The importance and clinical significance of the development of Miao Medicine PRO scale

Xian-man Wei, Zhu Yang, Feng-xi Long, Wen-yu Wu, Hui-li Shui, Dong-xin Tang*

1.The First Affiliated Hospital of Gui Zhou University of Traditional Chinese Medicine,Guiyang,China;

2.Tumor Inheritance and Scientific and Technological Innovation Talents Base of Traditional Chinese Medicine in Guizhou Province,Guiyang,China.

Abstract

Keywords: Miao medicine,Patient Reported Outcome

Background

Miao medicine is an important part of Chinese national medicine.As a gem of the medical culture that the Miao people have worked hard through continuous practice and application,it is now receiving unprecedented attention.Its complete theoretical system,unique medical methods,the use of medicinal materials and the magical efficacy of numerous clinical verification also make us can not be ignored.In today's economic globalization,medicine has become borderless.Miao medicine deserves to be valued by the world's medical institutions,and it should also contribute to the health of all mankind and realize its value.As Chinese medicine gradually compensates for the limitations of Western medicine,ethnic medicine has also emerged in the world of medical science and has been widely accepted and trusted by the people.Due to the change of medical model,people's strong pursuit of high quality of life is destined to increase the proportion of patients' subjective feelings in the evaluation of therapeutic effects.Therefore, Patient Reported Outcome (PRO) is an advanced and scientific evaluation method for clinical efficacy.Therefore,PRO,an advanced and scientific method for evaluating clinical efficacy,from the standpoint of patients,takes the feelings directly transmitted by patients as the "index" to evaluate the clinical efficacy,and then guide the clinical program,improve the medical quality and improve the treatment effect and clinical outcome scale should also be popularized and used.

The concept and significance of the PRO scale

In order to evaluate the clinical curative effect in the past,we should refer to the biological report data of "cold".With the bio-psycho-social medical model,clinical biochemical indicators cannot be used as a single evaluation standard.Just nine years ago,the US Department of Health (US Department of Health and Human Services) and the Food and Drug Administration (FDA) issued a "patient report-based outcome measure: in support of pharmaceutical product development labeling instructions.The application of the clinical report PRO in the "Application Guide" happens to meet the needs of current clinical efficacy evaluation.This report is an evaluation scale for patients to express their quality of life,living status,treatment and effect directly.Doctors and their families and other personnel are not involved in the explanation [1].With the gradual improvement of material living standards,the patient's spiritual world is gradually enriched.They are not only satisfied with the achievement of biochemical indicators,but also pay more attention to their mental state and their own feelings,just like cancer patients,after undergoing surgery and other treatments,There will be fears of recurrence at any time,whether there will be metastasis,and there will be pressures on the economy and life.Therefore,there are still many psychological hidden dangers even after the end of treatment.The Pro scale is through the interview mode,"chat" with the patients to obtain the most real and effective data.The expression of patients can most reliably reflect the clinical treatment response,improve clinical efficacy,save medical costs,and ensure the quality of medical care [2].?

Overview of the research of contemporary PRO scale

The Pro scale is through the interview mode,"chat" with the patients to obtain the most real and effective data.The expression of patients can most reliably reflect the clinical treatment response,improve clinical efficacy,save medical costs,and ensure the quality of medical care [3].At the beginning of the 21st century,the US Food and Drug Administration (FDA) issued the draft Guide for the Application of Pro Research in Clinical Drug Development and Efficacy Evaluation,which regulates the development and evaluation of Pro scales.At present,the international research on the Pro scale is based on the model laid out by the above guidelines [4].

In recent years,there has been a new perspective on the use of the Pro scale.Some studies have said that the application of Pro must be collected through qualitative interviews,and should not be based on "multiple" or "less" quantitative collection,and for interviews.The training of personnel is also extremely important.Collectors should be proficient in communication skills on the basis of morality and ethics,participate in professional interview training,and understand the basic characteristics of different groups of children,teenagers and the elderly to obtain the most authentic and reliable [5].In the contemporary Pro scale,a mature and universal research model has been formed.In recent years,research on the Pro scale has been gradually developed in China,such as diabetes [6],nonalcoholic fatty liver [7],Chinese medicine heart disease [8],stroke [9],COPD with pulmonary heart disease [10],tumor scale [11],myasthenia gravis [12].The corresponding Pro scale with traditional Chinese medicine characteristics has been developed in the field of myasthenia gravis.

