University of Cologne, Institute of Medical Statistics, Informatics and Epidemiology, Medical Faculty, University at Cologne, 50924 Cologne, Germany.
Adv Ther. 2011 Mar;28(3):238-49. doi: 10.1007/s12325-010-0105-7. Epub 2011 Feb 3.
This study evaluated the efficacy and safety of mometasone furoate nasal spray (MFNS) in patients with chronic sinusitis.
In this double-blind, placebocontrolled, multicenter, parallel-group study, 60 patients with persistent sinusitis symptoms were randomized to receive either MFNS 200 μg twice daily or placebo, for 16 weeks (112 days). Eventually, 53 patients terminated the study in regular course.
Total Symptom Scores (TSS) in patients receiving MFNS changed by a mean of -7.27 (95% CI -9.71, -4.84), versus -5.35 (95% CI -6.73, -3.96) in the placebo group (P=0.51). MFNS reduced nasal congestion and discharge scores, and improved patients' olfactory function. There were few side effects. Considerably more patients in the MFNS group were satisfied with the treatment than those who had received placebo (P<0.05). Also, more patients would take the medication again in the event of symptoms, compared with those who had taken placebo (P<0.05). Furthermore, the MFNS patients would recommend it to others.
The positive patient assessment and few side effects are reflected in the efficacy evaluation performed by the physicians. The endoscopic results under MFNS were always numerically more favorable than those under placebo, and the overall difference reached statistical significance (P<0.01). MFNS offers an effective and safe treatment for chronic rhinosinusitis.
本研究评估了糠酸莫米松鼻喷雾剂（MFNS）在慢性鼻窦炎患者中的疗效和安全性。
在这项双盲、安慰剂对照、多中心、平行组研究中，60 名持续有鼻窦炎症状的患者被随机分为 MFNS 200μg 每日 2 次组或安慰剂组，治疗 16 周（112 天）。最终，53 名患者按计划退出研究。
接受 MFNS 治疗的患者总症状评分（TSS）平均变化为-7.27（95%CI-9.71，-4.84），而安慰剂组为-5.35（95%CI-6.73，-3.96）（P=0.51）。MFNS 降低了鼻塞和流涕评分，改善了患者的嗅觉功能。副作用较少。接受 MFNS 治疗的患者中，有更多的人对治疗感到满意，而接受安慰剂治疗的患者则较少（P<0.05）。此外，与接受安慰剂治疗的患者相比，更多的患者在出现症状时会再次服用该药（P<0.05）。此外，MFNS 患者会将其推荐给他人。
患者的积极评估和较少的副作用反映在医生进行的疗效评估中。MFNS 下的内镜结果始终比安慰剂下的结果更有利，总体差异具有统计学意义（P<0.01）。MFNS 为慢性鼻-鼻窦炎提供了一种有效且安全的治疗方法。
