【名称】: Remicade 【有效成分】:抗甲型肿瘤坏死因子(TNFa)的单克隆抗体 【用药途径】:静脉注射 【用药剂量】: Crohn氏病: 每公斤体重5毫克,一次静脉注射。类风湿性关节炎: 每公斤体重3毫克,首次、两周后、六周后、以及以后每八周一次静脉注射。 【作用机理】: Crohn氏病主要累及小肠的后部(空肠)和结肠,也可累及肠道的任何一个部位。肠道内壁慢性炎症,主要症状包括慢性长期腹泻, 痉挛性腹痛、食欲不振和体重减少。 Remicade能与TNFa结合并中和TNFa的生理活性。Remicade还能够杀死合成TNFa的细胞。后者是Remicade具有强有效的抑制TNFa的作用机理。 因为TNFa在Crohn氏病和类风湿性关节炎中是引起和维持炎症反应的主要因素,Remicade对两种疾病的治疗作用都非常显著。被美国食品药物局(FDA)先后批准应用。 【副作用】: 在小病人中有轻度的上呼吸道感染、头疼和恶心等 牛皮癣性关节炎是一种免疫调节的炎症性疾病,患者在出现典型牛皮癣的皮肤方面表现外,临床上同时会出现关节的疼痛和肿胀,周围组织的僵硬等表现,从而导致关节活动范围的减小、指甲的改变、眼睛的红肿和疼痛或葡萄膜炎。手、腕、膝、踝、足、下腰部及颈部是最常见的受累关节。据统计,美国约有100万牛皮癣关节炎患者,好发于30~50岁,男性和女性的发病率无显著差异。
Remicade是一种肿瘤坏死因子,对治疗类风湿性关节炎、炎症性肠病、强直性脊柱炎等疾病疗效显著。最新的一项有关牛皮癣性关节炎治疗的临床2期研究数据表明,牛皮癣性关节炎患者最早可在应用Remicade治疗后的2周即出现临床症状的改善,在用药的第14周,有58%的Remicade治疗患者出现至少20%的临床症状改善,而对照组中仅有11%。至第24周,27%的治疗患者的症状改善程度达70%,此比例在对照组中为2%。研究人员认为,Remicade能有效改善牛皮癣性关节炎的临床症状,美国食品和药物管理局近期已审批通过了Remicade用于牛皮癣性关节炎的治疗。
Plaque Psoriasis REMICADE is indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. REMICADE should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
Rheumatoid Arthritis REMICADE, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis.
Psoriatic Arthritis REMICADE is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis.
Adult Crohn's Disease REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.
REMICADE is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease.
Pediatric Crohn’s Disease REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.
Ulcerative Colitis REMICADE is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
Ankylosing Spondylitis
REMICADE is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis |