世界针灸学会联合会

国际抗疫专家大讲堂第二十四讲 赵一鸣教授在线答疑汇总

作者:世界针联 来源:世界针联 点击:1716次 更新:2020-06-30
  

  由世界针灸学会联合会、中华中医药学会、中国针灸学会主办的「国际抗疫专家大讲堂系列讲座」第二十四讲邀请到了北京大学第三医院博士研究生导师、北京大学第三医院临床流行病学和循证医学中心主任赵一鸣。

  赵一鸣教授为我们带来了题为《新冠肺炎临床研究的方法学思考》的讲座。他说,临床研究在应对疫情中扮演着重要角色,研究策略和技术路线既要符合科研规律,又要满足抗疫要求,因而矛盾冲突凸显,所以赵教授提出要按需求,按规律办事。首先要找到临床工作与临床研究共同的问题和需求,形成合力,互相促进,用利益和机制破解难题。其次,在认识新冠肺炎的过程中,按临床研究的阶段进行,循序渐进组织实施。还有,临床研究是在复杂的环境中开展简单的研究,需要多学科人员共同参与组织实施。最后,赵教授强调了临床科研一体化的实施思路,把临床记录病历资料的工作转变为同时收集临床研究资料,把临床工作中总结经验转变为临床研究源头创新的资源。在答疑环节,解答问题汇总如下:

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问题1:在这次新冠肺炎期间中医药做了这么多工作,如何用大家能接受的语言和方法,把这些中医临床效果和作用很好地展示出来,在这方面您还有哪些更好的建议?

Q1: Chinese medicine has done so much work during the COVID-19 outbreak. How can these clinical effects and functions of TCM be well demonstrated in a language and method that everyone can accept? Do you have good suggestions in this regard?

赵一鸣教授:其实这个问题非常好,现在临床研究主要有两种类型,一种是前瞻性研究,先有一个研究设计方案,按照设计方案去收集资料总结分析,都是按规范进行一系列操作;另一种是回顾性研究,我个人觉得在中医这个领域有这么多好的临床经验,有部分是按照前瞻性研究开展并做了总结,但做的并不是很理想,没有这么多设计在里面,因为疫情爆发当时紧急任务是先解决问题(控制住疫情,治疗感染病人),但治疗过程中一定有很好的诊疗方法,这些方法可以用回顾性的研究来总结分析。实际上回顾性研究是非常好的研究方法,因为过去大家在治疗新冠肺炎方面没有任何经验,还处于早期的探索阶段,不同的团队都在进行摸索分析,所以我认为完全可以用回顾性的研究方法来总结,按照回顾性研究的规范流程,把研究质量和科学性做的相对比较好。我们可以给予方法学上的帮助,比如说收集临床资料,做回顾性的调查,了解当时医务人员在诊疗过程中的具体做法,整理清楚之后,参照或按照一定的临床质量标准,将这些资料转为回顾性研究的数据质量的支撑,在论文中方法部分我们可以讲清楚,如患者发热或咳嗽等症状是怎样收集的,在不同疗程阶段治疗症状改善状态或程度等,把这个治疗方法讲清楚了也是非常不错的。

  临床研究的质量是个多维度的,回顾性研究尽管还有各种各样的问题,但是如果我们能抓住主要矛盾、因果关系,跟因或果相关的指标比较靠谱,拿这个研究的质量就有一定的保证了,剩下的问题就能做到什么程度就做到什么程度,把这样的工作整理阐述清楚,以论文的形式发表、固定下来,那么对于今后我们认识新冠肺炎疾病是非常有意义的,在介绍中国经验时也提供了相应的科学支撑,我认为这些工作还是值得去做。

Professor Zhao Yi Ming: This is a very good question indeed. Now there are two main types of clinical research: One is prospective research. First, there is a research and design plan according to which data are collected, summarized and analyzed. A series of operations are carried out according to specifications. 

The other is retrospective research. Personally, I think there are so many good clinical experiences in the field of TCM. Some of them are carried out and summarized according to prospective research, but they are not ideal. There are not so well designed. Because the urgent task at the time of the outbreak was to solve the problem first (control the epidemic and treat infected patients), but there must be good diagnosis and treatment methods in the treatment process. These methods can be summarized and analyzed by retrospective research. In fact, retrospective study is a very good research method, because no one had any experience in the treatment of COVID-19 in the past, and it is still in the early stage of exploration. Different teams are exploring and analyzing. So I think that retrospective research can be used to sum up the method according to the standard process of retrospective research. The research quality and scientific character are relatively guaranteed. We can give methodological help, such as collecting clinical data, conducting retrospective investigation, understanding the specific practices of medical personnel during the diagnosis and treatment process at that time, after sorting out, referring to or following certain clinical quality standards, and transferring these data to support the data quality of the retrospective research. We can make it clear in the method section of the paper, such as how the symptoms such as fever or cough are collected, and the state or degree of symptom improvement at different treatment stages. It is also very good to explain the treatment method clearly.

