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关于<\/b>EFFISAYIL临床试验项目<\/b><\/p> \n 关于圣利卓<\/b>®<\/sup><\/b><\/p> \n 圣利卓(佩索利单抗)是一款新型人源化选择性抗体,可阻断白介素-36受体 (IL-36R)的激活。IL-36通路是免疫系统内的一种信号通路,已被证明与GPP等多种自身炎症性疾病的发病机制有关[5],[10],[16]<\/sup>。佩索利单抗已获得包括美国、日本、中国大陆和欧盟等多国监管机构批准,用于治疗成人GPP发作。<\/p> \n 关于泛发性脓疱型银屑病(<\/b>GPP)<\/b><\/p> \n GPP是一种罕见的、异质性的、可危及生命的嗜中性粒细胞性皮肤病,临床上与斑块状银屑病不同[5]<\/sup>,[<\/sup>8]<\/sup>。GPP是由中性粒细胞(一种白细胞)在皮肤中积聚引起的,会在全身广泛爆发疼痛性的无菌性脓疱[5]<\/sup>,[<\/sup>8]<\/sup>。GPP患者的临床病程各不相同,有些患者可反复发作,而另一些患者则表现为疾病持续存在且间歇性发作[8]<\/sup>。虽然GPP发作的严重程度各不相同,但若不及时治疗,可能会出现败血症和多系统器官衰竭等并发症,可能会危及生命[5]<\/sup>。这种慢性全身性疾病会对患者的生活质量产生重大影响,并增加医疗负担[17]<\/sup>。GPP在不同区域的患病率各不相同,女性患者多于男性患者[5]<\/sup>,[<\/sup>17]<\/sup>,[18],[19],[20]<\/sup>。对于能够快速解决GPP发作症状并能预防复发,且具有可接受的安全性的疗法存在着高度未满足的需求[4]<\/sup>,[21]<\/sup>。<\/p> \n GPP的发作可导致住院并可能发生严重并发症,包括心力衰竭、肾衰竭和败血症,而疾病发作的不可预测性和严重程度极大地影响了患者的生活质量[5]<\/sup>,[<\/sup>21]<\/sup>。<\/p> \n [12] Bachelez H et al. Trial of spesolimab for generalized pustular psoriasis. NEJM. 2021;385:2431-40.<\/span><\/p> <\/td> \n <\/tr> \n [13] Federal Drug Administration. New Drug Approvals for 2022. Available at: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/761244s000lbl.pdf. Accessed January 2023.<\/span><\/p> <\/td> \n <\/tr> \n [14] EC approval statement (data on file).<\/span><\/p> <\/td> \n <\/tr> \n [15] Effisayil ON: An open-label, long term extension study to assess the safety and efficacy of spesolimab treatment in patients with generalized pustular psoriasis (GPP). https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03886246?term=Effisayil&draw=2&rank=1. Last accessed January 2023.<\/span><\/p> <\/td> \n <\/tr> \n [16] Furue K, et al. Highlighting Interleukin-36 Signalling in plaque psoriasis and pustular psoriasis. Acta Derm Venereol. 2018;98:5–13<\/span><\/p> <\/td> \n <\/tr> \n [17] Hanna M, et al. Economic burden of generalized pustular psoriasis and palmoplantar pustulosis in the United States. Curr Med Res Opin. 2021. 37(5):735-742.<\/span><\/p> <\/td> \n <\/tr> \n [18] Augey F, et al. Generalized pustular psoriasis (Zumbusch): a French epidemiological survey. Eur J Derm. 2006; 16(6):669-673.<\/span><\/p> <\/td> \n <\/tr> \n [19] Ohkawara A et al. Generalized pustular psoriasis in Japan: two distinct groups formed by differences in symptoms and genetic background. Acta Derm Venereol. 1996 Jan;76(1):68–71.<\/span><\/p> <\/td> \n <\/tr> \n [20] Jin H, et al. Clinical features and course of generalized pustular psoriasis in Korea. J Dermatol. 2015; 42(7):674-678.<\/span><\/p> <\/td> \n <\/tr> \n [21] Puig L, Choon SE, Gottlieb AB, et al. Generalized pustular psoriasis: a global Delphi consensus on clinical course, diagnosis, treatment goals, and disease management. J Eur Acad Dermatol Venereol. 2023 Jan 6. doi: 10.1111\/jdv.18851.<\/span><\/p> <\/td> \n <\/tr> \n <\/tbody> \n <\/table> \n<\/div> \n <\/p>"];
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