| Objective:1. Getting distributated situation of TCM syndromes and symptoms in chronic cough by ten years’ literatures research so as to lay the foundation of making clinical report form and carrying out clinic research; Evaluating objectively curative effect of herbs in randomized controlled trial of chronic cough by using methods of evidenced-based medicine so that these results can offer evidences for subsequent research of prescriptions corresponding to syndromes in chronic cough.2. Getting distributated situation of TCM syndromes and symptoms in chronic cough by clinical research and discussing different syndromes characteristics by using multiple methods of data mining. Meanwhile,exploring relevance between different diseases of chronic cough and TCM syndromes.3. Proving curative effect that method of WenRunXinJinPeiBen treats chronic cough from multiple sides by clinical research. Getting better effect syndroms of chronic cough, which may supply evidences for syndrome standardized research and clinical treatment in chronic cough.Medthods:1. Literature ResearchRetrieve systematicly modern literature data base, colleet and organize all literatures about TCM syndromes and symptoms of chronic cough; Build database with Epidata3.0,standardize name of TCM syndromes and symptoms and analyze distributated situation of TCM syndromes and symptoms with SPSS17.0.Firstly,Retrieve modern literature database systematicly,collect and organize all literatures about RCT of curative effect of herbs in chronic cough. Secondly,design data extraction table and withdraw useful informations by two researchers. when they have quest ions, they must consult the third researcher and resolve it by negotiation. Thirdly,evalua tequalities of included studies(including method, object, intervention measure and outcome,etc) and analyze curative effect of chinese herbs with Revman5.1.2.Clinical ResearchAccording to theories and methods of clinic epidemiology and evidence-based medicine, prospective observational study was launched by ways of supervision with combination of non-supervision methods in multiple study centers.Chronic cough patients’ informationswere collected comprehensively, including patients’ basic informations, informations of four diagnostic methods and diagnosis of syndromes informations. At last539reports were finished, among which there are458TCM reports and81west medical reports. Analyze these repots with proportion ratio analysis, factor analysis, clustering analysis and logistic regression analysis. Accordingly, it may be revealed that specialties of syndromes, symptoms and the relevance between different diseases with syndromes in chronic cough.81patients of western medicine and97TCM patients were chosed, which was used to compare the effect of WenRunXinJinPeiBen with western medicine by ways of statistical methods, such as chi-square test,rank sum test, t-test, and analysis of variance.114TCM reports that were treated with medthod of WenRunXinJinPeiBen were chosed, among which there are17reports of Qi depression and lung injury,40reports of qi deficiency of lung and kidney,27reports of defensive Qi instability and30reports of lung and spleen deficiency. Curative effect variance were compared among four different syndromes by ways of statistical methods, such as chi-square test,rank sum test,t-test,and analysis of variance.Results:1.Results Of Literature Research1.1Results Of Syndromes Study1.1.1Distributed Characteristics Of Syndromes128TCM Syndromes were obstained in this study.There are114single syndromes and14compounded syndromes among these.Ten syndromes are ranked in sequence according to their frequencies and they respectively are syndromes of Qi and Yin deficiency, lung Qi deficiency, phlegm-heat storing in lung, liver fire invading lung, Qi-stagnation and blood stasis, lung Yin deficiency, Blood deficiency and phlegm wet, Yin deficiency and lung dryness, phlegm-wet storing in lung, Qi deficiency in lung and spleen.1.1.2Distributed Characteristics Of Syndromes In Different DiseasesUp Airway Cough Syndromes:wind-phlegm staying in lung, wind-phlegm stagnated in lung, Yin deficiency and lung dryness and weakness of the spleen and stomach.Cough Variant Asthma:main TCM syndromes are syndromes of lung qi deficiency,liver fire invading lung, Cold evil storing in lung and wind-heat affecting