Kivisaari E, Baker R C, Price M J
Lääkärikeskus ITE, Siltakatu 10 A, Joensuu, Finland.
Clin Exp Allergy. 2001 Jun;31(6):855-63. doi: 10.1046/j.1365-2222.2001.01097.x.
Previous studies comparing the corticosteroids fluticasone propionate (FP) and budesonide (BUD) in both perennial and seasonal rhinitis have shown no consistent difference between treatments. However, the therapeutic outcomes may have been influenced by study design.
To compare the effect of FP aqueous nasal spray (ANS; 200 microg/day) with BUD reservoir powder device (RPD; 200 microg/day) on rhinitis symptoms, productivity loss and device preference in patients with perennial rhinitis.
After a 2-week run-in period, 440 patients were randomized to receive either FPANS, BUD RPD or matched placebo (ANS or RPD) for 8 weeks, followed by an open-label 4-week follow-up treatment with FPANS. Patients completed diary card visual analogue scores for nasal symptoms, and questionnaires on satisfaction with the treatment and preferred choice of device.
During weeks 1-4, the visual analogue total nasal symptom scores (VATNS) in the FPANS group were significantly lower than scores in the BUD RPD group (mean difference = -17.8; 95% CI = -34.4, -1.3; P = 0.036). FPANS also significantly reduced the VATNS compared with the ANS placebo at all time-points assessed (P < or = 0.005). BUD RPD did not significantly differ from the RPD placebo at weeks 5-8 (P = 0.167), or the ANS placebo at any time-point (P < or = 0.151). Over the 8-week treatment period FPANS was significantly more effective than BUD RPD at reducing sneezing (mean difference = -4.4; 95% CI = -8.6, -0.3; P = 0.036) and nasal itching (mean difference = -5.3; 95% CI = -9.9, -0.8; P = 0.022), and was significantly superior to the ANS placebo for all symptoms assessed at weeks 1-4 and 1-8 (P < 0.016). At the same time-points BUD RPD was no better at alleviating nasal itching than the RPD placebo (P < or = 0.306), and compared with the ANS placebo, significantly reduced only one symptom; nasal blockage (P < or = 0.016). After 8 weeks of treatment, patients preferred the ANS device to the RPD (P < 0.001), and at 12 weeks a significantly greater number of patients were satisfied with FPANS treatment compared with BUD RPD (P = 0.0019) or the respective placebos (P = 0.0001).
FPANS and BUD RPD are effective therapies with a good safety profile for the treatment of perennial rhinitis but, in this direct placebo-controlled comparison, FPANS was more efficacious than BUD RPD, and the patients preferred the ANS device to the RPD.
既往比较丙酸氟替卡松（FP）和布地奈德（BUD）治疗常年性和季节性鼻炎的研究显示，两种治疗方法之间没有一致的差异。然而，治疗结果可能受到研究设计的影响。
比较FP水基鼻喷雾剂（ANS；200微克/天）与BUD储库干粉吸入器（RPD；200微克/天）对常年性鼻炎患者鼻炎症状、生产力损失和器械偏好的影响。
经过2周的导入期后，440例患者被随机分为接受FP-ANS、BUD-RPD或匹配的安慰剂（ANS或RPD）治疗8周，随后进行为期4周的FP-ANS开放标签随访治疗。患者完成鼻症状的日记卡视觉模拟评分，以及关于治疗满意度和器械首选选择的问卷调查。
在第1-4周期间，FP-ANS组的视觉模拟总鼻症状评分（VATNS）显著低于BUD-RPD组（平均差异=-17.8；95%可信区间=-34.4，-1.3；P=0.036）。在所有评估的时间点，与ANS安慰剂相比，FP-ANS也显著降低了VATNS（P≤0.005）。在第5-8周，BUD-RPD与RPD安慰剂之间无显著差异（P=0.167），在任何时间点与ANS安慰剂之间也无显著差异（P≤0.151）。在8周的治疗期内，FP-ANS在减少打喷嚏（平均差异=-4.4；95%可信区间=-8.6，-0.3；P=0.036）和鼻痒（平均差异=-5.3；95%可信区间=-9.9，-0.8；P=0.022）方面显著比BUD-RPD更有效，并且在第1-4周和1-8周评估的所有症状方面显著优于ANS安慰剂（P<0.016）。在相同时间点，BUD-RPD在缓解鼻痒方面并不比RPD安慰剂更好（P≤0.306），与ANS安慰剂相比，仅显著减轻了一种症状；鼻塞（P≤0.016）。治疗8周后，患者更喜欢ANS器械而不是RPD（P<0.001），并且在12周时，与BUD-RPD（P=0.0019）或各自的安慰剂（P=0.0001）相比，对FP-ANS治疗满意的患者数量显著更多。
FP-ANS和BUD-RPD是治疗常年性鼻炎安全有效的疗法，但在这种直接的安慰剂对照比较中，FP-ANS比BUD-RPD更有效，并且患者更喜欢ANS器械而不是RPD。
