艾思瑞科室会(贵阳年会).pptVIP

* （国家卫生与临床技术优化研究所） * （来自欧盟EMA网站的InterMune公司的吡非尼酮信息）。 * * The distribution of PFS time was compared between the high-dose and placebo groups with the log-rank test, and a significant difference was found (p50.0280; fig. 4). In addition, a marginally significant difference was found in the distribution between the low-dose and placebo groups (p50.0655).吡非尼酮高剂量组显著延长了PFS，有统计学显著差异 (p=0.0280)。 吡非尼酮低剂量组也延长了PFS，接近统计学显著差异(p=0.0655)。 因此，吡非尼酮治疗IPF可以延长无进展生存期（PFS）。 * 高剂量组比安慰剂组更明显出现： 光过敏、食欲不振, 头昏 和升高的谷氨酰基转肽酶 (g-GTP) 。 低剂量组比安慰剂组更明显出现： 光过敏、皮脂缺乏性湿疹、腹部不适和白细胞下降。 相反，安慰剂组比吡非尼酮组更明显出现： 呼吸道感染，譬如鼻咽炎和上呼吸道炎症。 * The percentages of patients with diagnoses of idiopathic pulmonary fibrosis within 1 year, on supplemental oxygen, and enrolment at US sites were higher in study 006 than in study 004 (table 1). 713 (92%) of 779 patients met criteria for definite idiopathic pulmonary fi brosis with HRCT; 391 (50%) underwent surgical lung biopsy, with 372 (95%) having definite usual interstitial pneumonia. The 2403 mg/day dose was derived by normalisation of the 1800 mg/day dose used in the Japanese studies to the predicted bodyweights of the predominantly US-based study population. Concomitant treatments for idiopathic pulmonary fibrosis were prohibited, with exceptions for short courses of azathioprine, cyclophosphamide ,corticosteroids, or acetylcysteine for protocol defined acute exacerbation of idiopathic pulmonary fibrosis, acute respiratory decompensation呼吸代偿障碍, or progression of disease Secondary efficacy endpoints were categorical FVC (5-level scale), progression-free survival (time to confirmed ≥10% decline in percentage predicted FVC, ≥15% decline in percentage predicted DLco or death), worsening idiopathic pulmonary fibrosis (time to acute exacerbation, death, lung transplantation, or admission to hospital for respiratory problems), dyspnoea (University of California San Diego Shortness of Breath Questionnaire),15 6MWT distance, worst peripheral oxygen saturation (SpO2)