杨忠奇;高蕊;胡思源;元唯安;张磊;唐健元;邹冲;李博;李晓晖;唐雅琴;鲁路;倪世豪;
YANG Zhong-qi;GAO Rui;HU Si-yuan;YUAN Wei-an;ZHANG Lei;TANG Jian-yuan;ZOU Chong;LI Bo;LI Xiao-hui;TANG Ya-qin;LU Lu;NI Shi-hao;the First Affiliated Hospital of Guangzhou University of Chinese Medicine;Xiyuan Hospital, China Academy of Chinese Medical Sciences;First Teaching Hospital of Tianjin University of Traditional Chinese Medicine;Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine;Shanghai University of Traditional Chinese Medicine;Hospital of Chengdu Univer

• 1:广州中医药大学第一附属医院
• 2:中国中医科学院西苑医院
• 3:天津中医药大学第一附属医院
• 4:上海中医药大学附属曙光医院

摘要(Abstract)：

人用经验对于中药新药研发具有重要意义，为获得可靠的人用经验数据，中国药学会中药临床评价专业委员会组织专家起草《中药人用经验研究专家共识》。强调人用经验研究目的要明确，围绕临床适应症和处方阐述中医药理论依据；通过处方临床定位、目标人群分析临床优势或治疗特点，阐述临床价值；评估处方饮片剂量和药味数量，说明制备工艺及与中药新药工艺路线基本一致，分析工艺未来大生产的可行性，说明剂型选择的合理性，初步评估处方中药材资源。制定合理的人用经验研究方案，在人用经验临床资料收集中要符合医学伦理学要求和避免利益冲突，根据不同临床资料特点采用不同的收集方法；制定质量控制措施保证临床数据真实、准确、完整、可靠和可溯源。临床数据相关定义应统一明确，采取措施避免偏倚，数据经过治理后方可开始统计分析。通过人用经验研究明确处方临床定位、应用人群、常用剂量、疗程、初步的有效性和安全性，从而对人用经验数据开展讨论，形成规范的中药人用经验研究报告。
Human use experience(HUE) is important for the research and development of Chinese medicine. For the sake of more reliable data, the Professional Committee for Clinical Evaluation of Chinese Medicine of Chinese Pharmaceutical Association drafted the Expert Consensus on Human Use Experience Research of Traditional Chinese Medicine. It highlights that the research on HUE should have clear purposes, describe the theoretical basis of traditional Chinese medicine(TCM) for the clinical indications and prescriptions and the clinical value of prescriptions, especially the advantages or characteristics in clinical orientation and target population, evaluate the dosages and number of medicinals of prescriptions, verify the accordance with the preparation process of new Chinese medicine, analyze feasibility of the process for large-scale production and the rationality of the dosage form, and assess the medicinal material resources. Moreover, such research should have reasonable protocol and the collection of clinical data on HUE must comply with medical ethics and avoid conflicts of interest. The collection method should be selected depending on the characteristics of clinical data. Quality control measures should be formulated to ensure the authenticity, accuracy, completeness, reliability, and traceability of clinical data. The definitions on the clinical data should be uniform and clear, and methods should be adopted to avoid bias. The data can be statistically analyzed after the processing. Through the study of HUE, the clinical orientation, target population, commonly used dosage, course of treatment, preliminary efficacy and safety of Chinese medicine prescriptions will be clarified. On this basis, the data on the HUE should be discussed and conclusions will be drawn. Finally, a standardized report will be formed.

关键词(KeyWords)： 中药新药;人用经验;专家共识
new drug of traditional Chinese medicine;human use experience(HUE);expert consensus

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划项目(2018YFC1707401);; 广东省药品监督管理局科技创新项目(2020JDB07);; 广州市科技计划项目(202102010013)

作者(Authors): 杨忠奇;高蕊;胡思源;元唯安;张磊;唐健元;邹冲;李博;李晓晖;唐雅琴;鲁路;倪世豪;
YANG Zhong-qi;GAO Rui;HU Si-yuan;YUAN Wei-an;ZHANG Lei;TANG Jian-yuan;ZOU Chong;LI Bo;LI Xiao-hui;TANG Ya-qin;LU Lu;NI Shi-hao;the First Affiliated Hospital of Guangzhou University of Chinese Medicine;Xiyuan Hospital, China Academy of Chinese Medical Sciences;First Teaching Hospital of Tianjin University of Traditional Chinese Medicine;Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine;Shanghai University of Traditional Chinese Medicine;Hospital of Chengdu Univer

DOI: 10.19540/j.cnki.cjcmm.20220601.501

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