机构地区:[1]北京中医药大学东直门医院,北京100700 [2]北京中医药大学,北京100029
出 处:《中国中西医结合肾病杂志》2024年第7期596-603,共8页Chinese Journal of Integrated Traditional and Western Nephrology
基 金:国家自然科学基金资助项目(No.82074361)。
摘 要:目的:为系统评价益肾化湿颗粒联合血管紧张素转化酶抑制剂(ACEI)或者血管紧张素Ⅱ受体阻滞剂(ARB)治疗糖尿病肾脏疾病(DKD)的临床疗效。方法:该研究检索了七大医学数据库,包括PubMed、Embase、The Cochrane Library、CNKI、CBM、VIP和Wan Fang data,检索时间均从建库至2023年11月20日,根据预先确定的纳排标准筛选益肾化湿颗粒联合ACEI/ARB治疗DKD的标准随机对照试验(RCT),并提取相关临床数据。随后采用“Cochrane风险评估工具”对所纳入文献进行质量评价,使用Revman 5.3软件进行偏倚评估和绘图的meta分析。最终共纳入13篇RCT,涉及1049例患者,其中实验组530例,对照组519例。结果:益肾化湿颗粒联合ACEI/ARB能提高DKD的总体有效率[RR=1.24,(95%CI:1.17,1.33),P<0.01],并且能够降低尿白蛋白排泄率(UAER)[MD=-23.29(95%CI:-26.93,-19.65),P<0.01]、24 h尿蛋白(24 h-UTP)[SMD=-0.31(95%CI:-0.52,-0.09),P<0.01]、血肌酐(Scr)[MD=-25.60(95%CI:-33.13,-18.07),P<0.01]和血尿素氮(BUN)[MD=-2.28(95%CI:-2.49,-2.07),P<0.01]等水平,同时在降低空腹血糖(FBG)水平[MD=-0.58(95%CI:-1.00,-0.17),P<0.01]和缓解不良反应方面上亦优于对照组。结论:益肾化湿颗粒联合ACEI/ARB治疗DKD患者相比于单独使用ACEI/ARB有较好的疗效和安全性,可充分发挥糖尿病患者肾脏保护作用。但鉴于本次纳入研究数量较少,质量较低,因此该结论需开展更大样本的高质量、双盲的RCT研究来予以验证。Objective:To systematically evaluate the clinical efficacy of Yishen Huashi granule combined with ACEI/ARB in the treatment of diabetic kidney disease(DKD).Methods:Seven medical databases including PubMed,Embase,The Cochrane Library,CNKI,CBM,VIP and Wan Fang data,were retrieved from the database until November 20,2023.Standard randomized controlled trial(RCTS)of Yishen Huashi Granule for the treatment of DKD was screened according to the pre-determined admission criteria,and relevant data were extracted.Then,we used Cochrane bias risk assessment tool to evaluate the quality of the included literature,and Revman5.3 software were used for bias assessment and meta-analysis.Ultimately,a total of 13 articles and 1049 cases were involved,including 530 in the experimental group and 519 in the control group.Results:The results showed that Yishen Huashi Granule combined with ACEI/ARB could improve the overall effective rate of DKD[RR 1.24,(95%CI:1.17,1.33),P<0.01],and reduce the urinary albumin excretion rate(UAER)[MD=-23.29(95%CI:-26.93,-19.65),P<0.01],24 h-UTP[MD=-0.04(95%CI:-0.06,-0.01),P<0.01],Scr[MD=-25.60(95%CI:-33.13,-18.07),P<0.01],blood urea nitrogen(BUN)[MD=-2.28(95%CI:-2.49,-2.07),P<0.01],etc.And at the same time,it can reduce fasting blood glucose(FBG)[MD=-0.58(95%CI:-1.00,-0.17),P<0.01]and alleviate adverse reactions.Conclusion:The existing evidence shows that Yishen Huashi Granule combined with ACEI/ARB has better efficacy and safety than ACEI/ARB alone in treating DKD patients,which can give full renal protection of diabetic patients.However,in view of the low quality of included study,the conclusion still needs to be verified by a larger sample of high quality and double-blind RCT.
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