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丙酸氟替卡松鼻喷雾剂治疗鼻息肉病

Fluticasone propionate aqueous nasal spray in the treatment of nasal polyposis.

作者信息

Holmberg K, Juliusson S, Balder B, Smith D L, Richards D H, Karlsson G

机构信息

Department of Otorhinolaryngology, Mölndal Hospital, Sweden.

出版信息

Ann Allergy Asthma Immunol. 1997 Mar;78(3):270-6. doi: 10.1016/s1081-1206(10)63180-8.

DOI:10.1016/s1081-1206(10)63180-8
PMID:9087151
Abstract

BACKGROUND

Topical glucocorticoids are the medical treatment of choice in a majority of patients suffering from nasal polyposis. Fluticasone propionate is a fluorinated steroid reported to be highly effective when used topically in the nose for seasonal and perennial allergic and nonallergic rhinitis.

OBJECTIVES

To evaluate the efficacy and tolerability of intranasal fluticasone propionate in the treatment of long-standing polyposis.

METHODS

Fifty-five patients with long-standing nasal polyposis were treated over a 26-week period with fluticasone propionate aqueous nasal spray 200 micrograms bid, beclomethasone dipropionate aqueous nasal spray 200 micrograms bid or placebo, administered intranasally in an aqueous spray in a double-blind, placebo-controlled parallel-group design at a single center. The primary efficacy endpoint was the physicians' assessment of symptoms and polyp score. Peak nasal inspiratory flow was performed twice daily and on every visit to evaluate the effect of the corticosteroids on nasal air flow.

RESULTS

A significant difference in the primary efficacy endpoint between fluticasone propionate aqueous nasal spray and beclomethasone dipropionate aqueous nasal spray compared with placebo was seen after 14 weeks of treatment. This was further verified by the peak nasal inspiratory flow results. There was some evidence of earlier onset in the fluticasone propionate aqueous nasal spray group compared with the beclomethasone dipropionate aqueous nasal spray group after 4 weeks in terms of the primary efficacy endpoint. From the daily record cards patients receiving fluticasone propionate aqueous nasal spray had a significantly higher percentage of days on which they required no rescue medication (P < .009) and a higher percentage of days with an overall nasal blockage score on waking of < 2 (P < .013) when compared with placebo-treated patients. No other statistically significant results were found between the two active compounds.

CONCLUSION

Fluticasone propionate aqueous nasal spray 200 micrograms bid and beclomethasone dipropionate aqueous nasal spray 200 micrograms bid are effective in treating the symptoms of nasal polyps, with some evidence that fluticasone propionate aqueous nasal spray has a faster onset of action and is tolerated at least as well as beclomethasone dipropionate aqueous nasal spray at the same dose.

摘要

背景

局部用糖皮质激素是大多数鼻息肉患者的首选药物治疗方法。丙酸氟替卡松是一种含氟类固醇,据报道,局部用于鼻腔治疗季节性和常年性变应性及非变应性鼻炎时效果显著。

目的

评估鼻用丙酸氟替卡松治疗长期鼻息肉的疗效和耐受性。

方法

55例长期鼻息肉患者在26周内接受治疗,分别使用200微克/次、每日2次的丙酸氟替卡松水性鼻喷雾剂、200微克/次、每日2次的二丙酸倍氯米松水性鼻喷雾剂或安慰剂,在单一中心采用双盲、安慰剂对照平行组设计,以水性喷雾剂经鼻给药。主要疗效终点是医生对症状和息肉评分的评估。每天进行两次鼻吸气峰流速测量,并在每次就诊时测量,以评估皮质类固醇对鼻气流的影响。

结果

治疗14周后,与安慰剂相比,丙酸氟替卡松水性鼻喷雾剂和二丙酸倍氯米松水性鼻喷雾剂在主要疗效终点上存在显著差异。鼻吸气峰流速结果进一步证实了这一点。就主要疗效终点而言,在4周时,与二丙酸倍氯米松水性鼻喷雾剂组相比,丙酸氟替卡松水性鼻喷雾剂组有更早起效的迹象。与接受安慰剂治疗的患者相比,接受丙酸氟替卡松水性鼻喷雾剂治疗的患者在每日记录卡上显示,无需使用急救药物的天数百分比显著更高(P < 0.009),醒来时总体鼻塞评分<2的天数百分比更高(P < 0.013)。在两种活性化合物之间未发现其他具有统计学意义的结果。

结论

200微克/次、每日2次的丙酸氟替卡松水性鼻喷雾剂和200微克/次、每日2次 的二丙酸倍氯米松水性鼻喷雾剂对治疗鼻息肉症状有效,有证据表明丙酸氟替卡松水性鼻喷雾剂起效更快,且在相同剂量下的耐受性至少与二丙酸倍氯米松水性鼻喷雾剂相同。

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