Efficacy of Oral Metronidazole with Vaginal Clindamycin or Vaginal Probiotic for Bacterial Vaginosis Randomised Placebo-Controlled Double-Blind Trial 英文参考文献.docVIP

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Efficacy of Oral Metronidazole with Vaginal Clindamycin or Vaginal Probiotic for Bacterial Vaginosis Randomised Placebo-Controlled Double-Blind Trial 英文参考文献.doc

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Efficacy of Oral Metronidazole with Vaginal Clindamycin or Vaginal Probiotic for Bacterial Vaginosis Randomised Placebo-Controlled Double-Blind Trial 英文参考文献

EfficacyofOralMetronidazolewithVaginalClindamycin orVaginalProbioticforBacterialVaginosis:Randomised Placebo-ControlledDouble-BlindTrial CatrionaS.Bradshaw1,2,3*,MariePirotta4,DeborahDeGuingand1,JaneS.Hocking1,5,AnnaN.Morton2, SuzanneM.Garland6,7,8,GlendaFehler2,AndreaMorrow1,SandraWalker1,LenkaA.Vodstrcil1, ChristopherK.Fairley1,2 1MelbourneSchoolofPopulationHealth,UniversityofMelbourne,Melbourne,Australia,2MelbourneSexualHealthCentre,TheAlfredHospital,Melbourne,Australia, 3DepartmentofEpidemiologyandPreventiveMedicine,MonashUniversity,Melbourne,Australia,4DepartmentofGeneralPractice,UniversityofMelbourne,Melbourne, Australia,5CentreforWomen’sHealth,GenderandSociety,UniversityofMelbourne,Melbourne,Australia,6DepartmentofMicrobiologyandInfectiousDiseases,The Royal Women’s Hospital, Melbourne, Australia, 7Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia, 8Department of Microbiology,TheRoyalChildren’sHospital,Melbourne,Australia Abstract Background: To determine if oral metronidazole (MTZ-400mg bid) with 2% vaginal clindamycin-cream (Clind) or a Lactobacillusacidophilusvaginal-probioticcontainingoestriol(Prob)reduces6-monthbacterialvaginosis(BV)recurrence. Methods:Double-blindplacebo-controlledparallel-groupsingle-sitestudywithbalancedrandomization(1:1:1)conducted atMelbourneSexualHealthCentre,Australia.ParticipantswithsymptomaticBV[NugentScore(NS)=7–10or$ 3Amsel’s criteria and NS=4–10], were randomly allocated to MTZ-Clind, MTZ-Prob or MTZ-Placebo and assessed at 1,2,3 and 6 months.MTZandClindwereadministeredfor7daysandProbandPlacebofor12days.PrimaryoutcomewasBVrecurrence (NS of 7–10) on self-collected vaginal-swabs over 6-months. Cumulative BV recurrence rates were compared between groupsbyChi-squaredstatistics.Kaplan-Meier,logrankandCoxregressionanalyseswereusedtocomparetimeuntiland riskofBVrecurrencebetweengroups. Results:45018–50yearoldfemaleswererandomizedand408(91%),equallydistributedbetweengroups,provided$ 1NS post-rand