新质生产力赋能中药新药临床研究:现状、问题与展望  

Empowering Clinical Research on New Drugs from Traditional Chinese Medicine with New Quality Productive Forces:Status,Challenges,and Prospects

作　　者：谢磊 张敏 万江帆 王露莎 成斌 贺敬龙 XIE Lei;ZHANG Min;WAN Jiang-fan;WANG Lu-sha;CHENG Bin;HE Jing-ong(Guangdong-Hong Kong-Macao Greater Bay Area Center for Drug Evaluation and Inspection of National Medical Products Administration,Shenzhen 518000,China)

机构地区：[1]国家药品监督管理局药品审评检查大湾区分中心,广东深圳518000

出　　处：《中国现代中药》2024年第10期1627-1638,共12页Modern Chinese Medicine

摘　　要：在新质生产力的发展浪潮中,医疗大数据、人工智能等先进技术在中药新药研发领域发挥着重要的作用。对新质生产力及其创新技术在中药新药临床试验各个关键环节的应用现状进行系统综述,包括处方组成及优化、临床试验的精准定位、试验方案的科学设计、数据的收集与管理、试验过程的质量控制及对有效性和安全性的评价等。此外,还深入分析了科技创新成果在实际应用过程中遇到的具体挑战,如数据安全性及受试者隐私保护、结果的可靠性和可解释性、算法模型的精确性和普适性、跨学科合作的复杂性等;并在此基础上展望了未来的发展方向,即继续深化新质生产力及其创新技术在中药新药研发中的应用,特别是融合人工智能、医疗大数据等技术以进一步释放中药研发的新潜能。Amid the surge of new quality productive forces,advanced technologies such as medical big data and artificial intelligence have begun to play a significant role in the development of new drugs derived from traditional Chinese medicine(TCM).This article systematically reviewed the application status of new quality productive forces and their innovative technologies across various critical aspects of clinical trials for new drugs from TCM.These aspects encompass,but are not limited to,the composition and optimization of prescriptions,precise targeting of clinical trials,scientific design of trial protocols,data collection and management,quality control during the trial process,and evaluations of efficacy and safety.Moreover,the paper delves into specific challenges encountered in practical applications,such as data security and privacy protection of subjects,the reliability and interpretability of results,the accuracy and generalizability of algorithm models,and the complexity of interdisciplinary collaboration.Building on this,the paper anticipates future developments,suggesting that the advancement will further enhance the integration of new quality productive forces and their innovative technologies in the research and development of new drugs from TCM.Special emphasis is placed on further merging artificial intelligence and medical big data to unlock new potentials in the research and development of new drugs from TCM.

关 键 词：新质生产力 中药新药开发 临床试验 医疗大数据 人工智能 

分 类 号：R24[医药卫生—中医临床基础]