| Asthma is a chronic inflammatory disorder of the airway caused by many inflammatory cells. Corticosteroids are the most efficacious anti-inflammatory drugs for asthma treatment.Inhaled corticosteroids(ICS) are the most commonly used corticosteroids and their side effects are significantly slighter than oral corticosteroids, but there are still parts of patients who can't obtain effective asthma control by treatment with high dose of ICS.Therefore, increasing the dosage of ICS or addition of other 'second line drugs' such as slow-released theophyllines(SRT) should be recommended. Theophyllines are non-specific phosphodiesterase inhibitory and were used only as bronchodilator in the past. However, many recent studies have found that theophyllines exert some anti-inflammatory effects and modulate immune function.This study was performed to compare ICS combined with SRT with double-dose ICS in asthma control, the effects of anti-airway inflammation and therapeutic security, in order to provide another way for asthma clinical therapy.Methods:A randomised, opened, parallel, control study was performed in moderate and severe persistent asthmatics. After one to two weeks run-in period, 38 patients with continuing symptomatic asthma were randomly treated with either beclomethasone dipropionate 500(g bid (BDP group) (n=19) or combination of BDP 250(g bid and SRT 0.2g bid (the combination group) (n=19) for 6 weeks. The changes of symptom scores, percentage of the no-symptom days, use of albuterol, morning and evening PEF, FEV1, FVC were compared between two groups. At the start and end of the treatment period differential cell counts and IL-5 level in induced sputum and the plasm cortisol level were observed, and their changes were compared in two groups.The side effects during the study period were recorded.Results:1. At the end of the treatment period, in two groups, the proportion of patients who achieved well-controlled asthma were 15.9%(3/19) and no significant difference was observed(p>0.05). 2. Compared with pretreatment, in two groups, obvious increases were observed in thepercentage of no-symptom days, morning PEF, FEV1(p<0.05) and obvious decreases were showed in symptom scores and use of albuterol (p<0.05). There were no differences in the changes of above indexes between two groups(p>0.05). After the treatment, FVC and evening PEF showed increases in the combination group(p<0.05), but not in BDP group.3. In both groups, the significant decreases were observed for the percentage of eosinophils(Eos), the level of IL-5 in induced sputum after the treatment (p<0.05) and there were no significant differences in the changes of above indexes in two groups (p>0.05). The percentage of neutrophils, lymphocytes, macrophages and epithelial cells in induced sputum had not marked changes in two groups after the treatment(p>0.05).4. The incidences of the side effects in BDP group and the combination group respectively were 40.0%(8/20)and 61.91%(13/21), however there was no significant difference in two groups (p>0.05). Compared with pretreatment, there was no significant change in the plasm cortisol of the two groups (p>0.05).Conclusions:Both therapys of ICS combined with SRT and double-dose ICS have the same effects in asthma control, improving the symptoms and ameliorating lung function. Both therapys have similar anti-airway inflammation effects and therapeutic security. Clinical implication: ICS combined with SRT plays a role of saving the dosage of ICS used in asthma therapy. It can decrease the occurrence risk of potential side effects that are caused by inhaling high dose corticosteroids for the long term.
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