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目的:评价复方薄荷脑鼻用吸入剂治疗鼻卡他的疗效和安全性。方法:对132例鼻卡它引起的鼻塞患者进行多中心、随机、双盲、阳性药物平行对照临床研究。采用国产复方薄荷脑鼻用吸入剂的试验组患者66例,采用进口复方薄荷脑鼻用吸入剂的对照组患者66例。试验药和对照药均采用吸入给药,每次深吸3次,每天4次,疗程1周。以鼻塞改善程度和改善的持续时间作疗效判断依据,同时观察药物的不良反应。结果:完成研究124例,淘汰8例,淘汰率为6％;国产和进口复方薄荷脑鼻用吸入剂均能显著改善患者鼻塞症状,试验组和对照组的总有效率分别为95.2％和96.7％。国产和进口药物间疗效无统计学差异(P>0.05),未见不良反应发生。结论:国产复方薄荷脑鼻用吸入剂治疗鼻卡他鼻塞具有良好的临床疗效和安全性,可替代进口产品用于临床。
Objective: To evaluate the efficacy and safety of compound menthol nasal inhalation in the treatment of nocardia. METHODS: A multicenter, randomized, double-blind, positive-drug parallel controlled clinical study of 132 nasal obstruction patients with nasal congestion was performed. Sixty-six patients in the experimental group treated with homemade compound menthol nasal inhalers and 66 patients in the control group receiving inhaled compound menthol nasal inhalers. Test drugs and control drugs are used inhalation, each deep draw 3 times a day, 4 times a course of treatment for 1 week. In order to improve the degree of nasal congestion and improve the duration of efficacy to determine the basis, while observing the adverse drug reactions. Results: 124 cases were completed and 8 cases were eliminated, and the elimination rate was 6%. Both domestic and imported compound menthol nasal inhalers significantly improved nasal obstruction. The total effective rates of the experimental group and the control group were 95.2% and 96.7%, respectively %. There was no significant difference between domestic and imported drugs (P> 0.05), no adverse reactions occurred. CONCLUSION: Domestic compound menthol nasal inhalation for the treatment of nasal catarrhal nasal obstruction has good clinical efficacy and safety, and can replace imported products for clinical use.