Importance: This post-marketing surveillance study was conducted to evaluate real-world information about the efficacy and safety of oral Tinefcon<sup>?</sup> tablets (Sphaeranthus indicus based) in plaque...Importance: This post-marketing surveillance study was conducted to evaluate real-world information about the efficacy and safety of oral Tinefcon<sup>?</sup> 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<sup>?</sup> 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<sup>?</sup> 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<sup>?</sup> tablets showed good efficacy and had a favorable safety profile in plaque psoriasis patients.展开更多
目的评价Q开关激光联合瑞恩诗皓白聚能素治疗面部色素型黄褐斑的临床效果、安全性及复发率。方法 2018年1月至2018年12月,色素型黄褐斑患者60例,按照随机数字表平均分为两组,每组患者30例。试验组,给予Q开关激光联合瑞恩诗皓白聚能素治...目的评价Q开关激光联合瑞恩诗皓白聚能素治疗面部色素型黄褐斑的临床效果、安全性及复发率。方法 2018年1月至2018年12月,色素型黄褐斑患者60例,按照随机数字表平均分为两组,每组患者30例。试验组,给予Q开关激光联合瑞恩诗皓白聚能素治疗,激光波长1 064 nm,每月1次,6次为一个疗程;对照组,仅采用Q开关Nd:YAG激光治疗,每月一次,6个月为一个疗程。比较两组患者治疗前后的黄褐斑面积、严重指数(Melasma Area and Severity Index Score,MASI)、皮肤图像分析系统分析(VISIA)、临床疗效,同时记录不良反应和复发率等。结果试验组患者治疗后黄褐斑的MASI分值明显低于对照组(P<0.05);试验组的治疗总有效率高于对照组(P<0.05);试验组VISIA分析,其中斑点及棕色斑的评分优于对照组(P<0.05);试验组复发率低于对照组(P<0.05),试验组无一例发生不良反应。结论 Q开关激光联合瑞恩诗焕皓白聚能素治疗面部色素型黄褐斑疗效好,复发率低,安全性高,值得推广应用。展开更多
文摘Importance: This post-marketing surveillance study was conducted to evaluate real-world information about the efficacy and safety of oral Tinefcon<sup>?</sup> 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<sup>?</sup> 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<sup>?</sup> 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<sup>?</sup> tablets showed good efficacy and had a favorable safety profile in plaque psoriasis patients.
文摘目的评价Q开关激光联合瑞恩诗皓白聚能素治疗面部色素型黄褐斑的临床效果、安全性及复发率。方法 2018年1月至2018年12月,色素型黄褐斑患者60例,按照随机数字表平均分为两组,每组患者30例。试验组,给予Q开关激光联合瑞恩诗皓白聚能素治疗,激光波长1 064 nm,每月1次,6次为一个疗程;对照组,仅采用Q开关Nd:YAG激光治疗,每月一次,6个月为一个疗程。比较两组患者治疗前后的黄褐斑面积、严重指数(Melasma Area and Severity Index Score,MASI)、皮肤图像分析系统分析(VISIA)、临床疗效,同时记录不良反应和复发率等。结果试验组患者治疗后黄褐斑的MASI分值明显低于对照组(P<0.05);试验组的治疗总有效率高于对照组(P<0.05);试验组VISIA分析,其中斑点及棕色斑的评分优于对照组(P<0.05);试验组复发率低于对照组(P<0.05),试验组无一例发生不良反应。结论 Q开关激光联合瑞恩诗焕皓白聚能素治疗面部色素型黄褐斑疗效好,复发率低,安全性高,值得推广应用。
