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中国雅美罗(ACTEMRA)能治疗全身型幼年特发性关节炎?

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印度代购提示您,本品sJIA是一种自身免疫性疾病,是幼年特发性关节炎(JIA)中最严重的一种亚型,严重影响儿童的生长发育,致残率和死亡率都很高。sJIA一般在16岁前发病,发病高峰集中在5-7岁。我国目前约有15000sJIA患儿,男性患儿发病率高于女性患儿。其发病率约为万分之一,参照国际标准,属于罕见病。sJIA具体发病原因尚不明确,遗传、感染、自身免疫等原因都可能导致sJIA,目前在国内尚无有效治疗药物。

SJIA is an autoimmune disease, the most serious subtype of juvenile idiopathic arthritis (JIA), which seriously affects the growth and development of children, and has a high rate of disability and mortality. The onset of sJIA generally occurs before the age of 16, with a peak onset between the ages of 5 and 7. At present, there are about 15,000 children with sJIA in China, and the incidence of male children is higher than that of female children. Its incidence is about 1 in 10,000, referring to international standards, is a rare disease. The specific pathogenesis of sJIA is not clear, genetic, infection, autoimmune and other reasons may lead to sJIA, currently there is no effective treatment drugs in China.

 

雅美罗

 

印度代购提示您,本品典型的sJIA表现为发热、皮疹及关节炎三联征,并常常有全身多系统多脏器受累。sJIA的诊断主要为临床诊断,目前无特异性客观指标帮助诊断,而且其临床表现也无特异性,容易与许多发热性疾病混淆,所以往往容易误诊及漏诊。另一方面,部分sJIA患者治疗非常困难,需要较长时间或反复应用肾上腺皮质激素来控制炎症,药物的副作用较大但疾病却不能完全有效控制,在某些情况下可能发生巨噬细胞活化综合征的并发症,从而会危及生命。所以,这是一种可以致残甚至致命的疾病,给患儿和家庭都带来很大的痛苦。

 

印度代购提示您,本品作为白介素6受体(IL-6R)单克隆抗体,雅美罗是全球首个获批治疗sJIA的生物制剂。自2008年以来,雅美罗sJIA适应症已分别在日本、美国和欧洲相继上市。1997年,Chugai Pharmaceuticals开始进行治疗类风湿性关节炎 (RA)的临床试验,2001年和2002年又陆续开展治疗Castlemans disease和全身型幼年特发性关节炎 (sJIA)的临床试验。

 

印度代购提示您,本品2003年,ChugaiRoche达成许可,共同对tocilizumab进行临床试验研究和商业化开发。雅美罗可单独使用或与其他药物一起用于治疗成人中度至重度类风湿关节炎。雅美罗还可用于治疗儿童类风湿性关节炎(例如全身型幼年特发性关节炎-SJIA,多关节性幼年特发性关节炎-PJIA)。

In 2003, Chugai and Roche agreed to conduct clinical trials and commercial development of Tocilizumab together. Yamelol can be used alone or in combination with other drugs to treat moderate to severe rheumatoid arthritis in adults. Yamelol may also be used to treat rheumatoid arthritis in children (e.g., systemic juvenile idiopathic arthritis -SJIA, multi-articular juvenile idiopathic arthritis -PJIA).

 

 


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