| As a pathological evolution stage of asthma,chronic persistence of bronchial asthma has a decisive impact on the prognosis of the disease and plays an important role in clinical diagnosis and treatment.The treatment process of asthma is relatively slow and long.Only by paying attention to the diagnosis and treatment of chronic persistence can we control the symptoms and avoid the acute exacerbation of asthma and this phase of medical intervention is the focus of asthma prevention efforts.Western medicine has achieved remarkable results in alleviating the attack of asthma patients in acute stage.With the long-term use of drugs in chronic persistence period,its side effects become more and more obvious,which may appear effective in the initial stage but long-term reduction,or even ineffective.Traditional Chinese medicine treatment has its unique features in this respect,but there are also obvious shortcomings,such as:the understanding of the etiology and pathogenesis of asthma has not been fully unified,and there is no unified standard for diagnosis and treatment,which is a major problem for many doctors in the process of clinical diagnosis;lack of multi-center and large sample survey,lack of clinical verification and evidence-based medicine support.Following and adopting the principles and methods of clinical epidemiology,this subject objectively evaluates the intervention program of "Wen Run Xin Jin Pei Ben"based on syndrome differentiation of viscera from a holistic perspective in order to provide an effective diagnosis and treatment program for chronic persistence of bronchial asthma,which is a common,multiple and refractory disease in clinic.And give full play to the advantages and characteristics of traditional Chinese medicine,improve the level of prevention and control of bronchial asthma,promote the standardization of clinical decision-making of traditional Chinese medicine,and provide evidence-based medical basis for the treatment of chronic persistent bronchial asthma.Objectives1 To elaborate the origin and development of the theory of"syndrome differentiation of viscera as a whole in which lung and spleen as the core",and to obtain the theoretical basis of applying the principle of"Wen Run Xin Jin Pei Ben"to treat the chronic persistence of bronchial asthma.On the basis of theoretical and clinical research,the symptoms,syndromes and clinical characteristics of bronchial asthma patients are revealed in many ways,and the pathogenesis essence of chronic persistence of bronchial asthma.2Randomized controlled trials were used to verify the superiority of the "Wen Run Xin Jin Pei Ben" Principle in the treatment of chronic persistence of bronchial asthma under the guidance of the theory system of "syndrome differentiation of viscera as a whole in which lung and spleen as the core",aiming at solving the problem of complete control of chronic persistence of bronchial asthma,a common refractory chronic disease in the world.Method:1 Through the combination of retrospective and prospective studies,combined with supervised and unsupervised methods,the clinical basic information,symptoms,tongue and vein signs and other relevant data of 139patients with chronic persistent bronchial asthma who met the inclusion criteria were collected.Descriptive statistical analysis method summarizes the distribution characteristics of clinical syndromes of chronic duration of bronchial asthma.Factor analysis,cluster analysis and other multivariate statistical methods were used to reduce dimensions to explore the symptoms of chronic persistence of bronchial asthma with "syndrome differentiation of viscera as a whole in which lung and spleen as the core",and to summarize the clinical syndrome differentiation and classification.2 Using a multicenter practical randomized controlled clinical superiority trial design,128 patients with chronic persistent bronchial asthma were randomly divided into Wenrunfang group(n=64)and conventional syndrome group(n=64)in a 1:1 ratio.The Wenrunfang group applied the "Wen Run Xin Jin Pei Ben"principle series of prescriptions from the Key Research Laboratory of the State Administration of TCM(chronic cough and asthma of pulmonary diseases)as the intervention program of TCM,while the conventional syndrome differentiation group used the actual clinical syndrome differentiation prescriptions of TCM outside the program for a period of 4 weeks.The main efficacy indicators were disease control rate(%);secondary efficacy indicators included asthma control test(ACT),pulmonary cough and asthma PRO scale(developed by the project team),syndrome efficacy,efficacy of individual symptoms,and laboratory efficacy indicators(Serum IgE,blood eosinophil count,pulmonary ventilation function,diastolic test or provocation test);safety evaluation includes general physical examination items,routine examination of blood,urine and stool,electrocardiogram and liver and kidney function examination.Result:1 The