北京中医药大学学报2025，Vol.48Issue(1)：80-90,11.DOI:10.3969/j.issn.1006-2157.2025.01.010
利妥昔单抗联合中医辨证治疗儿童激素依赖型肾病综合征疗效观察及中药用药规律分析
Observation of the therapeutic effect of rituximab combined with traditional Chinese medicine syndrome differentiation on treating steroid-dependent nephrotic syndrome in children and the regularity of traditional Chinese medicine use
摘要
Abstract
Objective To investigate the efficacy,safety,and traditional Chinese medicine(TCM)medication patterns of rituximab(RTX)combined with TCM on treating children with steroid-dependent nephrotic syndrome(SDNS).Methods One hundred and forty-three children with SDNS who visited the Pediatric Nephrology Department of the First Affiliated Hospital of Henan University of Chinese Medicine from January 2018 to December 2022 were enrolled.A cohort study design was adopted,with"RTX treatment"as the exposure factor.Children who met this exposure factor were assigned to the RTX cohort(RTX,glucocorticoid,immunosuppressive agent,combined with traditional Chinese medicine syndrome differentiation treatment),whereas those who did not were assigned to the basic treatment cohort(glucocorticoid,immunosuppressive agent,combined with traditional Chinese medicine syndrome differentiation treatment),and followed up for 6 months.The frequency of urinary protein recurrences,urinary protein remission duration,proportion and duration of steroid reduction and cessation,cumulative usage of steroids,proportion of recurrence,recurrence amount of steroid used,efficacy of TCM syndrome,and laboratory and safety indicators after treatment,and height and CD19+B cell count before and after treatment were compared between the two cohorts.The medication patterns of TCM in the two cohorts were analyzed using frequency statistics,association rule analysis,and systematic clustering analysis.Results Compared with the basic treatment cohort,the RTX cohort showed a decrease in the frequency of urinary protein recurrence,extended sustained remission of urinary protein,an increase in the proportion of steroid reduction and cessation,a shorter duration of steroid reduction and cessation,a decrease in cumulative steroid dosage,a lower recurrence rate,a decrease in CD19+B cell count,and a decrease in 24-h urinary total protein quantification and the level of cholesterol(P<0.05).No significant difference in the recurrence amount of steroid used,height,TCM syndrome efficacy,albumin,aspartate transaminase,blood urea nitrogen,platelet count,and safety indicators between the two cohorts.Children with SDNS were mostly characterized by qi and yin deficiency syndrome,followed by spleen and kidney yang deficiency syndrome.A total of 175 TCMs were included,including 28 high-frequency drugs such as Huangqi,Fuling,Gancao,Baizhu,Dangshen,and Jiuyurou.The primary use of medication is to nourish the qi and spleen,nourish the kidney,and warm yang.The analysis of association rules yielded eight binary associations and ten three-phase associations,with Huangqi,Baizhu,Fuling,and Dangshen,being the most closely related.Cluster analysis identified four TCM combinations,primarily focusing on tonifying kidney and replenishing essence,benefiting qi and nourishing yin,and removing blood stasis.Conclusion RTX combined with TCM syndrome differentiation treatment can reduce the recurrence frequency of SDNS,prolong the remission period,reduce the glucocorticoid dosage,and have no marked effect on height growth.No apparent adverse reactions were observed.TCM should focus on nourishing qi and yin while removing blood stasis.关键词
利妥昔单抗/激素依赖型肾病综合征/用药规律/儿童Key words
rituximab/steroid-dependent nephrotic syndrome/medication rules/children分类
医药卫生引用本文复制引用
张霞,李雪军,徐婷婷,李广,李一凡,宋纯东,翟文生,任献青,丁樱..利妥昔单抗联合中医辨证治疗儿童激素依赖型肾病综合征疗效观察及中药用药规律分析[J].北京中医药大学学报,2025,48(1):80-90,11.基金项目
国家自然科学基金项目(No.82474568) （No.82474568）
2022 年度河南省健康中青年学科带头人培养项目(豫人才[2022]26 号) （豫人才[2022]26 号）
河南省科技研发计划联合基金(No.222301420078) （No.222301420078）
河南省中医科学研究专项课题(No.20-21ZY2045) （No.20-21ZY2045）
河南省中医学"双一流"创建科学研究专项(No.HSRP-DFCTCM-2023-2-10,No.HSRP-DFCTCM-2023-3-15) National Natural Science Foundation of China(No.82474568) （No.HSRP-DFCTCM-2023-2-10,No.HSRP-DFCTCM-2023-3-15）
