Comparison of Different Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis Patients After Endoscopic Sinus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Total Subjective Symptoms Visual Analog Scores (VAS)
研究概览
简要总结
Endoscopic sinus surgery (ESS) is widely considered to be the gold standard in the surgical management of chronic rhinosinusitis (CRS) that has failed maximal medical therapy. Nevertheless, the postoperation medical therapy was considered as a crucial procedure for the success of ESS. Both glucocorticoids and macrolide antibiotics have been recommended for the treatment of CRS, but their effect as postoperation medical therapies of ESS need more clinical data to clarify.
The purpose of this prospective, randomized,study is to determine the effect of glucocorticoids and macrolide antibiotics for the postoperation medical therapy of ESS in different subtypes of CRS.
详细描述
Chronic rhinosinusitis (CRS) is a multifactorial inflammatory disorder that causes various symptoms including nasal obstruction, rhinorrhea, olfactory dysfunction, facial pain, and headache . Endoscopic sinus surgery (ESS) is usually recommended for patients who do not response well to conservative treatments. Although surgery is effective to alleviate symptoms and improve the quality of life of CRS patients, a followed long-term postoperative medical treatment is indispensable. Current European and American guidelines recommend glucocorticoids and antibiotics as the primary pharmacotherapeutic approaches for CRS before and after ESS. However, there are a number of CRS patients not responding well to glucocorticoid treatment and conflicting results exist regarding the efficacy of long-term, low-dose macrolide treatment. One potential reason is that CRS is a heterogeneous group of disorders unified by similar clinical presentations and its phenotypes and/or endotypes may be important factors determining the efficacy of treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the CRS diagnostic criteria including CRSsNP and CRSwNP based on the EP3OS definition
- •Age ≥16 and ≤70 years
- •Chinese of either sex
- •Failure to conventional medical therapies according to EP3OS recommendation
排除标准
- •Pregnant or breast-feeding women
- •Cystic fibrosis
- •Congenital ciliary dyskinesia
- •Sinonasal fungal disease
- •Systemic vasculitis
- •Granulomatous disease
- •Immunodeficiency
- •Allergic to clarithromycin or topical corticosteroid
- •With an upper respiratory tract infection within 4 weeks of entering the study
- •With serious metabolic, cardiovascular, autoimmune, neurology, blood, digestive, cerebrovascular, respiratory system disease, or any disease interfering with the evaluation of results or affecting subjects' safety such as glaucoma and tuberculosis
- •With emotional or mental problems
- •Have received immunotherapy within the previous 3 months
- •Have had a history of local or systemic medications, such as glucocorticoids and macrolides within 4 weeks
- •Have had an acute asthmatic within the 4 weeks before entering the study
研究组 & 干预措施
Glucocorticoid
Fluticasone propionate nasal spray
干预措施: Glucocorticoid (Drug)
Clarithromycin
Clarithromycin tablet
干预措施: Clarithromycin (Drug)
结局指标
主要结局
Total Subjective Symptoms Visual Analog Scores (VAS)
时间窗: Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit.
The treatment will begin one week after ESS. Symptoms visual analog scores (VAS) were recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit. All of the patients were assessed by using symptom questionnaire after enrollment and at follow-up visits. Subjective symptoms were scored by patients on a VAS of 0-10, with 0 being "no complaint whatsoever" and 10 being "the worst imaginable complaint."Five major symptoms were focused on: nasal obstruction, rhinorrhea, loss of sense of smell, facial pain or pressure, and headache. Total VAS score was calculated based on the sum of VAS scores of these five symptom domains. Total subjective symptoms VAS range: 0\~50, with higher scores indicating greater severity of symptoms.
次要结局
- Total Nasal Endoscopic Scores(Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit.)
研究者
Zheng Liu
Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Huazhong University of Science and Technology