clinical features of chronic persistent bronchial asthma patients are mainly the symptoms of lung and spleen system,such as dry mouth,bitter taste,insomnia,fatigue,chills,nasal obstruction,sneezing,runny nose and loose stool,besides the main symptoms of asthma,chest tightness,suffocation,shortness of breath,cough and expectoration.The high tongue texture is light red,dark red and red in turn,with dental marks on the edge of the tongue and plump tongue;the tongue coating is thin and white,yellow and greasy coating can also be seen;the pulse manifestation is most common in thready pulse and deep pulse.Through factor analysis of 41 common symptoms of chronic persistence of bronchial asthma,14 common factors can objectively reflect the distribution of clinical symptoms of chronic persistence of bronchial asthma;summarizing the etiology and pathogenesis reflected by 14 common factors is helpful to grasp the nature of the disease and clinical syndrome differentiation.Cluster analysis showed that the clinical syndromes of chronic persistent asthma patients clustered into three categories were most in line with the clinical syndrome differentiation,and were consistent with the diagnostic criteria of TCM syndromes of chronic persistent asthma,which were formulated by the research team and accorded with the principle of"Wen Run Xin Jin Pei Ben".2Baseline data of the two groups,including age,gender,height,weight,BMI,marital status,course of disease,drug allergy history and treatment history of TCM and Western medicine,showed that P>0.05,with no statistical difference and comparability.The disease control rate of asthma patients in Wenrun prescription group was 75.44%after 4 weeks of treatment,and 48.33%in routine syndrome differentiation group.The results of comparison between the two groups showed P<0.05,with significant difference.The disease control rate of Wenrun prescription group was 89.47%according to ACT self-evaluation,which was significantly higher than that of routine syndrome differentiation group(66.67%)(P<0.05).The scores of PRO scale and total symptoms of patients decreased significantly after treatment(P<0.05);the results of single symptom score comparison showed that the two groups of prescriptions could significantly improve the symptoms of patients,wheezing,shortness of breath,cough,sputum,dry mouth,bitter taste,dyspepsia,palpitation,fatigue,dizziness,soreness and weakness of waist and knees and other symptoms(P<0.05).In the treatment of cough,thirst,poor appetite,abdominal distension,sweating,etc.,the results in Wenrun prescription group showed that P<0.05,better than that in conventional syndrome differentiation group;the results of TCM symptom evaluation showed that the total effective rate of Wenrun prescription group was 70.18%,and that of conventional syndrome differentiation group was 60.00%,there was significant difference between the two groups(P<0.05);the levels of serum total IgE and EO in the two groups were lower than those before intervention withTCM(P<0.05),but no significant difference was observed(P>0.05).The FEV1%level of Wenrun prescription group increased significantly(P<0.05),and the negative rate of diastolic test was more significant than that of the conventional syndrome differentiation group.No significant adverse effects of the subjects during the trial were discontinued or withdrawn from the trial,and no significant side effects related to heart,brain and kidney were found clinically,suggesting good safety of medication.Conclusion:1”Syndrome differentiation of viscera as a whole in which lung and spleen as the core"in view of the characteristics of chronic persistent asthma pathogenesis and syndrome,rooted in clinical practice,adhere to the idea of seeking cause and treatment based on syndrome diflferentiation,follow the concept of Holism,conform to the needs of viscera,and restore viscera function.The application of the principle of "Wen Run Xin Pei Ben"prescriptions is of great benefit to guide clinical treatment of asthma.2 The clinical characteristics of chronic persistent bronchial asthma patients are more common in the symptoms of both lung and spleen system,existence deficiency of other viscera or stagnation of heat or phlegm turbidity simultaneously.The application of "syndrome differentiation of viscera as a whole in which lung and spleen as the core"in chronic persistent bronchial asthma is in line with clinical practice.3 "Wen Run Xin Pei Ben" program can improve the level of prevention and control of chronic persistence of bronchial asthma,promote the standardization of clinical decision-making ot traditional Chinese medicine,apply"syndrome differentiation of viscera as a whole in which lung and spleen as the core " to guide clinical syndrome differentiation and medication,can effectively alleviate clinical symptoms,obtain obvious curative effect advantages and clinical medication is safe. |
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