Adams N, Bestall J M, Lasserson T J, Jones P W
Cochrane Database Syst Rev. 2005 Apr 18(2):CD002310. doi: 10.1002/14651858.CD002310.pub3.
Beclomethasone dipropionate (BDP) and budesonide (BUD) are commonly prescribed inhaled corticosteroids for the treatment of asthma. Fluticasone propionate (FP) is newer agent with greater potency in in-vitro assays.
To compare the efficacy and safety of Fluticasone to Beclomethasone or Budesonide in the treatment of chronic asthma.
We searched the Cochrane Airways Group trial register (January 2004) and reference lists of articles. We contacted trialists and pharmaceutical companies for additional studies and searched abstracts of major respiratory society meetings (1997 to 2003).
Randomised trials in children and adults comparing Fluticasone to either Beclomethasone or Budesonide in the treatment of chronic asthma.
Two reviewers independently assessed articles for inclusion and methodological quality. One reviewer extracted data. Quantitative analyses were undertaken using RevMan analyses 1.0.1.
Fifty six studies (12, 119 participants) met the inclusion criteria. Methodological quality was variable. Dose ratio 1:2: FP produced a significantly greater FEV1 (0.14 litres, 95% Confidence Interval (CI) 0.06 to 0.22), morning PEF (11.10 L/min, 95%CI 3.12 to 19.09 L/min) and evening PEF (9.31 L/min, 95%CI 5.12 to 13.5 L/min). This applied to all drug doses, age groups, and delivery devices. No difference between FP and BDP/BUD were seen for trial withdrawals. Symptoms and rescue medication use were widely reported but few trials provided sufficient data for analysis. When given at half the dose of BDP/BUD, FP led to a greater likelihood of pharyngitis. There was no difference in the likelihood of oral candidiasis. Plasma cortisol and 24 hour urinary cortisol was measured frequently but data presentation was limited. Dose ratio 1:1: FP produced a statistically significant difference in am PEF (9.58 L/min (95% CI 5.20 to 13.97)), pm PEF (7.41 L/min (95% CI 2.61 to 12.22)), and FEV1 (0.09 L (0.02 to 0.17)). The effects on exacerbations were mixed. There was an increase in the incidence of hoarseness, but no significant difference in pharyngitis, candidiasis, or cough.
AUTHORS' CONCLUSIONS: Fluticasone given at half the daily dose of beclomethasone or budesonide leads to small improvements in measures of airway calibre, but it appears to have a higher risk of causing hoarseness when given at the same daily dose. Future studies should attempt to establish the relative efficacy of inhaled steroids delivered with CFC-free propellants.
二丙酸倍氯米松(BDP)和布地奈德(BUD)是治疗哮喘常用的吸入性糖皮质激素。丙酸氟替卡松(FP)是一种新型药物,在体外试验中效力更强。
比较氟替卡松与倍氯米松或布地奈德治疗慢性哮喘的疗效和安全性。
我们检索了Cochrane Airways Group试验注册库(2004年1月)及文章的参考文献列表。我们联系了试验研究者和制药公司以获取更多研究,并检索了主要呼吸学会会议(1997年至2003年)的摘要。
比较氟替卡松与倍氯米松或布地奈德治疗慢性哮喘的儿童和成人随机试验。
两名评价者独立评估文章是否纳入及方法学质量。一名评价者提取数据。使用RevMan分析1.0.1进行定量分析。
56项研究(12119名参与者)符合纳入标准。方法学质量参差不齐。剂量比1:2时,FP使第一秒用力呼气容积(FEV1)显著增加更多(0.14升,95%置信区间(CI)0.06至0.22),晨间呼气峰值流速(PEF)增加更多(11.10升/分钟,95%CI 3.12至19.09升/分钟),晚间PEF增加更多(9.31升/分钟,95%CI 5.12至13.5升/分钟)。这适用于所有药物剂量、年龄组和给药装置。在试验退出方面,未发现FP与BDP/BUD之间存在差异。症状和急救药物使用情况报告广泛,但很少有试验提供足够数据进行分析。当给予FP的剂量为BDP/BUD的一半时,FP导致咽炎的可能性更大。口腔念珠菌病的可能性没有差异。血浆皮质醇和24小时尿皮质醇经常进行测量,但数据呈现有限。剂量比1:1时,FP在上午PEF(9.58升/分钟(95%CI 5.20至13.97))、下午PEF(7.41升/分钟(95%CI 2.61至12.22))和FEV1(0.09升(0.02至0.17))方面产生了统计学显著差异。对病情加重的影响不一。声音嘶哑的发生率有所增加,但在咽炎、念珠菌病或咳嗽方面无显著差异。
给予氟替卡松的日剂量为倍氯米松或布地奈德的一半时,气道管径测量指标有小幅改善,但在相同日剂量下,它似乎导致声音嘶哑的风险更高。未来研究应尝试确定使用无氯氟烃推进剂递送的吸入性糖皮质激素的相对疗效。