Safety and efficacy of ciprofloxacin in the management of pediatric post-tympanostomy tube otorrhea: a systematic review and meta-analysis
摘要
This systematic review and meta-analysis aim to evaluate the efficacy and safety of Ciprofloxacin compared to alternative treatments for managing PTTO.
MethodsA comprehensive search was carried out in PubMed, MEDLINE, Springer, and Embase. Randomized controlled trials and interventional studies were included if they assessed Ciprofloxacin in children (0–18 years) with PTTO following tympanostomy tube insertion. The primary outcomes analyzed were clinical resolution of otorrhea, time to resolution, recurrence rates, and adverse effects. For the meta-analysis, only studies comparing Ciprofloxacin to placebo were included to minimize heterogeneity, and outcomes were analyzed using a random effects model with risk ratios and 95% confidence intervals via RevMan 5.4 software.
ResultsOut of 704 identified records, four randomized controlled trials met the inclusion criteria, comprising a total of 1,025 pediatric patients aged 6 months to 14 years. These studies evaluated Ciprofloxacin, either as topical drops or sustained-release intratympanic injections, against a placebo for the prevention or treatment of PTTO. All studies reported that Ciprofloxacin significantly reduced the incidence of otorrhea compared to placebo, with relative risk reductions ranging from approximately 46% to 66%. The pooled meta-analysis of 892 participants demonstrated a statistically significant reduction in otorrhea with Ciprofloxacin treatment (risk ratio 0.53; 95% confidence interval 0.35 to 0.79; p = 0.002), with no observed heterogeneity (I² = 0%).
ConclusionThis systematic review and meta-analysis demonstrated that ciprofloxacin, whether administered as topical drops or sustained-release formulations, reduces post-tympanostomy tube otorrhea in children without significant safety concerns.