特比萘芬散与咪康唑散随机对照治疗手足癣体股癣临床研究.doc

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1、特比荼芬散与咪康卩坐散随机对照治疗于足癣体股癣临床研究中国临床药理学杂志2000年第4期第16卷论著作者：王克玉李春阳粱临平张树孝孙志坚孙希香高惠荣单位：王克玉李春阳粱临平(山东医科大学附属医院皮扶科，济南250012)；张树孝孙志坚孙希香高惠荣(山东省立医院皮扶科，济南250021)关键词：特比蔡芬散；咪康卩坐散；皮肤真菌病摘要目的：特比蔡芬(terbinatine)^jAj烯胺类抗真菌药，对皮肤癣菌具有较强的杀菌作用。为评价新剂型1%特比蔡芬散的疗效及安全性。方法：以咪康哇散为对照药，采用随机对照临床试验方法治疗浅部真菌病210

2、例，其中特比蔡芬纽.104例，咪康II坐纽.106例。患者随机接受特比荼芬散或咪康卩坐散，均为每日2次，体股癣疗程2周，于-癣、足癣疗程3周。治疗结束后根据临床症状和体征、真菌镜检和/或培养结果综合评价临床疗效及真菌学疗效。结果：结果表明：特比蔡芬与咪康II坐组的治愈率分别为50.0%和35.8%(PV0.05),有效率分别为88.5%和88.7%(P>0.05)，真菌清除率分别为88.5%和78.3%(PV0.05),药物不良反应发生率分别为4.8%和4.7%(P>0.05)o縱:1%盐酸特比荼散剂治疗浸溃、糜烂型浅部真菌病疗效好

3、、安全性高。ARandomizedControlledClinicalStudyofTerbinafinePowderVersusMiconazolefortheTreatmentofTineamamum/PedisandTineaCorporis/CnirisWANGKe-YuLICHun-YangLIANGLin-Ping(DepartmentofDermatology,TheAffiliatedHospitalofShandongMedicalUniversity,Jinan250012)ZHANGSHu-XiaoSUNZHi

4、-Jian(DepartmentofDermatology,ThePeoplessHospitalofShandongProvince,Jinan250021)SUNXi-XiangGAOHui-Rong(DepartmentofDermatology,TheCentralHospitalofJinanCity,Jinan250014)AbstractObjective:Terbinafineisasyntheticallyamineantifungiagentwhichhasbeenshowntobefungicidalagain

5、stdermatophytes.Inordertoevaluatethesafetyandefficacyofthenewformulation1%terbinafinepowderinthetreatmentofdermatomycoses.Methods:Arandomizedcontrolledclinicalobservationwasconducted.2%miconazolepowderwaschosenasthecontrol.210patientswithdermatomycoseswererandomlydivid

6、edintoterbanifinegroupormiconazolegroup,ofwhich104patientswereassignedtoterbinafinegroup,106patientstomiconazolegroup.Theywereadministedtopicallywithterbinafineormiconazolepowdertwiceperdayfor2weekswithtineacorporisandtineacruris,for3weekswithtineamannusandtineapedis.B

7、othclinicalandmycologicalefficacywereevaluatedbyclinicalmanifestationsandtheresultsofdirectmicroscopyancl/orculture.Resu!ts:Thecurativeratesofterbinafineandmiconazolegroupwere50.0%and35.8%(P0.05),themycologicalclearanceratesw

8、ere88.5%and78.3%(P<0.05),respectively.Theadversedrugreactionrateswere4.8%and4.7%(P>0.05).Conclusion:Itwasthesafetyand