Effect of bufei yishen granule on pulmonary ventilation function and immunological function of patients with chronic obstructive pulmonary disease in remission phase: A randomized grouping and placebo controlled study / 中国组织工程研究

ABSTRACT

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 groupsObservation 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 courseThe 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.