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法德兩公司聯(lián)合開發(fā)吸入皮質(zhì)內(nèi)固醇

【?2005-07-09 發(fā)布?】 美迪醫(yī)訊
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最新資料顯示:一種實驗性吸入皮質(zhì)內(nèi)固醇能夠顯著減少嚴重持續(xù)哮喘成年患者的口服皮質(zhì)內(nèi)固醇用量,同時能夠維持對哮喘癥狀的控制。2005年5月美國圣地亞哥舉行的美國胸科學(xué)會國際會上報道了這些資料。

Alvesco (ciclesonide)是一種吸入皮質(zhì)內(nèi)固醇,具有新型釋放和分布特性。吸入皮質(zhì)內(nèi)固醇能夠減輕肺部和氣道的炎癥,這些炎癥導(dǎo)致了疾病過程。

在一項為期12周的多國多中心141例嚴重持續(xù)哮喘患者的III期臨床試驗中,評估了口服皮質(zhì)內(nèi)固醇(OCS)用量減少以及環(huán)索奈德(CIC)替代治療的效果。結(jié)果顯示大約有30%使用環(huán)索奈德治療的患者能夠完全無需使用OCS。與安慰劑相比較,所有劑量的環(huán)索奈德都減少了OCS的基礎(chǔ)用量。相似的是,OCS給藥也能夠顯著改變環(huán)索奈德治療患者。最常報道的不良事件是鼻咽炎、頭痛和上呼吸道感染。

國家猶太醫(yī)療和研究中心教授Sally E. Wenzel說:“這些結(jié)果十分重要,因為口服皮質(zhì)內(nèi)固醇例如強的松能夠產(chǎn)生嚴重的系統(tǒng)不良事件,而這可以通過使用吸入皮質(zhì)內(nèi)固醇來減少。我們的研究結(jié)果發(fā)現(xiàn):嚴重持續(xù)哮喘患者使用環(huán)索奈德治療能夠顯著降低口服皮質(zhì)內(nèi)固醇的使用。”

環(huán)索奈德是由法國Sanofi-aventis公司和德國Altana Pharma公司聯(lián)合研制開發(fā)的。 

Compound Reduces Oral Corticosteroid Use
 
New data show that an investigational inhaled corticosteroid can significantly reduce the use of oral corticosteroids in adults with severe, persistent asthma while maintaining asthma control. The data were presented at the International Conference of the American Thoracic Society in San Diego (CA, USA) in May 2005.

Alvesco (ciclesonide) is an inhaled corticosteroid with novel release and distribution properties. Inhaled corticosteroids work by reducing inflammation, the underlying disease process, in the lungs and airways.

The reduction of oral corticosteroid (OCS) use with the replacement of ciclesonide (CIC) was evaluated in a phase III, 12-week multinational, multicenter trial involving 141 patients with severe, persistent asthma. Results showed that about 30% of patients treated with ciclesonide were able to eliminate their OCS use entirely. All ciclesonide doses resulted in a significant percent change from baseline in OCS dose compared to placebo. Similarly, OCS dose was significantly changed from baseline in ciclesonide-treated patients. The most frequently reported adverse events were nasopharyngitis, headache, and upper respiratory tract infection.

“These findings are important because oral corticosteroids such as prednisone are known to cause systemic adverse events, which can be reduced by replacing them with inhaled corticosteroids,” said Sally E. Wenzel, M.D., professor at the National Jewish Medical and Research Center (Denver, Colorado). “Our study found a significant reduction in the need for oral corticosteroid use by patients with severe, persistent asthma who were treated with ciclesonide.”

Ciclesonide was jointly developed by the Sanofi-aventis Group (Paris, France) and Altana Pharma (Konstanz, Germany).

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