Efficacy and Safety of Tongqiao Biyan Granules in the Treatment of Moderate and Severe Persistent Allergic Rhinitis:A multicenter open-label randomize-controlled clinical study
Objective To evaluate the efficacy and safety of Tongqiao Biyan Granules in the treatment of moderate to severe persistent allergic rhinitis(AR).Methods 251 patients with moderate to severe persistent allergic rhinitis recruited in 5 hospitals were randomly assigned to 3 treatment groups.The patients of the first group were treated with loratadine capsule 10mg qd and mometasone furoate aqueous nasal spray 100μg qd for 2 weeks.The patients of the second group were treated with tongqiao biyan granules 2g tid for 3 weeks.The patients of the third group were treated with loratadine capsules and mometasone furoate nasal spray for 2 weeks,combined with tongqiao biyan granules for 3 weeks.The total nasal symptom scores(TNSS),the total ocular symptom scores(TOSS),the quality of life questionnaire scores(RQLQ),the anterior rhinoscopy scores,and recurrence of AR after treatment of 24 weeks,the serum levels of IL-4、IL-5、IL-13 and TGF-β,were used to evaluate the efficacy of each group.Abnormalities in serum levels of AST、ALT、CTE、BUN at the third week after treatment,and the incidence of adverse events reported by patients were used to evaluate the safety of different treatments.Results TNSS,TOSS,RQLQ,the anterior rhinoscopy scores,the serum levels of IL-4,IL-5,IL-13 and TGF-β all had been shown to decrease in each group with statistical differences after treatment.(P<0.05).The overall effective(TNSS reduction rate≥50%)rate was 80.9%with no statistical difference among groups(P=0.5552).It was shown that recurrence rate of AR at the 24 weeks after treatment was 61.9%in the first group,45.8%in the second group and 21.4%in the third group,and the differences among the 3 groups were statistically significant(P<0.01).The overall incidence of adverse reactions was 6.0%,with no statistical difference(P=0.8267).Conclusion Tongqiao biyan granule has been shown to achieve a superior Efficacy and Safety on the treatment of moderate and severe persistent AR in patients,and has a good long-term effect in preventing recurrence.
Tongqiao rhinitis granularlung and spleen deficiency syndromemoderate-to-severe persistentallergic rhinitis
NETL
NSTL
万方数据
