美国食品药品监督管理局(FDA)于2013年度共批准27个新药,其中小分子药物25个,生物制品2个,涉及抗肿瘤、代谢和内分泌系统、抗病毒、精神神经系统、呼吸系统、伴随诊断试剂,以及医学影像产品等治疗和应用领域。与2012年批准的39个新药相比,虽然在产品数量上有所下降,但这些药物却具备广阔的商业前景。简要介绍其中的重点品种,并就新药研发的现状与趋势进行分析。

The US Food and Drug Administration (FDA) approved 27 new drugs in 2013. There were 25 small molecules and 2 biologics in 2013. The current focus for drug R & D were on antineoplastic drugs, metabolic and endocrinological therapies, antivirals, neuropsychiatric drugs, chronic pulmonary disease treatments, companion diagnostic reagents, and medical imaging products. Although the number of approvals in 2013 was down from 2012 with 39 approvals, the newcomers were set to achieve powerful earning potential. The profile of some exciting products and the trends of drug R&D were provided.

骨髓纤维化(MF)是临床常见的复杂难治性疾病,Incyte公司研发的新药卢索替尼(Ruxolitinib)是首个获得美国FDA批准的口服治疗MF的药物。本文对其作用机制,药动学和药代学特性,临床药效学评价及药物不良反应等方面进行了综述。卢索替尼对重症MF患者具有重要的临床治疗作用,其批准上市将为骨髓纤维化的治疗带来希望。

Myelofibrosis is a commonly refractory disease. The new medication Ruxolitinib produced by Incyte Corporation is the first U.S.FDA approved oral MF therapeutic drug. Here its mechanism of action, pharmacokinetic and pharmacodynamic properties, clinical efficacy evaluation and adverse drug reactions were reviewed. Ruxolitinib will play an important role in treatment of serious MF.

稳心颗粒1995年由卫生部批准为三类新药，其药物组成和处方工艺已获国家发明专利。稳心颗粒主要用于治疗气阴两虚、心脉瘀阻之心动悸、脉结代。症见气短乏力，心悸不宁，头晕心烦、胸闷胸痛，脉结代或虚数。目前稳心颗粒国在内外的实验室方面已做过很多研究，本文就稳心颗粒抗心律失常的离子通道作用机制研究进展作一概述。

1995 Wenxin granule was approved three new medicines by the Ministry of Health, its medicines composition and prescription craft have gained national patent. Wenxin granule mainly for treating Yin Deficiency, systolic blood stasis of heart palpitations, pulse knot generation. Symptoms refer shortness of breath, fatigue, restlessness, palpitations, dizziness, irritability, chest pain, pulse knot generation or imaginary. Currently Wenxin granule has been done a lot of laboratory research, in this article antiarrhythmic action mechanism of Wenxin granule was reviewed.

埃博拉病毒是世界上最具威胁的病原体之一，2013年12月始于西非几内亚的埃博拉病毒病（Ebola virus disease，EVD）疫情，成为有记载以来最严重的一次暴发。由于对疫情的估计不足以及缺乏有效的治疗药物，本次疫情的防治效果并不乐观。美国FDA紧急批准了未经系统研究的ZMapp和TKM—Ebola用于埃博拉病毒病的治疗，但限于未知的疗效、安全性和产能的不足，意义有限。本文综述了现有的治疗埃博拉病毒病的方法以及新药的最新研究进展，方便相关人员了解此方面的信息。

As we all know, the Ebola virus is one of the most dangerous pathogens in the world. The outbreak of the Ebola virus diseases, began in December 2013, Guinea, West Africa, was the most serious one ever recorded in the history of mankind. Due to underestimation of the epidemic and the lack of effective drug, the effect of the prevention and control of this epidemic was not optimistic. ZMapp and TKM-Ebola were emergently approved by FDA for the treatment of the Ebola virus disease. However, the signiifcance of the use of two drugs was limited because of the unknown efifcacy, safety and the shortage of production capacity. In this paper, the existing therapies and the latest research progress of new drugs for Ebola virus diseases are reviewed so as to help the relevant persons get this information.