Dyer Matthew J, Halpin David M G, Stein Ken
Peninsula Medical School, University of Exeter, UK.
BMC Fam Pract. 2006 Jun 5;7:34. doi: 10.1186/1471-2296-7-34.
Ciclesonide is a new inhaled corticosteroids licensed for the prophylactic treatment of persistent asthma in adults. Currently beclomethasone dipropionate, budesonide and fluticasone propionate are the most commonly prescribed inhaled corticosteroids for the treatment of asthma but there has been no systematic review comparing the effectiveness and safety ciclesonide to these agents. We therefore aimed to systematically review published randomised controlled trials of the effectiveness and safety of ciclesonide compared to alternative inhaled corticosteroids in people with asthma.
We performed literature searches on MEDLINE, EMBASE, PUBMED, the COCHRANE LIBRARY and various Internet evidence sources for randomised controlled trials or systematic reviews comparing ciclesonide to beclomethasone or budesonide or fluticasone in adult humans with persistent asthma. Data was extracted by one reviewer.
Five studies met the inclusion criteria. Methodological quality was variable. There were no trials comparing ciclesonide to beclomethasone. There was no significant difference between ciclesonide and budesonide or fluticasone on the following outcomes: lung function, symptoms, quality of life, airway responsiveness to a provoking agent or inflammatory markers. However, the trials were very small in size, increasing the possibility of a type II error. One trial demonstrated that the combined deposition of ciclesonide (and its active metabolite) in the oropharynx was 47% of that of budesonide while another trial demonstrated that the combined deposition of ciclesonide (and its active metabolite) in the oropharynx was 53% of that of fluticasone. One trial demonstrated less suppression of cortisol in overnight urine collection after ciclesonide compared to fluticasone (geometric mean fold difference = 1.5, P < 0.05) but no significant difference in plasma cortisol response.
There is very little evidence comparing CIC to other ICS, restricted to very small, phase II studies of low power. These demonstrate CIC has similar effectiveness and efficacy to FP and BUD (though equivalence is not certain) and findings regarding oral deposition and HPA suppression are inconclusive. There is no direct comparative evidence that CIC causes fewer side effects since none of the studies reported patient-based outcomes.
环索奈德是一种新型吸入性皮质类固醇药物，已获许可用于成人持续性哮喘的预防性治疗。目前，二丙酸倍氯米松、布地奈德和丙酸氟替卡松是治疗哮喘最常用的吸入性皮质类固醇药物，但尚无系统评价比较环索奈德与这些药物的有效性和安全性。因此，我们旨在系统评价已发表的关于环索奈德与其他吸入性皮质类固醇药物治疗哮喘有效性和安全性的随机对照试验。
我们在MEDLINE、EMBASE、PUBMED、Cochrane图书馆及各种互联网证据来源上进行文献检索，查找比较环索奈德与二丙酸倍氯米松、布地奈德或丙酸氟替卡松治疗成人持续性哮喘的随机对照试验或系统评价。由一名评价者提取数据。
五项研究符合纳入标准。方法学质量参差不齐。没有将环索奈德与二丙酸倍氯米松进行比较的试验。在以下结局方面，环索奈德与布地奈德或丙酸氟替卡松之间没有显著差异：肺功能、症状、生活质量、气道对激发剂的反应性或炎症标志物。然而，这些试验规模非常小，增加了Ⅱ类错误的可能性。一项试验表明，环索奈德（及其活性代谢物）在口咽部的联合沉积量是布地奈德的47%，而另一项试验表明，环索奈德（及其活性代谢物）在口咽部的联合沉积量是丙酸氟替卡松的53%。一项试验表明，与丙酸氟替卡松相比，环索奈德治疗后过夜尿皮质醇抑制作用较小（几何平均倍数差异=1.5，P<0.05），但血浆皮质醇反应无显著差异。
与其他吸入性皮质类固醇药物比较，环索奈德的证据非常少，仅限于规模非常小、低效能的Ⅱ期研究。这些研究表明，环索奈德与丙酸氟替卡松和布地奈德具有相似的有效性和疗效（尽管等效性不确定），关于口咽部沉积和下丘脑-垂体-肾上腺轴抑制的研究结果尚无定论。没有直接的比较证据表明环索奈德的副作用更少，因为没有研究报告基于患者的结局。
