Clinical Study of Bencycloquidium Bromide Nasal Spray in the Treatment of Rhinitis after Cold / 中国药房

ABSTRACT

OBJECTIVE:To evaluate the effects and safety of Bencycloquidium bromide nasal spray in the treatment of acute rhinitis after a cold. METHODS:A multicenter,dose parallel controlled,randomized,double-blind,placebo-controlled clinical tri-al was conducted. Two hundred and thirty-eight patients with acute rhinitis after a cold were selected and divided into group A(24 cases),B(24 cases),C(24 cases),D(24 cases),E(23 cases),F(24 cases),G(23 cases),H(24 cases),I(24 cases),J (24 cases). Group A-C were given Bencycloquidium bromide nasal spray 22.5μg,45μg,90μg,respectively,bid,spraying it once for each nostril. Group D-F were given Bencycloquidium bromide nasal spray 22.5 μg,45 μg,90 μg,respectively,tid,spraying it once for each nostril. Group G-I were given Bencycloquidium bromide nasal spray 22.5 μg,45 μg,90 μg,respectively,qid,spray-ing it once for each nostril. Group J was given placebo. All groups were treated for(4±1)d. Rhinorrhea score and continuous rhi-norrhea duration were compared among 10 groups,and the safety was evaluated. RESULTS:The rhinorrhea score and continuous rhinorrhea duration of 10 groups were improved significantly,with statistical significance (P0.05). There was no statistical significance in the incidence of ADR among 10 groups(P>0.05). CONCLUSIONS:Bencycloquidium bromide nasal spray with 90 μg,qid times significantly improves rhinorrhea score and continuous rhinorrhea duration with good safety.