两产地二丙酸倍氯米松鼻喷雾剂治疗过敏性鼻炎的双盲平行对照试验

A Double-blind Parallel Group Study of Beclomethasone Dipropoinate Nasal Spray of Two Different Sources in the Treatment of Allergic Rhinitis

为比较重庆葛兰素公司（Ａ组）和英国葛兰素公司（Ｂ组）生产的二丙酸倍氯米松鼻喷雾剂（ＢＤＮＳ）的疗效和安全性，采用多中心、双盲、平行组对照方法，对２０３例过敏性鼻炎患者进行为期两周的临床试验。结果Ａ组总有效率为８８％（其中显效率为５５％），Ｂ组为９０％（其中显效率为５１％）；两组副作用相似，以鼻干为主，其发生率均为４．９％。两组疗效及副作用经统计学检验，均未见有显著性差异。同时，以花粉计数为依据，分别比较在花粉季节高峰期前、中、后３个时间段就诊患者的疗效，也未见差异（Ｐ＞０．０５）。

In order to compare the clinical efficacy and safety of beclomethasone dipropionate nasal spray(BDNS)manufactured in Chongqing Glaxo Limited(Group A)and Glaxo UK(Group B),a randomised double-blind parallel group study was performed.A total of 204 patients with seasonal or perennial allergic rhinitis were recruited into the study for a period of 2weeks.Overall efficacy(excellent/good)was 88%for Group A (excellent 55%)and 90%for Group B(excellent 51%)respectively. Side effects were similar for both groups where dry nose was the most common complaint(4.9%for both groups).However,there was no statistical difference(P>0.05)between the two groups either in efficacy or side effects.Pollen count was monitored throughout the study period.Pollen season was divided into three periods,i.e.the beginning,the peak and the end.There was no statistical difference(P>0.05)between the two groups in any period.