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长期低剂量克拉霉素治疗内镜鼻窦手术后难治性慢性鼻窦炎患者的疗效和安全性:一项前瞻性临床试验。

Efficacy and Safety of Long-Term Low-Dose Clarithromycin in Patients With Refractory Chronic Sinusitis After Endoscopic Sinus Surgery: A Prospective Clinical Trial.

机构信息

Department of Otorhinolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Key Laboratory of Otorhinolaryngology Head and Neck Surgery (Capital Medical University), Ministry of Education, Beijing, China.

出版信息

Ear Nose Throat J. 2024 Jan;103(1):NP31-NP39. doi: 10.1177/01455613211032020. Epub 2021 Jul 27.

DOI:10.1177/01455613211032020
PMID:34315239
Abstract

OBJECTIVE

To observe the efficacy and safety of postoperative long-term low-dose oral administration of clarithromycin in patients with refractory chronic rhinosinusitis (RCRS), to explore the characteristics of postoperative microbiota in the nasal cavity in patients with RCRS, and to compare the differences and changes in microbiota in the nasal cavity before and after medication.

METHODS

This was a prospective, self-controlled study. Eighteen patients with RCRS who had persistent symptoms after endoscopic sinus surgery and standard therapy with normal immunoglobulin E and eosinophil level were included. Low dose (250 mg, once daily) clarithromycin was orally administrated for 12 weeks. Symptom severity and endoscopic findings were evaluated before, after 4 weeks, and 12 weeks of treatment, and nasal cavity microbiota was analyzed simultaneously.

RESULTS

A total of 18 patients with RCRS were enrolled and 17 patients completed the study. Four weeks after oral administration of clarithromycin, significant improvement was observed in subjective symptoms including nasal congestion, rhinorrhea, postnasal drip, and general discomfort, as well as endoscopic findings including general surgical cavity condition, rhinedema, and rhinorrhea ( < .05). After continuous treatment to the 12th week, symptoms showed significant improvement compared with baseline, and endoscopic score showed significant improvement compared with both baseline and 4 weeks after treatment. Analysis of middle nasal meatus flora revealed a significant decrease of after 12 weeks of clarithromycin treatment ( < .05), while the richness, composition, and diversity were similar before and after treatment. Patients enrolled experienced no adverse drug reaction or allergic reaction, nor clinical significant liver function impairment observed.

CONCLUSION

Postoperative low-dose long-term oral administration of clarithromycin in patients with RCRS can improve the clinical symptoms and facilitate the mucosal epithelialization, with good tolerance and safety. The efficacy of clarithromycin in patients with RCRS may be related to its regulatory effect on nasal cavity microbiota.

摘要

目的

观察术后长期低剂量口服克拉霉素治疗难治性慢性鼻-鼻窦炎(RCRS)的疗效和安全性,探索 RCRS 患者鼻腔术后微生物群的特征,并比较用药前后鼻腔微生物群的差异和变化。

方法

这是一项前瞻性、自身对照研究。纳入 18 例内镜鼻窦手术后持续存在症状且免疫球蛋白 E 和嗜酸性粒细胞水平正常的 RCRS 患者,给予低剂量(250mg,每日 1 次)克拉霉素口服治疗 12 周。分别在治疗前、治疗后 4 周和 12 周评估症状严重程度和内镜表现,并同时分析鼻腔微生物群。

结果

共纳入 18 例 RCRS 患者,17 例完成研究。克拉霉素口服 4 周后,患者主观症状(鼻塞、流涕、后鼻滴注和全身不适)和内镜表现(总体手术腔状况、鼻黏膜肿胀和流涕)均有明显改善(<0.05)。连续治疗至 12 周时,症状较基线时明显改善,内镜评分较基线和治疗后 4 周时均明显改善。中鼻道菌群分析显示,克拉霉素治疗 12 周后显著减少(<0.05),但治疗前后丰富度、组成和多样性相似。患者均未出现药物不良反应或过敏反应,也未观察到临床显著的肝功能损害。

结论

RCRS 患者术后长期低剂量口服克拉霉素可改善临床症状,促进黏膜上皮化,具有良好的耐受性和安全性。克拉霉素治疗 RCRS 的疗效可能与其对鼻腔微生物群的调节作用有关。

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