Ease of handling and clinical efficacy of fluticasone propionate Accuhaler/Diskus inhaler compared with the Turbohaler inhaler in paediatric patients. UK Study Group.

J Williams, K A Richards
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Abstract

A total of 323 children aged 4-11 years who were receiving, or had symptoms indicating a clinical requirement for, inhaled corticosteroid at a daily dose of 400 micrograms budesonide (BUD) or beclomethasone dipropionate (BDP), or 200 micrograms fluticasone propionate (FP), were randomised into this multicentre, open-label, parallel group study. Patients received either FP 100 micrograms b.d. administered via the Accuhaler/Diskus inhaler (n = 159) or BUD 200 micrograms b.d. administered via a Turbohaler inhaler (n = 164) for four weeks and recorded daily their morning and evening peak expiratory flow (PEF), asthma symptoms and use of relief medication. Device handling was assessed by a questionnaire, with responses recorded on three- or five-point ordinal scales. The primary efficacy parameter was mean percent predicted morning PEF. The device handling results showed the Accuhaler/Diskus inhaler was rated more favourably than the Turbohaler inhaler in terms of ease of correct inhaler use, ease of telling how many doses were left, ease of knowing whether a dose had been inhaled and overall liking of the device. More patients in the Accuhaler/Diskus group (85%) than in the Turbohaler group (58%) said they would be happy to receive the same device again, while 8% and 25% respectively said they would not be happy to be given it again. In addition, the change from baseline to week 4 of treatment in mean percent predicted morning PEF was greater in the FP Accuhaler/Diskus group, indicating that FP 200 micrograms daily via Accuhaler/Diskus inhaler is at least as clinically effective as BUD 400 micrograms daily via the Turbohaler inhaler.

小儿丙酸氟替卡松Accuhaler/Diskus吸入器与Turbohaler吸入器的易操作性及临床疗效比较英国研究小组。
共有323名4-11岁的儿童接受或有症状表明临床需要吸入皮质类固醇,每日剂量为400微克布地奈德(BUD)或二丙酸倍氯米松(BDP),或200微克丙酸氟替卡松(FP),被随机分为多中心、开放标签、平行组研究。患者通过Accuhaler/Diskus吸入器(n = 159)每天服用100微克的FP,或通过Turbohaler吸入器(n = 164)每天服用200微克的BUD,持续四周,并记录每日早晚呼气峰流量(PEF)、哮喘症状和缓解药物的使用情况。设备处理通过一份问卷进行评估,调查结果按3或5分的顺序记录。主要疗效参数为预测早晨PEF的平均百分比。设备处理结果显示,Accuhaler/Diskus吸入器比Turbohaler吸入器在易于正确使用,易于告诉多少剂量剩余,易于知道剂量是否被吸入和设备的整体喜欢方面被评为更有利。Accuhaler/Diskus组(85%)比Turbohaler组(58%)更多的患者表示他们愿意再次接受相同的设备,而分别有8%和25%的患者表示他们不愿意再次接受相同的设备。此外,从基线到治疗第4周,FP Accuhaler/Diskus组预测早晨PEF的平均百分比的变化更大,这表明每天通过Accuhaler/Diskus吸入器治疗200微克FP与每天通过Turbohaler吸入器治疗400微克BUD的临床效果至少相同。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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