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[关于新发突发公共卫生事件循证中医药临床研究设计的建议]

[Suggestions on design of evidence-based traditional Chinese medicine clinical study for new public health emergencies].

作者信息

Wang Lian-Xin, Xie Yan-Ming

机构信息

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2020 May;45(10):2291-2295. doi: 10.19540/j.cnki.cjcmm.20200318.501.

Abstract

2019 novel coronavirus(2019-nCoV) has occurred for 2 months, and seriously affected the people's health in the world. Therefore, scientific prevention and control strategies and effective intervention measures are the only ways to solve the world problem. In the determination of intervention measures, not only the effectiveness evaluation, but also accessibility, treatment cost, inventory and production capacity and other relevant sociological issues shall be considered, especially in low and middle-income countries and regions. With the introduction of clinical epidemiological experiment design and evidence-based medicine evidence evaluation into the evaluation of curative effect of traditional Chinese medicine(TCM), TCM has officially entered the studies of syndrome regularity of new public health emergencies(such as SARS and influenza) clearly diagnosed by modern medicine for many years, as well as the development of relevant guidelines, consensus and paths. The results of curative effect show that TCM could significantly alleviate symptoms, control disease and tendency, reduce the occurrence of critical illness, and improve the clinical efficacy and the prognosis and quality of life of patients, which fully reflects the consciousness and self-confidence of traditional Chinese medicine workers. For the evidence-based evaluation of TCM intervention in new public health emergencies, the basic principles and general methods of clinical epidemiology and evidence-based medicine shall be followed to obtain high-quality evidence; besides, we shall also fully realize that clinical scientific study is carried out with the epidemic treatment as the primary task. The scientific hypothesis comes from the clinical problems unsolved. The scientific study conclusions aim to give feedbacks to clinical diagnosis and treatment regimens. The core elements of clinical trials are population(P), intervention(I), control(C), outcome(O), which are abbreviated as "PICO". The evaluation of intervention measures for new public health emergencies with traditional Chinese medicine shall have clear study objectives and a high quality, with a correct analysis method as the guarantee of real and reliable results. Then, the selection of patients, the de-finition of intervention measures and control measures, the development of end-point indicators, the clinical quality control under special epidemics, the data verification, and the data analysis methods to be adopted are all characteristics and key points that need special consideration. It is suggested that scientific experimental design, rigorous collection and scientific data analysis shall be conducted to reflect the therapeutic value of traditional Chinese medicine, so that the study results could be adopted and shared, and become the scientific evidence for China and even the global to republish the diagnosis and treatment regimens.

摘要

2019新型冠状病毒(2019 - nCoV)已出现两个月,严重影响了全球人民的健康。因此,科学的防控策略和有效的干预措施是解决全球问题的唯一途径。在确定干预措施时,不仅要考虑有效性评估,还要考虑可及性、治疗成本、库存和生产能力等相关社会学问题,尤其是在低收入和中等收入国家及地区。随着临床流行病学实验设计和循证医学证据评估引入到中医药疗效评价中,中医药正式进入了对现代医学明确诊断多年的新型突发公共卫生事件(如非典和流感)证候规律的研究,以及相关指南、共识和路径的制定。疗效结果表明,中医药能显著缓解症状、控制病情及发展趋势、减少危重症的发生,提高临床疗效以及患者的预后和生活质量,这充分体现了中医药工作者的自觉和自信。对于中医药干预新型突发公共卫生事件的循证评价,应遵循临床流行病学和循证医学的基本原则和一般方法来获取高质量证据;此外,还应充分认识到临床科学研究是以疫情救治为首要任务开展的。科学假设源于未解决的临床问题。科学研究结论旨在反馈于临床诊断和治疗方案。临床试验的核心要素为人群(P)、干预(I)、对照(C)、结局(O),简称为“PICO”。中医药对新型突发公共卫生事件干预措施的评价要有明确的研究目标且高质量,以正确的分析方法作为结果真实可靠的保障。那么,患者的选择、干预措施和对照措施的界定、终点指标的制定、特殊疫情下的临床质量控制、数据核查以及拟采用的数据分析方法等都是需要特别考虑的特点和要点。建议进行科学的实验设计、严谨的数据收集和科学的数据分析,以体现中医药的治疗价值,使研究结果能够被采纳和共享,成为我国乃至全球重新发布诊疗方案的科学依据。

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