目的 对非奈利酮治疗糖尿病肾病(DN)进行临床综合评价，为临床用药决策提供循证医学证据。方法 系统检索PubMed、Web of Science、Embase、Cochrane Library、WanFang Data和CNKI数据库，同时检索卫生技术评估(HTA)机构网站等，搜集非奈利酮治疗DN的系统评价/Meta分析、HTA报告和经济学评价证据，检索时限均从建库至2023年11月31 日，通过快速HTA方法对非奈利酮的有效性、安全性和经济性进行评价。综合国家药品监督管理局、国家药品监督管理局药品审评中心等专业网站以及药品说明书中的相关数据，对非奈利酮的创新性、适宜性与可及性进行分析。结果 有效性方面，与安慰剂或传统盐皮质激素受体拮抗剂(MRA)相比，非奈利酮可以显著降低DN患者肾脏复合终点事件风险和心血管复合终点事件风险。安全性方面，非奈利酮不良反应发生率和急性肾损伤发生率与安慰剂或传统MRA相似，但高钾血症发生率高于安慰剂对照组。经济性方面，2篇国外HTA报告显示，非奈利酮对比标准治疗整体具有经济性。创新性方面，非奈利酮是全球首个获批用于治疗2型DN的非甾体类选择性MRA类创新药物。适宜性方面，非奈利酮每日仅需要服用1次，在药学特性和药品临床使用过程都具有较好的适宜性。可及性方面，非奈利酮的国内价格低于国际售价，且已进入医保目录，市场覆盖率高，具有较好的可负担性和可获得性。结论 非奈利酮治疗DN的有效性和安全性均较好，但需注意高钾血症的发生风险。其经济性需要在我国进一步开展经济学评价研究。作为全球首个获批的非甾体类、选择性MRA类创新药物，非奈利酮的创新性、适宜性和可及性均较好。
Clinical comprehensive evaluation of finerenone in the treatment of diabetic nephropathy
Objective To investigate the clinical comprehensive value of finerenone in the treatment of diabetic nephropathy(DN),and to provide evidence-based medicine evidence for clinical drug decision.Methods PubMed,Web of Science,Embase,Cochrane Library,WanFang Data,CNKI and health technology assessment(HTA)official website were systematically searched to collect the systematic review/Meta-analysis and pharmacoeconomic evaluation on finerenone in treatment of DN from the inception to November 31,2023.The method of rapid HTA was used to evaluate the effectiveness,safety and economic evaluation.The innovation,suitability and accessibility of finerenone were analyzed by relevant data from drug instructions,professional websites such as the National Medical Products Administration(NMPA)and Center for Drug Evaluation,NMPA.Results In terms of effectiveness,finerenone significantly reduced the risk of the renal composite events and composite cardiovascular outcomes in DN compared with placebo and traditional mineralocorticoid receptor antagonist(MRA).In terms of safety,the incidence of adverse reactions and acute kidney injury of finerenone was similar to that of placebo and traditional MRA,but the incidence of hyperkalemia was higher than that of placebo.In terms of economy,two foreign HTA reports showed that finerenone was more economical than standard treatment.In terms of innovation,finerenone was the world's first approved non-steroidal,selective MRA innovative drug for the treatment of type 2 DN,making its efficacy and adverse reactions more advantageous.In terms of suitability,finerenone should only be taken once a day,which had good suitability in pharmaceutical properties and clinical use.In terms of accessibility,the domestic price of finerenone was lower than the international price,and it was included in the medical insurance,and the market coverage was high,it had a good affordability and availability.Conclusion Finerenone has good effectiveness and safety in the treatment of DN,but attention should be paid to the risk of hyperkalemia,and its economy requires further economic research in China.As the world's first approved non-steroidal,selective MRA innovative drug,finerenone has better innovation,suitability and accessibility.
万方数据
维普
