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对合理设计急性细菌性结膜炎临床试验的思考 被引量：4

Consideration on design of clinical trials for acute bacterial conjunctivitis
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摘要 本文探讨了对急性细菌性结膜炎临床试验方案合理设计的相关考虑,希望对我国相关创新性药物的临床研发有所提示和参考。 This article is likely to help understanding comprehensive meaning of appropriate clinical trial design of acute bacterial conjunctivitis, and further help designing the better protocol as well as carrying on clinical trial successfully.
作者 刘瑄 李娅杰
机构地区 首都医科大学附属北京友谊医院眼科 国家食品药品监督管理局药品审评中心
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2009年第1期86-89,共4页 The Chinese Journal of Clinical Pharmacology
关键词 急性细菌性结膜炎 临床试验设计 acute bacterial conjunctivitis clinical trial design
分类号 R978.1 [医药卫生—药品] R777.31 [医药卫生—眼科]
  • 相关文献

参考文献8

  • 1Schwab IR, Friedlaender M, McCulley J, et al. A phase III clinical trial of 0.5% levofloxacin ophthalmic solution versus 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis [ J ]. Ophthalmology, 2003; 110: 457- 465.
  • 2美国食口药口监督管理局.Guidelines for the clinical evaluation of anti - infective drugs (systemic) ( adults and children) [ EB/OL]. http ://www. fda. gov/cder/guidance/old047fn. pdf. , 1977 - 09.
  • 3美国食品药品监督管理局.Zymar ( Gatifloxacin ) : Medical review ( EB/OL ). http://www. fda. gov/cder/ foi/nda/2003/021493 _ Zymar. htm, 2008 - 10 -26.
  • 4美国食品药品监督管理局.QUIXIN (levofloxacin) : Medical review (EB/OL). http ://www. fda. gov/cder/foi/nda/2000/21 - 199_Quixin. htm, 2008 - 10 -26.
  • 5美国食品药品监督管理局.Vigamox ( moxifloxacin ) : Medical review (EB/OL). http://www. fda. gov/cder/foi/ndaf2003/21 - 598_Vigamox. htm, 2008 - 10 -26.
  • 6Rose PW, Harnden A, Brueggemann AB, et al. Chloramphenicol treatment for acute infective conjunctivitis in children in primary care : a randomised double - blind placebo - controlled trial [ J ]. Lancet, 2005 ; 366: 37- 43.
  • 7Sheikh A, Hurwitz B. Topical antibiotics for acute bacterial conjunctivitis : Cochrane systematic review and meta - analysis update [J]. Br J Gen Pract, 2005 ; 55 : 962 - 964.
  • 8杨进波,赵德恒,赵明,李娅杰,谢松梅.美国FDA对抗菌药物临床试验非劣效设计的考虑[J].中国临床药理学杂志,2008,24(3):273-274. 被引量：2

二级参考文献2

  • 1FDA. Antibacterial drug products: use of non - inferiority studies to support approval [ EB/OL]. http://www. fda. gov/cder/guidance/ 7884dft. pdf. ,2007 - 10 - 12.
  • 2International Conference on Harmonisation Guidance. Guidance EIO. Choice of control group and related issues in clinical trials [ EB/OL]. http//www. emea. europa eu/pdfs/human/ich/036496en, pdf. , 2000 -07 -01.

共引文献1

同被引文献31

  • 1王丽娅,张月琴,祝磊,王印其,贺燚,李家臣,张俊杰.盐酸左氧氟沙星滴眼液治疗细菌性结膜炎及角膜炎随机双盲对照临床研究[J].眼科研究,2004,22(4):403-405. 被引量：13
  • 2陈晓莲,刘杏,钟兴武,梁洪光,蔡志伟,梁志光.急性细菌性结膜炎致病菌和药物敏感性分析[J].中国实用眼科杂志,2005,23(3):319-322. 被引量：24
  • 3MONTAGNANI F, MA LANDRIN IA, STOLZUOLI L, et al.Microbiological features of acute bacterial conjunctivitis in a central Italian area[J]. New Microbiol, 2008, 31 (2) : 291- 294.
  • 4BHARATHI MJ, RAMAKR ISHNAN R, SHIVAKUMAR C, et al. Etiology and antibacterial susceptibility pattern of community-acquired bacterial ocular infections in a tertiary eye care hospital in south India[J].Indian J Ophthalmology, 2010,58 (6) :497-507.
  • 5ADEBAYO A, PARIKH JG, MCCORMICK SA, et al. Shifting trends in in vitro antibiotic susceptibilities for common bacterial conjunetival isolates in the last decade at the New York Eye and Ear Infirmary [J].Graefes Arch Clin Exp Ophthamlol,2011,249(1)111- 119.
  • 6葛坚.眼科学[M]北京:人民卫生出版社,2005153-160.
  • 7Abelson MB,Heller W,Shapiro AM. Clinical cure of bacterial conjunctivitis with azithromycin 1%:vehicle-controlled,double-masked clinical trial[J].American Journal of Ophthalmology,2008.959-965.
  • 8Hwang DG,Schanzlin DJ,Rotberg MH. Levofloxacin Bacterial Conjunctivitis Place-controlled Study Group.A phase Ⅲ,placebo controlled clinical trial of 0.5％ levofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis[J].British Journal of Ophthalmology,2003.1004-1009.
  • 9Hutnik C,Mohammad-Shahi MH. Bacterial conjunctivitis[J].Clin Ophthalmol,2010.1451-1457.
  • 10Protzko E,Bowman L,Abelson M. Phase 3 safety comparisons for 1.0％ azithromycin in polymeric mucoadhesive eye drops versus 0.3％tobramycin eye drops for bacterial conjunctivitis[J].Investigative Ophthalmology & Visual Science,2007.3425-3429.

引证文献4

二级引证文献35

中国临床药理学杂志
2009年 第1期

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