糠酸莫米松鼻喷剂治疗非变应性鼻炎的多中心临床研究

摘要

目的 评价糠酸莫米松鼻喷剂连续3个月治疗非变应性鼻炎(non-allergic rhinitis,NAR)的临床结局.方法 采用多中心队列研究设计,从国内8家医院选择NAR患者,给予糠酸莫米松鼻喷剂治疗,每日1次,每侧鼻孔2喷,每喷50μg,连续使用3个月.在治疗前、治疗后1个月、治疗后3个月,分别应用总体症状等级评定量表、分类症状视觉模拟量表、鼻内镜检查等方法 ,对患者的总体症状、分类症状和鼻腔黏膜形态等临床结局进行全面评估,同时对发生的药物不良事件进行分析.采用SPSS 16.0软件进行数据分析.结果 8家医院共计纳入188例NAR合格病例进行临床观察.总体症状评估:治疗前为(2.67±0.68)分、治疗后1个月为(1.70±0.75)分、治疗后3个月为(0.95±0.79)分,3次评分依次出现明显下降(Z值范围-11.603～-10.491,P值均<0.01).分类症状评估:治疗前、治疗后1个月、治疗后3个月的分类症状,包括鼻塞程度、鼻涕增多、与鼻塞有关的头昏头痛、与鼻塞有关的嗅觉减退、影响睡眠质量、影响日常生活、影响工作与学习、影响精神状态等症状的评分,均依次出现明显下降(Z值范围-11.313～-6.802,P值均<0.01);鼻内镜评估:治疗前为(2.27±0.73)分、治疗后1个月为(1.40±0.62)分、治疗后3个月为(0.75±0.71)分,3次评分依次出现明显下降(Z值范围-11.484～-10.002,P值均<0.01).药物不良事件:治疗3个月期间不良事件发生率5.3%(10/188),主要是轻度涕血和鼻腔干燥,无严重不良事件.结论 糠酸莫米松鼻喷剂连续治疗3个月能安全有效地改善NAR患者的临床症状与鼻黏膜形态.%Objective To evaluate the outcome of mometasone furoate nasal spray (MFNS) used for 3 months on non-allergic rhinitis (NAR). Methods In this multicenter study, NAR patients were enrolled from eight hospitals and received MFNS 200 microgram once daily for 3 months. The patients were followed-up for three times (at baseline, month 1 and month 3) to record the symptom scores and nasal endoscopic appearances. At the same time, the adverse events frequency was recorded and analyzed.Results A total of 188 NAR cases were enrolled in the study. The total nasal symptom score assessment descended significantly at month 1 (1.70 ± 0. 75) and month 3 (0. 95 ± 0. 79) visits versus at baseline (2. 67 ± 0. 68, Z value were from - 11. 603 to - 10. 491, all P < 0. 01). The individual symptoms,including nasal stuffiness, nasal discharge, nasal stuffiness-related dizziness or headache, hyposmia, sleep quality, daily life activity, work or study efficiency, mental status, and whole body fatigue, also showed less scores at month 1 and month 3 visits versus at baseline (Z value were from - 11. 313 to - 6. 802, all P <0. 01). At the same time, nasal mucosal appearances assessed by endoscopy had lower scores at month 1 (1.40±0. 62) and month 3 (0. 75 ± 0. 71) visits versus at baseline (2. 27 ± 0. 73, Z value were from - 11. 484 to - 10. 002, all P <0. 01). Additionally, adverse events were only observed in 5. 3% cases with light rhinorrhagia and nasal dryness. No other side effect was found. Conclusions A 3-months administration of intranasal mometasone can effectively and safely improve NAR patients' clinical symptom and nasal mucosal appearances.