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[民族医药人体使用经验的技术要点]

[Technical points of human use experience of ethnic medicine].

作者信息

Yang Zhong-Qi, Tang Ya-Qin, Ling Yan, DU Yan-Ping, Yuan Wei-An, Zou Chong, Tang Jian-Yuan, Hu Si-Yuan, Gao Rui, Zhang Lei

机构信息

the First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou 510405, China.

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Shanghai 200021, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2023 Mar;48(5):1402-1406. doi: 10.19540/j.cnki.cjcmm.20221126.501.

Abstract

Ethnic medicine has a rich history of application. Because of the large number of ethnic groups, wide geographical distribution, and unique medical systems in China, the research on the human use experience(HUE) of ethnic medicine should combine the characteristics of ethnic medicine, be based on practical experience, and respect folk practice and tradition. The clinical positioning of ethnic medicine should consider three factors, i.e., population region, dominant diseases, and clinical demand. We should consider the development of traditional preparations that meet the needs of ethnic regions and encourage the development of new drugs that can be popularized and used nationwide for the dominant diseases of ethnic medicines. Attention should be paid to the problems such as a large number of customary articles or substitutes of ethnic medicinal materials, the phenomena of foreign bodies with the same name and different names for the same substance, the different standards of medicinal materials, and the poor processing standards. The name, processing method, source, medicinal parts, and dosage of ethnic medicinal materials or decoction pieces should be determined, and resources should be carefully evaluated to ensure the safety of medicinal resources and ecology. The preparation of ethnic medicine is mostly in the form of pills, powder, ointment, etc., with simple processing technology. The problems of low-quality stan-dards of some preparations, different prescriptions with the same name, and inconsistent processing technology should be overcome, and the process route and main process parameters should be clarified to lay the foundation for the subsequent empirical research on HUE. In the collection and analysis of the HUE data of ethnic medicine, the core guiding ideology of "patient-centered" should be established, and the experience data of patients should be collected. The problems of weak links existing in the inheritance of ethnic medicine should be solved, and flexible and diverse methods should be adopted. Meanwhile, on the premise of complying with the requirements of the principles of medical ethics, we should respect the religion, culture, and customs of ethnic areas to obtain the key HUE information of ethnic medicine. On the basis of the patient preference information and differences in regional disease epidemiology, population characteristics, and medical practice, whether the HUE conclusions of ethnic medicine can be extrapolated to patients outside the region is evaluated from the aspects of clinical benefits, risk tolerance, risk acceptance, etc. The HUE research on ethnic medicine is carried out in a clear way to guide the research and development of new ethnic medicines.

摘要

民族医学有着丰富的应用历史。由于中国民族众多、地域分布广泛且拥有独特的医学体系,民族医学的人体使用经验(HUE)研究应结合民族医学特点,立足实践经验,尊重民间实践与传统。民族医学的临床定位应考虑三个因素,即人群地域、优势病种和临床需求。应考虑开发满足民族地区需求的传统制剂,并鼓励研发可在全国推广用于民族医学优势病种的新药。应关注民族药材大量存在习惯用品或代用品、异物同名异物、同名异名以及药材标准不一、炮制规范较差等问题。应确定民族药材或饮片的名称、炮制方法、来源、药用部位及用量,并对资源进行审慎评估,以确保药用资源和生态安全。民族医学制剂多为丸、散、膏等形式,加工工艺简单。应克服部分制剂质量标准低、同名异方、炮制工艺不统一等问题,明确工艺路线及主要工艺参数,为后续HUE实证研究奠定基础。在民族医学HUE数据的收集与分析中,应树立“以患者为中心”的核心指导思想,收集患者的经验数据。应解决民族医学传承中存在的薄弱环节问题,采用灵活多样的方法。同时,在遵守医学伦理原则要求的前提下,尊重民族地区的宗教、文化和习俗,获取民族医学关键HUE信息。基于患者偏好信息以及区域疾病流行病学、人群特征和医疗实践的差异,从临床获益、风险耐受、风险接受等方面评估民族医学HUE结论能否外推至区域外患者。民族医学HUE研究应明确开展,以指导民族新药研发。

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