Tos M, Svendstrup F, Arndal H, Orntoft S, Jakobsen J, Borum P, Schrewelius C, Larsen P L, Clement F, Barfoed C, Rømeling F, Tvermosegaard T
ENT Department, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.
Am J Rhinol. 1998 May-Jun;12(3):183-9. doi: 10.2500/105065898781390217.
Nasal polyps are commonly treated surgically. Intranasal administration of topical corticosteroids has gained increased acceptance as a treatment alternative. The aim of our study was to compare the efficacy of treatment of two formulations of budesonide with placebo on nasal polyps. At four Danish clinics 138 patients suffering from moderate or severe nasal polyps were randomized to a twice daily treatment with Rhinocort Aqua 128 micrograms, Rhinocort Turbuhaler 140 micrograms or placebo (Astra Draco, Sweden) for 6 weeks. Polyp size (primary efficacy variable), nasal symptoms, sense of smell, and patients' overall evaluation of treatment of efficacy were assessed by scores. Polyp size was reduced significantly in both budesonide treated groups compared with placebo, but there was no statistical difference between the two actively treated groups. Patients' nasal symptom scores was significantly more reduced in the Aqua compared to the Turbuhaler treated group, and both reduced symptom scores were significantly better compared to placebo. Sense of smell was significantly improved in the actively treated groups compared to placebo. The proportion of patients rating substantial or total control over symptoms after 6 weeks treatment was 60.9% and 48.2% in the Aqua and Turbuhaler-treated groups, respectively, which was significantly better compared with 29.8% in the placebo-treated group. Rhinocort Aqua and Rhinocort Turbuhaler were equally well tolerated.
鼻息肉通常采用手术治疗。鼻内局部应用皮质类固醇作为一种替代治疗方法已越来越被认可。我们研究的目的是比较两种布地奈德制剂与安慰剂治疗鼻息肉的疗效。在丹麦的四家诊所,138例患有中度或重度鼻息肉的患者被随机分为每日两次接受128微克的雷诺考特水性鼻喷雾剂、140微克的雷诺考特都保或安慰剂(瑞典阿斯特拉·德拉科公司)治疗,为期6周。通过评分评估息肉大小(主要疗效变量)、鼻部症状、嗅觉以及患者对治疗效果的总体评价。与安慰剂相比,两个布地奈德治疗组的息肉大小均显著减小,但两个积极治疗组之间无统计学差异。与都保治疗组相比,水性鼻喷雾剂治疗组患者的鼻部症状评分显著降低,且两组降低的症状评分均显著优于安慰剂组。与安慰剂相比,积极治疗组的嗅觉显著改善。在水性鼻喷雾剂和都保治疗组中,治疗6周后对症状有显著或完全控制的患者比例分别为60.9%和48.2%,显著优于安慰剂治疗组的29.8%。雷诺考特水性鼻喷雾剂和雷诺考特都保的耐受性相当。