lung.Gastroesophageal Reflux Cough:main syndrome is heat stagnated in liver and stamoch. Others are syndromes of liver-stomach disharmony, Gallbladder heat invading stomach and Qi-phlegm stagnation and stasis. Atopic Cough:main TCM Syndromes are Syndromes of wind-cold affecting lung, weakness of lung qi, wind-heat affecting lung and dryness injuring lung. Lung Carcinoma:main TCM Syndromes are Syndromes of Qi and Yin deficiency,weakness of lung qi,Qi deficiency and phlegm heat, lung Qi deficiency and spleen, etc. Chronic Bronchi tis: main TCM Syndromes are Syndromes of Qi deficiency in lung and kidney, insufficiency of both the spleen and the kidney, phlegm-heat stagnated in lung, Yin deficiency in lung and kidney, etc. Bronchiactasis:Syndrome of phlegm-heat stagnated in lung, Syndrome of liver fire invading lung, Syndrome of Qi deficiency in lung and spleen. Tuberculosis:insufficiency of both Qi and Yin, fire excess from yin deficiency, lung Qi deficiency and Qi deficiency in lung and spleen.1.1.3Distributed Characteristics Of symptoms in chronic cough(1) Distributed Characteristics Of Main Symptoms:there are17common types of main symptoms, including paroxysmal cough, worsening of cough at night, little sputum, chest pain, dyspnea, oppress ion in chest,Viscous sputum,etc.(2) Distributed Characteristics Of associated symptoms:There are19types of associated symptoms and they respectively are Pharyngeal iten ing,fatigue, dry mouth, dry Pharyngeal, insomnia,sweat ing,etc.(3) Distributed Characteristics Of Tongue Picture And Pulse Condition:tongue color based on red, light, light red and light dark tongue. Tongue body are mostly fat,big and indented. The thin,greasy and short coating are main coating on the tongue. The coat ing colors are mostly yellow and white. Thready pulse is the most of pulse condition, the others are string-like pulse, slippery pulse, thin and count ing pulse, thin and weak pulse, string-like and slippery pulse and count ing pulse.1.2Systematic Review Results That Chinese Herbs Treat Chronic Cough In RCTChinese herbs treating chronic cough has regular superiority according to included literatures at present.It may be definitely manifested by curative effect that Chinese herbs treats CVA,Bronchiactasis and Chronic Bronchitis.The results showed that Chinese herbs was superior to west medicine, P=0.001, P<0.01, P<0.01.At present it can’t be proved that Chinese herbs is superior to western medicine in Atopic cough (P=0.32), eosinophilic bronchitis (P=0.86) and gastroesophageal reflux cough (P=0.05).2. Results Of Clinical Research 2.1Distributed Characteristics Of Syndromes And Symptoms2.1.1Distributed Characteristics Of Syndromes24kinds of TCM Syndromes were obstained after collected syndroms were standardized, in which common syndromes are syndromes of lung injured by Qi stagnation, qi deficiency of lung and kidney,deficiency of lung Yin, defensive Qi instability, deficiency of both lung and spleen,cool dry invading lung and dry-heat stagnation in lung.2.1.2Distributed Characteristics Of Symptoms141kinds of main Symptoms and associated symptoms of chronic cough were collected. There are26types of tongue pictures and twelve kinds of pulse conditions in this clinical study.Common Symptoms and tongue and pulse presentations are summed to52types.11types of symptoms are common, which are paroxysmal cough, low voice, cold wind triggering cough, sputum, etc. There are28kinds of common associated symptoms of chronic cough, which are foreign body sensation in oropharyngeal area,sensation of chill, fatigue,Easy cold, pharyngeal itching, insomnia and dreaminess,dry mouth,fear of wind,short of breath and loose stool,etc.2.1.3Distributed Characteristics Of Tongue and Pulse PresentationsThin white tongue coating is main in tongue pictures, the others are yellow,thick and greasy tongue coating. Tongue less Jin,light dark color of the tongue,dull-red tongue, scarlet tongue and dark purple tongue with ecchymosis are also common tongue picture. Pulse conditions are based on deep pulse and feeble pulse, slippery pulse and string-like pulse are next.2.2Results Of Factor AnalysisFifteen common factors and Equat ions are obstained. It may be concluded that fifteen common factors represent fifteen syndromes,which are lung qi deficiency syndrome, lung Yang deficiency syndrome,Qi depression and