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补肾类中医经典方剂治疗糖尿病肾病Ⅲ—Ⅳ期的网状Meta分析

Network Meta-Analysis on Classical Prescriptions of Kidney-Tonifying Traditional Chinese Medicine in the Treatment of StageⅢtoⅣDiabetic Nephropathy
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摘要 目的:通过网状Meta分析方法,评价与比较补肾类中医经典方剂治疗糖尿病肾病Ⅲ—Ⅳ期的临床疗效与安全性。方法:检索并筛选中国知网、万方数据库、维普数据库、中国生物医学文献数据库、PubMed、Web of Science、the Cochrane Library、Embase自建库至2023年10月31日收录的补肾类中医经典方剂治疗糖尿病肾病Ⅲ—Ⅳ期的随机对照试验(对照组为常规治疗,观察组为中医经典方剂或其加减方联合常规治疗;或对照组与观察组均为中医经典方剂或其加减方联合常规治疗),应用R 4.2.1软件进行统计分析与图形绘制。结果:纳入67篇文献,涉及参芪地黄汤、六味地黄丸(汤)、真武汤、金匮肾气丸、济生肾气丸、玉液汤6首经典方剂,共5476例患者。分析结果显示,在降低24 h尿蛋白(24 hUTP)水平方面,金匮肾气丸+常规治疗效果较优;在降低尿白蛋白排泄率(UAER)方面,六味地黄丸(汤)+常规治疗效果较优;在降低血肌酐(SCr)、尿素氮(BUN)、糖化血红蛋白(HbA1c)及空腹血糖(FBG)水平方面,济生肾气丸+常规治疗效果较优。肾阴不足亚组中,参芪地黄汤+常规治疗在降低24 hUTP、HbA1c、FBG水平方面效果较优;六味地黄丸(汤)+常规治疗在降低UAER、BUN水平方面效果较优;玉液汤+常规治疗在降低SCr水平方面效果较优。肾阳不足亚组中,金匮肾气丸+常规治疗在降低24 hUTP水平方面效果较优;济生肾气丸+常规治疗在降低UAER、SCr、BUN、HbA1c、FBG水平方面效果较优。12篇文献报告了不良反应发生情况,均未出现严重不良反应,所有不良反应可自行缓解或经对症处理后消失。结论:现有证据表明,补肾类中医经典方剂联合常规治疗用于糖尿病肾病Ⅲ—Ⅳ期患者具有优势,能够有效降低尿蛋白、保护肾功能、控制血糖,且不良反应较少,但其临床疗效及安全性仍需要多中心、大样本、长时间的随机对照试验来验证。 OBJECTIVE:To evaluate and compare the clinical efficacy and safety of classical prescriptions of kidney-tonifying traditional Chinese medicine in the treatment of stageⅢtoⅣdiabetic nephropathy by network Meta-analysis.METHODS:CNKI,Wanfang Data,VIP,CBM,PubMed,Web of Science,the Cochrane Library and Embase databases were retrieved to collect the randomized controlled trials(the control group was treated with conventional treatment,while the observation group received traditional Chinese medicine classical prescriptions or modified prescriptions combined with conventional treatment;or both the control group and observation group received traditional Chinese medicine classical prescriptions or modified prescriptions combined with conventional treatment)for the treatment of stageⅢtoⅣdiabetic nephropathy with classical prescriptions of kidney-tonifying traditional Chinese medicine from the establishment of the database to Oct.31st,2023.R 4.2.1 software was used for statistical analysis and graphics drawing.RESULTS:A total of 67 literature were enrolled,including 6 classical prescriptions of Shenqi Dihuang decoction,Liuwei Dihuang pills(decoction),Zhenwu decoction,Jingui Shenqi pills,Jisheng Shenqi pills and Yuye decoction,with a total of 5476 patients.Results showed that Jingui Shenqi pills+conventional treatment had significant effect in reducing 24 h urinary protein(24 hUTP).In terms of reducing urinary albumin excretion rate(UAER),Liuwei Dihuang pills(decoction)+conventional treatment had significant effect.In terms of reducing serum creatinine(SCr),urea nitrogen(BUN),glycosylated hemoglobin(HbA 1c)and fasting blood glucose(FBG),Jisheng Shenqi pills+conventional treatment had significant effect.In the subgroup of kidney Yin deficiency,Shenqi Dihuang decoction+conventional treatment had better therapeutic effect in reducing 24 hUTP,HbA 1c and FBG;Liuwei Dihuang pills(decoction)+conventional treatment had better therapeutic effect in reducing UAER and BUN;Yuye decoction+conventional treatment had better therapeutic effect in reducing SCr.In the subgroup of kidney Yang deficiency,Jingui Shenqi pills+conventional treatment had better therapeutic effect in reducing 24 hUTP;Jisheng Shenqi pills+conventional treatment had better therapeutic effect in reducing UAER,SCr,BUN,HbA 1c and FBG.Twelve literature reported the occurrence of adverse drug reactions,none of which were severe,and all of which resolved spontaneously or with symptomatic treatment.CONCLUSIONS:Existing evidence shows that the classical prescription of kidney-tonifying traditional Chinese medicine combined with conventional treatment has advantages in the treatment of stageⅢtoⅣdiabetic nephropathy,which can effectively reduce urinary protein,protect renal function,control blood glucose,and have fewer adverse drug reactions.However,its clinical efficacy and safety still need to be verified by multi-center,large-sample,long-term randomized controlled trials.
作者 李翔宇 谢雁鸣 张宁 张倩 黄雪莹 李同侠 张旭明 LI Xiangyu;XIE Yanming;ZHANG Ning;ZHANG Qian;HUANG Xueying;LI Tongxia;ZHANG Xuming(Dept.of Nephrology and Endocrinology,Wangjing Hospital of China Academy of Chinese Medical Sciences,Beijing 100102,China;Institute of Basic Theory of Traditional Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处 《中国医院用药评价与分析》 2024年第7期833-842,847,共11页 Evaluation and Analysis of Drug-use in Hospitals of China
基金 全国名老中医药专家传承工作室建设项目(国中医药人教函[2022]75号) 国家中医药管理局2021岐黄学者支持项目(国家中医药人教函[2022]6号) 首都卫生发展科研专项项目(No.首发2024-2-4166) 中国中医科学院望京医院高水平中医医院建设项目中医药临床循证研究专项(No.WJYY-XZKT-2023-04)。
关键词 糖尿病肾病 网状Meta分析 经典方剂 中医 Diabetic nephropathy Network Meta-analysis Classic prescriptions Traditional Chinese medicine
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