Meltzer E O
Ann Allergy Asthma Immunol. 1998 Aug;81(2):128-34. doi: 10.1016/S1081-1206(10)62798-6.
Intranasal corticosteroids are among the most effective treatments for perennial allergic rhinitis (PAR). Some individuals unable to tolerate aerosols may prefer an aqueous nasal spray.
To determine the efficacy, safety, and antiinflammatory effects of an intranasal aqueous pump spray formulation of budesonide.
Four hundred seventy-eight patients [257 adults, 221 children (6 to 17 years)] with PAR were randomized to budesonide aqueous pump spray (Rhinocort Aqua) 32, 64, 128, or 256 microg, or placebo once daily for 6 weeks. Patients recorded nasal/ocular symptom severity daily. Nasal cytology was evaluated at baseline and end of treatment. The study was powered only to evaluate the overall population for significance.
Following 6 weeks of treatment, significant differences from baseline in nasal index score (NIS)--sum of blocked nose, runny nose, and sneezing scores--were observed in the 32-, 64-, and 256-microg aqueous budesonide groups compared with placebo (P < or = .031). No dose response was found for changes in NIS. Significant reductions from baseline NIS were observed with 256-microg aqueous budesonide compared with placebo in the first 24 hours following treatment (P = .004). Aqueous budesonide also significantly reduced individual nasal symptoms in two or more of the active treatment groups (P < or = .035). Patients' overall treatment efficacy assessments showed significantly greater symptom control with aqueous budesonide (P < or = .006), and overall quality of life improved. Significantly greater decreases in eosinophils and basophils were found in aqueous budesonide-treated groups (P < or = .007). The frequency of adverse events was similar among all treatments.
Once daily aqueous budesonide is well tolerated and effective in relieving nasal symptoms and inflammation associated with PAR.
鼻内用皮质类固醇是治疗常年性变应性鼻炎（PAR）最有效的方法之一。一些无法耐受气雾剂的患者可能更喜欢水性鼻喷雾剂。
确定布地奈德鼻内用水泵喷雾制剂的疗效、安全性和抗炎作用。
478例PAR患者[257例成人，221例儿童（6至17岁）]被随机分为接受32、64、128或256微克布地奈德水性泵喷雾剂（雷诺考特水剂型），或安慰剂，每日一次，共6周。患者每天记录鼻/眼症状的严重程度。在基线和治疗结束时评估鼻细胞学。该研究仅旨在评估总体人群的显著性。
治疗6周后，与安慰剂相比，32微克、64微克和256微克布地奈德水剂型组的鼻指数评分（NIS）（鼻塞、流涕和打喷嚏评分之和）与基线相比有显著差异（P≤0.031）。未发现NIS变化的剂量反应。与安慰剂相比，治疗后最初24小时内，256微克布地奈德水剂型组的NIS较基线有显著降低（P = 0.004）。在两个或更多活性治疗组中，布地奈德水剂型也显著减轻了个体鼻症状（P≤0.035）。患者对总体治疗效果的评估显示，布地奈德水剂型对症状的控制显著更好（P≤0.006），总体生活质量得到改善。布地奈德水剂型治疗组的嗜酸性粒细胞和嗜碱性粒细胞显著减少（P≤0.007）。所有治疗中不良事件的发生率相似。
每日一次的布地奈德水剂型耐受性良好，可有效缓解与PAR相关的鼻症状和炎症。