lung injury syndrome, deficiency of both qi and yin syndrome,deficiency of both lung and spleen syndrome,qi deficiency of lung and kidney syndrome, defensive Qi instability syndrome, lung and kidney Yang deficiency syndrome,dry-heat stagnation in lung syndrome, Cool-dry invading lung syndrome, Intense Heat of Heart and Lung syndrome, Phlegm-heat storing in lung syndrome,lung yin deficiency syndrome,dry lung and jin deficiency syndrome and syndrome of qi stagnation and coagulated phlegm in throat.2.3Results Of Cluster Analysis Fifty-two symptoms were grouped seven clusters. The results may be concluded that twelve syndromes were inferred:lung qi deficiency syndrome,lung Yang deficiency syndrome, Qi depression lung injury syndrome, deficiency of both qi and yin syndrome, deficiency of both lung and spleen syndrome, qi deficiency of lung and kidney syndrome, defensive Qi instability syndrome,lung and kidney Yang deficiency syndrome, dry lung syndrome, Phlegm-heat storing in lung syndrome, syndrome of Qi deficiency in heart and lung and syndrome of qi stagnation and coagulated phlegm in throat.2.4Results Of Logistic Regression Analysis2.4.1Symptoms And Syndromes Of Logistic Regression AnalysisSymptoms related to Qi depression lung injury syndrome are yellow sputum, thin sputum,foreign body sensation in oropharyngeal area,short of sputum, dry stools, insomnia and dreaminess, yellow tongue coating and dark red tongue.Symptoms related to qi deficiency of lung and kidney syndrome are thin sputum,asthma when moving, diarrhea,fear of wind.Symptoms related to lung yin deficiency syndrome are yellow sputum, Cold wind induced cough, short of sputum, dry stools, insomnia and dreaminess, yellow and white tongue coating.Symptoms related to defensive Qi instability syndrome are sputum, asthma when moving, choking sensation in chest,easy cold,faint pulse.Symptoms related to deficiency of both lung and spleen syndrome are low voice, sputum, asthma when moving, dry stools,dry mouth,diarrhea,white tongue coating.Symptoms related to Cool-dry invading lung syndrome are short of sputum,easy cold,white tongue coating.Symptoms related to dry-heat stagnation in lung syndrome are dry mouth, asthma when moving, skin allergy,yellow tongue coating,dry stools.2.4.2Diseases And Syndromes Of Logistic Regression AnalysisSyndrome char act erist ic of Up Airway Cough Syndromes is dry-heat stagnation in lung syndrome.Syndrome of qi deficiency in lung and kidney and defensive Qi instability syndrome are common syndromes of Post infectious Cough. Syndrome characteristics of Cough Variant Asthma are Qi depression lung injury syndrome, defensive Qi instability syndrome and deficiency of both lung and spleen syndrome. Syndrome characteristics of Chronic Bronchitis are Qi depression lung injury syndrome,qi deficiency in lung and kidney syndrome and lung yin deficiency syndrome. Syndrome characteristics of Chronic Obstructive Pulmonary Disease are Qi depression lung injury syndrome,qi deficiency in lung and kidney syndrome and defensive Qi instability syndrome. Syndrome characteristics of Bronchiectasis are lung yin deficiency syndrome and qi deficiency in lung and kidney syndrome.2.5Results Of Curative Effect Of WenRunXinJinPeiBen Priscription2.5.1Results Of curative Effect Compared With Western Medicine(1)The total effect:effect rate of WenRunXinJinPeiBen reached97.94%, Significant efficiency was74.23%. Effect rate of western medicine group was81.48%, and significant efficiency was45.68%.Curative effect of WenRunXinJinPeiBen is superior to western medicine, P<0.01.(2)The cough improvement:the cough improvement of is better than western medicine, P<0.01.(3)LCQ:The method of WenRunXinJinPeiBen can arise patients’ quality of life,and its effect is superior to western medicine, P<0.01.2.5.2Results Of curative Effect Compared With Other Chinese Therapies(1)The total effect:effect rate of WenRunXinJinPeiBen reached95%, Significant efficiency was73.20%.Effect rate of other chinese therapies was91.67%, and s ignificant efficiency was70.37%. So we can’t think curative effect of WenRunXinJinPeiBen is superior to other chinese therapies, P>0.05.(2)The cough improvement:the cough improvement at night of WenRunXinJ inPeiBen is better than other chinese therapies, P<0.01.