OBJECTIVE: To compare the clinical efficacy and safety of salmeterol-fluticasone alone versus fluticasone propionate combined with montelukast sodium in the treatment of children with moderate persistent asthma. METHODS: 275 children with moderate persistent asthma were randomly divided into inhaled corticosteroids (ICS)+ long acting β2 receptor agonist (LABA) group (139 cases) and ICS+ leukotriene receptor antagonists (LTRA) group (136 cases). ICS+LABA group was given Salmeterol-fluticasone powder inhalant, 1 inhalation, bid; ICS+LTRA was given Fluticasone propionate inhalation aerosol, bid+Montelukast sodium chewable tablet 5 mg, before bedtime, qd. Both groups received more than 12 weeks of treatment. Body indexes of 2 groups were observed after treatment, such as asthma control degree, asthma score, the percentage of peak expiratory flow(PEF) in estimated value, aberration rate of PEF, the levels of eosinophi cationic protein(ECP) and leukotrienes E4 (LTE4) in peripheral blood, the times of taking short acting β2 receptor agonist (SABA) during treatment, asymptomatic days, compliance, the incidence of ADR, etc. RESULTS: Total effective rate of ICS+LABA group (86.33%) after 4 weeks treatment was higher than that of ICS+LTRA group (58.09%), with statistical significance (P<0.05); that of ICS+LABA (99.28%) after 12 weeks treatment was higher than that of ICS+LTRA group (98.53%), without statistical significance (P>0.05). The day and night asthma score of 2 groups decreased significantly and the percentage of PEF in estimated value increased significantly after treatment, there was statistical significance compared to before treatment (P<0.05). There was no statistical significance in above indexes between 2 groups after treatment (P>0.05). The levels of ECP and LTE4 decreased significantly in 2 groups after treatment, there was statistical significance compared to before treatment (P<0.05); those of ICS+LTRA group decreased significantly compared to ICS+LABA group, there was statistical significance between 2 groups (P<0.05). There was no statistical significance in the aberration rate of PEF after treatment, the times of taking SABA, asymptomatic days, compliance and the incidence of ADR between 2 groups during treatment(P>0.05). CONCLUSIONS: Salmeterol-fluticasone alone versus fluticasone propionate combined with montelukast sodium in the treatment of children with moderate persistent asthma both have good therapeutic efficacy and safety, while the latter one has stronger inhibition effect on ECP and LTE4, and to control asthma symptoms more rapidly.
Laboratory of Child Development and Disorder,National Clinical Research Center for Child Health and Disorders(Chongqing),China International Science and Technology Cooperation Base of Child Development and Critical Disorders,Chongqing Key Laboratory of Pediatrics,Children’s Hospital of Chongqing Medical University