The Establishment Of Chronic Obstructive Pulmonary Disease Tcm Therapeutic Index System Study

Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily cause by cigarette smoking. Chinese medicine has a lot of experiences to treat and prevent COPD, but there are some shortages on therapeutic evaluation. This research used ways of drawing psychological tables, theory research and investigating clinical cases to pick the Chinese medical indexes.Objective1 To search for the methods of clinical evaluation of Chinese medicine.2 To get a uniform clinical evaluation of COPD.Methods1 theory researchBy regressing and analyzing the literature, we found many problems of clinical evaluation of Western medicine and Chinese medicine about COPD and we also recognized COPD again.2 clinical researchWe used clinical questionnaire which was separated into self evaluation part and clinical observation part. By using the ways of Patient- Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, we added the patient-reported outcomes. We also used three ways of measure. On the same time, we did the reliability, validity and responsibility test by twice clinical investigations.Results1 item choiceWe got 375 items by the literature including magazine and book. Focus group interview was also used to choose patient-reported outcomes as items. Several experts were chose to select useful and hypersensitive items from 375 items. Finally, we got 33 items which included dim complexion,pallid complexion,sallow complexion,white fur tongue, yellow fur tongue, dry tongue, cyanotic lips,cough, dyspnea,shortness of breath, spiritlessness and weakness, bitter taste in mouth, oppression in thest, soreness and weakness of waist and knees, spontaneous sweating, night sweating, dry mouth, excessive phlegm, few phlegm, yellow phlegm, white phlegm, thin phlegm, ropy phlegm, foamy phlegm, anorexia, fear of cold, easy to catch a cold, constipation, deep pulse, slippery pulse, rapid pulse, stringy pulse, and thready pulse.2 item scoreWe used the method of visual analysis scale on self evaluated symptoms, four scales on clinical observed symptoms, two scales on those symptoms that could not be described, color analysis on face and tongue.3 clinical researchPatients who were available with COPD were chose to observe in five centers.4 reliability, validity and responsibility testWe did reliability, validity and responsibility test each time, then we found the clinical questionnaire was available to reflect the change of curative effect.ConclusionFrom this research, we got three conclusions. First, we could use a lot of methods to therapeutic evaluation, but the criteria should be the same one. Second, questionnaire was available to clinical research. Third, Patient-reported outcomes had important status on the therapeutic evaluation.