Lack of efficacy of long-term, low-dose azithromycin in chronic rhinosinusitis: a randomized controlled trial

作者：Videler W J; Badia L; Harvey R J; Gane S; Georgalas C; van der Meulen F W; Menger D J; Lehtonen M T; Toppila Salmi S K; Vento S I; Hytonen M; Hellings P W; Kalogjera L; Lund V J; Scadding G; Mullol J; Fokkens W J^*

来源：Allergy, 2011, 66(11): 1457-1468.

DOI：10.1111/j.1398-9995.2011.02693.x

• antibiotic treatment
• azithromycin
• chronic rhinosinusitis
• long-term low dose
• nose diseases
• nasal polyps
• oral administration
• paranasal sinus diseases
• randomized controlled trial
• sinusitis

Background: In persistent chronic rhinosinusitis (CRS), conventional treatment is often insufficient. Long-term, low-dose administration of macrolides has been suggested as a treatment option. The MACS (Macrolides in chronic rhinosinusitis) study is a randomized placebo-controlled trial evaluating the efficacy of azithromycin (AZM) in CRS.
Methods: We describe a group of patients with recalcitrant CRS with and without nasal polyps unresponsive to optimal medical and (in 92% also) surgical treatment. Patients were treated with AZM or placebo. AZM was given for 3 days at 500 mg during the first week, followed by 500 mg per week for the next 11 weeks. Patients were monitored until 3 months post-therapy. The assessments included Sino-Nasal Outcome Test-22 (SNOT-22), a Patient Response Rating Scale, Visual Analogue Scale (VAS), Short Form-36 (SF-36), rigid nasal endoscopy, peak nasal inspiratory flow (PNIF), Sniffin' Sticks smell tests and endoscopically guided middle meatus cultures.
Results: Sixty patients with a median age of 49 years were included. Fifty per cent had asthma and 58% had undergone revision sinus surgery. In the SNOT-22, Patient Response Rating Scale, VAS scores and SF-36, no significant difference between the AZM and the placebo groups was demonstrated. Nasal endoscopic findings, PNIF results, smell tests and microbiology showed no relevant significant differences between the groups either.
Conclusion: At the investigated dose of AZM over 3 months, no significant benefit was found over placebo. Possible reasons could be disease severity in the investigated group, under-dosage of AZM and under-powering of the study. Therefore, more research is urgently required.

• 出版日期2011-11