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1、与安慰剂对照治疗子宫内膜异位症骨盆痛 GModelEURO-6937;No.ofPages6EuropeanJournalofObstetrics&GynecologyandReproductiveBiologyxxx (xx)xxx–xxxContentslistsavailableatScienceDirectEuropeanJournalofObstetrics&GynecologyandReproductiveBiologyjournalhomepage:www.elsevier./locate/ejogrbDienogestinthetreatmentofendometrios
2、is-associatedpelvicpain:a12-week,randomized,double-blind,placebo-controlledstudyThomasStrowitzkia,*,ThomasFaustmannb,ChristophGerlingerc,ChristianSeitzdaDepartmentofGynecologicalEndocrinologyandReproductiveMedicine,UniversityofHeidelberg,Vossstrasse9,69115Heidelberg,GermanyBayerScheringPharmaAG,Glo
3、balMedicalAffairsWomen’sHealthcare,Berlin,GermanycBayerScheringPharmaAG,GlobalBiostatistics,Berlin,GermanydBayerScheringPharmaAG,GlobalClinicalDevelopmentWomen’sHealthcare,Berlin,GermanybARTICLEINFOABSTRACTArticlehistory:Received2SeptemberxxReceivedinrevisedform2FebruaryxxAepted2AprilxxKeywords:Die
4、nogestProgestinsEndometriosisPelvicpainPlaceboObjective:Toinvestigatetheefficacyandsafetyoforaldienogest2mgparedwithplacebointhetreatmentofendometriosis-associatedpelvicpain(EAPP).Studydesign:Thiswasa12-week,randomized,double-blind,placebo-controlled,multicenter(n=33)studyinGermany,Italy,andUkraine
5、of198womenaged18–45yearswithlaparoscopicallyconfirmedendometriosisandEAPPscore!30mmonavisualanalogscale(VAS).Dienogest2mgorplacebowasadministeredorallyoncedaily.TheprimaryefficacyvariablewasabsolutechangeinEAPPfrombaselioWeek12,asdeterminedbythetargetvariablesofchangeinVASscoreandchangeinintakeofsu
6、pportiveanalgesicmedication(ibuprofen)forpelvicpain.Results:MeanreductionsinVASscorebetweenbaselineandWeek12inthefullanalysissetwere27.4mmand15.1mminthedienogestandplacebogroups,respectively—asignificantscoredifferenceof12.3mminfavorofdienogest(P<0.0001).Changesinintakeofsupportiveanalgesicmedicati
7、onweremodestinbothgroups.TheprimaryefficacymeasureofabsolutechangeinEAPPdemonstratedthesuperiorityofdienogestoverplacebo.Dienogestwasgenerallywelltoleratedandfewadverseeventswereassociatedwiththerapy.Conclu
