cycles of treatment, the levels of IgA [(1.84±0.41) g/L] and IgG [(9.53±1.37) g/L] in the experimental group were higher than those in the control group [(1.53±0.38) g/L and (8.86±1.17) g/L], but the level of Gd-IgA1 [(6.23±0.95) mg/L] was lower than that in the control group [(7.01±1.59) mg/L], with statistically significant differences (all P<0.05). The total effective rate of the experimental group [89.47% (34/38)] was higher than that of the control group [65.71% (23/35)], with a statistically significant difference (P<0.05). There was no statistically significant difference in the total incidence of adverse drug reactions between the two groups (P>0.05). Conclusion The combination of rituximab and Tacrolimus in the treatment of refractory primary IgA nephropathy has shown good efficacy and safety.

Key words:

Refractory primary IgA nephropathy, Rituximab, Tacrolimus, Gd IgA1, Estimated glomerular filtration rate