Abstract: Background：In adult asthma studies, salmeterol/fluticasone propionate combination(FSC) has been shown to achieve better efficacy and comparable safety than fluticasone propionate alone(FP), but reliable clinical evidence is still lacking in children with asthma. Objective：To conduct a systematic review and meta-analysis on salmeterol/fluticasone propionate combination and fluticasone propionate alone in the step-up treatment of children with asthma, and to explore the efficacy and safety of the two groups. Design:Systematic review and meta-analysis. Methods:Randomized controlled trials(RCTs) of salmeterol/fluticasone propionate combination versus fluticasone propionate alone were systematically searched in Cochrane, MEDLINE (via PubMed), Embase, Web of Science, CBM, CNKI and Wanfang databases from the inception to September 2023. Two researchers independently finished literature screening, data extraction, risk of bias assessment, and evidence quality summary. Data analysis was completed through R Studio1.4.1717. Main outcome measures:Asthma exacerbations and adverse events related to inhaled corticosteroids (ICS) and FSC. Results:A total of 11 RCTs with 9 438 children with asthma were included. The comparison between fluticasone propionate/salmeterol combination and fluticasone propionate alone showed a statistical difference in the improvement in maximal expiratory flow at 50% vital capacity(MEF50) (MD=0.17, 95%CI: 0.16-0.18,P<0.000 1), mean morning peak expiratory flow(PEF) (MD=4.84, 95%CI: 4.53-5.15,P<0.000 1) before and after treatment, improved percentage of symptom-free days (MD=1.39, 95%CI: 1.36-1.41,P<0.05) and albuterol-free days (MD=1.09, 95%CI: 1.06-1.12, P<0.05) before and after treatment. But there was no statistically significant difference in the reduction in asthma exacerbations(RR=0.87, 95%CI: 0.70-1.09, P=0.22),the incidence of reduced ICS and FSC-related adverse events(RR=0.99, 95%CI: 0.61-1.60, P=0.95) and other adverse events(RR=0.98, 95%CI: 0.91-1.05, P=0.55). Conclusions:Compared with fluticasone propionate, salmeterol/Fluticasone propionate combined therapy significantly improved lung function (MEF50, mean morning PEF) and asthma symptoms, and reduced the use of salbutamol in treatment, but there was no difference in the reduction in asthma exacerbations. The safety was similar in both groups, with no additional drug-related adverse events or increased incidence of adverse events due to the addition of salmeterol.

Key words: Concentrated cod liver oil, Children, Salmeterol combination, Fluticasone propionate, Meta-analysis