Efficacy and safety of pulmicort repulas-impregnated nasal dressing following endoscopic sinus surgery: a randomized, single-blind, placebo-controlled study
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摘要: 目的 探讨慢性鼻窦炎伴鼻息肉鼻内镜术后填塞浸润激素纳吸棉的有效性和安全性。方法 33例行鼻内镜手术的慢性鼻窦炎伴鼻息肉患者，手术结束时随机分配两侧术腔，分别填塞浸润普米克令舒或生理盐水的纳吸棉，于手术前后检测血清皮质醇水平，并于手术前及术后第2、4、8、12、24周随访时分别采集症状的VAS评分及Lund-Kennedy内镜评分，比较2组间在手术前后主、客观评分的差异，评估其安全性。结果 共有30例患者完成实验规定的6个月的术后随访。主观评分术后较术前明显下降，但术后第2周至24周实验侧评分与对照侧相当，差异无统计学意义。客观评估显示实验侧评分明显低于对照侧，且术后第2~24周均差异有统计学意义。患者术后COR水平(5.97±4.10) mmol/L较术前(12.48±4.33) mmol/L明显降低，但未出现用药后下丘脑垂体肾上腺轴抑制的相关临床表现。结论 浸润普米克令舒纳吸棉行鼻腔术后填塞可有效改善慢性鼻窦炎伴鼻息肉患者鼻内镜术后主观症状，加快术腔黏膜恢复和上皮化，临床应用安全性良好。Abstract: Objective To investigate the efficacy and safety of pulmicort respulas immerse with nasopore as nasal packing after nasal endoscopic surgery on patients with chronic rhinosinusitis with nasal polyps.Method This single-blind, randomized study recruit 33 patients diagnosed as chronic rhinosinusitis with polyposis. All of them underwent bilateral endoscopic sinus surgery and randomized to receive pulmicort respulas immersed nasopore in one nasal cavity and saline immersed nasopore contralaterally. Both groups were followed up at 2, 4, 8, 12, 24 weeks after operation. Subjective (VAS score) and objective (Lund-Kennedy score) scores are collected at each time point from both sides of nasal cavity.Result There are 30 enrolled patients in the study completed the 24-week trial. Both the subjective and objective scores of two groups shows a significant reduction after the ESS operation. The VAS score of the two groups remains roughly unchanged during week 2 to week 24. A statistically significant difference of the Lund-Kennedy score can be detected between the groups from week 2 to week 24. Though the serum cortisol reduced (5.97±4.10) mmol/L vs (12.48±4.33) mmol/L after the surgery, neither group shows any clinical symptoms related with the hypothalamic-pituitary-adrenal axis suppression.Conclusion This study demonstrated a significant improvement in postoperative healing in nasal cavities receiving pulmicort respulas immersed nasopore as nasal packing following ESS. This method of using budesonide is generally safe for patients with chronic rhinosinusitis with polyposis.
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Key words:
- sinusitis /
- nasal polyp /
- nasal tamponade /
- glucocorticoid
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图 5 术后2周鼻腔鼻窦黏膜实验侧(5a)和对照侧(5b)比较; 图 6 术后4周鼻腔鼻窦黏膜实验侧(6a)和对照侧(6b)比较; 图 7 术后8周鼻腔鼻窦黏膜实验侧(7a)和对照侧(7b)比较; 图 8 术后12周鼻腔鼻窦黏膜实验侧(8a)和对照侧(8b)比较; 图 9 术后24周鼻腔鼻窦黏膜实验侧(9a)和对照侧(9b)比较
表 1 治疗前后两侧Lund-Kennedy评分比较
时间 实验侧 对照侧 P 基线水平 3.48±1.15 3.60±1.15 0.256 术后2周 0.89±0.89 1.26±0.87 0.002 术后4周 1.83±0.75 2.17±0.97 0.028 术后8周 1.41±0.92 1.87±1.00 0.001 术后12周 1.36±0.36 1.45±0.80 0.014 术后24周 0.86±0.61 1.03±0.74 0.006 
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