Gustafsson P, Tsanakas J, Gold M, Primhak R, Radford M, Gillies E
Department of Paediatrics, University Hospital, Linkoping, Sweden.
Arch Dis Child. 1993 Aug;69(2):206-11. doi: 10.1136/adc.69.2.206.
This study was designed to compare the efficacy and safety of a new inhaled corticosteroid, fluticasone propionate at a total daily dose of 200 micrograms, with beclomethasone dipropionate 400 micrograms/day in childhood asthma. A total of 398 asthmatic children (aged 4-19 years) were randomised to receive either fluticasone propionate 200 micrograms daily or beclomethasone dipropionate 400 micrograms daily for six weeks inhaled via a spacer device from a metered dose inhaler. During the study the patients recorded morning and evening peak expiratory flow rate (PEFR), symptom scores, and use of beta 2 agonist rescue medication. In addition, clinic visit PEFR and forced expiratory volume in one second were measured. Safety was assessed by recording all adverse events and by performing routine biochemistry and haematology screens including plasma cortisol concentration before and after treatment. For the purposes of analysis the diary card data were grouped into three periods: week 3 (days 15-21), week 6 (days 36-42), and weeks 1-6 (days 1-42). The results showed no significant difference between treatments on most efficacy parameters. However, there were significant differences in changes from baseline in favour of fluticasone propionate for % predicted morning PEFR both at week 3 (fluticasone propionate 6.1%, beclomethasone dipropionate 3.9%) and at week 6 (fluticasone propionate 8.3%, beclomethasone dipropionate 5. 9%) and % predicted evening PEFR at week 6 (fluticasone propionate 7.3%, beclomethasone dipropionate 4.9% and over weeks 1-6 (fluticasone propionate 5.5%, beclomethasone dipropionate 3.6%. Comparison between groups showed that the group receiving fluticasone propionate had a lower % of days with symptom-free exercise at week 6 (fluticasone propionate 87%, beclomethasone dipropionate 81%) and % days without rescue medication at week 6 (fluticasone propionate 87%, beclomethasone dipropionate 80%) and over weeks 1-6 (fluticasone propionate 80%, beclomethasone dipropionate 73%). Except for a higher incidence of sore throat in the fluticasone propionate group, the two treatments did not differ with regard to safety. There was no evidence of adrenal suppression with either treatment. In conclusion, fluticasone propionate 200 microgram daily ws at least as effective and as well tolerated as beclomethasone dipropionate 400 microgram daily in childhood asthma.
本研究旨在比较一种新型吸入性皮质类固醇丙酸氟替卡松（每日总剂量200微克）与二丙酸倍氯米松（每日400微克）用于儿童哮喘的疗效和安全性。共有398名哮喘儿童（年龄4 - 19岁）被随机分组，分别接受每日200微克丙酸氟替卡松或每日400微克二丙酸倍氯米松治疗，通过定量气雾剂经储物罐吸入，为期六周。在研究期间，患者记录早晚的呼气峰值流速（PEFR）、症状评分以及β2激动剂急救药物的使用情况。此外，还测量了门诊就诊时的PEFR和一秒用力呼气量。通过记录所有不良事件以及进行包括治疗前后血浆皮质醇浓度在内的常规生化和血液学检查来评估安全性。为了分析目的，将日记卡数据分为三个时间段：第3周（第15 - 21天）、第6周（第36 - 42天）以及第1 - 6周（第1 - 42天）。结果显示，在大多数疗效参数上，两种治疗方法之间无显著差异。然而，在第3周（丙酸氟替卡松6.1%，二丙酸倍氯米松3.9%）和第6周（丙酸氟替卡松8.3%，二丙酸倍氯米松5.9%）时，预测的早晨PEFR自基线的变化方面，以及在第6周（丙酸氟替卡松7.3%，二丙酸倍氯米松4.9%）和第1 - 6周（丙酸氟替卡松5.5%，二丙酸倍氯米松3.6%）时，预测的晚上PEFR自基线的变化方面，丙酸氟替卡松组均显著优于二丙酸倍氯米松组。组间比较显示，接受丙酸氟替卡松治疗的组在第6周无症状锻炼天数的百分比更低（丙酸氟替卡松87%，二丙酸倍氯米松81%），在第6周无需急救药物天数的百分比更低（丙酸氟替卡松87%，二丙酸倍氯米松80%），在第1 - 6周也是如此（丙酸氟替卡松80%，二丙酸倍氯米松73%）。除了丙酸氟替卡松组喉咙痛的发生率较高外，两种治疗方法在安全性方面无差异。两种治疗均未发现肾上腺抑制的证据。总之，在儿童哮喘中，每日200微克丙酸氟替卡松至少与每日400微克二丙酸倍氯米松疗效相当且耐受性良好。
