治疗真性红细胞增多症新药ropeginterferon alfa-2b  

Ropeginterferon alfa-2b:A new drug for polycythemia vera

作　　者：张芳[1] 刘杰[1] 孙韬华[2,3] 陈安进 ZHANG Fang;LIU Jie;SUN Tao-hua;CHEN An-jin(Department of Pharmacy,Qingdao Municipal Hospital,Qingdao 26601l,Shandong Province,China;Department of Drug Clinical Trials,Qingdao Municipal Hospital,Qingdao 26601l,Shandong Province,China;National Medical Products Administration Key Laboratory for Quality Research and Evaluation of Traditional Marine Chinese Medicine,Qingdao Institute for Food and Drug Control,Qingdao 266000,Shandong Province,China)

机构地区：[1]青岛市市立医院药学部,山东青岛266011 [2]青岛市市立医院药物临床试验研究科,山东青岛266011 [3]青岛市食品药品检验研究院、国家药品监督管理局海洋中药质量研究与评价重点实验室,山东青岛266000

出　　处：《中国临床药理学杂志》2023年第1期131-134,共4页The Chinese Journal of Clinical Pharmacology

基　　金：2020年山东省医学会治疗药物监测科研基金资助项目(YXH2020ZX058)。

摘　　要：真性红细胞增多症是一种骨髓及外骨髓增殖性肿瘤,患者出现头痛、瘙痒等多种不适,血栓和出血的风险增加,且有可能发展成为骨髓纤维化和白血病。2021年11月,美国食品药品监督管理局批准首个用于新发和初治阶段的真性红细胞增多症药物ropeginterferon alfa-2b上市。Ropeginterferon alfa-2b是在重组脯氨酸干扰素α-2b的脯氨酸N端残基上共价结合上聚乙二醇形成的,其疗效确切并能长期维持,耐受性良好,给药间隔时间长。本文对ropeginterferon alfa-2b的作用机制、药代动力学、临床研究和安全性进行综述。Polycythemia vera(PV)is a myeloproliferative neoplasm with various discomforts such as headache and pruritus,increase the risk of thrombosis and bleeding,and may develop into myelofibrosis and leukemia.In November 2021,the U.S.Food and Drug Administration(FDA)approved the first drug ropeginterferon alfa-2 b for newly diagnosed and initial treatment period PV.Ropeginterferon alfa-2 b is produced by covalent attachment of pegylated molecule directly to the N-terminal proline residue of recombinant proline-interferon alfa-2 b,with proven efficacy and long-term maintenance,well tolerated,and long dosing intervals.This article reviews the mechanism of action,pharmacokinetics,clinical studies and safety of ropeginterferon alfa-2 b.

关 键 词：真性红细胞增多症 Α干扰素 临床研究 

分 类 号：R97[医药卫生—药品]