咪唑斯汀治疗过敏性鼻炎的多中心随机平行组对照的临床试验报告

A multicenter, randomized, comparative study on the safety and efficacy of Mizolastine versus Loratadine for the treatment of allergic rhinitis

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 。

In order to evaluate the efficacy and safety of Mizolastine for treatment of allergic rhinitis , a multicenter randomized comparative study versus Loratadine was carried out from April to October in 2000. 141subjects completed the trial, including 72 cases in Mizolastine group and 69 cases in Loratadine group. Total 14 subjects withdraw and dropped out from the trial. All symptom scores decreased significantly after treatment ( P <0.05) in both group. The score decrease (score before treatment minus score after treatment) of stuffy nose in Mizolastine group was significantly greater than that in Loratadine group ( P <0.05). The score decrease of other symptoms did not show statistical difference between two groups ( P >0.05). Efficacy assessment based on symptom score reducing index (SSRI) showed that the efficacy of Mizolastine was 88.1%, and the excellent rate was 26.9%, while the efficacy of Loratadine was 76.6%, and the excellent rate was 13.3%. No serious adverse events were reported in the two groups. The incidences of adverse reaction assessment (ADRs) of Mizolastine and Loratadine were 38.8% and 45%, respectively. The ADRs in Mizolastine group were mild or moderate drowsiness (19.4%) and dry mouth (7.5%),and in Loratadine group were mild or moderate drowsiness (16.7%)and light dry mouth (13.3%). There were no significant changes in blood and urine routine tests, liver and renal functions, and ECG after treatment in the two groups. No significant change on QTc was found. Conclusion: The efficacy of Mizolastine and Loratadine is similar in the treatment of AR, however the score decrease of stuffy nose with Mizolastine group is significantly more evident than that with Loratadine. The incidences of ADR are not different in the two groups.