Clinical research on the treatment of moderate bronchial asthma with inhaled inactivated-mycobacterium phlei

Abstract

Objective To introduce inhaled inactivated-mycobacterium phlei on prevention and treatment of moderate bronchial asthma to observe the clinical effect. Method This study was a prospective and controlled study. The patients diagnosed with asthma in our out-patient from March 2009 to December 2010 were collected, who met the following conditions were included in the study: age≥ 14 years; met the criteria of moderate chronic persistent bronchial asthma in Global Initiative for Asthma (GINA) in 2008; suspended receiving systemic corticosteroids, Montelukast, ketotifen and other anti-inflammatory and anti-allergic drugs in one month; no significant respiratory tract infections; and other serious illnesses or abnormalities known.A total of 100 patients with asthma were selected, including 37 males and 63 females, age (32.11 ± 12.95 )years. The patients were randomly(random number) divided into two groups: A group(treatment group; 16males and 34 females, age 33.56 ± 14.23 years) and B group (control group; 21 males and 29 females,age 30.66 ± 11.50 years); 50 in each group. No significant difference was noted between the two groups on age and gender composition. The patients in A group were treated with inhaled inactivated-mycobacterium phlei F. U. 36 Injection 1.72 μg/mL × 2 that adding 3 mL normal saline, once a day for 5 days. The patients in B group were treated with salmeterol xinafoate and fluticasone propionate powder for inhalation (50/100 μg), twice daily for sustainable use. The patients in the two groups were observed for one month. During this course, the patients in the two groups could inhale the salbutamol sulphate aerosol as need to relieve symptoms. And the number of using was recorded. Pulmonary function test and asthma provocative test were carried out on the Day O, 6 and 31. ACT scores were measured before and after the treatment. Results On Day 6 and 31 after treatment, the negative conversion rates of asthma provocative test of the patients in A group were 82% and 78% respectively, B group were 84% and 90% respectively. Provocative test of the patients in the two groups were negative conversion significantly before and after treatment. There was no significant difference between the two groups by chi-square test (P ＞ 0. 05 ). Completely random designed data was analyzed by analysis of variance. The analysis showed that the accumulated doses of methacholine of the patients in the two group increased significantly ( P ＜ 0. 05 ), but no difference between the two groups.There was a improvement trend on forced expiratory volume in one second( FEV1 )of the patients in A group after treatment, but no difference. FEV1 of the patients in B group increased significantly higher ( P ＜0.05), which was significantly higher than A group on the 31th day (P ＜0. 05); Peak expiratory flow (PEF) of the patients in the two group increased significantly on Day 6 and 31 after treatment (P ＜0.05 ).On Day 31, B group was significantly higher than A group ( P ＜ 0. 05 ); Scores of asthma control test (ACT)of the patients in the two group were significantly increased, and the number of using of salbutamol sulfate aerosol was significantly reduced (P ＜0.01 ). B group was obvious than group A (P ＜0.05 ). During treatment, there were only two adverse reaction cases of transient low fever; most obvious was on the third day.Conclusions Inhaled inactivated-mycobacterium phlei would inhibit the airway hyperresponsiveness of the patients with moderate bronchial asthma in short time, improve the symptoms, reduce the acute exacerbation, and reduce the use of rescue medication, which has the roles of prevention and treatment of moderate asthma in a certain period of time. Key words: Asthma; Mycobaterium phlei; Airway hyperresponsiveness; Aerosol inhalation; Asthma control test; Forced expiratory volume in one second; Peak expiratory flow