国家医保局27日公布了集采二甲双胍质量真实世界研究结果。二甲双胍是治疗糖尿病的一线用药,2020年8月被纳入第三批国家组织药品集采范围,共有8家国内仿制药企业提供口服常释和缓释2个剂型的产品。这次质量真实世界研究旨在评价不同生产企业的同一通用名药物之间的疗效和安全性差异。研究选择了10万例服用集采二甲双胍的2型糖尿病患者作为研究对象,结论表明8家企业生产的二甲双胍疗效和安全性均符合标准,不同品种之间无显著统计学差异。医保局相关负责人表示,质量真实世界研究有利于指导药品集采政策的制定,确保患者用药安全性。
Title: Results of quality real-world study on procured metformin drugs released
Keywords: procured drugs, metformin, quality study
News content: The National Healthcare Security Administration released the results of a quality real-world study on procured metformin on the 27th. Metformin is a first-line drug for treating diabetes and was included in the third batch of nationally organized drug procurement in August 2020. A total of 8 domestic generic drug manufacturers provide oral regular-release and extended-release formulations. This quality real-world study aims to evaluate the efficacy and safety differences between drug products with the same generic name produced by different manufacturers. The study selected 100,000 type 2 diabetes patients taking the procured metformin as research subjects. The conclusion shows that the efficacy and safety of metformin produced by the 8 manufacturers meet the standards, and there is no significant statistical difference between different varieties. Relevant officials from the Healthcare Security Administration said that quality real-world studies are conducive to guiding the formulation of drug procurement policies to ensure the safety of patient medication.
【来源】http://www.chinanews.com/gn/2024/02-27/10170905.shtml
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