Oral and IV metronidazole show similar tissue concentrations in oral cancer flap reconstruction
This randomized clinical trial compared the tissue pharmacokinetics of oral versus intravenous metronidazole for perioperative prophylaxis in 18 patients undergoing facial artery musculomucosal (FAMM) flap reconstruction after oral cancer surgery. Patients received 500 mg metronidazole twice daily either orally (Group PO) or intravenously (Group IV). The primary outcome was the tissue-specific AUC/MIC ratio and attainment of the treatment target (AUC/MIC ≥ 70).
For the mean AUC/MIC ratio, no statistically significant differences were observed between the oral and IV groups across three MIC values. For MIC 0.5 μg/mL, the range was 423 to 531 (PO) versus 437 to 553 (IV). For MIC 2 μg/mL, the range was 106 to 133 (PO) versus 109 to 138 (IV). For MIC 4 μg/mL, the range was 53 to 66 (PO) versus 55 to 69 (IV). Regarding target attainment, all tissues in both groups achieved the AUC/MIC ≥ 70 target for MIC values of 0.5 and 2 μg/mL. However, none of the tissues in any group achieved the target for an MIC of 4 μg/mL.
Safety and tolerability data were not reported. The study's key limitation is its small sample size of 18 patients. The findings suggest pharmacokinetic equivalence between administration routes for metronidazole in this specific surgical context, but this represents an association, not proof of equal clinical efficacy. Practice relevance is restrained; while the data support the potential interchangeability of routes for achieving certain pharmacokinetic targets, clinicians should note the small study size and the lack of data on clinical infection outcomes.