复方薄荷脑鼻吸入剂治疗鼻卡他引起鼻塞的随机、双盲、多中心研究  

A Randomized Double-blind Controlled Multicenter Clinical Trail of Compound Menthol Nasal Inhalant in Treatment of Patients with Common Cold

作　　者：杨春娥[1] 倪殿涛[1] 李宏力[1] 王岳松[2] 孟广明[3] 刘颖格[1] 夏青生[3] 赵建中[2] 

机构地区：[1]第四军医大学西京医院,陕西西安710032 [2]中国人民解放军空军总医院 [3]青岛市立医院

出　　处：《中国药师》2003年第11期685-687,共3页China Pharmacist

摘　　要：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 inhalant in cold patients with symptom of nasal obstruction. Method: A double-blind randomized controlled multicenter clinical trial was designed. 132 patients (trail group, n = 66, control group, n = 66)) with symptom of nasal obstruction were enrolled to the study, the curative effect and adverse drug reaction were observed within 7 d after patients received domestic (fourth daily) or imported (fourth daily) Result: The discontinued rate is 6%; the symptoms of nasal obstruction were significantly recovered after treatment in both groups, the total effective rate were 95.2% and 96.7% in both groups, respectively. The therapy effect in both groups were similar(P>0.05) and no adverse drug reaction were observed. Conclusion: The domestic compound menthol nasal inhalant has good tharapy effects and safety for patients with symptom of nasal obstruction caused by common cold, and it could be applied for clinic to substitute imported compound menthol nasal inhalant.

关 键 词：复方薄荷脑 鼻用吸入剂 鼻卡他 双盲对照试验 多中心研究 治疗 

分 类 号：R969.4[医药卫生—药理学] R987[医药卫生—药学]