Safety of azithromycin in pediatric infectious diseases: a clinical systematic review and meta-analysis

Background: Azithromycin is a second-generation macrolide antibiotic which can be used in the treatment of diseases caused by sensitive bacterial infections. This article aimed to investigate the safety of azithromycin in the treatment of infectious diseases in children by meta-analysis.

Methods: PubMed, Embase, and Cochrane were selected as the search database platforms. Randomized controlled trials (RCTs) published after 2010 were searched using the following keywords: "azithromycin", "children", "adverse event", "intravenous event", and "oral". Included studies were all clinical trials of azithromycin in the treatment of pediatric diseases. After inclusion/exclusion criteria screening and bias risk assessment, data were extracted from the included studies. RevMan 5.3.5 software was used for statistical analysis to obtain both forest and funnel plots.

Results: A total of nine articles involving 3,597 pediatric patients were included in this study. The results of meta-analysis showed that the nine articles exhibited statistical heterogeneity (I²=70%; P=0.001), and thus, a random-effects model was used. The obtained statistic was [odds ratio (OR) =0.65; 95% confidence interval (CI): (0.43, 0.97)], the statistical effect value was Z=2.10, P=0.04, and the difference was statistically significant. After excluding one article, the remaining eight articles showed homogeneity (I²=12%; P=0.34). So, using fixed-effects model analysis, the statistic was [OR =0.79; 95% CI: (0.67, 0.94)], and the effect size value was Z=2.73, P=0.006.

Discussion: Compared with other antibiotics, the clinical safety of azithromycin is relatively good, but care should be taken when the dosage is high in treating some disease.