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1、依替米星与奈替米星随机对照治疗细菌性感染多中心临床试验屮国临床药理学杂志2000年第1期第16卷论著作者：李家泰赵彩云侯杰郭敏张炜陈亦芳张慧琳梁德荣穆国尧周际女刘晓晴赵鸣武姚婉贞朱红单位：李家泰赵彩云侯杰郭敏张炸陈亦芳(北京医科大学第一医院，临床药理研究所，耳鼻喉科，北京100034)；张慧琳梁徳荣穆国尧(华西傑科大学第一IK院，成都610041)；丿砾安刘晓晴(同济供科大学临床药理基地，武汉430030)；赵鸣武姚婉贞朱红(北京医科大学第三医院，北京100083)关键词：依替米星；奈替米星；随机对照；临床试验摘耍：以多中心临床试验以奈替米星为对照药，采用随机对照平行开放的试验方法
2、，目的是评价国产依替米星治疗临床常见细菌性感染的安全有效性。奈替米星与依替米星剂量均为100mg,每12h静脉注射，疗程7〜10d。本项临床试验共入选病例243例，其中入选依替米星组122例，临床疗效评价病例103例，安全性评价例数106例，入选奈替米星组121例，临床疗效评价病例101例，安全性评价病例102例。试验治疗结果如下：两组总有效率分别为87.4%和87.1%,治疗各种致病菌感染临床有效率分别为86.7%和87.6%,细菌清除率分别为89.9%和89.7%,药物不良反应发生率分别为8.5%与8.8%。结果表明，依替米星与奈替米星治疗临床帘见急性细菌性感染安全、有效，两纽
3、结果无统计学显著性差异(P>0.05)oARandomizedControlledMulticenterClinicalTrialonEtimicinVersusNetilmicinintheTreatmentofBacterialInfectionsLIJia-TaiZHAOCai-YunHOUJieGUOMinZHANGYeCHENYi-FANG(TheFirstHospital,InstituteofClinicalPharmacology,ENTDepartment,BeijingMedicalUniversity,Beijing100034)ZHANGHui-LingLI
4、ANGDe-RongMUGuo-Rao(TheFirstHospital,HuaxiMedicalUniversity,Chengdu610041)ZHOUJi-AnLIUXiao-Qing(ClinicalPharmacologyBase,TongjiMedicalUniversity,Wuhan430030)ZHAOMing-WuYAOWan-ZhenZHUHong(TheThirdHospital,BeijingMedicalUniversity,Beijing100083)Abstract：EtimicinsulfateisanewdrugdevelopedbytheIns
5、tituteofMicrobiologyofJiangsuProvince,China.Invitroantibacterialactivityshowedthatithadgoodactivityagainstclinicalisolates.Inordertocompareitsefficacyandsafetyoftwoaminoglycosideantibiotics-etimicinandnetilmicininthetreatmentofbacterialinfections,arandomizedopenlabeledcontrolledmulticenterclin
6、icaltrialwasconductedforthetreatmentof243hospitalizedpatientswithrespiratorytractinfection,urinarytractinfection,skinandtissueinfections.Thedosageofbothdrugswas100mgevery12hoursbyintravenousinfusion.Thedurationoftreatmentwas7〜10daysinbothgroups.Intherandomizedcontrolledstudy,122patientswereenr
7、olledinetimicingroup,106patientswereassessableforsafetyand103patientsassessableforefficacywhile121patientswereenrolledinnetilmicingroup,102patientswereassessedsafetyand101patientsassessedefficacy.Theresultsshowedthattheoverallefficacyra
