小儿鼻炎片治疗儿童慢性单纯性鼻炎319例临床研究

A clinical trial of Xiaoer Biyan tablet in the treatment of chronic simple rhinitis

目的以辛夷鼻炎丸为对照,评价小儿鼻炎片治疗慢性单纯性鼻炎(肺经风热证)的临床疗效及安全性。方法采用区组随机、双盲、双模拟、多中心临床试验的方法。320例患儿随机分为观察组和对照组。观察组240例,用小儿鼻炎片3~5岁的儿童每次服3片,6~10岁每次服用5片,1日3次;加辛夷鼻炎丸模拟剂,口服,3~5岁儿童每次14粒,6~10岁每次20粒,1日3次;对照组80例,用辛夷鼻炎丸,3~5岁儿童每次14粒,6~10岁每次20粒,1日3次,加小儿鼻炎片模拟剂,口服,3~5岁的儿童每次服3片,6~10岁每次服用5片,1日3次。疗程4周。结果两组总疗效愈显率:试验组67.36%,对照组65%,差异均无统计学意义(P>0.05);中医证候疗效愈显率:试验组53.14%,对照组46.25%,差异均无统计学意义(P>0.05)。说明两组药物治疗小儿慢性单纯性鼻炎总疗效相似,未发现明显不良反应及毒副作用。结论小儿鼻炎片和辛夷鼻炎丸治疗小儿慢性单纯性鼻炎(肺经风热证)作用相当。

Objective To evaluate the clinical efficacy and safety of Xiaoer Biyan tablet in the treatment of chronic simple rhinitis(wind heat syndrome of lung meridian)with Xinyi Biyan pill as control.Methods a randomized,double-blind,multicenter clinical trial was used.320 patients in the experimental group were randomly divided into the experimental group and the control group.In the experimental group,240 cases were given Xiaoer Biyan tablets,3 tablets each time for 3-5 years old children,5 tablets for 6-10 years old,3 times a day;14 tablets for 3-5-year-old children each time,20 tablets for 6-10-year-old children,3 times a day;80 cases in the control group were given Xinyi Biyan pills,14 tablets each time for children aged 3-5 years,20 tablets for 6-10 years old,3 times a day Children should take 3 tablets each time and 5 tablets for 6-10 years old,three times a day.The course of treatment was 4 weeks.Results The total effective rate of the two groups was 67.36%in the experimental group and 65%in the control group,with no significant difference(P>0.05);the effective rate of TCM syndrome was 53.14%in the experimental group and 46.25%in the control group,and the difference was not statistically significant(P>0.05).indicating that the total efficacy of the two groups of drugs in the treatment of children with chronic simple rhinitis was similar and no significant adverse reactions and toxic side effects were found.Conclusion Xiaoer Biyan tablets and Xinyi Biyan pills have similar effects in treating children with chronic simple rhinitis(wind heat syndrome of lung meridian).