Study On TCM Syndrome Elements Distribution And Miscellaneous Characteristics And Effects Of Yufeining Prescription On TCM Syndrome Elements In Patients With Stable COPD

Chronic obstructive pulmonary disease(COPD)is a chronic airway inflammatory disease characterized by persistent airflow limitation and is one of the common chronic diseases of respiratory system,which mainly manifests by chronic and progressive cough,sputum production,dyspnea after exercise and seriously affects the quality of life and exercise endurance of the patients.Up to now there is no reliable evidence to support that the current pharmacotherapy of modern medicine can reverse the progressive decline of pulmonary function in the natural course of COPD.While it has been proved that traditional Chinese medicine(TCM)in the treatment of COPD has obvious advantages after a long period of clinical practice.But the core of TCM lies in the treatment of TCM syndrome differentiation.Therefore,to accurate TCM syndrome differentiation and grasp the dynamic evolution regular of COPD is the precondition of TCM legislative prescription.Because TCM diagnostic methods are mainly based on experts’ experiences which may have many subjective factors that inevitably affect the objectivity and accuracy of the TCM syndrome differentiation.This study consisted of two parts of literature research and clinical research.First of all,the research progress in the diagnosis and treatment of COPD was reviewed by literature research.Secondly,the COPD TCM syndrome elements distribution and their miscellaneous characteristics were exploredusing "the TCM syndrome elements differentiation".The results showed that the main TCM syndrome elements of disease location in stable COPD were the lung and the kidney,but also affected the spleen,the heart,the exterior and the liver.And in the deficiency syndrome elements of disease nature,qi deficiency and yang deficiency were the basis for the pathogenesis of COPD,while the main sthenia syndrome element of disease nature was phlegm,which combined with the syndrome element of blood stasis in the latter course of the disease,leading to the phlegm and blood stasis combination with each other finally.At different ages,duration of disease,smoking index and body mass index,TCM syndrome elements of COPD had certain evolution tendency.The miscellaneous characteristics and combination patterns of syndrome elements in patients with COPD were identified using cluster analysis.The correlation between TCM syndrome elements and clinical comprehensive indexes were further analyzed.At last,the effects of Yufeining prescription on TCM syndrome elements in stable COPD patients with the deficiency of the lung,the spleen,and the kidney accompanied with retention of phlegm and blood stasis syndrome were explored and the feasibility of syndrome elements as curative effect evaluating indexes were discussed.Part I:Literature review Research Progress on Diagnosis and Treatment of COPDObjective:To recognize the understanding of TCM diagnosis and treatment on COPD in the past and recent years and review the research progress on COPD by modern medicine.Methods;First,to systematic review and sort out literature existed in the past and recent years and analyze TCM the name of disease,the clinical symptoms,the etiology and pathogenesis,and the treatment of COPD.Second,to review the research progress by modern physicians of the TCM syndrome elements,TCM syndromes and the correlation between TCM syndrome elements or TCM syndromes and the clinical comprehensive indexes.Finally the concept,epidemiology,disease evaluation and treatment of COPD in modern medicine were also reviewed.Rusults:The TCM name of the disease,TCM syndromes,etiology and pathogenesis and treatment for COPD has been formed a relatively comprehensive theoretical system by ancient physicians.The modern physicians based on the predecessors to further enrich the connotation of the TCM syndrome elements characteristics,TCM syndromes,pathogenesis and treatment of COPD.Modern medicine updated the definition,assessment and treatment of COPD and makes a new acquaintance.Conclusion:TCM has accumulated rich clinical experience in the TCM syndrome,pathogenesis and treatment of COPD.Modem medicine research on COPD continued to develop,and has achieved some achievement.But the COPD TCM syndrome study lacked standardized,unified understanding and objective quantitative indexes.Therefore,it is necessary to study COPD objectively and quantitatively.The efficacy evaluating system of TCM treatment for COPD should be further explored.Part II Clinical Research1.Study on TCM Syndrome elements distribution and their miscellaneous chara-cteristics in patients with stable COPDObjective:to investigate the distribution and miscellaneous characteristics of TCM syndrome elements of the disease location and the disease