However,at present,the development of Chinese medicine Pro scales is mixed,lacking in refinement and quantification.It lacks a clear guide to Chinese medicine as a reference and can not fully reflect the characteristics of Chinese medicine theory.It relies on foreign research backgrounds and methods,and does not break through innovation and thinking.It is still a long way to go to establish a Chinese medicine Pro scale that reflects both the characteristics of traditional Chinese medicine and international recognition.Of course,with the rich development of multi-disciplines such as evidence-based medicine,breaking the selfframework of traditional Chinese medicine is the only way to break through the current situation.In today's multi-disciplinary development of evidence-based medicine,breaking the selfframe of Chinese medicine is the only way to break the status quo.

The application and research significance of Miao medicine in clinic

Clinical application is divided into theoretical application and clinical treatment application.Miao medicine as a traditional motherland medicine,although the overall concept and syndrome differentiation as the criteria for diagnosis and treatment,but has its own unique theoretical cognition,for example,with regard to the characteristic disease in the field of cancerrelated fatigue,Miao medicine and traditional Chinese medicine hold different concepts in diagnosis,prevention and treatment.As far as the etiology and pathogenesis is concerned,Chinese medicine believes that the deficiency of visceral function,the yin,yang,qi and blood is the root of the incidence of stagnation,while Miao medicine believes that the root cause of the disease is "poison" and "disorder"; Chinese medicine is divided into multiple types of syndromes,and more traditional Chinese medicine treatment methods such as acupoint sticking,creaming,and acupuncture exercise therapy are used.Miao medicine make good use of fresh local medicinal materials,and use the the most direct split into two ideas,the implementation of one-to-one treatment,that is,hot medicine cure cold disease,cold medicine cure fever,etc.[13].This is only a small part of its theory in the field of tumors.In many disease fields,Miao medicine have their own characteristic theories to guide clinical treatment.In clinical diagnosis and treatment,Miao medicine is widely used,and it also has a special diagnosis and treatment method-pulse diagnosis [14].There are 28 kinds of pulse symptoms in traditional Chinese medicine,such as inch mouth,tarsal yang or Taixi,especially Cunkou,which is the most commonly used pulse diagnosis site in clinic.The principle and elements of Miao medicine pulse diagnosis are similar to those of traditional Chinese medicine pulse diagnosis,but the pulse location includes head pulse,neck pulse,upper limb pulse,chest vein and lower limb pulse.Although the clinical treatment part is divided into internal treatment and external treatment,in the Miao medicine,the external treatment has a large proportion and more characteristics,such as: Miao doctor medicinal acupuncture combined with the treatment of medicinal herbs (Nu Yaoye) Knee osteoarthritis [15],Miao medicine fumigation therapy for early femoral head necrosis [16],Miao medicine massage therapy for children with fever [17],asthma [18],enuresis [19],Miao medicine elastic muscle therapy treatment [20],Miao medicine shoe floor therapy for HanYin Fufei syndrome cough [21].There are the treatment methods and methods of Miao medicine characteristics.It has a wide range of treatments,good clinical results,easy to operate and economical advantages,the significance of research can not be ignored (Fig. 1,2).

The significance of the establishment of the Miao medicine Pro scaleThe clear division and correspondence between traditional disease names and Miao medicine diseases

At present,the extensive Western medical name has an accurate official definition in traditional Chinese medicine.In contrast,there is no clear correspondence in Miao medicine,and the establishment of the Pro scale can make the most intuitive confirmation of the clear division and correspondence of the disease types.Although the Pro Scale is a guideline for clinical evaluation of efficacy,its meticulous,itemized,and culturally adapted characteristics make its concept more operative.By defining symptoms and signs as accurately as possible,clearly standardized professional Miao medical terms.

