普卢利沙星治疗急性细菌性感染的多中心双盲双模拟随机对照临床研究

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1、普卢利沙星治疗急性细菌性感染的多中心双盲双模拟随机对照临床研究【摘要】目的评价国产普卢利沙星治疗轻、中度急性细菌感染的临床疗效与安全性。方法采用多中心、双盲双模拟、平行随机对照试验设计，以左氧氟沙星为对照药，普卢利沙星组200mg，左氧氟沙星组200mg，每日两次，疗程均为7～10d。结果本研究共纳入278例，普卢利沙星组和左氧氟沙星组各有139例，其中普卢利沙星组FAS分析130例，PP分析123例；左氧氟沙星组进行FAS分析126例，PP分析119例。疗程结束时，FAS分析普卢利沙星组和左氧氟沙星组的痊愈率分别为%和%，PPS分析两组的痊愈率

2、分别为%和%；FAS分析两组的有效率分别为%和%，PPS分析两组的有效率分别为%和%，两组细菌清除率分别为%和%。以上结果两组组间比较均无显著性差异。两组的不良反应发生率分别为%和%，主要表现为恶心、腹泻及血清转氨酶升高等。两组均未见严重不良事件发生。结论国产普卢利沙星注射液治疗轻、中度细菌感染疗效确切，安全性好。【关键词】普卢利沙星左氧氟沙星急性细菌感染双盲双模拟多中心临床试验AmulticenterdoubleblinddoubledummyrandomizedcontrolledclinicalstudyABSTRACTObjectiveT

3、oevaluatetheclinicalefficacyandsafetyofprulifloxacinforthetreatmentofslightandmoderateacutebacterialinfections.MethodsAmulticenterdoubleblinddoubledummyrandomizedcontrolledclinicalstudywasconductedtocomparetheefficacyandsafetyofprulifloxacinandlevofloxacin.Bothgroupswereadmin

4、isteredatthedoseof00mgtwicedailyforto10days.ResultsTwohundredandseventyEightpatientswereenrolledinthestudy,13ineachgroups.Duetosomeunexpectedevents,finally,therewereonly130casesinprulifloxacingroupand12casesinlevofloxacingroupwereassessableforclinicalefficacybyfullanalysisset

5、(FAS),12casesinprulifloxacingroupand11casesinlevofloxacingroupwereassessableforclinicalefficacybyperprotocolset(PPS)analysis.Attheendofthetreatment,inFASanalysisthetotalcureratsandeffectiverates%%inprulifloxacingroup,%%inlevofloxacingroup;inPPSanalysisthetotalcureratesandeff

6、ectiverates%%inprulifloxacingroup,%%inlevofloxacingroup.Thebacterialresistancerates%%respectively.Therewerenostatisticallysignificantdifferencesbetweenthetwogroups.Adversereactionswereobserved%%ofpatientsinthetwogroups,mainlynausea,diarrheaandelevatedtransaminases.Noseriousad

7、verseeventwasreportedinanygroup.ConclusionsPrulifloxacinisaseffectiveandsafeaslevofloxacininthetreatmentofslightandmoderateacutebacterialinfections.KEYWORDSPrulifloxacin;Levofloxacin;Acutebacterialinfections;Doubleblinddoubledummy;Multicenterrandomizedcontrolledclinicalstudy普

8、卢利沙星(prulifloxacin，商品名Quisnon)为第三代氟喹诺酮类广谱抗菌药，由日本新药公司和明治制果公司共同研发成功，于X