Clinical Observation Of Modified Zhihan Tongqiao Decoction Combined With Compound Huangbai Nasal Drops In The Treatment Of Adenoid Hypertrophy(Damp Heat Phlegm Coagulation Type)

Objective:In this study,a randomized controlled clinical trial was designed to explore the improvement of zhihantongqiao decoction combined with compound Huangbai nasal drops in the symptoms,signs and quality of life of children with adenoid hypertrophy(damp heat phlegm coagulation type),so as to provide a new idea and method of combining internal and external treatment of traditional Chinese medicine for the clinical treatment of adenoid hypertrophy.Methods:60 children with adenoid hypertrophy(damp heat and phlegm coagulation type)who met the inclusion criteria were selected from the ear,nose and throat clinic of Shandong hospital of traditional Chinese medicine from October 2020 to October 2021.60 children were randomly divided into treatment group(oral zhihantongqiao decoction combined with compound Huangbai nasal drops)and control group(oral montelukast sodium chewable tablets combined with mometasone furoate nasal spray).The treatment group was given 200ml oral Chinese medicine decoction and packed in 100ml traditional Chinese medicine bags.Children aged 3-7 years old were given one bag a day and children aged 8-12 years old were given two bags a day after meals;Combined with Compound Cortex Phellodendri nasal drops for external use,parents assist the child in the supine position,with the head hanging down by the bed,and maintain a fixed position with the nostrils facing the ceiling,2～3 drops on each side of the nostrils for about 10 minutes,three times a day.The control group was given montelukast sodium chewable tablets orally,with reference to the usage and dosage in the manual.Children aged 3-6 years were taken orally4 mg before going to bed;Children aged 6-12 years took 5mg orally before going to bed;Combined with mometasone furoate nasal spray,once a day,50%into each nostrilμg.The total amount is 100μg).After 6 weeks of treatment,the drug was stopped for 3 months for follow-up.Before enrollment,6 weeks after treatment and 3 months after drug withdrawal,the scores of main symptoms,total scores,secondary symptoms,adenoid A/Nratio and scores of quality of life questionnaire(OSA-18)were recorded respectively,and the adverse reactions were recorded.The data were processed and evaluated by Excel and SPSS 22.0.Results:In this study,60 children(30 in the treatment group and 30 in the control group)successfully completed the clinical triall.(1)The baseline data(age,gender,pre-treatment symptoms,signs and quality of life scores)of the two groups were tested respectively(P>0.05),indicating that there was no statistical difference between the two groups and they were comparable.(2)Total clinical effective rate:after treatment,the effective rate was93.33%in the treatment group and 80.00%in the control group;During the follow-up,the total effective rate was 90.00%in the treatment group and66.67%in the control group.After testing,P<0.01,the statistical difference is significant,indicating that the short-term and long-term effects of the combination of internal and external treatment of traditional Chinese medicine are better than those of the combination of internal and external use of Western medicine.(3)Comparison of recurrence rate:during follow-up,1 case recurred in the treatment group,with a recurrence rate of 3.34%,and 4 cases recurred in the control group,with a recurrence rate of 13.34%.Chi square test showed that x~2=0.873,P=0.350>0.05,the difference was not statistically significant.(4)Comparison of symptom score:the main symptom single score in the treatment group was compared before and after treatment,before treatment and during follow-up.After test,P<0.01,the difference was statistically significant.The scores of nasal congestion and snoring in the control group were compared before and after treatment,before treatment and during follow-up.After test,P<0.01,the difference was statistically significant;There was no significant difference in mouth opening breathing group(P>0.05).The total scores of main symptoms and secondary symptoms of the two groups were compared before and after treatment,before treatment and during follow-up.After test,P<0.01,the difference was statistically significant.After treatment and follow-up,the nonparametric rank sum test showed that there was significant difference between the two groups(P<0.01).(5)Comparison of physical signs and quality of life table scores:the adenoid A/N ratio and quality of life score of the two groups were compared before and after treatment,before treatment and during follow-up.After test,P<0.01,the difference was statistically significant.After treatment,the ratio of adenoid A/N was compared between groups,P<0.05;The A/N ratio of adenoids during follow-up was significantly different(P<0.01).The quality of life scores between the two groups after treatment and during follow-up were significantly different(P<0.01).(6)Safety evaluation:during the treatment period,3 cases in the treatment group had a slight burning feeling after dropping medicine at the inner canthus,and 2 cases in the control group had a slight feeling of nasal dryness.After the treatment,the symptoms disappeared without special treatment.Conclusion:zhihantongqiao decoction combined with Compound Cortex Phellodendri nasal drops has a significant effect in the treatment of adenoid hypertrophy in children.Zhisnor Tongqiao decoction is based on the principle of clearing heat and dampness,resolving phlegm and dredging orifices,so as to regulate the physique of children and improve the state of disease;Combined with Compound Cortex Phellodendri nasal drops for external use,nasal drops can clear away heat and detoxify.This is the embodiment of the overall concept of giving consideration to both internal and external aspects,treating both symptoms and root causes and treating both symptoms and root causes of traditional Chinese medicine.This study confirmed that the long-term efficacy of traditional Chinese medicine was better than that of montelukast sodium chewable tablets combined with mometasone furoate nasal spray,which provided a theoretical basis for the clinical treatment of children with adenoid hypertrophy(damp heat phlegm coagulation type).