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金匮肾气丸(汤)治疗糖尿病肾病的系统评价与Meta分析OA

Systematic Review and Meta-analysis of Randomized Controlled Trials of Jinkui Shenqi Pills(Decoction)in the Treatment of Diabetic Nephropathy

中文摘要英文摘要

目的 系统评价金匮肾气丸(汤)治疗糖尿病肾病的临床疗效和安全性.方法 系统检索中国期刊全文数据库、中文期刊全文数据库、万方数据知识服务平台、中国生物医学数据库、PubMed、Embase和Cochrane Library数据库,检索时间为建库至2023 年3 月.采用Cochrane风险评价工具(ROB 1.0)对纳入文献进行质量评价,应用RevMan 5.4软件进行Meta分析.结果 最终纳入随机对照试验(RCT)22篇,总样本量为1 686例.Meta分析结果显示金匮肾气丸(汤)联合常规西医治疗糖尿病肾病的疗效优于单用常规西医治疗方案,其中临床总有效率[RR=1.26,95%CI(1.20,1.32),P<0.000 01]、24 h尿蛋白定量(24hUP)[SMD=-4.40,95%CI(-5.52,-3.36),P<0.000 01]、尿白蛋白排泄率(UAER)[SMD=-3.80,95%CI(-5.50,-2.10),P<0.000 1]、血肌酐水平(Scr)[MD=-20.80,95%CI(-25.74,-15.86),P<0.000 01]、尿素氮水平(BUN)[MD=-1.30,95%CI(-1.88,-0.72),P<0.000 01]均优于对照组,差异有统计学意义;经亚组分析,在降低BUN方面,金匮肾气汤效果优于丸剂;仅有 7 篇研究报告了不良事件,本研究因为证据不足尚不能就金匮肾气丸(汤)干预糖尿病肾病的安全性得出结论.结论 金匮肾气丸(汤)联合西医常规治疗可提高糖尿病肾病临床总有效率,降低 24hUP、UAER、Scr和BUN,疗效明显优于单纯西医治疗.

Objective To systematically evaluate the clinical efficacy and safety of Jinkui Shenqi Pills(Decoction)in the treatment of diabetic nephropathy.Methods Seven databases were systematically searched,including CNKI,WANGFANG,VIP,CBM,PubMed,Embase and Cochrane Library,and the search time was limited to the period from inception till March 2023.The Cochrane Risk Assessment Tool(ROB 1.0)was used to evaluate the quality of the included literature,and Meta-analysis was performed by applying Review Manager 5.4 software.Results Twenty-two randomized controlled trials(RCTs)with a total sample size of 1 686 cases were eventually included.Meta-analysis results showed that the efficacy of Jinkui Shenqi Pills(Decoction)combined with conventional treatment of diabetic nephropathy was better than that of conventional treatment regimen alone,in which the total effective rate[RR=1.26,95%CI(1.20,1.32),P<0.000 01],24-hour urine protein quantification(24hUP)[SMD=-4.40,95%CI(-5.52,-3.36),P<0.000 01],urinary albumin excretion rate(UAER)[SMD=-3.80,95%CI=(-5.50,-2.10),P<0.000 1],serum creatinine(Scr)[MD=-20.80,95%CI(-25.74,-15.86),P<0.000 01],and blood urea nitrogen(BUN)[MD=-1.30,95%CI(-1.88,-0.72),P<0.000 01]were better than the control group,and the differences were statistically significant;through subgroup analysis,the effect of Jinkui Shenqi Decoction was better than that of pill in reducing BUN;only 7 studies reported adverse effects,and this study can not yet draw conclusions about the safety Jinkui Shenqi Pills(Decoction)because of insufficient evidence.Conclusion Jinkui Shenqi Pills(Decoction)combined with conventional treatment can improve the overall clinical efficiency of diabetic nephropathy,reduce 24hUP,UAER,Scr and BUN,and is significantly more effective than conventional treatment of Western medicine alone.

荣红国;邢叶一祎;郭慧娟;李红凯

北京中医药大学中医学院,北京 100029||北京中医药大学国际循证中医药研究院,北京 100029北京中医药大学中医学院,北京 100029北京同仁堂科技发展股份有限公司,北京 100079北京同仁堂股份有限公司科学研究所,北京 100079

临床医学

糖尿病肾病金匮肾气丸金匮肾气汤Meta分析

Diabetic nephropathyJinkui Shenqi PillsJinkui Shenqi DecoctionMeta-analysis

《中国药物经济学》 2024 (006)

33-44 / 12

国家中医药管理局监测统计中心课题(YGZXKT2024046)

10.12010/j.issn.1673-5846.2024.06.006

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