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为考察咪唑斯汀治疗过敏性鼻炎的疗效和安全性 ,于 2 0 0 0年 4月至 10月 ,进行了本项多中心平行对照的临床试验 (对照组为氯雷他定 ) ,共有 14 1例完成本试验 ,其中咪唑斯汀组 72例 ,氯雷他定组 6 9例 ,两组共脱落和退出 14例。主要症状评分显示两组用药后症状评分均明显下降 ,组内t检验差异显著 (P <0 .0 5 ) ,两组治疗前后症状评分差 (治疗前—治疗后 )的组间t检验显示 ,咪唑斯汀组鼻塞的评分下降幅度明显大于氯雷他定 (P <0 .0 5 ) ,其它症状评分下降幅度两组间的差异不明显 ,组间t检验P >0 .0 5。基于症状积分下降指数的四级疗效评估显示 ,咪唑斯汀的总有效率为88.1% ,其中显效率为 2 6 .9% ,而氯雷他定组分别为 76 .6 %和 13.3%。两组均未发现严重的不良反应。咪唑斯汀组与氯雷他定组的副作用的发生率分别为 38.8%和 4 5 %。咪唑斯汀主要副作用为轻度困倦 (19.4 % )和口干 (7.5 % ) ,氯雷他定组也有轻度困倦 (16 .7% )和口干 (13.3% )。两组用药前后血尿常规、肝肾功能均无有意义的改变。两组用药前后的心电图均正常 ,与用药前比治疗后QTc未见有意义的变化。结论 :两种药物治疗过敏性鼻炎的疗效相似 ,但咪唑斯汀对鼻塞的作用优于氯雷他定 ,两组的副作用也相似
To investigate the efficacy and safety of mizolastine in the treatment of allergic rhinitis, a multicenter parallel controlled clinical trial (loratadine) was conducted from April to October 2000, with a total of 14 One patient completed the trial, including 72 in the mizolastine group and 69 in the loratadine group, with 14 exfoliated and exited in both groups. The main symptom scores showed that the symptom scores of both groups were significantly decreased after treatment, t test significant difference (P <0.05), before and after treatment in both groups symptom scores were poor (before treatment - after treatment) between groups t test showed that, Mizolastine group nasal congestion score decreased significantly more than loratadine (P <0. 05), the other symptoms decreased the difference between the two groups was not significant, t-test between groups P> 0.05. The four-level efficacy evaluation based on the symptom score decline index showed that the overall effective rate of mizolastine was 88.1%, of which the effective rate was 26.9%, while the loratadine group was 76.6% and 13.3% respectively. No serious adverse reactions were found in either group. The incidence of side effects in the mizolastine and loratadine groups was 38.8% and 45%, respectively. The main side effects of mizolastine were mild drowsiness (19.4%) and dry mouth (7.5%), and loratadine was mild drowsiness (16.7%) and dry mouth (13.3%). Before and after treatment of two groups of blood and urine routine, liver and kidney function no meaningful change. The electrocardiogram of the two groups before and after treatment were normal, and no significant change was found in QTc after treatment. Conclusions: Both drugs have similar efficacy in the treatment of allergic rhinitis, but mizolastine is superior to loratadine in the efficacy of nasal obstruction with similar side effects