药械组合产品研究及应用进展

      Progress in Research and Application of Drug-Device Combination Product

      • 摘要: 药械组合产品作为药物和医疗器械的组合体,有效降低了传统医疗器械带来的并发症等风险,在临床应用尤其是植入式治疗领域取得巨大成功。该研究团队首先阐述了各个国家对药械组合产品的定义和要求,其次对几类常见的药械组合产品的市场应用及其研究进展进行总结分析,对药械组合产品目前存在的技术问题及未来发展趋势进行了分析展望。

         

        Abstract: Drug-device combination product, which comprises at least a drug and a medical device, has been proved to effectively reduce the risk of complications accompanied with conventional medical devices implantation, and has a great clinical success especially in implantable therapeutics. Herein, we firstly elaborated the definitions and requirements of drug-device combination product in different countries, then summarized the market application and research development of typical drug-device combination products. Technical problems and the trend of future development had also been analyzed.

         

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