Efficacy Of Long-Term Low Dose Macrolide Therapy In Preventing Early Recurrence Of Nasal Polyps 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
- 100
- 试验地点
- 1
- 主要终点
- Change in symptom and disease severity scores
研究概览
简要总结
This randomized controlled trial evaluated the effectiveness of long-term, low-dose clarithromycin (250 mg/day) in reducing symptoms, improving endoscopic and radiologic scores, and preventing early recurrence of nasal polyps after endoscopic sinus surgery. Conducted at the ENT Department of Sir Ganga Ram Hospital, Lahore, the study included patients aged 15-75 undergoing surgery for nasal polyps. Group A received clarithromycin for three months in addition to standard therapy, while Group B received standard therapy alone. Patients treated with clarithromycin showed significantly greater improvements in SNOT, Lund-Kennedy, and Lund-Mackay scores at 8 and 12 weeks compared to controls (p<0.05). Polyp recurrence at three months was also lower in the macrolide group (12%) than in the non-macrolide group (32%).
Overall, low-dose clarithromycin was found to be safe and effective in enhancing postoperative outcomes and reducing early recurrence of nasal polyps after endoscopic sinus surgery.
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
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 15 to 75 years
- •Clinical diagnosis of nasal polyps
- •Underwent endoscopic sinus surgery
- •Willing and able to provide informed consent
排除标准
- •Current or recent use of antibiotics or macrolide therapy
- •History of multiple facial fractures
- •Presence of neurological disorders
- •Presence of psychiatric or psychological disorders
研究组 & 干预措施
Group A
Received Macrolide (clarithromycin 250 mg) once day in addition to their usual prescription
干预措施: clarithromycin 250 mg (Procedure)
Group B
Patients in Group B received only their routine prescribed postoperative medications following surgery (no macrolide therapy).
干预措施: clarithromycin 250 mg (Procedure)
结局指标
主要结局
Change in symptom and disease severity scores
时间窗: 3 months
(Change in Sinonasal Outcome Test-22 (SNOT-22) , Lund-Kennedy score, and Lund-Mackay score) from baseline to 12 weeks after endoscopic sinus surgery.
次要结局
未报告次要终点