Clinical Research On The Treatment Of Moderate Bronchial Asthma With Inhaled Inactivated-Mycobacterium Phlei

Objective: To observe the clinical effect of inhaled inactivated mycobacterium phlei on treatment of moderate bronchial asthma patients.Methods: This study was a prospective and controlled study. 100 patients diagnosed as asthma in our out-patient from March 2009 to December 2010 were collected, who met the criteria of moderate chronic persistent bronchial asthma in Global Initiative for Asthma (GINA) in 2008; including 37 males and 63 females, age 32.11±12.95 years.The patients were randomly divided into three groups: A group was treatment group, B group was positive control and C group was negative control. The patients in A group were treated with inhaled inactivated-mycobacterium phlei F.U.36 Injection 1.72μg/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 50/100μg, twice daily for sustainable use The patients in C group were treated with inhaled 5 mL normal saline, once a day for 5 days. After the treatment the patients in group C who had no significantly improved in lung function and positive of provocation test would be randomly divided into A and B groups. The patients in A and B groups were observed for three months. 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 0, 6 , 31 and the end of the third month. ACT scores were measured before and after the treatment, and at the end of the third month . Eight patients were lost to follow-up in A group, and seven patients were lost in B group at the end of the third month.Results: On Day 6 , 31 and the end of the third month after treatment, the negative conversion rates of asthma provocative test of the patients in A group were 82%, 78% and 71% respectively, B group were 84% , 90% and 98% respectively. On Day 6, there was no patients in guoup C had the negative provocation test. Provocative test of the patients in the A and B 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) on the 31st day, but at the end of the third month group B was higher then group A(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 group A and B increased significantly (P<0.05), but no difference between the two groups on the 31st day, but at the end of the third month group B was more then group A(P<0.05). Group C had no obvious difference before and after treatment. Forced expiratory volume in one second(FEV1) of the patients in B group increased significantly higher (P<0.05), which was significantly higher than A group on the 31th day and the end of the third month (P<0.05). Peak expiratory flow (PEF) of the patients in the two group increased significantly after treatment (P<0.05). On Day 31 and the end of the third month B group was significantly higher than A group (P<0.05). Group C had no obvious difference before and after treatment. Scores of asthma control test (ACT) of the patients in the group A and B 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 in group A, most obvious was on the third day; one patient appeared voice hoarse in group B and continued about a week. There were no patients needed go to emergency room because of acute exacerbations of asthma in all patients.Conclusion: (1) Inhaled inactivated-mycobacterium phlei would inhibit the airway hyperresponsiveness of the patients with moderate bronchial asthma, improve the symptoms, reduce the acute exacerbation, and reduce the use of rescue medication, which has the roles of treatment on moderate asthma in maintain at least one month. (2) At the end of the third month, the therapeutic effects of inhaled inactivated-mycobacterium phlei for moderate bronchial asthma patients declined, so it is necessary to atomomize again to maintain the effect at certain time such as at the end of the first month an the third month. (3) Inhaled inactivated-mycobacterium phlei would treat the moderate asthma patients, and this therapeutic schedule is simple, and has short course, fewer side effects, so it will be easily implemented in basic-level hospitals.