重组人促甲状腺激素(rhTSH),来源于中国仓鼠卵巢(CHO)细胞,由美国Sanofi Genezyme公司研发,于1998年12月在FDA批准上市,2000年3月,在欧洲上市,主要用于甲状腺癌的辅助诊断和辅助治疗。目前在中国尚无上市产品。由苏州泽璟生物制药股份有限公司研制的rhTSH,其药学性质与原研产品基本一致。
rhTSH常见不良反应(≥1%)包括恶心、头痛、疲乏、呕吐、头晕、虚弱。其它不良反应还包括:
(1)一过性流感样综合征,主要症状为发热(38°C),寒战,肌痛/关节痛,疲乏/虚弱,头痛等,一般在48小时内消失。
(2)过敏反应:包括荨麻疹,皮疹,瘙痒,脸红,呼吸道症状等。
(3)注射部位反应:包括疼痛,结节性红斑,瘀斑和瘙痒。
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