nature,and combination rules in patients with COPD at stable stage.The dynamic evolution rules of TCM syndrome elements were also analyzed.Methods:A total of 289 stable COPD cases who met the inclusion criteria were enrolled.The general condition,four diagnostic information of TCM were collected.The distribution characteristics of the TCM syndrome elements of the disease location and the disease nature in COPD patients by TCM syndrome elements differentiation system were analyzed.The effects of the age,disease duration,smoking index and body mass index(BMI)on TCM syndrome elements were observed.The TCM syndrome elements of the disease location and the disease nature were analyzed by cluster analysis to explore their combination rules.Results:1.The general condition:The prevalence of COPD in man was higher than that in women,and the ages were generally older with long duration of illness,high smoking index and low BMI.The majority of COPD patients were with moderate and severe lung dysfunction.2.Distribution of TCM syndrome elements:Frequency of TCM syndrome elements of disease location from high to low in turn involved the lung,the kidney,the spleen,the heart,the exterior and the liver.Frequency of TCM syndrome elements ofdeficiency disease nature involved qi deficiency,yang deficiency,yin deficiency and blood deficiency,and the sthenia syndrome elements of disease nature involved phlegm,heat.blood stasis,dampness,and rheum.3.The dynamic evolution rules of TCM syndrome elements in patients with COPD at stable phase:As the age increasing,the proportion of the syndrome elements of the kidney,qi deficiency,yang deficiency,yin deficiency increased gradually.The proportion of the syndrome elements of the kidney,qi deficiency,yang deficiency,yin deficiency,blood deficiency and heat increased gradually with the increase of disease duration.The proportion of the syndrome element of the spleen in the group of disease course between 20 to 29 years was higher than those of groups of disease course between 10 to 19 years and less than 10 years(P<0.05,respectively).Compared with non-smoking group,the proportion of the kidney,the spleen,yin deficiency,phlegm and heat in the high smoking index group were higher(P<0.05,respectively).The frequency of the kidney,the spleen,yin deficiency,and heat were higher when patients’ BMI was lower than 21Kg/m2,while the frequency of dampness was opposite.4.Cluster analysis and TCM syndrome differentiation system analysis:many TCM syndrome elements of disease locations and/or disease natures were combined together.Most of TCM syndrome.elements of disease location mixed with disease nature syndromes concurrently,and simple TCM syndrome was fewer.Conclusion:COPD could affect multiple disease locations and disease natures.Among them the main syndrome elements of disease location were the lung and the kidney,then were the spleen,the heart,the exterior and the liver.The relationships of five zang-ogans were close.Qi deficiency and yang deficiency were thepathological essence of COPD.Yin deficiency and blood deficiency may be involved during the later course of COPD.The sthenia elements of disease nature were phlegm,heat,blood stasis,dampness and rheum.Among them the phlegm was the important pathogenic factor of COPD,the phlegm and blood stasis combined with each other in the later period.The age,disease duration,smoking,BMI could affect the distribution of the TCM syndrome elements of COPD to varying degrees.TCM syndromes mixed usually.The major pathogenesis of COPD was intermingled of ben deficiency and biao excess,exterior and interior which resulted in the complex TCM syndromes of COPD finally.2.Study of the correlation between TCM syndrome elements and clinical comprehensive indexes in patients with stable COPDObjective:To explore the correlation between TCM syndrome elements and clinical comprehensive indexes in patients with stable COPD.Methods:The COPD assessment test(CAT)questionnaire,breathlessness measurement using the modified British Medical Research Council(mMRC)questionnaire and 6 minutes walking distance(6MWD)were measured among 289 patients with stable COPD.The evolution patterns of the TCM syndrome elements of disease locations and disease natures with different classificationofpulmonary function,CAT,mMRC and 6MWD were observed.Results:1.The grades of severity of CAT,mMRC and 6MWD reached moderate and abovein more than half patients with COPD,indicating that the quality of life and exercise endurance of patients with COPD were severely affected.2.Distribution of TCM syndrome elements in different grades of lung function in patients with COPD:With the progression of the pulmonary function of COPD from grade I to grade IV,the disease location progressed dynamically from the lung and the kidney→the lung,the kidney and the spleen→the lung,the kidney,the spleen and the heart,the asthenia