咪唑斯汀治疗季节性变应性鼻炎的临床试验

Clinical examination of mizolastine in the seasonal allergic rhinitis

目的 :观察咪唑斯汀治疗季节性变应性鼻炎的疗效和安全性。方法 :将符合入选标准的 72例患者随机分为咪唑斯汀组和氯雷他定组 ,两组给药方法相同 ,口服 10mg/d ,连续服药 14d ,根据症状积分下降指数进行疗效评估。通过对患者的询问、体检以及血、尿常规 ,肝、肾功能和心电图检查来发现不良事件。结果 :试验过程中剔除 5例 ,实际完成试验 6 7例 ,其中咪唑斯汀组 34例 ,氯雷他定组 33例。咪唑斯汀组总有效率为 82 .4 % ,其中显效 2 0 .6 % ;氯雷他定组总有效率为 6 6 .7% ,其中显效 6 .1%。两组均未发现严重不良反应。咪唑斯汀组与氯雷他定组的副作用发生率分别为 38.2 %和 33.3% ,咪唑斯汀主要副作用为困倦 (2 6 .5 % )和口干 (8.8% ) ;氯雷他定的主要副作用亦为困倦 (18.2 % )和口干(9.0 % )。两组治疗前后的血、尿常规 ,肝、肾功能和心电图检查均无明显改变。结论 :咪唑斯汀治疗季节性变应性鼻炎疗效好 ,不良反应发生率低 ,疗效和副作用与氯雷他定相似。

Objective: An open randomized comparative study versus loratadine was conducted in order to examine the efficacy and safety of mizolastine in the treatment of seasonal allergic rhinitis(SAR). Method: Six-seven adult patients completed mizolastine 10 mg (34/67) and loratadine 10 mg (33/67) once daily for 14 days. Other 5 patients withdrew or dropped out from the trial. Result:All symptom score decreased significantly after treatment in both groups. Efficacy assessment based on symptom score reducing index showed that the efficacy of Mizolastine was 82.4 %, and the excellent rate was 20.6 %, while the efficacy of Loratadine was 66.7 %, and the excellent rate was 6.1 %. No serious adverse events were reported in the two groups. The incidences of adverse drug reactions(ADRs) of Mizolastine and Loratadine were 38.2 % and 33.3 % respectively. The mild or moderate drowsiness and dry mouth in Mizolastine group were 26.5 % and 8.8 % respectively, and in Loratadine group they were 18.2 % and 9.0 %. There were no significant changes in laboratory examinations including blood and urine routine tests, liver and renal functions and ECG. Conclusion: Mizolastine is effective in relieving SAR symptoms. The efficacy and ADR of mizolastine is similar to Loratadine in the treatment of SAR.