咪唑斯汀治疗慢性荨麻疹的随机双盲研究

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。

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

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 for 28 days.Itching,number of wheals,diameter of the largest wheal and lasting time of urticarial attacks were evaluated.According to a scale from 0(absent)to 3(severe),the patientrated severity of itch measured by visual analogue scale(VAS).The number of weekly urticaria episodes was recorded.Control visits were scheduled after 7,14 and 28 days of therapy.Results 213 patients were enrolled and206patients completed the trial,including 104 cases in mizolastine group and 102 cases in loratadine group.There were 12 patients 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 were 80.8% and 74.5% respectively,no statistically significant difference was observed 28 days 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 group 7 days 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(χ²=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.