The analysis of treatment effects in chronic rhinosinusitis patients with amphotericin B nasal irrigation

• Main Authors: Tzu-Kai Lin, 林子凱
• Other Authors: 郝宏恕
• Format: Others
• Language: zh-TW
• Published: 2006
• Online Access: http://ndltd.ncl.edu.tw/handle/60554978659555794023

碩士 === 中國醫藥大學 === 醫務管理學研究所碩士班 === 94 === Background： Chronic rhinosinusitis (CRS) is a prevalent disease among the general population and is recognized to have a great impact on a patient’s quality of life. No medical care procedure has been proved as treatment standard yet. Antibiotics, intranasal steroid, and endoscopic sinus surgery (ESS) are used to treat CRS, but none of these treatments have satisfactory long-term outcome. Recently fungal infection has been suggested to play an important role in the causation of CRS. In addition, traditional outcome measures of CRS often focus on the physiologic parameters and not enough attention on patient’s quality of life. Recently, health-related quality of life was advocated as one of the primary and important outcome variables. However there is still not any disease-specific questionnaire available for CRS in Taiwan. Objectives： We tested the hypothesis that intranasal antifungal treatment improves the quality of life and the objective nasal endoscopic scores and fungal burden of CRS in a prospective, double-blind, randomized, and placebo-controlled clinical trial. Another focus of this study is to evaluate the Chinese-version of RSOM-31 and the quality-of-life data from CRS patients in Taiwan. Methods： From September 2005 to March 2006, 40 CRS patients at Taichung Veterans General Hospital were recruited with 37 patients completed the trial. Patients applied 500 mL amphotericin B saline solution (0.04mg/mL) or placebo to each nostril twice a day by using pulsatile nasal irrigation. The nasal endoscopy, fungus culture rate and RSOM-31 were evaluated pre- and post-treatment. Results： The overall Cronbach’s alpha coefficient of Chinese-version RSOM-31 was 0.92, suggesting a high degree of internal consistency. The average Symptom-Impact score was 6.4, which was a little higher compared to Dr. Piccirillo’s score 5.8. The domains most affected were sleep and emotional. The amphotericin B group had a better quality-of-life improvement compared to the placebo group after treatment, especially in general symptoms and practical problems subscales. However the endoscopic disease-severity score and fungus culture rate were not significantly different between groups after treatment. Conclusions： The Chinese-version of RSOM-31 was proved to be a convenient and valid tool for evaluating the CRS health status and quality of life. Patients with amphotericin B nasal irrigation in the described dosing and time schedule appear to be both safe and effective and have better life quality compared to placebo. Keywords: Chronic rhinosinusitis, Quality of life, RSOM-31, Nasal irrigation, Amphotericin B