呼吸系统疾病是全球范围内的高发疾病，中药在其防治中具有独特优势，临床试验将为中药新药的注册提供科学依据，提升试验质量是确保数据真实、准确、完整、及时、合法的重要环节。然而，中药治疗呼吸系统疾病的临床试验仍面临诸多挑战，包括临床定位不够清晰、疗效指标设计不合理、对照组选择困难、受试者依从性等问题。系统梳理中药治疗呼吸系统疾病临床研究的现状与特点，分析当前存在的突出问题，并指出提升临床试验质量的具体策略，包括选择客观化疗效指标，规范量表的使用与填写，确保原始数据的真实性与完整性，设计合理的对照组，优化访视节点与检查方案，加强肺功能设备的质量控制，并适当引入药动学/药效学动力学（PK/PD）研究以阐明作用机制。通过上述措施，可构建符合中医特色且遵循药物临床试验质量管理规范的质量控制体系，为中药新药研发提供更可靠的循证依据，推动中医药在呼吸系统疾病防治中的科学化与国际化发展。

Respiratory diseases are highly prevalent globally, and traditional Chinese medicine（TCM） holds unique advantages in their prevention and treatment. Clinical trials provide scientific evidence for the registration of new TCM drugs. Improving trial quality is a key link to ensure the authenticity, accuracy, completeness, timeliness, legality of source data. However, clinical trials of TCM for respiratory diseases are still facing numerous challenges including unclear clinical positioning, unreasonable design of efficacy indicators, difficulties in selecting control groups and subject compliance issues. This paper systematically reviewed the current status and characteristics of clinical research on TCM for respiratory diseases, analyzed the existing prominent issues and proposed specific strategies to enhance clinical trial quality, including selecting objective efficacy indicators, standardizing the use and completion of scales, ensuring the authenticity and integrity of raw data, employing reasonable control groups, optimizing visit nodes and examination schemes, strengthening the quality control of pulmonary function equipment, and appropriately introducing pharmacokinetic/pharmacodynamic studies to elucidate action mechanisms. Through these measures, a quality control system that aligns with the characteristics of TCM and follows the provisions of corresponding regulations can be established, which provides a more reliable evidence-based foundation for the research and development of new TCM drugs and promoted scientific and international development of TCM in the prevention and treatment of respiratory diseases.

R969.4;R974

国家中医药管理局中药创新能力提升项目(BJTH 2024-02F-0009); 上海市卫健委医学新技术研究与转化种子计划项目(2024ZZ1006)