syndrome elements of disease nature developed from qi deficiency,yang deficiency to qi deficiency,both yin-yang deficiency,sthenia syndrome elements of disease nature evoluted from phlegm to retention of phlegm and blood stasis.The more decreased of lung function,the more increased of the TCM syndrome elements scores of qi deficiency,yang deficiency and phlegm,the more damaged of pathology,and presented a positive correlation(all P<0.05,R=0.227,0.224,0.143,respectively).3.Distribution of TCM syndrome elements in different grades of CAT,mMRC and 6MWD in COPD patients:Firstly,the proportion of the TCM syndrome elements of the kidney,the heart,qi deficiency,Yang deficiency and phlegm in different grades of CAT with COPD patients were differenct significantly(P<0.05).And with the CAT grade rise,the ratio of the TCM syndrome element of the kidney and the heart increased,the proportion of yi deficiency in level 3 was higher than that of in level 1,yang deficiency ratio in level 2,3,4 were higher than that of the level 1,sputum ratio in level 2,3,4were higher than that of the level I.Secondly,the difference of ratio of the TCM syndrome elements of the kidney,the spleen,theheart,yin deficiency and phlegm in different mMRC grades in COPD patients were statistically significant(P<0.05).As mMRC grade rise,the proportion of the TCM syndrome elements of the kidney and spleen at level 3,4 increased significantly compare with those of level 0,1,the proportion of the heart in 4th level was significantly higher than that of in the level 0,the proportion of yin deficiency at level 2,3,4 were significantly higher that those of level 0,1,phlegm syndrome element proportion in the 4th level was obviously higher than that of level 0.Thirdly,the ratio of the TCM syndrome elements of the kidney,the heart and yin deficiencywere significantly different in different grades of 6MWD(P<0,05).As the shorten of 6MWD,the proportion of the kidney and heart in level 1 increased significantly compared with level 2,3,and the proportion of yin deficiency in level 1 raised significantly compared with that of level 3.Conclusion;The TCM syndrome elements of disease location were based on the lung and the kidney but further could affect the spleen and the heart when pulmonary function in patients with COPD declined gradually.The asthenia syndrome elements of disease nature were based on qi deficiency and yang deficiency,yang deficiency further involved yin deficiency and formatted asthenia of both yin-yang at last.And the main sthenia syndrome element of disease nature was phlegm,mixed with blood stasis at the later course of disease,leading to the phlegm and blood stasis combination with each other finally.Therefore the TCM syndrome elements evolved accordingly with the decline of quality of life and exercise tolerance in patients with COPD.3.Effects of Yufeining prescription on TCM syndrome elements in patientswith COPDat stable phaseObjective:To evaluate the clinical curative effect of Yufeining prescription in treating COPD patients with the deficiency of the lung,the spleen,and the kidney accompanied with retention of phlegm and blood stasis syndrome,and to discuss the feasibility of syndrome elements as the indexes in the evaluation of curative effect.Methods:A randomized,doubled-blind and placebo control study was designed.60 patients with stable COPD who met the deficiency of the lung,the spleen,and the kidney accompanied with retention of phlegm and blood stasis of TCM syndrome were enrolled.The patients were randomly divided into therapeutic group of 30 cases and placebo group of 30 cases,respectively.They were given Yufeining or placebo for 8 weeks besides basic therapy.The syndrome elements of the disease location and the disease nature were extracted by syndrome elements differentiation methods.The changes of integrals of disease location and disease nature before and after the treatment were recorded in two groups.Rusults:Comparison of the frequency and the integral of the syndrome elements of the disease location and nature before and after treatment in the two groups:in the treatment group,the integrals of the lung and the spleen decreased significantly after the treatment(P<0.05,respectively).And there was a downward trend in the integrals of the kidney,but it was not statistically significant.Meanwhile the integrals of qi deficiency and yang deficiency decreased significantly in the treatment group(P<0.01,respectively).There were no obvious differences of the integrals of the TCM syndrome elements of disease location and disease nature before and after treatment in the control group(P>0.05).Conclusion:Yufeining prescription could reduce the degree of pathologic damage of the lung and the spleen,qi deficiency and yang deficiency.The dynamic changes of TCM syndrome elements may be used as the indexes of TCM curative effect evaluation.