咪唑斯汀治疗慢性荨麻疹的随机双盲研究

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1、维普资讯http://www.cqvip.com审垡杂志2003年6月第366期ChinJDetmatol，June2003，Vol36，No．6·论著·咪唑斯汀治疗慢性荨麻疹的随机双盲研究刘玲玲朱学骏姜薇陈喜雪李明彭振辉郭在培李福秋【摘要】目的评价咪唑斯汀治疗慢性荨麻疹的疗效和安全性，并与氯雷他定进行比较。方法多中心、随机双盲、平行XCNI~床试验。结果5个研究中心共入选慢性荨麻疹患者213例，纳入疗效分析共206例，其中咪唑斯汀组104例，氯雷他定组102例。治疗结束时，咪唑斯汀组总有效率(痊愈+显效)为80．8％，氯雷他定组为74．5％，两组差异无显著性(=

2、1．16，P=O．28)。咪唑斯汀组于治疗后第l周时，对控制风团大小、每周发作次数及直观模拟标尺法(VAS)瘙痒程度平均值明显优于对照组，两组差异均有显著性(P=O．05，P=O．03和P：O．02)。至第2、4周时，两组间比较差异无显著性(P>O．05)咪唑斯汀组不良事件发生率为28．6％，对照组为25．5％，差异无显著性(=O．25，P=O．62)。结论口服咪唑斯汀或氯雷他定10mg／d治疗慢性荨麻疹疗效相似，但咪唑斯汀似乎比氯雷他定组起效更快，两组不良事件发生率及表现无明显差异。，【关键词】荨麻疹；氯雷他定；咪唑斯汀AMulticentre，Double-b

3、lind，Randomized，ParallelComparativeStudyontheEficacyandSafetyofMizolastineversusLoratadinelntheTreatmentofChronicUrticariaLIULing-ling*,zHUXue-junJIANGWei，CHENXi—xue，LIMing,PENGZhen—hui，GUOZai-pei，LIFu—qiu．*DepartmentofDermatology，PekingUniversityFirstHospital，Beijingl00034，China【Abst

4、ract】ObjectiveToevaluatetheeficacyandsafetyofmizolastineversusloratadineinthetreatmentofchronicidiopathicurticaria(CIU)．MethotisAfive—centre，double—blind，randomized，comparativestudywasconducted．Thepatientswererandomlydividedintotwotherapeuticgroups：receivedmizolastine(10mg)orloratadin

5、e(10rag)oncedailyfor28days．Itching，numberofwheals，diameterofthelargestwhealandlastingtimeofurticarialattackswereevaluated．Accordingtoascalefrom0(absent)to3(severe)．thepatient—ratedseverityofitchmeasuredbyvisualanaloguescale(VAS)．Thenumberofweeklyurticariaepisodeswasrecorded．Controlvis

6、itswerescheduledafter7．14and28daysoftherapy．Results213patientswereenrolledand206patientscompletedthetria1．including104casesinmizolastinegroupand102casesinloratadinegroup．Therewere12patientswithdrewanddroppedoutfromthetria1．Eficacyassessmentbasedonsymptomscorereducingindex(SSRI)showedt

7、hattheeffectiverateofmizolastineandloratadinewere80．8％and74．5％respectively，nostatisticallysignificantdifferencewasobse~ed28daysaftertreatmentbetweentwogroups(=1．16，P=0．28)．Thescoresofthediameteroflargestwheal，weeklyurticariaepisodesandVASscoreinmizolastinegroupweredecreasedsignificant

8、lytha