Objective To evaluate the reliability,validity and responsibility of the efficacy satisfaction scale for COPD patients at stable stage.Methods One hundred and fifty-five COPD patients at stable stage were selected from January to October of 2008.All subjects came from The First Affiliated Hospital of Hean College of TCM.The Cronbach' ? coefficient,Guttman split-half coefficient and re-test reliability were used as the indexes to reflect the reliability of the scale.The content validity and the construct validity were used to evaluate the validity of the sacle.The average score between pre-treatment and post-treatment was compared to evaluate the feasibility.Results The Cronbach'? coefficinent and Guttman split-half coefficinent of the efficacy satisfaction scale for COPD at stable stage respective was 0.906 and 0.758.The Cronbach'? coefficinent of the four domains respective were 0.905(working and life ability),0.645(clinical symptoms),0.788(efficacy) and 0.793(therapy convenience) for the efficacy satisfaction scale.The correlation coefficient between the four domains and it's items were within 0.70～0.87.The factor analysis of the scale extracted three common factors.The scores improvement with four domains was of great effect size change.The effective response rate was 91.2%.Conclusion The efficacy satisfaction scale for COPD patients at stable stage has better reliability,good content validity and common construct validity which could better distinguish therapeutic efficacy.

Objective To study the distribution regularity of TCM syndromes of respiratory failure of chronic obstructive pulmonary diseases (COPD) for the standardization research on TCM syndromes. Methods Literatures on respiratory failure of COPD of the latest 15 years were collected from the Chinese Biomedical Literature Database, Chinese Academic Periodical Full-text Database and China TCM Document Retrieval System Database. The name of the disease was filtered and standardized. The database was established. The formation and distribution regularity of TCM syndromes of respiratory failure of COPD were calculated and analyzed.Results The common syndromes of respiratory failure of COPD were excess in Biao-symptom, such as accumulation of phlegm and blood stasis, phlegm-heat obstructing the lung, accumulation of phlegm-turbidity in the lung, and phlegm misting the brain, and most cases were accompanied with blood stasis. The deficiency syndromes, commonly qi deficiency of the lung and kidney, were complicated in nature of disease and zangfu attribution.Conclusion The accumulation of phlegm and blood stasis, phlegm-heat obstructing the lung, accumulation of phlegm-turbidity in the lung, and phlegm misting the brain are the basic syndromes of respiratory failure of COPD, and most cases are accompanied with blood stasis. The deficiency syndromes have a complicated inner law, and qi deficiency of the lung and kidney is the common one.

BACKGROUND: Promoting immunological function of patients with chronic obstructive pulmonary disease (COPD) can control development of COPD.OBJECTIVE: To investigate the effect of bufei yishen granule on pulmonary ventilation function and immunological function of COPD patients and compare with placebo.DESIGN: A randomized grouping comparison and placebo controlled study.SETTING: Respiration Department of the First Affiliated Hospital of Henan Traditional Chinese Medical.PARTICIPANTS: A total of 62 COPD patients selected from Department of Respiration of the First Affiliated Hospital of Henan College of Traditional Chinese Medicine from January 1999 to October 2004,were randomly divided into two groups :Observation group and control group with 31 in each group.METHODS: Patients in observation group were treated with bufei yishen granule consisting of ginseng, mongolian milkvetch root, largehead atractylodes rhizome, divaricate saposhnikovia root, dwarf lilyturf tuber, Chinese magnoliavine fruit, malytea scurfpea fruit, medicinal evodia fruit, Chinese cster pillar fungus, Chinese eaglewood wood, scorpion, almond, thunberg fritillary bulb, szechwan lovge rhizome, etc., produced by Pharmaceutic Department of the First Affiliated Hospital of Henan College of Traditional Chinese Medicine. Each granule of 1 g contained an equivalent of 5.78 g raw drugs. Three times a day with 10 g for each; and patients in control group were treated with placebo consisting of hawthorn fruit and malt. The dosage and medication were the same as those in observation group. Both therapies were respectively administered in a treatment course of two months. Before and after the therapy course,the followed indexes were measured.① Assay of immunological function: The levels of IgG, IgA and IgM from blood serum were detected with simple agar diffusion.② Assay of Ag level in nucleolus organizer region (Ag-NORs): The ratios non-histone staining acidity non-histone vs core area (IS%) was calculated by staining the activating lymphocytes of the blood by silver staining technique with microscope image analysis technique. ③ Assay of pulmonary function: The pulmonary function was measured by Sensor Medics Ros System in all of the people with the levels of forced expiratory volume in first second (FEV1.0), mean maximu expiratory flow (MMEF), peak expiratory flow (PEF), once after and before treatment. The examination was repeated three times in order to obtain the peak number. The difference of the three examinations was within ±5%.MAIN OUTCOME MEASURES: Comparison of T lympholeukocyte subpopulation and pulmonary ventilation function in the patients before and after 1 course.RFSULTS: Data of totally 62 patients was entered the final analysis without any loss.① Comparison of pulmonary ventilation function of patients in the two groups before and after 1 course: FEV1.0, MMEF, PEF,and ratio of FEV1.0 and forced vital capacity (FEV1%) in observation group were significant higher than those before treatment (t=2.12-3.41,P ＜ 0.05-0.01), thoseindexes in observation group were higher than those in control group (t=2.54-3.17, P ＜ 0.05-0.01). ② Changes of T lymphocyte subgroups of patients in the two groups before and after 1 course:The levels of CD3+, CD4+, CD4+/CD8+ in observation group after 1 course were high.er than those before treatment (t=2.71-13.20, P ＜ 0.01), but the level of CD8+ was decreased as compared with that before treatment (t =8.63, P ＜ 0.01). The levels of CD3+, CD4+, CD4+/CD8+ in observation group were higher than those in control group (t=2.85-11.84, P ＜ 0.01), but the level of CD8+ was decreased as compared with that in control group (t =5.83, P ＜ 0.01).CONCLUSION: The bufei yishen granule can obviously improve the pulmonary ventilation function and immunological function of COPD patients,and its intervention is superior to that of placebo.

