Objective This study aims to verify the clinical efficacy of Huatan Sanjie Formula and provide evidence for the treatment of adenoidal hypertrophy in children with traditional Chinese medicine by comparing the clinical effects of Huatan Sanjie Formula and Menglust Sodium Tablets in the treatment of adenoidal hypertrophy in children(phlegm dampness syndrome).Methods 100 children with adenoid hypertrophy(phlegm dampness syndrome)who met the inclusion criteria were randomly divided into observation group and control group,with 50 cases in each group.The children in the observation group took Huatan Sanjie formula orally,and the children in the control group took montelukast sodium tablets orally for 6 weeks.After the course of treatment,observe and compare the quality of life,A/N value,the integral change of the scale of TCM syndrome of phlegmdampness type adenoidal hypertrophy,and the recurrence after 4 weeks of drug withdrawal of the two groups of children before and after treatment,and carry out statistical analysis on the clinical data.Results1.After a course of clinical study(6 weeks),95 cases were finally completed,48 cases in the observation group and 47 cases in the control group.The age,sex,course of disease,main medical history and inducement composition of the two groups of children were statistically analyzed,and the difference was not statistically significant(P>0.05);The comparison of the score of the quality of life scale,A/N value and the score of TCM syndrome scale between the two groups before treatment and the baseline was basically the same(P>0.05).2.Comparison of quality of life scale: the scores of quality of life scale before and after treatment in the two groups were compared and the difference was statistically significant,indicating that both groups could improve the quality of life of children(P<0.05);The comparison of OSA-18 scale scores between the two groups before and after treatment showed that the quality of life in the observation group was better than that in the control group after one course of treatment(P<0.05).3.Comparison of TCM syndrome scale: the score of TCM syndrome scale before and after treatment in the two groups was statistically significant(P<0.05);The comparison between the two groups before and after treatment on the score of TCM syndrome scale showed that the improvement of symptoms in the observation group was better than that in the control group after one course of treatment(P<0.05).4.A/N value comparison: A/N value comparison between the two groups before and after treatment the difference is statistically significant,indicating that both groups can improve A/N value after treatment(P<0.05);The comparison of A/N value between the two groups before and after treatment showed that the improvement of A/N value in the observation group was greater than that in the control group after one course of treatment(P<0.05).5.Comparison of clinical efficacy: after the treatment,the total effective rate of the observation group was 93.75%,and the total effective rate of the control group was 70.21%.The difference between the two groups was statistically significant(P<0.05).The total effective rate of the observation group was higher than that of the control group.6.Comparison of recurrence rate: Follow-up was conducted 8 weeks after the treatment.The recurrence rate of the observation group was 4.16%,and that of the control group was 14.89%.The difference was statistically significant(P<0.05).The recurrence rate of the observation group was lower than that of the control group.7.Safety observation: During the study,the children in the observation group and the control group did not have drug allergy and side effects after taking the medicine.Conclusion1.Both Huatan Sanjie Formula and montelukast sodium can significantly improve the quality of life,clinical symptoms and A/N value of children with adenoid hypertrophy(phlegm dampness syndrome),and the treatment effect of Huatan Sanjie Formula is better than montelukast sodium.2.The total effective rate of Huatan Sanjie Formula in treating adenoid hypertrophy(phlegm dampness syndrome)is better than that of montelukast sodium.3.Compared with montelukast sodium,Huatan Sanjie Formula can reduce the recurrence rate of adenoid hypertrophy(phlegm dampness syndrome)after4 weeks of drug withdrawal.4.No obvious adverse reactions and adverse events occurred during the treatment of Huatan Sanjie Formula,and the treatment of adenoid hypertrophy(phlegm dampness syndrome)is safe and effective. |