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(ROB1.0)对纳入文献进行质量评价,应用RevMan5.4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1686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<0.00001]、24 h尿蛋白定量(24hUP)[SMD=-4.40,95%CI(-5.52,-3.36),P<0.00001]、尿白蛋白排泄率(UAER)[SMD=-3.80,95%CI(-5.50,-2.10),P<0.0001]、血肌酐水平(Scr)[MD=-20.80,95%CI(-25.74,-15.86),P<0.00001]、尿素氮水平(BUN)[MD=-1.30,95%CI(-1.88,-0.72),P<0.00001]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 1686 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<0.00001],24-hour urine protein quantification(24hUP)[SMD=-4.40,95%CI(-5.52,-3.36),P<0.00001],urinary albumin excretion rate(UAER)[SMD=-3.80,95%CI=(-5.50,-2.10),P<0.0001],serum creatinine(Scr)[MD=-20.80,95%CI(-25.74,-15.86),P<0.00001],and blood urea nitrogen(BUN)[MD=-1.30,95%CI(-1.88,-0.72),P<0.00001]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.
作者
荣红国
邢叶一祎
郭慧娟
李红凯
RONG Hong-Guo;XING YE Yi-Yi;GUO Hui-Juan;LI Hong-Kai(School of Traditional Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029,China,;Institute for Excellence in Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029,China;Beijing Tong Ren Tang Technology Development Co.,Ltd,Beijing 100079,China;Scientific Research Institute of Beijing Tongrentang Co.,Ltd,Beijing 100079,China)
出处
《中国药物经济学》
2024年第6期33-44,共12页
China Journal of Pharmaceutical Economics
基金
国家中医药管理局监测统计中心课题(YGZXKT2024046)。
关键词
糖尿病肾病
金匮肾气丸
金匮肾气汤
META分析
Diabetic nephropathy
Jinkui Shenqi Pills
Jinkui Shenqi Decoction
Meta-analysis
