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首页> 外文期刊>Journal of Cosmetics, Dermatological Sciences and Applications >Efficacy and Safety of Tinefcon® Tablets in Subjects with Plaque Psoriasis: An Open Label, Non-Comparative, Multicenter, Phase IV Trial
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Efficacy and Safety of Tinefcon® Tablets in Subjects with Plaque Psoriasis: An Open Label, Non-Comparative, Multicenter, Phase IV Trial

机译：Tinefcon＆reg片对斑块状牛皮癣患者的疗效和安全性：开放标签，非比较，多中心，IV期试验

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Importance: This post-marketing surveillance study was conducted to evaluate real-world information about the efficacy and safety of oral Tinefcon? tablets (Sphaeranthus indicus based) in plaque psoriasis patients. Materials and Methods: Patients aged at least 18 years and older with clinical diagnosis of plaque psoriasis, were enrolled in this open label, non-comparative, multicenter trial. All eligible subjects received four 700 mg Tinefcon? tablets/day for 12 weeks. The primary outcome measure was percent change in Psoriasis Area Severity Index (PASI) score from baseline to week 12. The secondary outcome measures were Physician Global Assessment (PGA), Nail Psoriasis Severity Index (NAPSI), Psoriatic Arthritis Evaluation and Gene Expression Profiling and Immunohistochemistry. Results: After completion of Tinefcon? treatment at 12 weeks, more than half of subjects (52%) achieved PASI 50 response; PASI 75 response was attained in 68 (23%) subjects and PASI 90 response in 22 (7%) subjects. Five subjects with severe psoriasis achieved PASI 90 without receiving any concomitant medication. Reduction in severity as assessed by PGA was observed in more than half of patients with moderate disease. Histopathological evaluation revealed that epidermal thickness was considerably reduced in 66% of subjects. The expression of inflammatory marker S100A9 protein was(meaningfully reduced in 60% patients with non-significant reduction of Keratin 10 protein expression. Gene expression analysis showed increase down regulation of SERPINB4; PI3 and KRT16 genes after a 12-week treatment period in subjects with higher PASI scores. Conclusion: Oral Tinefcon? tablets showed good efficacy and had a favorable safety profile in plaque psoriasis patients.
机译：重要性：进行了这项上市后监督研究，以评估有关口服Tinefcon？疗效和安全性的真实信息。片状银屑病患者服用片（基于印度菊苣）。材料和方法：这项年龄至少18岁且具有临床诊断为斑块状牛皮癣的患者参加了这项开放性，非对照，多中心试验。所有符合条件的受试者都接受了四次700毫克的Tinefcon？平板电脑/天，持续12周。主要结局指标是从基线到第12周的牛皮癣区域严重程度指数（PASI）分数变化百分比。次要结局指标是医师全球评估（PGA），指甲牛皮癣严重程度指数（NAPSI），银屑病关节炎评估以及基因表达谱分析和免疫组织化学。结果：Tinefcon完成之后？在治疗12周时，超过一半的受试者（52％）达到了PASI 50反应; 68（23％）位受试者获得PASI 75反应，22（7％）位受试者获得PASI 90反应。五名严重牛皮癣的受试者未接受任何药物治疗就达到了PASI 90。通过PGA评估的严重程度降低在一半以上的中度患者中观察到。组织病理学评估显示表皮厚度在66％的受试者中显着降低。炎症标记物S100A9蛋白的表达降低（在60％角蛋白10蛋白表达无显着降低的患者中明显降低。基因表达分析显示，在12周的治疗后，SERPINB4，PI3和KRT16基因的下调增加）结论：口服Tinefcon？片对斑块状牛皮癣患者显示出良好的疗效，并具有良好的安全性。

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