(3) LCQ:The method of WenRunXinJinPeiBen can arise patients’quality of life,and its effect is superior to other chinese therapies, P<0.01.2.5.3Results Of Curative Effect In Different Syndromes(1)The total effect:It was effective that mothod of WenRunXinJinPeiBen treated four TCM Syndromes. Significant efficiency of Qi depression lung injury syndrome was58.82%, qi deficiency in lung and kidney syndrome was80%, defensive Qi instability syndrome was74.08%, deficiency of both lung and spleen syndrome was80%. The results are no statistical difference by the statistical tests, P>0.05.Effect rate of Qi depression lung injury syndrome reached76.47%; Effect rate of qi deficiency in lung and kidney syndrome was95%, defensive Qi instability syndrome was100%, and deficiency of both lung and spleen syndrome was93.33%. The curative effect of four syndromes exists statistical difference, P<0.05.(2)The cough improvement:the cough improvement of four syndromes exists notable statistical difference,and the cough improvement of Qi deficiency in lung and kidney syndrome, defensive Qi instability syndrome and deficiency of both lung and spleen syndrome is the most significant among these, P<0.01.(3) LCQ:The method of WenRunXinJinPeiBen can arise four syndromes’qual i ty of life in different degrees. As far as total scores, its curative effect can be ranked as follows:deficiency of both lung and spleen syndrome> defensive Qi instability syndrome>qi deficiency in lung and kidney syndrome>Qi depression lung injury syndrome, P<0.01. For psychological scores, the best curative effect is Qi depression lung injury syndrome and qi deficiency in lung and kidney syndrome is next, P<0.01.Conclusions:By literature research and cinical study, the conclusions can be made as follows:1.The syndromes of chronic cough are relative to the five internal organs and they are intermingled deficiency and excess, mixed coldness and heat.The characteristics of syndromes are based on deficiency of lung, spleen and kidney. The results of literature research are mainly coincided with results of clinical s tudy.2.As far as characteristics of syndromes in different diseases of chronic cough, if diseases are different, accordingly, their syndromes will be not same. For example, Up Airway Cough Syndromes, its deficiency syndromes are not significant, but "dry" and "heat" are moresignificant. Allergic Rhinitis is one disease of UACS, but its Syndromes are based on deficiency syndromes. There haven’ t been exterior syndrome in Post infectious Cough, and its syndromes are main of Qi deficiency syndromes and defensive Qi instability syndrome. Syndromes characteristics of cough variant asthma, chronic bronchitis, COPD and bronchiectasis basically reflect features of these disease, whose conditions are complex and syndromes are intermingled deficiency and excess too. The study that combined disease and syndromes accords with clinical practice and disease characteristics.It can provide the basis evidences for clinical syndrome differentiation and treatment. 3. Through clinical research, further confirmed the clinical curative effect of "WenRunXinJinPeiBen". Curative effect of this method is superior to western medicine in the treatment of chronic cough; In the same way, its curative effect is better than other Chinese therapies in improving the nighttime cough and quality of life.Study suggests:curative effect of WenRunXinJinPeiBen is better in the treatment of chronic cough. It can be used to treat qi depression lung injury syndrome, deficiency of both lung and spleen syndrome, defensive Qi instability syndrome and qi deficiency in lung and kidney syndrome. But curative effect also exists differences between different four syndromes, mainly reflected in two aspects improvement:symptoms and quality of life.In aspect of symptoms improvement,curative effect of qi depression lung injury syndrome is not better than deficiency of both lung and spleen syndrome,defensive Qi instability syndrome and qi deficiency in lung and kidney syndrome, while in aspect of LCQ psychological dimension,curative effect of qi depression lung injury syndrome is best.The results are illuminated from various aspects that the priscription and syndrome are relative. At the same time, study indicates the method of WenRunXinJinPeiBen is suitable for the four types, can improve the symptoms in different levels and enhance the clinical curative effect. |