RESUMO
Objective To evaluate the efficacy of the bacterial lysate Broncho-vaxom on chronic obstructive pulmonary disease(COPD)in elderly patients.Methods A total of 150 patients with stable COPD were randomized into the Broncho-vaxom group(n=78)treated with Broncho-vaxom as add-on to conventional treatment and the control group(n=72)treated with conventional treatment.The number of acute exacerbation of COPD per patient per year,quality of life,lung function,T cell subsets were evaluated for the therapeutic effects.Results After one year of treatment,the number of acute exacerbation per patient per year was lower in Broncho-vaxom group than in control group[(1.44 ± 1.05) times/y vs.(1.82 ± 0.61) times/y,t =2.754,P =0.007].The proportions of acute exacerbationfree patients were higher in Broncho-vaxom group than in control group(20.5％ or 16/78 vs.4.2％ or 3/72,x2 =9.043,P =0.003).There were significant differences in the forced vital capacity(FVC),forced expiratory volume in one second(FEV1),and forced expiratory volume in one second/predicted value ratio(FEV1 ％)between the two groups at 5 different time points(before,at 3,6,9 and 12 months after treatment) (Broncho-vaxom group:F =90.819,50.674 and 51.233,P =0.000;control group:F =84.928,90.654 and 86.117,P =0.000).After treatment,the symptom scores were lower in Broncho-vaxom group than in control group,and the ratios of CD4/CD8 T-cell were increased and level of CD8 T-cell was decreased in Broncho-vaxom group(all P ＜ 0.05).The rate of adverse reactions had no significant difference between Broncho-vaxom group and control group(3/78 or 3.8％ vs.2/ 72 or 2.8％,x2 =0.132,P=0.717).Conclusions The oral administration of Broncho-vaxom for six months can modulate and enhance immune functions,significantly decrease acute exacerbation frequency,improve quality of life and delay the deterioration in lung function in elderly patients with stable COPD.