The quality of clinical research is multi-dimensional. Although there are various problems in retrospective research, if we can grasp the main contradictions, causality and reliable indicators related to cause or effect, the quality of this research will be guaranteed to a certain extent, and the remaining problems will be solved to the same extent. To sort out such work clearly, publish and fix it in the form of a paper is very significant for us to understand the COVID-19 in the future and provide corresponding scientific support when introducing Chinese experience. I think the work is worth doing.

问题2:在医学临床研究中找因果关系,往往是找有这种有针对性的特效药物,因为它能抑制病毒的生长和复制,所以就成了特效的药物。但是从中医药来看,无论是防治新冠肺炎,还是甲流、SARS,用的大多数药物都可以在古人方子中找到它的渊源,说明中医药不是针对某种病毒的特异性药物,而是具有非特异性,这种非特异性主要是针对病毒的宿主发挥作用,它能增强人体免疫力,提升人体对病毒的自我防控能力,减少对人体的伤害。目前来看,这次新冠肺炎是没有特异性药物治疗的疾病,用单一的治疗方法难度很大,我想请教一下,在这种情况下我们中医药临床发挥的作用,到底应该如何开展相关研究来拿出比较可靠的结论或结果?

Q2: When looking for causality in medical clinical research, it is often to find a specific and targeted drug. Because it can inhibit the growth and replication of virus, it has become a specific drug. However, from the perspective of TCM, most of the drugs used in the prevention and treatment of COVID-19, H1N1 influenza and SARS can find their origin in ancient prescriptions, which shows that TCM is not specific to a certain virus, but has non-specificity. This non-specificity mainly acts on the host of the virus, which can strengthen the immunity of human body, enhance its self-prevention and control ability to the virus, and hence reduce damage to human body. At present, COVID-19 is a disease without specific drug treatment, and it is very difficult to use a single treatment method. I would like to ask how to carry out relevant research to come up with more reliable conclusions or results on the role of Chinese medicine in clinical practice under such circumstances.

赵一鸣教授:我举个例子,青霉素是不是特效药?青霉素为什么是特效药?因为当时感染者用了青霉素就能治愈,不用青霉素就会死亡,至于青霉素的药物机制对于临床来讲,不是临床研究能解决的问题,这需要基础研究去做相关药物机制方面的工作,比如有无靶点问题。以我个人的理解和认识来说,临床研究就是使用某种药物之后临床疗效特别明显,那么它就是特效药。我注意到在新冠肺炎的治疗过程中有个特点,疫情初期,轻型和普通型这一类型的患者中有一定比例的患者会转为重症或危重症甚至死亡,但是在使用中医药治疗后,很少有转为重症的,也没有死亡的,这就是说新冠肺炎治疗中,中医药治疗的参与使得感染患者避免或者降低转为成重症或死亡的风险,我认为中医药这样的治病能力和临床疗效可以堪称特效药,我们就可以改变整个抗疫的策略,把中医药的成果整合起来作为疫情期间保驾护航的核心技术,使得医疗体系有保障,进一步减少社会的隔离或其他限制措施,促使整个社会的运行回到正常状态,关键是拿出研究证据,我认为中医药能够真正发挥作用,但是问题主要在于循证依据不足。

Professor Zhao Yi Ming: Let me give an example. Is penicillin a specific drug? Why is penicillin a specific drug? At that time, the infected person could be cured with penicillin and die without penicillin. As for the drug mechanism of penicillin, it is not a problem that can be solved by clinical research. This requires basic research to do relevant work on drug mechanism, such as whether there is a target or not. As far as my personal understanding and knowledge are concerned, clinical research means that the clinical effect is particularly obvious after using a certain drug, then it is a specific drug. I have noticed a characteristic in the treatment process of COVID-19. At the beginning of the epidemic, a certain percentage of patients of light and common types will turn to severe or critical or even die. However, few patients turn to severe or die after using TCM treatment. This means that in the treatment of COVID-19, the participation of TCM treatment will prevent or reduce the risk of infected patients turning to severe or die. In my opinion, Chinese medicine can be regarded as a specific drug in terms of its ability to treat diseases and clinical efficacy. We can change the whole anti-epidemic strategy and integrate the achievements of Chinese medicine as the core technology to protect the health system during the epidemic. In this way, we can further reduce social isolation or other restrictive measures, and promote the operation of the entire society back to normal. The key is that we have to come up with research evidence. I think Chinese medicine can really play a role, but the main problem lies in the lack of evidence-based basis.