Wallwork Ben, Coman William, Mackay-Sim Alan, Greiff Lennart, Cervin Anders
School of Biomolecular and Biomedical Science, Griffith University, and Princess Alexandria Hospital, Brisbane, Australia.
Laryngoscope. 2006 Feb;116(2):189-93. doi: 10.1097/01.mlg.0000191560.53555.08.
The antiinflammatory effect of macrolide antibiotics has been well-established, as has their role in the treatment of certain disorders of chronic airway inflammation. Several studies have suggested that long-term, low-dose macrolides may be efficacious in the treatment of chronic rhinosinusitis; however, these studies have lacked a control group. To date, this effect has not been tested in a randomized, placebo-controlled study.
The authors conducted a double-blind, randomized, placebo-controlled clinical trial on 64 patients with chronic rhinosinusitis. Subjects received either 150 mg roxithromycin daily for 3 months or placebo. Outcome measures included the Sinonasal Outcome Test-20 (SNOT-20), measurements of peak nasal inspiratory flow, saccharine transit time, olfactory function, nasal endoscopic scoring, and nasal lavage assays for interleukin-8, fucose, and a2-macroglobulin.
There were statistically significant improvements in SNOT-20 score, nasal endoscopy, saccharine transit time, and IL-8 levels in lavage fluid (P<.05) in the macrolide group. A correlation was noted between improved outcome measures and low IgE levels. No significant improvements were noted for olfactory function, peak nasal inspiratory flow, or lavage levels for fucose and a2-macroglobulin. No improvement in any outcome was noted in the placebo-treated patients.
These findings suggest that macrolides may have a beneficial role in the treatment of chronic rhinosinusitis, particularly in patients with low levels of IgE, and supports the in vitro evidence of their antiinflammatory activity. Additional studies are required to assess their place in clinical practice.
大环内酯类抗生素的抗炎作用已得到充分证实，其在治疗某些慢性气道炎症性疾病中的作用也已明确。多项研究表明，长期、低剂量的大环内酯类药物可能对慢性鼻窦炎有效；然而，这些研究均缺乏对照组。迄今为止，尚未在随机、安慰剂对照研究中对这种效果进行测试。
作者对64例慢性鼻窦炎患者进行了一项双盲、随机、安慰剂对照临床试验。受试者分别接受每日150毫克罗红霉素治疗3个月或安慰剂治疗。观察指标包括鼻窦结局测试-20（SNOT-20）、鼻腔最大吸气流量测量、糖精转运时间、嗅觉功能、鼻内镜评分以及鼻腔灌洗液中白细胞介素-8、岩藻糖和α2-巨球蛋白的检测。
大环内酯类药物治疗组的SNOT-20评分、鼻内镜检查、糖精转运时间和灌洗液中白细胞介素-8水平有统计学意义的改善（P<0.05）。观察指标的改善与低免疫球蛋白E（IgE）水平之间存在相关性。嗅觉功能、鼻腔最大吸气流量或灌洗液中岩藻糖和α2-巨球蛋白水平无显著改善。接受安慰剂治疗的患者在任何观察指标上均无改善。
这些发现表明，大环内酯类药物可能在慢性鼻窦炎的治疗中发挥有益作用，尤其是在IgE水平较低的患者中，并支持了其抗炎活性的体外证据。需要进一步研究以评估其在临床实践中的地位。
