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关于外阴阴道念珠菌病临床研究设计关键问题的思考 被引量:1

Consideration for the key issues of clinical study design on vulvovaginal candidiasis
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摘要 外阴阴道念珠菌病临床研究设计相关问题,笔者结合FDA关于外阴阴道念珠菌病临床研究指南、国内诊治规范、国内临床实际情况以及临床研究评价理念,对其重点问题进行了阐述,并提出参考性建议。
作者 钱思源 王涛
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2011年第4期318-320,共3页 The Chinese Journal of Clinical Pharmacology
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参考文献2

  • 1Guidance for Industry. Vulvovaginal eandidiasis - developing antimi- crobial drugs for treatment [ EB/OL] . http://www, fda. gov. 1998.
  • 2Vulvovaginal candidiasis[EB/OL].http: //www. cdc. gov/std/ Treatment/TOC2002TG. htm., 2010.

同被引文献17

  • 1中华妇产科学分会感染性疾病协作组.外阴阴道念珠菌病诊治规范(草案)[J].中华妇产科杂志,2004,39(6):430-431. 被引量:493
  • 2卞美璐,陈庆云,张友忠,辛晓燕,李茜,张爱华,李桂云.盐酸特比萘芬阴道泡腾片治疗外阴阴道假丝酵母菌病71例[J].中国新药杂志,2005,14(9):1184-1186. 被引量:9
  • 3PAAVONEN J,STAMM WE.Sexually transmitted diseases:lower genital tract infections in women[J].Infect Dis Clin North Am,1987,1(1):179-198.
  • 4HURLEY R,de LOUVOIS J.Candida vaginitis[J].Postgrad Med J,1979,55(647):645-647.
  • 5ROSA MI,SILVA BR,PIRES PS,et al.Weekly fluconazole therapy for recurrent vulvovaginal candidiasis:a systematic review and meta-analysis[J].Eur J Obstet Gynecol Reprod Biol,2013,167(2):132-136.
  • 6FDA.Guidance for industry:developing antimicrobial drugs—general considerations for clinical[EB/OL].(1998-07-22)[2014-04-14].http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070983.pdf.
  • 7FDA.Guidance for industry.Evaluating clinical studies of antimicrobials in the division of anti-infective drugs products[EB/OL].(1997-02-17)[2014-04-14].http://www.fda.gov/downloads/Drugs/Guidance Compliance Regulatory Information/Guidances/UCM071162.pdf.
  • 8DAVID HU,FREDERICK L,CATHLEEN AL,et al.Singledose miconazole nitrate vaginal ovule in the treatment of vulvovaginal candidiasis:two single-blind,controlled studies versus miconazole nitrate 100 mg cream for 7 days[J].J Womens Health Gend Based Med,2000,9(4):421-429.
  • 9FDA.Guidance for industry.Vulvovaginal candidiasis—developing antimicrobial drugs for treatment[EB/OL].(1998-07-22)[2014-04-01].http://www.fda.gov/downloads/Drugs/Guidance-Compliance Regulatory Information/Guidances/UCM071204.pdf.
  • 10TOBIN MJ.Vulvovaginal candidiasis:topical vs.oral therapy[J].Am Fam Physician,1995,51(7):1715-1720.

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