III期临床试验
筛选例，入选例。
随机分为三组：
第一组（对照组）：isoniazid,rifampin,pyrazinamide,andethambutolfor8weeks，然后，isoniazidandrifampin18周；
第二组：isoniazid,rifampin,pyrazinamide,andmoxifloxacinfor17weeks，然后，9周空白对照；
第三组：moxifloxacin,rifampin,pyrazinamide,andethambutolfor17weeks，然后，9周空白对照。
观察治疗失败或复发率。
结论：
两个包含莫西沙星的治疗方案比对照组有更快速的细菌学阴转率，而且疗程缩短至4个月，也没显示出更劣的治疗效果。
KateJohnson
September07,
WASHINGTON—Hopesforanew,moxifloxacin-containingtuberculosis(TB)treatmentthatmighthaveshortenedtherapyfrom6to4monthssufferedasetbacktodaywiththeresultsofREMoxTBstudy,oneofthelargestphase3TBtrialsinhistory.
Butfindingsfromthestudyarenotalldisappointing,accordingtoleadinvestigatorStephenGillespie,MD,fromtheUniversityofSt.AndrewsMedicalSchool,inScotland.
Whiletheresultsarenotwhatwehadhopedfor,thetrialwilldramaticallyimproveknowledgeinthefieldandalsopavethewayforfutureTBtrials―especiallythosethatmightincludemoxifloxacinaspartoftheregimen,Dr.GillespietoldMedscapeMedicalNews.
TheresultswerereportedhereattheInterscienceConferenceonAntimicrobialAgentsandChemotherapy(ICAAC)andpublishedsimultaneouslyintheNewEnglandJournalofMedicine.
FailuretoShowNoninferiority
TheREMoxTB(RapidEvaluationofMoxifloxacininTuberculosis)trialinvestigatedwhetherreplacing1ofthefirst-lineTBdrugs(isoniazid,rifampicin,pyrazinamide,orethambutol)withashortercourseofmoxifloxacinwasnoninferiortostandardtreatment.
Thetrialrandomlyassignedpatientswithdrug-sensitiveTBtoacontrolgroup,whichreceivedisoniazid,rifampin,pyrazinamide,andethambutol(Myambutol,STIPharmaLLC)for8weeks,followedby18weeksofisoniazidandrifampin,orto2separatemoxifloxacin-containingarms:1thatreplacedethambutolwithmoxifloxacinfor17weeks,followedby9weeksofplacebo(INHarm),andonethatreplacedisoniazidwithmoxifloxacinfor17weeks,followedby9weeksofplacebo(ETHarm).
Theprimaryendpointofthenoninferioritytrialwastreatmentfailureorrelapsewithin18monthsafterrandomization.
Thestudyfailedtoshownoninferiorityofthemoxifloxacinregimens北京哪家皮肤病医院好专家详细介绍白癜风丸说明书
