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目的:初步评价苯环喹溴铵喷鼻剂对感冒后急性鼻炎患者流涕症状的影响及安全性。方法:选取感冒后急性鼻炎患者238例,采用多中心、剂量平行对照、随机、双盲、安慰剂对照临床试验设计方法,将患者分为A组(24例)、B组(24例)、C组(24例)、D组(24例)、E组(23例)、F组(24例)、G组(23例)、H组(24例)、1组(24例)、J组(24例),A~C组患者分别给予苯环喹溴铵喷鼻剂22.5、45、90μg,均bid,每个鼻孔各1次;D~F组分别给予苯环喹溴铵喷鼻剂22.5、45、90μg,均tid,每个鼻孔各1次;G~I组分别给予苯环喹溴铵喷鼻剂22.5、45、90μg,均qid,每个鼻孔各1次;J组给予安慰剂。所有患者均连续治疗(4±1)d。比较10组患者流涕症状评分及流涕持续时间,并评价其安全性。结果:10组患者流涕症状评分及流涕持续时间较治疗前显著改善,差异有统计学意义(P<0.05);1组患者改善情况和趋势略优于其余9组,但组间比较,差异无统计学意义(P>0.05)。10组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论:苯环喹溴铵喷鼻剂90μg,qid给药治疗感冒后急性鼻炎流涕症状评分及持续时间改善趋势较为明显,安全性好。
OBJECTIVE: To evaluate the safety and safety of Benoxycyclopentamir nasal spray on runny nose symptoms in patients with acute rhinitis after cold. Methods: A total of 238 patients with acute rhinitis after cold were selected. Patients were divided into group A (24 cases), group B (24 cases), control group Group C (24 cases), Group D (24 cases), Group E (23 cases), Group F (24 cases), Group G (23 cases), Group H (24 cases), Group 1 (N = 24). The patients in group A ~ C were given 22.5, 45 and 90μg of bencycloquaternium nasal spray separately, once per nostril. Groups D ~ F were treated with benquindron bromide Agents 22.5,45,90μg, were tid, each nostril 1 times; G ~ I group were given benzene quinoline bromide nasal spray 22.5,45,90μg, were qid, each nostril each one; J group given Placebo. All patients were treated continuously (4 ± 1) d. The scores of runny nose symptoms and the duration of runny nose in 10 groups of patients were compared and their safety was evaluated. Results: The scores of runny nose symptoms and the duration of runny nose were significantly improved in 10 groups (P <0.05), while the improvement and trend in 1 group were slightly better than those in the other 9 groups. However, The difference was not statistically significant (P> 0.05). There was no significant difference in the incidence of adverse reactions between the 10 groups (P> 0.05). CONCLUSION: The dose of phenylcyclohexaenium bromide nasal spray 90μg, qid for acute rhinitis after treatment of runny nose symptom scores and duration of improvement is more obvious, good safety.