A Randomized Double-blind Placebo-controlled Multicenter Study Of Yuchan Weifei Pill In The Prevention Of Seasonal Allergic Rhinitis

OBJECTIVE:To observe the clinical efficacy of taking Yuchan Weifei Pill before the onset of the disease and during the winter and summer solstices to prevent seasonal allergic rhinitis;To explore the factors that may affect the preventive effect of seasonal allergic rhinitis;This paper discusses the principle of preventing seasonal allergic rhinitis by "preventive treatment of disease" from the Angle of corresponding nature and man.METHODS:A randomized,double-blind,placebo-controlled multicenter clinical study was conducted in this study.According to the random number table and considering the stratification factors of different administration time,144 patients with seasonal allergic rhinitis were divided into treatment group and control group,with 96 patients(There were 48 cases before onset,and 48 cases from winter to summer)in the treatment group and 48 patients(There were 24 cases before onset,and 24 cases from winter to summer)in the control group.patients in the treatment group took the in-hospital preparation Yuchan Weifei Pills of Xiyuan Hospital of China Academy of Chinese Medical Sciences 2 weeks before the onset of illness or the winter and summer solstices for 2 weeks,patients in the control group took Yuchan Weifei pill placebo(containing 10%Yuchan Weifei pill)for 2 weeks before the onset or winter solstice or summer solstice.The main symptoms of nose,extranasal symptoms,secondary symptoms of traditional Chinese medicine,and quality of life of nasal conjunctivitis were compared among groups(treatment group and control group),subgroups(The pre-onset treatment group and the pre-onset control group?winter and summer solstice treatment group and winter and summer solstice control group),and within groups(Pre-onset treatment group and winter and summer solstice treatment group).The recurrence rate of seasonal allergic rhinitis was compared among groups,subgroups,and within groups.To explore the factors that may affect the preventive effect of seasonal allergic rhinitis.RESULTS:1.In the onset stage of seasonal allergic rhinitis,there were no statistically significant differences in the single item scores and total scores of the questionnaire of primary nasal symptoms,extrasal symptoms,secondary TCM symptoms and nasal conjunctivitis among groups,subgroups and within groups(P>0.05);At the time of second diagnosis,there were statistically significant differences in four indicators of wheezing,chest tightness,shortness of breath and spontaneous sweating between the treatment group before onset and the winter and summer solstice treatment group(P<0.05),and the average score of the treatment group before onset was lower than that of the winter and summer solstice treatment group.2.During the onset of seasonal allergic rhinitis,the recurrence rate was 80.22%in the treatment group and 88.89%in the control group.The recurrence rate was 75.00%in the pre-onset treatment group and 81.82%in the pre-onset control group.The recurrence rate was 83.72%in the winter and summer solstice treatment group and 95.65%in the control group.The recurrence rate was 75.00%in the treatment group before onset and 83.72%in the winter and summer solstice treatment group,there was no statistical significance in the recurrence rate among groups,subgroups and within groups(P>0.05),but it had certain clinical significance.3.Napping situation could affect the preventive efficacy of SAR,and there was a significant correlation(P<0.05),eating habits,sleep at night,occupation,work intensity,exercise,personality,family history,course of disease,onset time,duration,impact on work and life,and accompanying symptoms during onset are not significantly correlated(P>0.05).When the test level was set at 0.15,the results showed that family history and onset time also affected the prophylactic efficacy of SAR.Among them,the preventive effect of nap patients is better than that of patients who do not take a nap.The preventive effect of patients without family history tends to be better than that of patients with family history.Only patients with spring onset have a tendency to be better than those with fall onset or both.CONCLUSION:1.Yuchan Weifei pill can reduce the recurrence rate of seasonal allergic rhinitis,and the pre-onset treatment group was more effective in reducing the recurrence rate;2.Nap break,family history and onset time can affect the prophylactic effect of SAR.Among them,the preventive effect of nap patients is better than that of patients who do not take a nap.The preventive effect of patients without family history tends to be better than that of patients with family history.Only patients with spring onset have a tendency to be better than those with fall onset or both.