Figure 1 Miao doctor medicinal acupuncture combined with the treatment of medicinal herbs(Nu Yaoye) Knee osteoarthritis.

Figure 2 Separate medicine paper fire moxibustion treatment for low back pain.

The comprehensiveness of the domain system

The traditional Miao medicine books often describe the symptoms of the disease very simple.The language barriers and the damage and loss of the literature books are the main reasons for this situation.For example,the labor in the Miao medicine corresponds to Jiang Binwo [13].And the understanding of the etiology and pathogenesis is only the internal and external causes.What is more distinctive is that the three basic substances in Miao medicine,namely,the circulatory and metabolic disorders of blood,qi and water,bear the most important causes of the disease.The root cause comes down to "poison" and "chaos".The specific description of the symptoms is similar to traditional Chinese medicine,including qi deficiency and blood deficiency,which can be characterized by dizziness,shortness of breath,tinnitus,spontaneous sweating,burnout and lazy speech.Most of them are dialectical about labor,and the Pro scale can divide the specific symptoms in many fields in detail,such as: 1.changes in the field of physiological functions: changes in symptoms such as normal physical activity and self-care; 2.changes in the psychological field: whether the disease causes anxiety,irritability,depression and other psychological dysfunction; 3.Changes in the field of social life: whether it will affect normal work and social interaction; 4.Evaluation of the effect of treatment: will directly evaluate the effect of treatment objectively,by the subjective evaluation of patients,more reliable,but also intuitive understanding of the treatment of adverse reactions or the reasons for poor compliance,there are many areas can be established by themselves,so that the system is better,more comprehensive,objective,real reaction treatment.

Promoting minority medicines to realize their own value

In modern clinical research,the proportion of traditional medicines such as Miao medicine,Mongolian medicine,and Tibetan medicine is still small,and most of them exist only in local or minority groups.Most of the reasons for this situation are the lack of official medicine for minority medicine.It has neither a clear clinical path nor a clear treatment evaluation.Their unique treatment theories and ideas have not been widely publicized and accepted by the masses,so the value of traditional minority medicine itself is far.Most of the reasons for this situation are the lack of official "guidelines" for minority medicine,and there is neither a clear clinical pathway nor a clear evaluation of treatment.If we establish a clear therapeutic evaluation system,it will protect the theoretical basis of the clinical use of ethnic medicine and provide objective and scientific arguments for the promotion of ethnic medicine.

Discussion

In the past ten years or so ,the proportion of subjective willingness of patients in clinical efficacy evaluation has been increasing year by year.The Pro scale is widely used in clinical applications,such as: 1.clinical trial,2."real world" research; 3.clinical practice [5].It has more practical significance,more scientific and objective evaluation of clinical efficacy,more effective guidance of clinical practice,improve clinical efficacy,reduce the consumption of clinical resources and improve the satisfaction of patients,and reduce the economic burden of patient families.However,in the period when the diagnosis and treatment of patients have no mechanical biochemical indicators,they can rely on the unique thinking and characteristic theory of "four diagnoses" to cure the disease.The only source of evaluation of the treatment is the patient.Judging by whether the patient's self-reported symptoms have changed,whether the spirit has improved,and the truest feelings in the depths of the mind.This "oldest" clinical evaluation standard is completely compatible with the original intention of the Pro scale.Therefore,it is imperative to create a Pro scale that meets the trend of clinical efficacy evaluation of traditional Chinese medicine characteristics,and as an important part of ethnic medicine in China,Miao medicine has good clinical efficacy and practical value,so we should establish a scientific and objective Miao medicine Pro scale.But its establishment should pay attention to how to meet its unique theoretical system,meet the purpose of clinical treatment,and how to reflect its outstanding clinical efficacy and distinctive treatments.In short,in combination with the development of Pro scales at home and abroad,the Pro scale for creating Miao medicine has important research value and clinical significance.It also provides new methods and new ways for evaluating the clinical therapeutic effect of Miao medicine.