口服特比萘芬加外用益康唑短程联合疗法治疗足癣的临床对照研究.doc

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1、口服特比萘芬加外用益康唑短程联合疗法治疗足癣的临床对照研究作者：杨斌，杨琴，晏洪波，吴宁，余君贤，李曾三【摘要】　　目的评价口服特比萘芬片加外用益康唑乳膏短程联合疗法治疗足癣的疗效和安全性。方法采用随机数字表法将124名患者分为两组：试验组予特比萘芬片250mg口服，1次/d，联合益康唑乳膏外用，2次/d，共7d；对照组予益康唑乳膏外用，2次/d，同时口服维生素C片0.1g，1次/d，共28d。于停药时和停药后4周时观察临床疗效和真菌学疗效，停药后4周时观察复发情况。结果共有113例患者完成临床观察，脱落7例(试验组1例，对照组6例)，剔除4例(对照组4例)。停药时两组相比试验组治

2、愈率明显低于对照组(χ2＝23.03，P＜0.01)，有效率及真菌清除率差异无统计学意义(χ2＝0.33，P＞0.05；χ2＝0.03，P＞0.05)；停药后4周时两组相比试验组治愈率、有效率及真菌清除率均显著高于对照组(χ2＝17.21，P＜0.01；χ2＝14.56，P＜0.01；χ2＝23.03，P＜0.01)；停药后4周时两组相比试验组复发率明显低于对照组(χ2＝14.04，P＜0.01)；两组不良反应发生率相比差异无统计学意义(χ2＝3.27，P＞0.05)。结论口服特比萘芬片加外用益康唑乳膏短程联合疗法治疗足癣依从性和安全性高、疗效好。【关键词】足癣；特比萘芬；联合疗法

3、　　Abstract：ObjectiveTostudytheefficacyandsafetyofshort-termoraladministrationofterbinafinecombinedwithtopicalapplicationofeconazoleinthetreatmentoftineapedis.MethodsAnopenlabelled,randomized,controlledandparallelclinicaltrialwascarriedout.Atotalof124patientswithclinicalandmycologicaldiagnosis

4、oftineapedisweredividedintotwogroups.Thetrialgroupwastreatedwithoralterbinafine250mgdaily,and1%ofeconazoleointmenttwicedaily,continuouslyfor7days.Thecontrolgroupwastreatedwith1%ofeconazoleointmenttwicedailyandoralvitamineC(asplacebo)0.1gdaily.Efficacyandsafetywerecompared.ResultsAttheendoftrea

5、tment,theclinicalcurerateofthetrialgroupwassignificantlylowerthanthatofthecontrolgroup(χ2=23.03,P<0.01),andtherewerenosignificantdifferencesineffectiverateandmycologicalclearanceratebetweenthetwogroups(χ2=0.33,P>0.05;χ2=0.03,P>0.05).Fourweekslateraftertheendoftreatment,theclinicalcure

6、rate,theeffectiverateandthemycologicalclearancerateofthetrialgroupweresignificantlyhigherthanthatofthecontrolgroup(χ2=17.21,P<0.01;χ2=14.56,P<0.01;χ2=23.03,P<0.01),andtherecurrenceratewassignificantlylowerthanthatofthecontrolgroup(χ2=14.04,P<0.01).Theincidenceofadverse5eventsinthet

7、rialgroupwasnotsignificantlydifferentfromthatinthecontrolgroup.ConclusionShorttermoraladministrationofterbinafinecombinedwithtopicalapplicationofeconazoleissafe,welltoleratedandeffectiveinthetreatmentoftineapedis.　　Keywords：tineapedis;