Department of Otorhinolaryngology, Academic Medical Centre, Amsterdam, the Netherlands.
Allergy. 2011 Nov;66(11):1457-68. doi: 10.1111/j.1398-9995.2011.02693.x. Epub 2011 Sep 2.
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.
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.
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.
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.
在持续性慢性鼻-鼻窦炎（CRS）中，常规治疗往往不够。长期低剂量使用大环内酯类药物已被提议作为一种治疗选择。MACS（慢性鼻-鼻窦炎中的大环内酯类药物）研究是一项随机安慰剂对照试验，评估阿奇霉素（AZM）在 CRS 中的疗效。
我们描述了一组患有难治性 CRS 且对最佳药物和（92%的患者也进行了）手术治疗无反应的患者，包括有和无鼻息肉的患者。患者接受 AZM 或安慰剂治疗。AZM 在第一周的前 3 天每天给予 500mg，然后接下来的 11 周每周给予 500mg。患者在治疗后 3 个月内进行监测。评估包括鼻-鼻窦炎结局测试 22 项（SNOT-22）、患者反应评分量表、视觉模拟量表（VAS）、简明健康状况调查问卷 36 项（SF-36）、硬性鼻内镜检查、鼻峰吸气流量（PNIF）、Sniffin' Sticks 嗅觉测试和内镜引导下中鼻道培养。
共纳入 60 名中位年龄为 49 岁的患者。50%的患者患有哮喘，58%的患者接受过鼻窦手术修正。在 SNOT-22、患者反应评分量表、VAS 评分和 SF-36 中，AZM 组与安慰剂组之间未显示出显著差异。鼻内镜检查结果、PNIF 结果、嗅觉测试和微生物学检查也未显示出两组之间存在显著差异。
在研究的 AZM 剂量下，3 个月内未发现 AZM 相对于安慰剂有显著获益。可能的原因包括研究组疾病的严重程度、AZM 的剂量不足和研究的效能不足。因此，迫切需要更多的研究。
