非奈利酮对糖尿病肾病有效性及安全性的系统评价和meta分析

    Systematic Review and Meta-analysis on the Efficacy and Safety of Fenelidone in Diabetic Nephropathy

    • 摘要:
      目的 研究非奈利酮治疗糖尿病肾病的有效性及安全性。
      方法 检索中国知网、万方、维普、Sinomed、Pubmed、Cochrane图书馆、Embase等数据库,截至2023年5月9日的出版文献,采用建议分级、评估、发展和评价方法评估证据的确定性。进行随机效应meta分析以汇总研究间的效应量。文献筛选、数据提取及质量评估根据Cochrane系统评价手册提供的方法进行。采用Review Manager 5.3、Stata 12.0软件对纳入文献的数据进行meta分析。
      结果 最终纳入8篇文献,共计32 075例患有糖尿病肾病、伴或不伴有心力衰竭的患者。Meta分析结果显示,在复合心血管、肾脏结局方面,与安慰剂相比,非奈利酮降低了复合心血管事件的风险(P<0.000 01),在降低尿蛋白/肌酐方面,非奈利酮有效(P=0.003);但对于降低NT-ProBNP,非奈利酮与依普利酮相比,差异无统计学意义(P=0.37);安全性方面,非奈利酮的严重不良反应发生率均低于安慰剂/依普利酮组(P<0.000 01)。
      结论 相对安慰剂,非奈利酮对于改善心肾预后优势明显,但相对于依普利酮,非奈利酮的优势仍有待研究。在安全性方面,非奈利酮均优于安慰剂组和依普利酮组。

       

      Abstract:
      OBJECTIVE To study the efficacy and safety of finerenone in the treatment of diabetic nephropathy.
      METHODS The published literatures of CNKI, Wanfang, VIP, Sinomed, Pubmed, Cochrane Library and Embase up to May 9, 2023 were retrieved, and the certainty of evidence was evaluated by suggested grading, evaluation, development and evaluation methods. A meta-analysis of random effects was conducted to summarize the effects between studies. Literature screening, data extraction and quality evaluation were carried out according to the methods provided by Cochrane system evaluation manual. Review Manager 5.3 and Stata 12.0 were used to make a meta-analysis of the data included in the literature.
      RESULTS Eight articles were finally included. A total of 32 075 patients with diabetic nephropathy with or without heart failure. Meta-analysis showed that compared with placebo, fenelidone reduced the risk of complex cardiovascular events (P<0.000 01), and fenelidone was effective in reducing urine protein/creatinine(P=0.003), but there was no significant difference in reducing NT-ProBNP between fenelidone and eplerenone(P=0.37). In terms of safety, the incidence of serious adverse reactions of fenelidone was lower than that of placebo/eplerenone group(P<0.000 01).
      CONCLUSION Compared with placebo, fenelidone has obvious advantages in improving the prognosis of heart and kidney, but compared with eplerenone, the advantages of fenelidone still need to be studied. In terms of safety, fenelidone is superior to placebo group and eplerenone group.

       

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