Objective:To study the distribution and main symptom characteristics of TCM syndrome of chronic pulmonary heart disease(CPHD)with respiratory failure based on multicenter clinical research.Methods:TO select 330 patients with respiratory failure of CPHD from 4 hospitals by retrospective research method,and to collect related data of s TCM syndrome.All data were analyzed by description,logistic regression and clustering analysis.Results:327 qualified questionnaires were collected.The incidence frequency of TCM syndrome of CPHD with respiratory failure was syndrome of heat-phlegm stagnating the lung,syndrome of pulmonary stagnation of phlegm,syndrome of deficiency of the lung and kidney qi,syndrome of deficiency of qi and stagnation of blood,syndrome of edema due to yang deficiency,syndrome of kidney qi deficiency,syndrome of deficiency of both qi and yin.7 TCM syndromes were screened out by cluster analysis.They were syndrome of heat-phlegm stagnating the lung,syndrome of pulmonary stagnation of phlegm,syndrome of deficiency of the lung and kidney qi,syndrome of edema due to yang deficiency,syndrome of obstruction of pericardium by phlegm,syndrome of blood stasis and syndrome of deficiency of both qi and yin.7 were screened out as the main TCM syndromes of the disease,and the main symptoms and the sub-symptoms of the elementary symptom-complexes were screened out by statistical description.Conclusion:There were 7 main TCM syndromes of CPHD with respiratory failure,they were syndrome of heat-phlegm stagnating the lung,syndrome of pulmonary stagnation of phlegm,syndrome of deficiency of the lung and kidney qi,syndrome of obstruction of pericardium by phlegm,syndrome of blood stasis,syndrome of edema due to yang deficiency and syndrome of deficiency of both qi and yin.The results will provide references for next research.

Chronic obstructive pulmonary disease (COPD) is a major public health problem worldwide. Pulmonary rehabilitation (PR) is an established intervention for the management of patients with COPD. Exercise training is an important part of PR, and its effectiveness in patients with COPD is well established. However, alternative methods of PR training such as Daoyin have not been appropriately studied. Hence, alternative forms of exercise training that require less exercise equipment and no specific training place should be evaluated. This paper describes the study protocol of a clinical trial that aims to determine if pulmonary Daoyin training will improve the exercise capacity and psychosocial function of patients with COPD in China.

Objective:To establish a risk prediction model for acute exacerbation of chronic obstructive pulmonary disease (AECOPD) using regression analysis and verify the model.Methods:The risk factors and acute exacerbation of 1 326 patients with chronic obstructive pulmonary disease (COPD) who entered the stable phase and followed up for 6 months in the four completed multi-center large-sample randomized controlled trials were retrospectively analyzed. Using the conversion-random number generator, about 80% of the 1 326 cases were randomly selected as the model group ( n = 1 074), and about 20% were the verification group ( n = 252). The data from the model group were selected, and Logistic regression analysis was used to screen independent risk factors for AECOPD, and an AECOPD risk prediction model was established; the model group and validation group data were substituted into the model, respectively, and the receiver operating characteristic (ROC) curve was drawn to verify the effectiveness of the risk prediction model in predicting AECOPD. Results:There were no statistically significant differences in general information (gender, smoking status, comorbidities, education level, etc.), body mass index (BMI) classification, lung function [forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), etc.], disease status (the number and duration of acute exacerbation in the past year, duration of disease, etc.), quality of life scale [COPD assessment test (CAT), etc.] and clinical symptoms (cough, chest tightness, etc.) between the model group and the validation group. It showed that the two sets of data had good homogeneity, and the cases in the validation group could be used to verify the effectiveness of the risk prediction model established through the model group data to predict AECOPD. Logistic regression analysis showed that gender [odds ratio ( OR) = 1.679, 95% confidence interval (95% CI) was 1.221-2.308, P = 0.001], BMI classification ( OR = 0.576, 95% CI was 0.331-1.000, P = 0.050), FEV1 ( OR = 0.551, 95% CI was 0.352-0.863, P = 0.009), number of acute exacerbation ( OR = 1.344, 95% CI was 1.245-1.451, P = 0.000) and duration of acute exacerbation ( OR = 1.018, 95% CI was 1.002-1.034, P = 0.024) were independent risk factors for AECOPD. A risk prediction model for AECOPD was constructed based on the results of regression analysis: probability of acute exacerbation ( P) = 1/(1+ e- x), x = -3.274 + 0.518×gender-0.552×BMI classification + 0.296×number of acute exacerbation + 0.018×duration of acute exacerbation-0.596×FEV1. The ROC curve analysis verified that the area under ROC curve (AUC) of the model group was 0.740, the AUC of the verification group was 0.688; the maximum Youden index of the model was 0.371, the corresponding best cut-off value of prediction probability was 0.197, the sensitivity was 80.1%, and the specificity was 57.0%. Conclusion:The AECOPD risk prediction model based on the regression analysis method had a moderate predictive power for the acute exacerbation risk of COPD patients, and could assist clinical diagnosis and treatment decision in a certain degree.

