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目的:验证咪唑斯汀对中国人群中常年性变应性鼻炎患者的疗效和安全性。方法:本试验共纳入177例常年性变应性鼻炎患者,其中咪唑斯汀组72例,西替利嗪组69例,安慰剂组36例。采用多中心、随机、双盲、平行对照的研究方法,并与西替利嗪和安慰剂进行比较。结果:治疗7d时咪唑斯汀组和西替利嗪组临床症状积分和体征积分均降低,咪唑斯汀组积分降低显著优于西替利嗪组和安慰剂组。视觉模拟标尺症状评分中,治疗7d时鼻塞和鼻痒症状的改善咪唑斯汀组优于西替利嗪组;治疗21d时,咪唑斯汀组积分下降仍高于西替利嗪组,但差异无统计学意义。177例患者试验期间27例发生不良事件,无严重不良事件,其中与试验有关或可能有关的是乏力、口眼干燥和头痛。咪唑斯汀组发生不良事件10例,肯定有关1例,可能有关4例;西替利嗪组发生不良事件14例,肯定有关1例,可能有关4例;安慰剂组3例。结论:咪唑斯汀治疗常年性变应性鼻炎的总体疗效优于西替利嗪,其不良反应少,安全可靠。
Objective: To verify the efficacy and safety of mizolastine in Chinese patients with perennial allergic rhinitis. METHODS: A total of 177 patients with allergic rhinitis were enrolled in this study, including 72 in the mizolastine group, 69 in the cetirizine group and 36 in the placebo group. A multicenter, randomized, double-blind, parallel-controlled study was performed and compared with cetirizine and placebo. Results: The scores of symptom and symptom of mizolastine group and cetirizine group were all decreased on the 7th day after treatment, and the scores of mizolastine group were significantly lower than that of cetirizine group and placebo group. Visual analog scale symptom score, the treatment of nasal congestion and nasal itching at 7d symptom improvement Mizolastine group was better than cetirizine group; treatment 21d, mizolastine group score was still higher than cetirizine group, but the difference No statistical significance. Twenty-seven of the 177 patients had adverse events during the trial, with no serious adverse events, of which fatigue related to the study, or dry eye and headache. There were 10 adverse events in the mizolastine group, 1 in the affirmative case and 4 in the possible related cases. There were 14 adverse events in the cetirizine group, 1 in the definite case, 4 in the amiodarone group and 3 in the placebo group. Conclusion: The overall efficacy of mizolastine in the treatment of perennial allergic rhinitis is superior to cetirizine, with less adverse reactions and safety.