咪唑斯汀治疗慢性荨麻疹的随机双盲研究  

A Multicentre,Double-blind,Randomized,Parallel Comparative Study on the Efficacy and Safety of Mizolastine versus Loratadine in the Treatment of Chronic Urticaria

作　　者：刘玲玲[1] 朱学骏[1] 姜薇[1] 陈喜雪[1] 李明[2] 彭振辉[3] 郭在培[4] 李福秋[5] 

机构地区：[1]北京大学第一医院皮肤性病科,100034 [2]复旦大学附属中山医院皮肤科 [3]西安交通大学第二附属医院皮肤科 [4]四川大学华西医院皮肤科 [5]吉林大学第二医院皮肤科

出　　处：《中华皮肤科杂志》2003年第6期306-309,共4页Chinese Journal of Dermatology

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、平行对照临床试验。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(χ2=1.16,P=0.28)。咪唑斯汀组于治疗后第1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 =0.05,P=0.03和P=0.02)。至第2、4周时,两组间比较差异无显著性(P>0.05)。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(χ2=0.25,P=0.62)。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。Objective To evaluate the efficacy and safety of mizolastine versus loratadine in the treatment of chronic idiopathic urticaria(CIU).Methods A five-centre,double-blind,randomized,comparative study was conducted.The patients were randomly divided into two therapeutic groups:received mizolastine(10mg)or loratadine(10mg)once daily for28days.Itching,number of wheals,diameter of the largest wheal and lasting time of urticarial attacks were evaluated.According to a scale from0(absent)to3(severe),the patient-rated severity of itch measured by visual analogue scale(VAS).The number of weekly urticaria episodes was recorded.Control visits were scheduled after7,14and28days of therapy.Results213patients were enrolled and206patients completed the trial,including104cases in mizolastine group and102cases in loratadine group.There were12patients withdrew and dropped out from the trial.Efficacy assessment based on symptom score reducing index(SSRI)showed that the effective rate of mizolastine and loratadine were80.8%and74.5%respectively,no statistically significant difference was observed28days after treatment between two groups(χ2 =1.16,P=0.28).The scores of the diameter of largest wheal,weekly urticaria episodes and VAS score in mizolastine group were decreased significantly than those in loratadine group7days after treatment(P=0.05,P=0.03and P=0.02).But there was no statistically significant different between two groups14and28days after treatment(P>0.05).No serious adverse events were reported in these two groups.The incidences of adverse event of mizolastine and loratadine were28.6%and25.5%respectively,there were no statistically significant difference between two groups(χ 2 =0.25,P=0.62).Conclusions The efficacy of mizolastine and loratadine is similar in the treatment of CIU,but mizolastine is quicker in action than loratadine.The incidences of adverse events are not different in the two groups.

关 键 词：咪唑斯汀 慢性荨麻疹 不良事件 药物疗法 氯雷他定 

分 类 号：R758.24[医药卫生—皮肤病学与性病学] R969[医药卫生—临床医学]