This study was aimed to review of the selection and use of the therapeutic effect assessment indexes of randomized controlled trials ( RCTs ) on traditional Chinese medicine ( TCM ) syndrome differentiation and treatment of chronic obstructive pulmonary disease ( COPD ) based on clinical efficacy . Published studies were searched in the CBM , CNKI , VIP , Wanfang database , Cochrane Library , PubMed and Embase to identity all RCTS on TCM treatment of COPD . Two researchers selected studies and extracted data independently using a designed extraction form . The Cochrane collaboration software RevMan 5 . 1 was used for meta-analysis . The re-sults showed that a total of 40 RCTs were included . Meta-analyses showed that TCM syndrome differentiation and treatment of COPD can improve the pulmonary function and life quality , improve the clinical effect and TCM syndrome effect , reduce the number of acute exacerbation of COPD and improve clinical symptoms . Some therapeutic effect assessment indexes , such as pulmonary function , life quality , clinical comprehensive effect , the number of acute exacerbation of COPD, clinical symptoms and signs, syndrome effect and the integral of syndrome were used more frequent . Other indexes such as 6-min walk distance , BODE Index and health eco-nomic evaluation were used less frequently . It was concluded that TCM syndrome differentiation and treatment of COPD had certain therapeutic efficacy. A large number of strictly-designed, multicenter, high-quality RCTs are required because of the low quality of the included studies. The selection of therapeutic effect assessment indexes is still not standardized . The therapeutic effect assessment indexes should be selected based on differ-ent purposes of clinical studies with the clinical characteristics of TCM .

Objective: To study effects of Naomaitong on injury of cerebro-microvessel basement membrane in different periods and gene expression of gelatinase system after cerebral ischemia/reperfusion(I/R) in rats.Methods: Focal cerebral ischemia/reperfusion model was established by MCAO method of the intraluminal filament technique.Rats were divided into sham-operated group,model group,Naomaitong group and Nimodipine group at random,the later three groups with ischemia 3h and I/R 6h,12h,24h,3d,6d.Ransmission electron microscope and hybridization in situ method were used to observe the structure of micrangium and gene expression of gelatinase and its inhibitor.Results: Under electron microscope,the pathodamage in medico-group seemed lighter.According to the gene expression of gelatinase system,Naomaitong could step down the mRNA expression of MMP-2(I/R 6h-6d)and MMP-9(I/R 12h,I/R 3d).And increase the mRNA expression of TIMP-1(I/R 6h-3d).Conclusion: The protection of Naomaitong on cerebro-microvessel basement membrane after cerebral I/R in rats are related to the gene expression regulation of gelatinase system.

Objective:investigate the effect of β-caryophyllene(BCP)on cerebral ischemia-reperfusion(CIR)injury in mice.Methods: Mice were subjected to CIR with or without BCP(62,124,248 mg/kg).At 24 h of reperfusion,ischemic degrees were determined according to neurologic dysfunction score and cerebral infarct volume.The protein expression of Toll-like receptor(TLR)4 was measured by Western blot.Nuclear factor κB(NF-κB)p65 were measured by immunohistochemistry and Western blot.IL-1β,tumor necrosis factor-α(TNF-α)and serum high-mobility group box 1(HMGB1)levels were measured by ELISA kit.Results: Compared to the CIR group,BCP(248 mg/kg)reduced the neurological score and cerebral infarct volume.BCP reduced neuronal death in mice brain subjected to cerebral I/R.In addition,BCP also inhibited the activation of NF-κB pathway and decreased increases in TLR4,HMGB1,TNF-α,IL-1β levels by CIR(P<0.01).Conclusion: BCP protects mice brain against CIR injury,its neuroprotective mechanisms may involves HMGB1/TLR4/NF-κB pathway.