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首页> 外文期刊>BMC Rheumatology >A prospective, open-label, non-comparative study of ambrisentan with anti-fibrotic agent combination therapy in the treatment of diffuse systemic sclerosis
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A prospective, open-label, non-comparative study of ambrisentan with anti-fibrotic agent combination therapy in the treatment of diffuse systemic sclerosis

机译：Ambrisentan与抗纤维化剂联合疗法治疗弥漫性全身性硬化的前瞻性，开放性，非对照研究

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Systemic Sclerosis is a multifactorial autoimmune rheumatic disease characterized by inflammation, fibrosis, immune dysregulation and vascular dysfunction. An open label, prospective, non-comparative study evaluating ambrisentan with an antifibrotic agent in diffuse cutaneous systemic sclerosis (dcSSc). Recruited 15 consecutive patients with dcSSc who were already on a stable dose of an antifibrotic agent and if they met inclusion criteria they were initiated on ambrisentan 5 mg/day for 12 months. Primary outcome measure was the modified Rodnan skin score (mRSS) while secondary measures were the short form 36 (SF-36) questionnaire, the Medsger severity score and pulmonary function studies. Fifteen patients were recruited and ten patients completed all 12 months of the study. An intention to treat was used to analyze the data. There was statistical improvement of the mean mRSS and the perceived change in health component of the SF-36. The Medsger severity score and pulmonary function studies remained unchanged over the course of the study. Patients who tolerated the combination of an antifibrotic with ambrisentan had an improvement of their mRSS over the course of the study as well as an improvement of their perceived health. Clinicaltrials.gov, NCT01093885; March 2010.
机译：系统性硬化症是一种多因素的自身免疫性风湿性疾病，其特征在于炎症，纤维化，免疫失调和血管功能障碍。一项开放性，前瞻性，非对照性研究，评估了安布森坦与抗纤维化剂治疗弥漫性皮肤系统性硬化症（dcSSc）的情况。连续招募了15名已经使用稳定剂量的抗纤维化药物的dcSSc患者，如果符合纳入标准，则开始使用伏地生坦5 mg /天的治疗，持续12个月。主要结果指标是改良的Rodnan皮肤评分（mRSS），而次要指标是简短的36（SF-36）问卷，Medsger严重程度评分和肺功能研究。招募了15名患者，并且有12名患者完成了全部12个月的研究。治疗意图用于分析数据。统计表明，平均mRSS改善了，SF-36的健康状况发生了明显变化。 Medsger严重程度评分和肺功能研究在研究过程中保持不变。在研究过程中，耐受抗纤维化药物与安布森坦联合使用的患者的mRSS有所改善，并且其感知的健康状况也有所改善。 Clinicaltrials.gov，NCT01093885; 2010年3月。

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