期刊文献+
任意字段
题名或关键词
题名
关键词
文摘
作者
第一作者
机构
刊名
分类号
参考文献
作者简介
基金资助
栏目信息

2014年美国FDA批准的新分子实体与评价:感染和传染病治疗用药 被引量：6

Updates of New Molecular Entities Approved by FDA in 2014: Infections and Infectious Diseases
下载PDF
导出
摘要 2014年FDA批准了41个新分子实体和新的治疗生物制品。本文介绍和评价感染和传染病治疗领域新药。 FDA approved 41 new molecular entities and new therapeutic biological products in 2014. This article provides an update and evaluation of the new drugs approved for infections and infectious diseases.
作者 孙树森 李新辰 韩容 赵志刚
机构地区 美国西新英格兰大学药学院 首都医科大学附属北京天坛医院药剂科
出处 《药品评价》 CAS 2015年第2期8-14,32,共8页 Drug Evaluation
基金 "药物管理平台"子课题 国家科技部"脑血管病创新药物临床评价技术平台"重大专项基金 编号:2008ZX09312-00
关键词 FDA 2014年 新药 感染 传染病 FDA 2014 New Molecular Entity Infection Infectious Disease
分类号 R95 [医药卫生—药学]
  • 相关文献

参考文献23

  • 1BoucherHW, WilcoxM, TalbotGH, et al. Once-weekly dalbavancin versus daily conventional therapy for skin infection[J]. N Engl J Med,2014, 370(23):2169-2179.
  • 2Wilcox M, Boucher HW, Talbot GH, et al. Discover 2: a randomized, double-blind study of dalbavancin(DAL) compared to vancomycin(V)(with an option to switch to linezolid(L)) in treatment of acute bacterial skin and skin structure infections(ABSSI) [Abstract]. Presented at: 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy; September 10-13, 2013.
  • 3Denver, CO. Abstrct L-202. Corey GR, Kabler H, Mehra P, et al. Single-dose oritavancin in the treatment of acute bacterial skin infections[J]. N Engl J Med, 2014, 370(23):2180-2190.
  • 4Corey R, Perez A, Moeck G, et al. A single-dose of oritavancin(ORI) is comparable to 7-10 days of vancomycin(VAN) in the treatment of acute bacterial skin and skin structure infections(ABSSSI): the SOLO ii study [abstract no. L-206c]. In: 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy; 10-13 Sep 2013; Denver, Colorado.
  • 5Prokocimer P, De Anda C, Fang E, et al. Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin structure infections: the ESTABLISH-1 randomized trial[J]. JAMA, 2013, 309(6):559-569.
  • 6Moran GJ, Fang E, Corey GR, et al. Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skin-structure infections(ESTABLiSH-2): a randomized, double-blind, phase 3, non-inferiority trial[J]. Lancet Infect Dis, 2014, 14(8):696-705.
  • 7Drugs for MRSA skin and soft-tissue infections[J]. Med Lett Drugs Ther, 2014, 59:147.
  • 8Rybak JM, Marx K, Martin CA. Early experience with tezolid: clinical efficacy, pharmacodynamics, and resistance[J]. Pharmacotherapy, 2014, 34(11): 1198-1208.
  • 9Label of Ceftolozane/tazobactam. FDA website.http://www. acce ssdata.fda.gov/drugsat fda_docs/label/2014/2068291bl.pdf2 2014-12-19/2014-12-22.
  • 10Eckmann C, Solomkin J. Ceftolozane/tazobactam for the treatment of complicated intra-abdominal infections[J]. Expert OpinPharmacother, 2015, I6(2):271-280.

同被引文献104

  • 1Robert C, Ribas A, Wolchok JD, et al. Anti-programmed-death- receptor-I treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial[J]. Lancet, 2014, 384(9948): 1109-1117.
  • 2Deeks ED. Nivolumab: A review of its use in patients with malignant melanoma [J]. Drugs, 2014, 74: 1233-1239.
  • 3Kaufman B, Shapira-Frommcr R, Schmutzlcr RK. Olapraib monotherapy in patients with advance cancer and a germline BRCA1/2 mutation [J]. J Clin Oncol, 2015, 33(3): 244-250.
  • 4Deeks ED. Olaparib: first global approval[J]. Drugs, 2015, 75: 231- 240.
  • 5Blinatumomab药品说明书http://www.onyx.com/file.cfm/723/docs/blincytoAoi_hcp_english.pdf.
  • 6Thomas X. Blinatumomab: a new era of treatment for adult ALL?[J]. Lancet Oncol, 2105, 16(1): 6-7.
  • 7Furman RR, Sharman JP, Coutre SE, et al. Idelalisib and rituximab in relapsed chronic lympoeytic leukemia[J]. N Engl J Med, 2014, 370(1): 997-1007.
  • 8Markham A. Idelalisib: first global approval[J]. Drugs, 2014, 74: 1701-1707.
  • 9O' Connor OA, Masszi T, Savage KJ, et al. Belinostat, a novel pan- histone deacetylase inhibitor(HDACi), in relapsed or refractory peripheral T-cell lymphoma(R/R PTCL): results from the BELIEF trial [J]. J Clin Oncol, 2013, 31(15 Suppl. 1): 8507.
  • 10Coiffier B, Federico M, Caballero D, et al. Therapeutic options in relapsed or refractory peripheral T-cell lymphoma [J]. Cancer Treat Rev, 2014, 40: 1080-1088.

引证文献6

二级引证文献21

药品评价
2015年 第2期

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部