中医药治疗儿童难治性肾病综合征疗效和安全性的Meta分析及中医证型分析  

Meta-analysis of the Efficacy and Safety of Chinese Medicine in Treating Refractory Nephrotic Syndrome in Children and Analysis of Traditional Chinese Medicine Syndrome Types

作　　者：赵沛东 翟文生[1,2] ZHAO Pei-dong;ZHAI Wen-sheng(School of Pediatrics,Henan University of Chinese Medicine,Zhengzhou Henan 450000;The First Affiliated Hospital of Henan University of Chinese Medicine/Henan Children′s Hospital of Integrated Traditional Chinese and Western Medicine,Zhengzhou Henan 450000)

机构地区：[1]河南中医药大学儿科医学院,河南郑州450000 [2]河南中医药大学第一附属医院/河南省中西医结合儿童医院,河南郑州450000

出　　处：《世界中西医结合杂志》2024年第4期643-653,共11页World Journal of Integrated Traditional and Western Medicine

基　　金：国家自然科学基金面上项目(81873339);河南省特色骨干学科中医学学科建设项目(STG-ZYX03-202128)。

摘　　要：目的 系统评价中西医结合治疗儿童难治性肾病综合征(Refractory nephrotic syndrome,RNS)的疗效和安全性,并对纳入研究患儿的中医证型进行统计分析。方法 计算机检索中国知网(CNKI)、万方数据资源系统(Wanfang)、中文科技期刊数据库(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Cochrane library、Web of science数据库,检索时间为自建库起至2023年3月1日。根据预先设定纳排标准筛选中西医结合治疗儿童RNS的随机对照试验(Randomized controlled trial,RCT)文献并进行数据提取,应用Cochrane协作网风险偏倚评估工具对文献方法学进行质量评价,采用Revman 5.3软件对结局指标进行Meta分析,采用GRADE系统对结局指标进行证据质量评价,并对纳入文献的中医证型分布进行频次、频率统计。结果 共纳入27篇文献,共1876例患者,其中中西医结合治疗组967例,单纯西医治疗组909例。Meta分析结果表明,相较于单纯西医治疗,中西医结合治疗儿童RNS在提高临床总有效率(RR=1.21,95%CI[1.16,1.26],P<0.000 01)方面疗效显著;改善24 h尿蛋白定量(MD=-0.82,95%CI[-1.10,-0.54],P<0.000 01)、白蛋白(MD=6.51,95%CI[4.68,8.34],P<0.000 01)、总胆固醇(MD=-1.39,95%CI[-1.81,-0.98],P<0.000 01)、甘油三酯(MD=-0.48,95%CI[-0.72,-0.23],P=0.0001)、尿素氮(MD=-0.73,95%CI[-0.93,-0.53],P<0.000 01)、血肌酐(MD=-26.15,95%CI[-40.01,-12.29],P=0.0002)方面具有一定优势;在降低复发率(RR=0.37,95%CI[0.28,0.50],P<0.000 01)、不良反应(RR=0.42,95%CI[0.32,0.54],P<0.00001)方面优势明显。纳入研究文献的患儿中医证型分布以脾肾阳虚(31.4%)、气阴两虚(14.3%)、肝肾阴虚(11.4%)、肺脾气虚(8.6%)、脾虚湿困(8.6%)多见。结论 在现有证据支持下,中西医结合治疗儿童RNS对临床症状改善效果明显,且安全性良好。纳入研究的文献中医证型统计结果体现了儿童RNS虚实夹杂、本虚标实的病机特点。上述结论仍需更多大样本、高质量Objective To systematically evaluate the efficacy and safety of Chinese Medicine in treating refractory nephrotic syndrome(RNS)among children,and to statistically analyze the traditional Chinese medicine(TCM)syndrome types included in the study.Methods CNKI,Wanfang Data,VIP,SinoMed,PubMed,Cochrane Library,and Web of Science were searched from the inception of the databases to March 1,2023.Literature involving randomized controlled trials(RCTs)on integrated Chinese and western medicine treatment for children RNS was screened according to preset inclusion and exclusion criteria,and data were extracted.Cochrane risk of bias was used to assess the methodological quality of the literature.Outcome indexes were meta-analyzed using Revman 5.3,and the quality of evidence was evaluated by the GRADE system,along with frequency statistics of TCM syndrome types included in the literature.Results A total of 27 articles were included,comprising 1 876 patients,with 967 in the integrated Chinese and western medicine group and 909 in the single western medicine group.Meta-analysis indicated that,compared with single western medicine,integrated treatment for children RNS improved the total clinical effective rate(RR=1.21,95%CI [1.16,1.26],P<0.000 01).The integrated treatment also had certain advantages in improving 24 h urinary protein quantification(MD=-0.82,95%CI [-1.10,-0.54],P<0.000 01),albumin(MD=6.51,95%CI[4.68,8.34],P<0.000 01),total cholesterol(MD=-1.39,95%CI[-1.81,-0.98],P<0.000 01),triglycerides(MD=-0.48,95%CI[-0.72,-0.23],P=0.000 1),urea nitrogen(MD=-0.73,95%CI[-0.93,-0.53],P<0.000 01),and blood creatinine(MD=-26.15,95%CI[-40.01,-12.29],P=0.000 2).Additionally,it reduced recurrence rate(RR=0.37,95%CI[0.28,0.50],P<0.000 01)and adverse reactions(RR=0.42,95%CI[0.32,0.54],P<0.000 01).The TCM syndrome types most frequently observed in the included children were spleen and kidney yang deficiency(31.4%),qi and yin deficiency(14.3%),liver and kidney yin deficiency(11.4%),lung and spleen qi deficiency(8.6%),and spleen deficiency

关 键 词：中医药 儿童 难治性肾病综合征 中医证型 META分析 

分 类 号：R692[医药卫生—泌尿科学]