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法德两公司联合开发吸入皮质内固醇

【 2005-07-09 发布 】 美迪医讯
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最新资料显示:一种实验性吸入皮质内固醇能够显著减少严重持续哮喘成年患者的口服皮质内固醇用量,同时能够维持对哮喘症状的控制。2005年5月美国圣地亚哥举行的美国胸科学会国际会上报道了这些资料。

Alvesco (ciclesonide)是一种吸入皮质内固醇,具有新型释放和分布特性。吸入皮质内固醇能够减轻肺部和气道的炎症,这些炎症导致了疾病过程。

在一项为期12周的多国多中心141例严重持续哮喘患者的III期临床试验中,评估了口服皮质内固醇(OCS)用量减少以及环索奈德(CIC)替代治疗的效果。结果显示大约有30%使用环索奈德治疗的患者能够完全无需使用OCS。与安慰剂相比较,所有剂量的环索奈德都减少了OCS的基础用量。相似的是,OCS给药也能够显著改变环索奈德治疗患者。最常报道的不良事件是鼻咽炎、头痛和上呼吸道感染。

国家犹太医疗和研究中心教授Sally E. Wenzel说:“这些结果十分重要,因为口服皮质内固醇例如强的松能够产生严重的系统不良事件,而这可以通过使用吸入皮质内固醇来减少。我们的研究结果发现:严重持续哮喘患者使用环索奈德治疗能够显著降低口服皮质内固醇的使用。”

环索奈德是由法国Sanofi-aventis公司和德国Altana Pharma公司联合研制开发的。 

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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