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 steroiddependent nephrotic syndrome in children and the regularity of traditional Chinese medicine use

作　　者：张霞[1,2] 李雪军 徐婷婷 李广[1,2] 李一凡 宋纯东[1,2] 翟文生[1,2] 任献青[1,2] 丁樱[1,2] ZHANG Xia;LI Xuejun;XU Tingting;LI Guang;LI Yifan;SONG Chundong;ZHAI Wensheng;REN Xianqing;DING Ying(Pediatric Hospital of the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450003,China;School of Pediatrics of Henan University of Chinese Medicine,Zhengzhou 450046,China)

机构地区：[1]河南中医药大学第一附属医院儿科医院,郑州450003 [2]河南中医药大学儿科医学院

出　　处：《北京中医药大学学报》2025年第1期80-90,共11页Journal of Beijing University of Traditional Chinese Medicine

基　　金：国家自然科学基金项目(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);河南省科技研发计划联合基金(No.222301420078);河南省中医科学研究专项课题(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)。

摘　　要：目的探讨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(SDNS)的疗效、安全性及中药用药规律。方法收集2018年1月—2022年12月就诊于河南中医药大学第一附属医院儿科肾脏病区的SDNS患儿143例,采用队列研究设计,将“使用利妥昔单抗治疗”作为暴露因素,符合此暴露因素的患儿纳入利妥昔单抗队列(利妥昔单抗、糖皮质激素、免疫抑制剂联合中医辨证治疗),不符合者纳入基础治疗队列(糖皮质激素、免疫抑制剂联合中医辨证治疗),并随访6个月。比较2个队列治疗后蛋白尿复发次数、蛋白尿持续缓解期、激素减停比例、激素减停时长、激素累积用量、复发比例、易复发的激素量,治疗前后身高、CD19+B细胞计数情况,中医证候疗效、实验室指标及安全性指标;通过频次统计、关联规则分析、系统聚类分析对患儿中药用药规律进行研究。结果与基础治疗队列比较,利妥昔单抗队列尿蛋白复发次数降低,尿蛋白持续缓解期延长,激素减停比例增加,激素减停时长缩短,激素累积用量减少,复发比例降低,CD19+B细胞计数下降,24 h尿总蛋白定量和胆固醇水平降低(P<0.05)。2个队列易复发的激素量、身高、中医证候疗效,血清白蛋白、谷草转氨酶、尿素氮、血小板及安全性指标差异无统计学意义。SDNS患儿以气阴两虚证居多,其次是脾肾阳虚证;共纳入175味中药,高频药物28味,频数较多的为黄芪、茯苓、甘草、白术、党参、酒萸肉等;药物使用以益气健脾、补肾温阳为主;关联规则分析得到二项关联8条,三项关联10条,黄芪、白术、茯苓、党参之间的联系最为密切;聚类分析得到4个中药组合,以补肾填精、益气养阴兼化瘀为主。结论利妥昔单抗联合中医辨证治疗可减少SDNS的复发次数、延长缓解期,减少糖皮质激素的使用剂量,且对身高增长无明显影响,暂未发现明显的不良反�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 e

关 键 词：利妥昔单抗 激素依赖型肾病综合征 用药规律 儿童 

分 类 号：R272.6[医药卫生—中医儿科学]